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MicroPhage Opens Pivotal FDA Study On Bacterial Identification Platform

MicroPhage announced the launch of its multi-site clinical trial to support a U.S. Food and Drug Administration (FDA) premarket notification [510(k)]. The platform has been developed to rapidly identify bacterial infections and determine antibiotic susceptibility or resistance to aid physicians in antibiotic management.

FDA Statement On Release Of Bisphenol A (BPA) Subcommittee Report

We appreciate the hard work and long hours the subcommittee has invested in scientific peer review of the FDA's draft safety assessment of the use of BPA in food contact applications. The FDA requested this peer review to provide additional insight into this complex issue. This group of distinguished scientists has devoted their considerable knowledge and experience to this effort.

Theravance And Astellas Announce FDA Approval Of VIBATIVTM (telavancin) For The Treatment Of Complicated Skin And Skin Structure Infections

Theravance, Inc. (NASDAQ: THRX) and Astellas Pharma US, Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved VIBATIV™ (telavancin) for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria, including Staphylococcus aureus, both methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) strains.

ClinQua Inc. is one of CRO's focusing the Investigator on aspects critical for validating the drugs' therapeutic benefits.

ClinQua Inc. www.clinqua.com is one of CRO's (Contract Research Organizations), who specialize in evaluating the demands of the trial and eliminating redundant protocols and focusing the Investigator on aspects critical for validating the drugs' therapeutic benefits. Common sense would ...
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FDA Announces Possible Safety Concern For HIV Drug Combination

The U.S. Food and Drug Administration announced preliminary data suggesting that Invirase (saquinavir) in combination with Norvir (ritonavir) may have potentially important adverse effects on the heart. When used together, the drugs may cause prolongation of the QT and PR intervals on an electrocardiogram...

National Institute for Health and Clinical Excellence (NICE) Starts Work On Setting Quality Standards, UK

The National Institute for Health and Clinical Excellence (NICE) welcomes the referral of four clinical areas by the Department of Health following advice from the National Quality Board and will now begin work on setting NICE quality standards for the NHS using a pilot process. The Darzi report, High Quality Care For All (June 2008), expanded NICE's role to include setting and approving more independent quality standards for the NHS.

FDA Takes Action Against Seafood Processing Company, Executives

The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against seafood processor Haifa Smoked Fish Inc. of Jamaica, N.Y., and two of its top officers for violations of the Federal Food, Drug and Cosmetic Act.

Kriger Courses Are Indispensable To Break Into The Biopharmaceutical And Clinical Research Industry.

From what many of our students have said, Kriger www.kriger.com and their professional development courses are not only inspiring but also indispensable when trying to start a career in the biopharmaceutical and clinical research industry. These courses provide the necessary detailed ...
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Grassley, Dingell Call For Overhaul Of FDA, Say Agency Should Be Able To Levy Fines, Order Recalls, Limit Drug Industry Advertising

Sen. Chuck Grassley (R-Iowa) and Rep. John Dingell (D-Mich.) have led an effort to restructure FDA by "giving it broad powers to levy fines, order drug recalls and restrict drug industry advertising," and a "series of crises during the past year ... have given ammunition to the lawmakers, both longtime critics" of the agency, the

Supraventricular Tachycardia In Cardiac Patients - FDA Approval Of Adenosine Injection USP, 3 Mg/mL

Akorn, Inc. (NASDAQ: AKRX) today announced that the U.S. Food and Drug Administration has granted approval for Akorn's Abbreviated New Drug Application (ANDA) for Adenosine Injection USP, 3 mg/mL. Adenosine Injection is indicated for supraventricular tachycardia in cardiac patients. Annual sales for Adenosine Injection were approximately $22 million in 2007, according to IMS sales data. Arthur S.

HHS Opens Offices Of The Food And Drug Administration (FDA) In China

As part of an ongoing strategy to continually improve import safeguards to meet the changing demands of a global economy, the U.S. Department of Health and Human Services (HHS) is this week officially opening offices of its Food and Drug Administration (FDA) in Beijing, Guangzhou and Shangai in the People's Republic of China. HHS Secretary Mike Leavitt and FDA Commissioner Andrew von Eschenbach, M.D.

Patients enrolment is a greatest challenge for the clinical research industry in the USA, Canada and European Union.

The efficiency of a clinical trial can be greatly compromised by the challenge of efficiently enrolling patients, securing clinical trial sites, and collecting data. Pressure to expedite clinical trials, while reducing the cost of the trials, has led to yet another new, rapidly evolving ...
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FDA Warns Consumers, Food Service Operators, And Retailers To Avoid Oysters Recently Harvested From Mississippi Area 2C

The U.S. Food and Drug Administration is advising retailers and food service operators not to offer for sale oysters harvested between Feb. 24 and March 17, 2009, from Mississippi Area 2C, located in the Mississippi Sound portion of the Gulf of Mexico near Pass Christian, Miss. Further, consumers are advised not to eat such oysters.

Repros Submits Response To FDA Regarding Androxal(R) Indication For Treatment Of Hypogonadal Men Wishing To Preserve Fertility

Repros Therapeutics Inc. (NasdaqCM:RPRX) announced that the Company, as requested by the FDA during the Type C meeting held on January 25, 2010, has sent a revised indication statement to the FDA's Division of Reproductive and Urologic Products for the use of Androxal® in the treatment of men wishing to preserve fertility while being treated for their hypogonadal state...

Appendicitis - AspenBio Pharma 510(k) Filing For AppyScore Advances In FDA Review With Request For Additional Information

AspenBio Pharma, Inc. (NASDAQ: APPY) reported it has received a request from the U.S. Food and Drug Administration ("FDA") for additional information related to AspenBio's Premarket Notification 510(k) application for its AppyScore™ test filed in late June 2009. The AppyScore test is the first blood-based test designed to aid in the diagnosis of human appendicitis.

Why Clinical Research Companies Cannot Hire CRA’s Without Experience?

As per Bruce Kriger, CEO of Kriger Research Group International www.kriger.com , leading training institution and clinical research organization, there are three main reasons that actual experience is essential:Theoretical knowledge of GCP and CRA functions does not ensure the ...
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Independent Report Suggests Further Enhancements To NICE Methodology To Improve Evaluation Process For Cancer Medicines, UK

An Office of Health Economics report launched suggests further enhancements to NICE's methodology for assessing cancer drugs more effectively. These are in addition to those already addressed by NICE's own end of life review.1 The report makes constructive suggestions for further adjustments to current methodology which may help establish more accurately the value to patients of cancer treatments being assessed by NICE.

Top Doctors To Present Results Of FDA Clinical Trial Of Guided Therapeutics' Cervical Cancer Detection Technology At Scientific Meeting

Results of the U.S. Food and Drug Administration (FDA) pivotal clinical trial for the Guided Therapeutics, Inc. (GT) (Pink Sheets: GTHP) LightTouch™ Non-invasive Cervical Cancer Detection System are scheduled to be presented by five leading doctors at the American Society for Colposcopy and Cervical Pathology biennial meeting, March 24 - 27, 2010, in Las Vegas...

FDA Advisory Committee Recommends Approval Of Bausch & Lomb Besifloxacin Anti-Infective Eye Drop

The U.S. Food and Drug Administration (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee today voted unanimously to recommend approval of Bausch & Lomb's besifloxacin ophthalmic suspension, 0.6%, for the treatment of bacterial conjunctivitis. The company has developed this broad-spectrum, anti-infective drop specifically for ophthalmic use.

Kriger Research Group International joins TrialStat's CROFIRST Program

July 9, 2008, OTTAWA, ON - TrialStat Corporation, the industry's first clinical data solutions on demand company, today added Kriger Research Group International (KRC), a worldwide CRO specializing in the bio-medical field, to its CROFirst Program. The enhancements of TrialStat's CRO channel ...
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Antigenics Therapeutics Limited Withdraws Its Marketing Authorisation Application For Oncophage (vitespen), Europe

The European Medicines Agency has been formally notified by Antigenics Therapeutics Limited of its decision to withdraw its application for a centralised marketing authorisation for the medicine Oncophage (vitespen), 20 µg solution for infusion.

E Coli Confirmed In Nestlé Toll House Cookie Dough Says FDA

The US Food and Drug Administration (FDA) said yesterday, June 29, that it had found E. coli O157:H7 in a sample of prepackaged Nestlé Toll House refrigerated cookie dough that had been collected at the Nestlé factory in Danville, Virginia four days earlier.

FDA Ban On Flavored Cigarettes A Strong First Step Under Family Smoking Prevention And Tobacco Control Act

By David T. Tayloe, Jr., MD, FAAP, President, American Academy of Pediatrics "The American Academy of Pediatrics applauds the U.S. Food and Drug Administration (FDA) for its quick implementation of the ban on fruit-, candy- and clove-flavored cigarettes. The swift action by the FDA, under the authority of the new Family Smoking Prevention and Tobacco Control Act, marks the beginning of a historic time for public health advocates and pediatricians.

The paramount responsibility of Kriger Research Group International CRA-s is to ensure timely subjects recruitment, patient rights, safety and data integrity.

The paramount responsibility of Kriger Research Group International CRA-s is to ensure timely subjects recruitment, patient rights, safety and data integrity. In addition to on-site responsibilities each CRA is responsible for site management documentation and follow-up activities ...
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FDA Approves First Gout Drug For 40 Years

The US Food and Drug Administration has given marketing approval to a new drug that lowers levels of uric acid in the blood of patients with gout: the current treatment for the condition was developed over 40 years ago. The new drug is called ULORIC (generic name febuxostat) and Takeda Pharmaceuticals North America is the sole developer and marketer of the product in the US.

FDA Advisory Committee Unanimously Recommends Approval For New Ophthalmic Product Enabled By InSite's DuraSite® Technology

InSite Vision Incorporated (AMEX:ISV) announced that the U.S. Food and Drug Administration (FDA) Dermatologic and Ophthalmic Drugs Advisory Committee has voted unanimously to recommend approval of Bausch & Lomb's besifloxacin ophthalmic suspension, 0.6%, for the treatment of bacterial conjunctivitis, a product that utilizes InSite Vision's DuraSite® patented drug delivery system.

FDA Clears The First Rapid Test To Detect Bacteria In Pooled Platelets

Fenwal, Inc., a global medical technology company focused on improving blood collection, separation, safety and availability, announced that the U.S. Food and Drug Administration has cleared the Verax Platelet PGD® test as a quality control test to detect bacterial contamination in whole blood-derived, pooled platelets prior to transfusion. Fenwal is the exclusive global distributor of the test, which was developed by Verax Biomedical of Worcester, Mass.

CEREPROTEC Method for Neuroprotection with Glycoluril Derivatives Patent Application has been Published

September 18, 2008A method for prevention, inhibition or treatment of neuronal degeneration caused by injury, disease, disorder or condition in the central nervous system (CNS) comprises administering a glycoluril derivative to an individual in need thereof. View document here: ...
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FDA Warns Consumers About Counterfeit Alli

The U.S. Food and Drug Administration is warning consumers about a counterfeit and potentially harmful version of Alli 60 mg capsules (120 count refill kit). Preliminary laboratory tests conducted by GlaxoSmithKline (GSK)-the maker of the FDA approved over-the-counter weight-loss product- revealed that the counterfeit version did not contain orlistat, the active ingredient in its product...

AACR Takes Steps To Aid The FDA In Regulating Tobacco; Publishes Best Research Practices

When President Barack Obama signed the Family Smoking Prevention and Control Act in June, he ushered in a new era of tobacco policy that empowers the Food and Drug Administration to regulate one of the world's most controversial and deadly consumer products...

AstraZeneca Submits For New Dosage Strengths Of Atacand Plus - New Dosing Regimen Offers Patients Greater Chance To Reach Target Blood Pressure

AstraZeneca announced a European decentralized procedure (DCP) submission seeking approval for two new dose strengths of Atacand Plus, for those hypertensive patients not optimally controlled by monotherapy. The reference member state for the procedure is Sweden, and the submission incorporates data from three studies. 1,2,3 The new strengths of the fixed dose combination Atacand Plus, comprised of candesartan cilexetil and hydrochlorothiazide (HCT) in doses of 32/12.

Use of the Cereprotex prior to and after the CABG procedures to substantially reduce or eliminate the effects of neuro-impairment.

Cereprotec Inc. www.cereprotec.com proposes to use Cereprotex prior to and after CABG procedures in order to minimize or eliminate entirely the effects of neuro-impairment. Based on the successful animal trials Cereprotec Inc. believes that the human trials will show significant reduction in ...
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Merck Serono: European Commission Approves Erbitux For 1st-Line Use In Head And Neck Cancer

Merck Serono, a division of Merck KGaA, announced today that it has received approval from the European Commission to extend the use of its targeted therapy Erbitux® (cetuximab) to include 1st-line treatment of patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). Erbitux was previously approved for use in combination with radiotherapy for locally advanced disease.

European Drug Agency To Weigh Risks/Benefits Of Tysabri -- Cites 23 Cases Of PML

Today the EMEA, the European equivalent of the U.S. Food and Drug Administration, released a statement indicating that one of its advisory committees was launching a review of the risks and benefits of

FDA Requires Boxed Warning For All Botulinum Toxin Products

Prompted by reports of serious adverse events, the U.S. Food and Drug Administration announced that safety label changes, including a boxed warning, and a Risk Evaluation and Mitigation Strategy (REMS), are necessary for all botulinum toxin products.

Why Clinical Research Companies Cannot Hire CRA’s Without Experience?

As per Bruce Kriger, CEO of Kriger Research Group International www.kriger.com , leading training institution and clinical research organization, there are three main reasons that actual experience is essential:Theoretical knowledge of GCP and CRA functions does not ensure the ...
(613) 686-5745 Cerepotec Pharmalef

Sunquest Receives FDA Clearance For Updated Blood Bank Solution

Sunquest Information Systems, Inc., a market leader in laboratory and diagnostic information systems, today announced that it received clearance from the U.S. Food and Drug Administration (FDA) for the newest edition of its Sunquest Blood BankT software application.

European Union Commission Approves Expanded Use Of ISENTRESS(R) (raltegravir), From MSD, In Adult Patients With HIV-1 Infection

Merck Sharp & Dohme Limited (MSD) announced that ISENTRESS® (raltegravir) has been granted an expanded licence from the European Union Commission (Commission) for use in combination with other antiretroviral (ARV) medicinal products for the treatment of HIV-1 infection in adult patients, including adult patients starting HIV-1 therapy for the first time (treatment-naĂŻve), as well as treatment-experienced adult patients.

FDA Warns Consumers On Sexual Enhancement Products

The U.S. Food and Drug Administration is warning consumers that Stiff Nights, a product marketed as a dietary supplement for sexual enhancement, contains an ingredient that can dangerously lower blood pressure and is illegal. Over the past several years, the FDA has found

Anestvice Pressure Controller (APC), is build to maintain the pre-set constant pressure in the cuff throughout the surgery despite of the factors influencing and/or altering this parameter.

Anestvice (www.anestvice.com ) Pressure Controller (APC) is designed for massive use for improvement of patient safety during all kinds of surgical procedures with the use of Laryngeal Mask (LM) and Endotracheal Tube (ETT) . Use of this device doesn’t require any specific knowledge or ...
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Drugs Designated As Orphan Drugs, Australia, July 2008

The following drugs have been designated as "orphan drugs" for the purposes of Regulation 16J of the Therapeutic Goods Regulations, as at 8 July 2008. Drug: Adefovir dipivoxil Sponsor: Gilead Sciences Pty Ltd Date of designation: 12 August 2005 Indication: in monotherapy or in combination with other therapies, for prevention of recurrence of HBV infection in liver transplant recipients.

The Medicines Company Announces New Patent Issuance For Angiomax(R)

The Medicines Company (NASDAQ: MDCO) announced that the United States Patent and Trademark Office (PTO) issued a new U.S. patent No. 7,582,727 ('727 patent). The '727 patent relates to a more consistent and improved Angiomax drug product. The new patent has been submitted to the U.S. Food and Drug Administration (FDA) for listing in the FDA's publication "Approved Drug Products with Therapeutic Equivalence Evaluations," which is commonly known as the Orange Book, for Angiomax.

Gilead Receives Complete Response Letter From U.S. FDA For Aztreonam Lysine For Inhalation, Investigational Cystic Fibrosis Treatment

Gilead Sciences, Inc. (Nasdaq:GILD) announced that the company has received a complete response letter from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for aztreonam lysine for inhalation, an investigational therapy in development for people with cystic fibrosis who have Pseudomonas aeruginosa (P. aeruginosa). In this letter, the FDA informed Gilead that the review of the company's NDA has been completed.

Injury to myelinated axons in the CNS often has a devastating outcome in terms of neuronal loss, with accompanying loss of function.

Damage to the nervous system may result from traumatic injury, such as penetrating or blunt trauma, stroke, or neurodegenerative disorders such as Alzheimer's disease, Parkinson's disease, Huntington's disease, amyotrophic lateral sclerosis (ALS), diabetic neuropathy or senile dementia. ...
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FDA And EMEA Grant Orphan Drug Designation For Antisense Pharma's Investigational Drug Trabedersen In Pancreatic Carcinoma

The biopharmaceutical company Antisense Pharma GmbH has announced that it has received orphan drug designation from both the European Medicines Agency EMEA and the US Food and Drug Administration FDA for its investigational drug trabedersen in the treatment of pancreatic carcinoma. Trabedersen has already been granted orphan drug designation by both authorities in the treatment of high-grade gliomas in 2002.

Meda: FDA Approval For Onsolis Anticipated During Summer 2009

Since August 2008, Meda (STO:MEDAA) and BioDelivery Sciences International (BDSI) have worked in close collaboration with the U.S. Food and Drug Administration (FDA) to complete the final requirement of a Risk Evaluation and Mitigation Strategy (REMS) program for Onsolis (fentanyl - treatment of breakthrough cancer pain).

European Medicines Agency Makes Recommendations To Minimise Risk Of Nephrogenic Systemic Fibrosis With Gadolinium-containing Contrast Agents

The European Medicines Agency (EMEA) has adopted a set of recommendations aimed at minimising the risk of nephrogenic systemic fibrosis (NSF) with gadolinium-containing contrast agents in patients at risk of developing the condition. Gadolinium-containing contrast agents are used in patients undergoing magnetic resonance imaging (MRI) or magnetic resonance angiography (MRA) scans.

Streamlining the process of Clinical Trials

The process of clinical trials can be costly to say the least. Clinical affairs consumes an average of 37% of R&D budgets. Despite decades of practice, sponsors continue to underestimate the time required to complete 80% of studies, with the average Phase 1 study running over by 42%, ...
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BioDelivery Sciences Announces New Drug Submission In Canada For BEMA Fentanyl

BioDelivery Sciences International, Inc. (Nasdaq: BDSI) announced the filing of a New Drug Submission (NDS) to Health Canada, the regulatory authority in Canada, for BEMA Fentanyl, also known as fentanyl buccal soluble film. BEMA Fentanyl is marketed in the U.S. as ONSOLIS, and the Canadian tradename is to be determined. BEMA Fentanyl was submitted to Health Canada by Meda Valeant Pharma Canada Inc.

Postmarketing Studies Are Becoming The Norm In The U.S., Europe, And Japan, According To Tufts Center For The Study Of Drug Development

Post-approval study commitments, in which drug developers, as a condition of regulatory approval, agree to conduct research on newly marketed prescription drugs, are becoming routine in the United States, Europe, and Japan, according to a recently completed analysis conducted by the Tufts Center for the Study of Drug Development. Seventy-five percent of new drugs approved in the U.S.

FDA Accepts CyDex Pharmaceuticals' IND Application For Oncology Drug

CyDex Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted the company's Investigational New Drug (IND) application for a clinical study of Captisol-Enabled® melphalan HCL (CDX-353). Melphalan is an FDA-approved low dose chemotherapy for multiple myeloma marketed under the brand name Alkeran® by GlaxoSmithKline.

Over the past few years, CROs have received the lion's share of outsourced clinical research revenue.

CROs were first organized as outsourcing service companies that provided only clinical trial management. Today, many CROs have expanded their scope of services to provide comprehensive management of the complex drug trial processes for their client companies, as well as providing access to ...
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FDA Clears Hologic R2(TM) DigitalNow(TM) HD Software Application

Hologic, Inc. (Hologic or the Company) (Nasdaq: HOLX), a leading developer, manufacturer and supplier of premium diagnostics, medical imaging systems and surgical products dedicated to serving the healthcare needs of women, announced that it has received Food and Drug Administration (FDA) clearance for its R2(TM) DigitalNow(TM) HD software application.

FDA Strengthens Conflict Of Interest Policies For Advisors

The US Food and Drug Administration (FDA), the federal body that regulates food and drug safety, announced this week that it had strengthened policies and procedures, such as those governing conflict of interest, for FDA advisory committees: the independent national and global experts that make recommendations to the bureau on decisions about complex medical and scientific issues.

Ipsen: FDA's First-Cycle Review Of Reloxin(R) Extended

Ipsen (Paris:IPN) announced that the U.S. Food and Drug Administration (FDA) provided notification that the Prescription Drug User Fee Act (PDUFA) action date for Reloxin® (botulinum toxin of type A) Biologics License Application (BLA) in aesthetic indications (glabellar lines) has been extended to April 13, 2009. The FDA did not issue any specific request on the occasion of this extension.

Accurate Data Management can be the make or break for the success of the clinical trial.

It is widely known throughout the clinical research industry that the accurate and precise collection of data is crucial to the success of any trial. Limdato www.limdato.com along with its partners have created a software system dedicated to compiling all data collected in a precise and user ...
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Stirling Products Limited (ASX:STI) Gets Approval For TB And HIV Treatment "Immunoxel" In South Africa

Australian healthcare company Stirling Products Limited (ASX:STI) is pleased to announce another milestone in the expansion of the licensed (pending joint venture approval) botanical products to markets outside of Ukraine. Immunoxel (Dzherelo) has been granted approval in South Africa. This approval will allow immediate sales of the phytoconcentrate as an immune adjuvant for TB and HIV treatment.

Novartis Kidney Cancer Drug Gets US Approval

The US Food and Drug Administration (FDA) announced on Monday that it had approved Afinitor oral tables (everolimus) for the treatment of advanced kidney cancer in patients where the disease continued to progress after treatment with other drugs. Afinitor is manufactured by Novartis International AG of Basel, Switzerland.

FDA Approves Intravenous Formulation Of Pfizer's Revatio(R) (Sildenafil) For The Treatment Of Pulmonary Arterial Hypertension

Pfizer announced that the U.S. Food and Drug Administration (FDA) has approved Revatio® (sildenafil) Injection, an intravenous formulation of Revatio. Revatio is the only FDA-approved phosphodiesterase-5 (PDE5) inhibitor available in both tablet and intravenous formulations. Revatio is indicated for the treatment of adult patients with pulmonary arterial hypertension (WHO Group I) to improve exercise ability and delay clinical worsening.

The Birth of the Profession of Clinical Research Associate

According to the ICH Good Clinical Practice Guidelines, clinical research should be monitored by professionals—Clinical Research Associates, also known as Clinical Monitors. We asked Bruce Kriger, CEO of Kriger Research Group International www.kriger.com , leading training institution and ...
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Ark Files Cerepro(R) Application For Marketing Authorisation With EMEA

Ark Therapeutics Group plc (AKT: LSE) ("Ark" or "the Company") today announces that the Marketing Authorisation Application (MAA) for Cerepro®, Ark's novel gene-based therapy for operable malignant glioma (brain cancer), has been filed with the European medicines regulatory agency (EMEA). The MAA application for Cerepro®, filed following a pre-submission meeting with the EMEA, will now enter the validation stage, prior to commencing formal review.

FDA Grants Full Approval For SPRYCEL For The Treatment Of Adults With Chronic Myeloid Leukemia

Bristol-Myers Squibb Company (NYSE: BMY) announced that the U.S. Food and Drug Administration (FDA) has granted full approval for SPRYCEL® (dasatinib) for the treatment of adults in all phases of chronic myeloid leukemia (CML) (chronic, accelerated, or myeloid or lymphoid blast phase) with resistance or intolerance to prior therapy including Gleevec®* (imatinib mesylate).

APP Pharmaceuticals Receives Approval For Penicillin G Potassium For Injection, USP

APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc. (NASDAQ: APCVZ), announced that it has received approval from the U.S. Food and Drug Administration (FDA) to market penicillin G potassium for Injection, USP, in two dosage strengths. Penicillin G is therapeutically equivalent to the reference drug PfizerPen™ G, which is marketed by the innovator Pfizer, Inc.

The concept of outsourcing should not be new to pharmaceutical companies

The idea of outsourcing clinical trials took a dramatic increase two decades ago and continues to increase at a rapid pace. It is estimated that by 2006 close to 45% of all drug development finances will be allocated to outsourcing to such companies as Limdato, www.limdato.com. Prior to the ...
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Zogenix Obtains Approval In U.S. For Sumavel™ DosePro™

Aradigm Corporation (OTC BB: ARDM.OB) ("Aradigm") announced that Zogenix, Inc. was granted approval of the Sumavel™ DosePro™ (sumatriptan injection) needle-free delivery system which enables subcutaneous delivery of sumatriptan without a needle for the treatment of acute migraine. Aradigm is entitled to a $4 million milestone payment upon first commercial sale, and royalty payments upon any sales of products in the U.S.

Pioneer(R) Surgical Technology Receives 510(k) Clearance To Market FortrOss(TM), A Next Generation Bone Void Filler

Pioneer Surgical Technology, Inc. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market FortrOss, a novel bone graft substitute utilizing the power of nanotechnology for orthopaedic applications. The FortrOss bone void filler is a scaffold for the in-growth of new bone and other connective tissues, when superior bone regeneration is required.

Benvenue Medical Receives CE Mark Approval For KivaT VCF Treatment System

Benvenue Medical, Inc., a developer of minimally invasive solutions for spine repair, announced today that it has received CE Mark approval in Europe for the KivaT Vertebral Compression Fracture (VCF) Treatment System. Initial clinical cases in Europe using the Kiva System have been successfully performed and the company is preparing for the commercial launch of the product throughout the region.

Anestvice Pressure Controller (APC), is build to maintain the pre-set constant pressure in the cuff throughout the surgery despite of the factors influencing and/or altering this parameter.

Anestvice (www.anestvice.com ) Pressure Controller (APC) is designed for massive use for improvement of patient safety during all kinds of surgical procedures with the use of Laryngeal Mask (LM) and Endotracheal Tube (ETT) . Use of this device doesn’t require any specific knowledge or ...
(613) 686-5745 Cerepotec Pharmalef

The European Medicines Agency Recommends Suspension Of The Marketingauthorisation Of Acomplia

The European Medicines Agency (EMEA) has recommended the suspension of the marketing authorisation for Acomplia (rimonabant) from Sanofi-Aventis. The EMEA's Committee for Medicinal Products for Human Use (CHMP) has concluded that the benefits of Acomplia no longer outweigh its risks and the marketing authorisation should be suspended across the European Union (EU).

CytRx Files Report With The FDA In Response To The Partial Clinical Hold On Its Phase 2b Arimoclomol ALS Trial

CytRx Corporation (NASDAQ:CYTR), a biopharmaceutical research and development company engaged in the development of high-value human therapeutics, has filed a report with the U.S. Food and Drug Administrations (FDA) in response to the Agency's partial clinical hold on the Company's Phase 2b efficacy clinical trial with its molecular chaperone regulator drug candidate arimoclomol for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease).

Joint Commission Accreditation: Lab Decisions Will No Longer Affect Hospital Decisions

Beginning January 1, 2009, under new Joint Commission policy, laboratory accreditation decisions will no longer immediately impact hospital accreditation decisions. This policy establishes comparability in the way that a laboratory with an adverse accreditation decision rendered by The Joint Commission or one of its cooperative partners, College of American Pathologists (CAP) or COLA, impacts the hospital or other organization with which the laboratory is affiliated.

Anestvice Pressure Controller (APC) – device for maintaining of precisely set pressure in the cuff of Laryngeal Mask (LM) and Endotracheal Tube (ETT) during the surgery

Anestvice ( www.anestvice.com )Pressure Controller (APC) – device for maintaining of precisely set pressure in the cuff of Laryngeal Mask (LM) and Endotracheal Tube (ETT) during the surgery. During the surgery pressure in the cuff may fluctuate, thereby endangering the patient. Currently ...
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Analysts Find Growing Threat Of Food Counterfeiting: Contamination Outpacing International Regulatory Systems

Intentionally contaminated Chinese milk killed several children and sickened 300,000 more, causing concern around an increasingly connected world economy. Demand for inexpensive products virtually guarantees future repeats of food adulteration and counterfeiting from overseas, Michigan State University researchers said, as trade volumes overwhelm regulatory oversight.

Biogen Idec Receives Fast Track Designation From FDA For PEGylated Interferon Beta-1a For Relapsing Multiple Sclerosis

Biogen Idec (NASDAQ: BIIB) announced the U.S. Food and Drug Administration (FDA) has granted PEGylated interferon beta-1a (BIIB017) Fast Track designation for relapsing multiple sclerosis (RMS). Biogen Idec is currently enrolling patients in a global Phase III study evaluating the efficacy and safety of either bi-weekly or once-monthly injections of PEGylated interferon beta-1a in this patient population.

Toxic Drugs, Toxic System: Sociologist Predicts Drug Disasters, Says Prescription Drug Harm Growing, Drug Testing, Approval And Marketing Flaws

Toxic drugs, toxic system: Sociologist predicts drug disasters, says prescription drug harm growing, drug testing, approval and marketing flaws Americans are likely to be exposed to unacceptable side effects of FDA-approved drugs such as Vioxx in the future because of fatal flaws in the way new drugs are tested and marketed, according to research to be presented today at the annual meeting of the American Sociological Association (ASA).

Ground breaking companies within the CRO industry

With over 1200 companies within the CRO industry Limdato www.limdato.com is one who is able to utilize cutting edge technology and innovations to ensure complete success for your clinical trial. During the 1970’s the industry was extremely limited to the services it could provide for ...
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Orexo Announces Kyowa Hakko Kirin's Submission Of KW-2246 (Abstral) For Approval In Japan

Orexo AB (STO:ORX) announces that its partner Kyowa Hakko Kirin Co., Ltd. has submitted the New Drug Application (NDA) in Japan for the cancer pain drug KW-2246 (Abstral). Kyowa Hakko Kirin has confirmed KW-2246's safety and efficacy in clinical trials conducted in Japan. The drug will be marketed by Kyowa Hakko Kirin and Hisamitsu Pharmaceutical Co., Inc...

Osmetech Submits Swine Flu Test To The FDA

Osmetech (LSE:OMH) announced that it has submitted a request to the US FDA for Emergency Use Authorization (EUA) for its Respiratory Pathogen Test Panel test to be used to screen for the swine flu virus. Osmetech's Respiratory Pathogen Test Panel test, which is expected to be launched as a research use only (RUO) product next quarter, detects and differentiates between 18 common bacterial and viral infections, including the Influenza A virus and its H1N1 subtype.

Meridian Bioscience Receives FDA Clearance For New Campylobacter Test

Meridian Bioscience, Inc. (NASDAQ: VIVO) announced that it has received FDA clearance from the U.S. Food and Drug Administration (FDA) for a new test for Campylobacter. Launched as PREMIERT CAMPY, the rapid EIA test provides for optimized detection of Campylobacter infection, the most commonly diagnosed bacteria for food borne illness in the U.S. Approximately 20 million tests are conducted each year in the U.S. to detect the illness, which is usually caused by poorly cooked poultry.

EBRecruiters has a well established database of over 60,000 candidates all over the world

EBRecruiters www.ebrecruiters.com consultants have a wealth of knowledge and experience in Clinical Research, Data Management, Quality Assurance, Regulatory Affairs and all aspects of Information Technology and Office Support. EBRecruiters has a well established database of ...
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FDA Clears A Test For Ovarian Cancer

The U.S. Food and Drug Administration cleared a test that can help detect ovarian cancer in a pelvic mass that is already known to require surgery. The test, called OVA1, helps patients and health care professionals decide what type of surgery should be done and by whom. OVA1 identifies some women who will benefit from referral to a gynecological oncologist for their surgery, despite negative results from other clinical and radiographic tests for ovarian cancer.

PPD Confirms Takeda's NDA Submission Of Alogliptin (highly Selective DPP-4 Inhibitor For The Treatment Of Type 2 Diabetes) In Japan

PPD, Inc. (NASDAQ:PPDI) today confirmed that Takeda Pharmaceutical Company Limited has submitted a new drug application for alogliptin, a highly selective DPP-4 inhibitor for the treatment of type 2 diabetes, to the Ministry of Health, Labour and Welfare in Japan. PPD partnered with Takeda to develop the compound.

FDA Awards Up To $2.5 Billion To Modernize Information Technology Over Ten Years - Cornerstone Of 21st Century Bioinformatics Initiative

The U.S. Food and Drug Administration today announced the selection of ten contractors to receive up to a total of $2.5 billion for information technology (IT) and data center management services over the next ten years. The contract is the cornerstone of the FDA's Information Technology for the 21st Century (ICT21) bioinformatics initiative, an extensive IT modernization program encompassing data management, data warehousing, IT infrastructure and IT security.

Anestvice Pressure Controller (APC), is build to maintain the pre-set constant pressure in the cuff throughout the surgery despite of the factors influencing and/or altering this parameter.

Anestvice (www.anestvice.com ) Pressure Controller (APC) is designed for massive use for improvement of patient safety during all kinds of surgical procedures with the use of Laryngeal Mask (LM) and Endotracheal Tube (ETT) . Use of this device doesn’t require any specific knowledge or ...
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President's FY 2010 Budget For FDA Invests Substantially In Food And Medical Product Safety

The U.S. Food and Drug Administration is requesting a budget of $3.2 billion to protect and promote the public health as part of the President's fiscal year (FY) 2010 budget - a 19 percent increase over the current FDA fiscal year budget. The FY 2010 request, which covers the period of Oct. 1, 2009, through Sept. 30, 2010, includes increases of $295.2 million in budget authority and $215.4 million in industry user fees.

ATS Medical Announces Regulatory Approval Of The ATS Open Pivot AP360 Mechanical Heart Valve In Japan

ATS Medical, Inc. (Nasdaq: ATSI), manufacturer and marketer of state-of-the-art cardiac surgery products and services, announced the Japanese Ministry of Health, Labor and Welfare has approved commercial distribution of the ATS Open Pivot(R) AP360(TM) Mechanical Heart Valve. The ATS AP360 heart valve maximizes hemodynamic performance with a new supra-annular cuff design that facilitates implantation.

FDA Issues Guidance For Food Manufacturers On Use Of Peanut-Derived Product

The U.S. Food and Drug Administration recommends that manufacturers obtain any peanut-derived ingredient only from suppliers who use production processes that have been demonstrated to adequately reduce the presence of Salmonella species (Salmonella spp.), or that they ensure that their own manufacturing process would adequately reduce the presence of Salmonella species. The recommendations are in FDA's

Pharmaceutical companies are relying on outsourcing strategies

It is imperative that pharmaceutical and biotechnology companies pass their product through the testing and regulatory process in a rapid, cost-effective manner. To accomplish this goal, pharmaceutical companies are relying on outsourcing strategies to provide the services that can ...
(613) 686-5745 Cerepotec Pharmalef

Hayashi Legislation Prompts Court Ruling To Expand Access To Prenatal Care - California

The San Francisco Superior Court has struck down a state law requiring that low-income working women must have resided in California for at least six months before they can be eligible to receive prenatal and other medical care services through California's Access for Infants and Mothers (AIM) insurance program.

Alcohol Dependence Drug Can Cause Adverse Reactions Warned FDA

The US Food and Drug Administration (FDA) issued an alert to healthcare professionals on Tuesday advising them of the risk of adverse injection site reactions in patients given injections of Vivitrol (generic name naltrexone), a drug that is used to treat alcohol dependence. Vivitrol ( naltrexone) is marketed in the US by Cephalon Inc.

EU Grants VIDAZA® Full Marketing Authorization For The Treatment Of Patients With Higher-Risk Myelodysplastic Syndromes And Acute Myeloid Leukaemi

Celgene International SĂ rl (Nasdaq:CELG) today announced that its cancer drug, VIDAZA (azacitidine), has been granted full marketing authorization by the European Commission for the treatment of adult patients who are not eligible for haematopoietic stem cell transplantation with: -- I

Clinproxy is on the leading edge of adaptive clinical trials.

Clinproxy, www.clinproxy.com believes that adaptive clinical trials can drastically reduce the cost, time and subject drug exposure of clinical development. Classical clinical trials are planned with extreme dutiful details but once initiated fails to acknowledge that changes often need to be ...
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FDA Approves Samsca To Treat Hyponatremia

The U.S. Food and Drug Administration has approved Samsca tablets (tolvaptan) to treat hyponatremia, an abnormally low concentration of sodium in the blood. "With the approval of Samsca, physicians will have an additional tool to treat hyponatremia," said Norman Stockbridge, M.D., director of the Division of Cardiovascular and Renal Products in the FDA's Center for Drug Evaluation and Research.

FDA Acts To Halt Marketing Of Certain Unapproved Prescription Narcotic Drugs

The U.S. Food and Drug Administration warned nine companies to stop manufacturing 14 unapproved narcotic drugs that are marketed in several dosage forms and are widely used to treat pain.

European REACH Legislation For Chemicals May Require More Animals And Funds Than Estimated

The European Union's REACH (Registration, Evaluation, Authorization and Restriction of Chemical) legislation is intended as a comprehensive safety evaluation for commercial chemicals used in consumer products that are traded in Europe at amounts more than one ton per year. However, implementation of the regulation may require 54 million research animals and ?9.5 billion ($13.

Anestvice Pressure Controller (APC), is build to maintain the pre-set constant pressure in the cuff throughout the surgery despite of the factors influencing and/or altering this parameter.

Anestvice (www.anestvice.com ) Pressure Controller (APC) is designed for massive use for improvement of patient safety during all kinds of surgical procedures with the use of Laryngeal Mask (LM) and Endotracheal Tube (ETT) . Use of this device doesn’t require any specific knowledge or ...
(613) 686-5745 Cerepotec Pharmalef

Dynavax Receives Canadian Approval To Conduct Phase 3 Trials Of HEPLISAVTM

Dynavax Technologies Corporation (NASDAQ: DVAX) announced that Health Canada, the Canadian equivalent of the U.S. Food and Drug Administration, has approved the initiation of the Company's next Phase 3 trials in Canada. Initiation of the Canadian studies is expected to facilitate enrollment for the multi-center trials. Immunizations in the U.S...

SEROQUEL XRT And SEROQUEL(R) Approved In Europe For New Indications For The Treatment Of Bipolar Disorder

AstraZeneca today announced that the once-daily formulation SEROQUEL XRT (quetiapine fumarate extended release tablets) and SEROQUEL® (quetiapine fumarate) have been approved via the Mutual Recognition Procedure for new indications in bipolar disorder. SEROQUEL XR and SEROQUEL have been approved for treatment of major depressive episodes in bipolar disorder. Additionally, SEROQUEL XR has been approved for treatment of moderate to severe manic episodes in bipolar disorder.

Biomerica Receives CE Mark Approval For 5-Minute Home Test For Kidney Disease Screening For Diabetic And Hypertensive Individuals

Biomerica, Inc. (OTCBB: BMRA) announced that it has received approval to CE mark its 5-minute home diagnostic test for detecting Microalbumin, micro amounts of albumin in urine. Albumin is normally found in the blood and filtered by the kidneys. When the kidneys are working properly, albumin is not present in urine in significant amounts. However, when the kidneys are damaged, small amounts of albumin leak into the urine, resulting in elevated levels.

Injury to myelinated axons in the CNS often has a devastating outcome in terms of neuronal loss, with accompanying loss of function.

Damage to the nervous system may result from traumatic injury, such as penetrating or blunt trauma, stroke, or neurodegenerative disorders such as Alzheimer's disease, Parkinson's disease, Huntington's disease, amyotrophic lateral sclerosis (ALS), diabetic neuropathy or senile dementia. ...
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New Advice On OTC Analgesics Containing Codeine

The Medicines and Healthcare products Regulatory Agency (MHRA) announced new advice on over-the-counter (OTC) medicines containing codeine and dihydrocodeine (DHC) to minimise the risk of overuse and addiction. This follows recent advice from the government's scientific advisory body, the Commission on Human Medicines (CHM).

Medical Acoustics Receives FDA 510(k) Clearance Of Therapeutic Lung Flute(R)

Medical Acoustics LLC, a commercial-stage medical device company which employs acoustic technologies for diagnostic and therapeutic medical applications, today announced that it has received FDA 510(k) clearance of its Therapeutic Lung Flute®...

MS Patients Still Positive For Tysabri Following July Announcement Of PML Cases - PatientsLikeMe Report Indicates

PatientsLikeMe, the leading online community for patients with life-changing conditions, announces the release of its newest PatientsLikeMeListen(TM) report: "Did the July 2008 PML announcement affect the Tysabri brand?"  Among its findings, the report reveals that patients retained an overall positive perception of the Tysabri brand despite the July 2008 announcement of two additional PML cases.

Clinical Trials Do Not Need To Be Expensive!

Many CRO Directors will argue that the foreseeable burden of clinical investigation is cost and the weight of that burden falls onto clients. The clinical climate has seen extraordinary escalation in federal regulations to make sure that the integrity of the products that are ...
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Genzyme Receives European Approval Of Renvela For Patients With Chronic Kidney Disease

Genzyme Corporation (Nasdaq: GENZ) announced that the European Commission has approved Renvela(R) (sevelamer carbonate) for the control of serum phosphorus in patients with chronic kidney disease (CKD). The approval includes patients not on dialysis with serum phosphorus levels greater than or equal to 1.78 mmol/L (5.5 mg/dL), and covers both the tablet and powder formulations.

Delivery Of Rx Estrogen Through The Skin May Show Safety Benefits As Opposed To Oral Delivery

Transdermal delivery of estrogen therapy available by prescription "seems not to alter" the risk of venous thromboembolism (VTE), or blood clotting, in postmenopausal patients when compared to oral delivery, a new study suggests. The study was conducted by researchers at NYU Langone Medical Center and was published in the latest issue of Menopause: The Journal of the North American Menopause Society.

Lannett Company Receives FDA Approval For Pilocarpine HCI Tablets 7.5 Mg Strength

Lannett Company, Inc. (AMEX: LCI), a manufacturer of generic pharmaceuticals, announced that it has received approval from the U.S. Food and Drug Administration (FDA) of its supplemental Abbreviated New Drug Application (ANDAs) for Pilocarpine HCI tablets, 7.5 mg, the generic equivalent of Salagen®, marketed by Eisai Pharmaceuticals. Lannett previously received and currently markets Pilocarpine HCI tablets, in the 5 mg strength.

Skyrocketing growth of the CRO market

The combination of the growing trend by pharmaceutical companies to outsource a wider range of services, and the need to pass products through the testing and regulatory process in a rapid, cost-effective manner, has lead to skyrocketing growth of the CRO market. The CRO market grew from $1 ...
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European Medicines Agency Makes First Recommendation For Use Of Amedicine In Children Based On PIP Data

The European Medicines Agency (EMEA) has made its first recommendation for the use of a centrally-authorised medicine in children on the basis of clinical trial data generated in accordance with an agreed paediatric investigation plan (PIP). This is the first example of the changes brought in by the Paediatric Regulation benefiting children in Europe.

CE Mark Extended For Disc Dynamics' DASCOR(R) Disc Arthroplasty System

Disc Dynamics, Inc., a leading developer of minimally invasive treatment options for low back pain caused by degenerative disc disease (DDD), announced that the CE Mark received in the European Union for its DASCOR® Disc Arthroplasty System has been expanded to incorporate a posterior-lateral surgical approach, as well as an endoscopic approach.

Regulatory Affairs Professionals Society (RAPS) Opens RAPS Europe In Brussels

The Regulatory Affairs Professionals Society (RAPS), the world's largest international membership organization of regulatory professionals in the medical device, pharmaceutical, and biotechnology sectors, announced the opening of its European office in Brussels. RAPS Europe will support RAPS programs, events and operations throughout Europe and serve as the organization's base for European operations.

Clinqua Inc. has embraced the concept that cooperation with other aspiring companies is the key to unlocking success in the clinical and biopharmaceutical research industry.

Clinqua is a Contract Research Organization www.clinqua.com that is attempting to change the age old notions that plagued the Clinical and Biopharmaceutical Industry, where in the past it was believed that for a company to survive it had to exist in competition with all others.

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FDA Publishes Guidance On Diagnostic Tests For 2009 H1N1 Influenza Virus

The U.S. Food and Drug Administration published a guidance document that should help manufacturers develop diagnostic tests for the 2009 H1N1 influenza virus. Although there are not any FDA-approved or cleared tests that diagnose this specific infection, during this pandemic, manufacturers can submit a request to the FDA for an Emergency Use Authorization (EUA).

European Medicines Agency, European Commission And Health Canada Agree Implementation Plan For Confidentiality Arrangement

The European Medicines Agency, the European Commission and Health Canada, the Canadian regulatory authority for medicines, have agreed on an implementation plan for their confidentiality arrangement. The implementation plan details the process for both regular and ad-hoc exchanges of information, and describes the process for monitoring the progress of the implementation plan.

Acusphere Announces FDA Acceptance Of ImagifyT NDA For Detection Of Coronary Artery Disease

Acusphere, Inc. (NASDAQ: ACUS) announced that the New Drug Application (NDA) for approval to market its lead product candidate, ImagifyT (Perflubutane Polymer Microspheres for Injectable Suspension), has been accepted for review by the U.S. Food & Drug Administration (FDA). Imagify is an ultrasound imaging agent for the detection of coronary artery disease, the leading cause of death in the United States.

Clinical Research Professionals are Still in Demand despite the World Economic Crisis

Despite the world economic crisis, the clinical research field is currently expanding faster than the introduction of newly qualified professionals that inevitably creates a demand. Most people are under the impression that the barriers to enter this industry are extremely difficult to ...
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Sen. Wyden Says He Would Not Oppose Consideration As Nominee For HHS Secretary; Rep. DeLauro Possible Nominee, Some Say

Sen. Ron Wyden (D-Ore.) on Thursday in an interview said that he would not oppose consideration as the nominee for HHS secretary after former Senate Majority Leader Tom Daschle (D-S.D.) withdrew his nomination this week,

FDA Approves Glaxosmithkline's Hib Vaccine, Hiberix(R)

In response to a U.S. shortage of a vaccine to protect infants from Haemophilus influenzae type b (Hib), GlaxoSmithKline (NYSE: GSK) has received accelerated approval from the FDA (Food and Drug Administration) for Hiberix® [Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)] as a booster dose in children 15 months through four years of age. Hib is an often severe and potentially deadly bacterial infection that can cause meningitis.

NICE Proposes To Refuse Nexavar(R) (Sorafenib) For Liver Cancer Patients

Today, in an alarming move, the National Institute for Health and Clinical Excellence (NICE) has, once again, proposed to deny Nexavar® (sorafenib) for the treatment of advanced hepatocellular carcinoma (HCC) - a form of liver cancer. Nexavar® is the only systemic treatment option that could potentially extend the survival of these patients.

Limdato’s Grasp On Streamlining Clinical Trials

Limdato, www.limdato.com understands that executing a successful clinical trial requires a seamless coordination and communication with all individuals involved on levels on the trial. On average clinical trials in Phases 1,2,3 go beyond deadlines by 30%. These delays cost the ...
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Off-Label Uses Of Drugs Should Be Approved For Very Ill Patients, Opinion Piece States

FDA and Congress "should protect physicians' and patients' right" to use FDA-approved drugs for off-label uses "and for the first time allow drugmakers to promote off-label uses that prove beneficial," Richard Epstein, a law professor at the University of Chicago and a senior fellow at the

The King's Fund's Response To Department Of Health Review Of Additional Private Drugs For NHS Care, UK

The King's Fund welcomes the opportunity to contribute to the Department of Health's review of the consequences of additional private drugs for NHS care. The King's Fund has raised a number of issues with the review team that will need to be considered by the government whatever choice of policy it adopts.

U.S FDA Grants Pralatrexate Orphan Drug Designation For The Treatment Of Patients With Follicular Lymphoma

Allos Therapeutics, Inc. (Nasdaq:ALTH), a biopharmaceutical company focused on the development and commercialization of small molecule therapeutics for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) granted orphan drug designation to the Company's novel antifolate, pralatrexate (PDX), for the treatment of patients with follicular lymphoma.

Anestvise Inc will Create New Jobs at New Manufacturing Facility in Eastern Europe

Anestvice Inc. www.anestvice.com , whose customers include major pharmaceutical industry players, specializes in manufacturing of medical devices. The company’s long-term plans call for it’s new facility to serve as a device manufacturing center, using advanced technology in ...
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Schering-Plough Europe Withdraws Its Marketing Authorisation Applicationfor Cylatron (peginterferon Alfa-2b)

The European Medicines Agency (EMEA) has been formally notified by SP Europe of its decision to withdraw its application for a centralized marketing authorisation for the medicine Cylatron (peginterferon alfa-2b), 200 micrograms /0.5 ml, 300 micrograms /0.5 ml and 600 micrograms/0.5 ml. Cylatron was expected to be used for the adjuvant treatment of patients with stage III melanoma as evidenced by microscopic, non-palpable nodal involvement.

FDA Seizes Contaminated Heparin From A Cincinnati Manufacturer

As part of the U.S. Food and Drug Administration's ongoing efforts to ensure that heparin for patients remains safe, the government today seized 11 lots of heparin from Celsus Laboratories Inc. in Cincinnati, Ohio. The five lots of Heparin Sodium Active Pharmaceutical Ingredient (API) and six lots of Heparin Lithium were seized at the FDA's request by U.S. Marshals.

FDA Acts To Halt Marketing Of Unapproved Codeine Sulfate Tablets

The U.S. Food and Drug Administration warned four companies that they must stop marketing unapproved codeine sulfate tablets. These drugs are opioid analgesics, commonly called narcotics, that are widely used to treat pain. These particular products have not received FDA approval and the agency has no evidence that they are safe and effective. Another manufacturer, Roxane Laboratories, markets FDA-approved codeine sulfate tablets and is able to meet the demand for the drug.

Pharmalef Developments plays a vital role in proper documenting the drug development process.

New drugs are the lifeblood of the pharmaceutical industry. Yet strict testing and documentation requirements mean only one in many drug candidates make it to market. Pharmalef Developments www.pharmalef.com can play a vital role in documenting the drug development process. By ...
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Meda: Positive Study Supporting A Potential Once-Daily Nasal Antihistamine

In October 2008, the US Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for the newly formulated higher strength azelastine nasal spray as complete for substantive review after initial evaluation. This NDA contained data on six phase III studies and a long-term safety study, involving more than 1,600 patients in total.

Alzheimer's Drugs Hope As NICE Appeal Denied

New hope has been offered to thousands of people in the early stages of Alzheimer's today, 29 October, following a landmark decision in the House of Lords. The Lord's denied the National Institute for Health and Clinical Excellence (NICE) the right to appeal a high court decision which, in May 2008, ordered NICE to release a copy of the model it used to restrict Alzheimer's drugs on the NHS.

EU Approval For Cymbalta In Generalised Anxiety Disorder

The European Commission has approved the use of Cymbalta (duloxetine) in treating generalised anxiety disorder (GAD), paving the way for the drug to be launched in all 27 member-states of the European Union. The verdict will also allow Cymbalta to be marketed in Iceland, Liechtenstein and Norway. Jointly produced by Eli Lilly (U.S.) and Boehringer Ingelheim (Germany), Cymbalta is already approved for treating GAD in the United States and Mexico.

Pharmaceutical companies are relying on outsourcing strategies

It is imperative that pharmaceutical and biotechnology companies pass their product through the testing and regulatory process in a rapid, cost-effective manner. To accomplish this goal, pharmaceutical companies are relying on outsourcing strategies to provide the services that can ...
(613) 686-5745 Cerepotec Pharmalef

FDA Recommends H1N1 For Inclusion In Next Year's Flu Vaccine

The U.S. Food and Drug Administration (FDA) on Monday recommended that the H1N1 (swine flu) strain be added to next year's seasonal flu vaccine, "putting an end to separate shots deployed against the pandemic," Bloomberg reports. The FDA committee voted unanimously to make the H1N1 strain one of the three strains included in the shot, according to the news service...

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Cereprotec Inc. and Institute of Applied Chemistry at Hebrew University are working together to synthesise new Glycoluril Derivatives with Possible Neuroprotection Effects.According to report of Institute of Applied Chemistry they have performed the third step as it appears in the synthesis route scheme. This took much longer than the other steps, after all, this reaction doesn't appear in any literature and in the end only took two and half weeks. This research is fully sponsored by Cereprotec Incorporated www.cereprotec.com a US company that already runs clinical tests of their first drug Cereprotex .<br />In the reaction between compound II and III, one gets two main products, three additional compounds in small quantities plus unreacted starting materials and one main side product. All together there were 8 compounds in the reaction mixture. <br /><br />One of the main materials precipitated out from the mixture and was removed via filtration from the reaction mixture. This material was cleaned up via crystallization but turned out not to be the desired compound. <br />The second main material was separated via silica gel column chromatography. Unfortunately, this main material came off at the same Rf value as another material. They tested out several solvents and found that ethyl acetate was able to crystallize out the main material. <br /><br />Using NMR and elemental analysis, Institute of Applied Chemistry were able to prove that the crystallized out material is indeed Compound III. Yield was 17%. Two grams of material was obtained, enough to try out Stage IV. <br /><br />This step can be repeated in the future in order to produce more of compound III. <br />Cereprotec Inc. Phase II clinical study of efficacy and safety of Cereprotex as preventive treatment of cognitive dysfunction as a complication of coronary artery bypass graft (CABG) surgery.Cerebral dysfunction is a significant complication of coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass (CPB).While overt neurological dysfunction occurs in 3% of patients, cognitive dysfunction is detectable in most patients early after CABG and in up to half of patients at six months.<br /><br />Cereprotec Inc. www.cereprotec.com proposes to use Cereprotex prior to and after CABG procedures in order to minimize or eliminate entirely the effects of neuro-impairment. Based on the successful animal trials Cereprotec Inc. believes that the human trials will show significant reduction in neuro-impairment. <br /><br />At this moment Cereprotec Inc. www.cereprotec.com is prepared to start clinical trials and is actively seeking serious investors.<br />Cereprotec Inc: Cerebral dysfunction is a significant complication of coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass (CPB). Cerebral dysfunction is a significant complication of coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass (CPB). Cognitive dysfunction is detectable in up to 70% of patients.<br /><br />In Phase II Cereprotec Inc. www.cereprotec.com study patients will undergo a standard battery of 10 cognitive tests performed by one examiner before surgery and at 7 and one month after CABG. Four tests (auditory verbal learning test (AVLT), adult memory and information processing battery (AMIBP), trail-making test B (TMTB), and verbal fluency test (VFT)) will be used to calculate a composite cognitive index.<br />US Patent Application No.11/723,011 to be assigned to CEREPROTEC INC. Method for Neuroprotection with Glycoluril DerivativesCereprotec Incorporated www.cereprotec.com is a US company involved in the development of neuroprotective drug Cereprotex. <br /><br />This company is also developing a family of other promising novel chemical compounds. <br /><br />Proof of efficacy of these compounds has been obtained in three animal studies including hypoxia in both mice and rats and brain trauma in mice. The proof of neuroprotection concept has been shown not only for prevention (hypoxia model), but also for the treatment paradigm post brain trauma which reflects a potential realistic situation in humans. <br />Professor Esther Shohami has joined the board of advisors of Cereprotec IncorporatedProfessor Esther Shohami has joined the board of advisors of Cereprotec Incorporated. Her research interests include: Pathophysiology of brain injury - mediators of delayed neuronal damage e.g., prostaglandins, reactive oxygen species, cytokines, cannabinoids, and the cholinergic system in rat and mouse models of injury (closed head injury, CHI). Evaluation of potential therapeutic strategies. CHI as a risk factor for delayed onset of Alzheimer's disease. Genetic manipulations (cytokines or apoE knockouts, acetylcholine-esterase transgenics, and more) as tools for investigating the role of specific mediators in traumatic brain injury. Interrelationship between traumatic brain injury and bone remodeling. Role of endocannabinoids in blood-brain barrier function and in bone remodeling after brain trauma. Mechanisms of neuroprotection induced by pre-conditioning (ischemic or heat acclimation). In vitro model for stretch injury that simulates traumatic conditions in astrocytes.<br /><br />Dr. Roman Kamburg CEO of Cereprotec and the registered owner of 1125 shares in CEREPROTEC Incorporated (the "Corporation") www.cereprotec.com a corporation incorporated in and under the laws of the State of Delaware, having its registered office at 108 West 13th Street, Wilmington, Delaware, transfered to Dr. Esther Shohami 40 Shares of Common Stock, for no consideration, to be held by the Transferee, her administrators and assignees, subject to all the terms and conditions on which such shares were held by the Transferor, and Transferee agreed to receive such shares.<br />Pharmalef Inc. is starting collaboration in development of new oral delivery platformPharmalef Inc. www.pharmalef.com is starting collaboration in development of new oral delivery platform offers pharmaceutical companies the ability to extend the shelf life and stability of medicinal compounds.<br /><br />Moreover, oral delivery improves patient compliance, improves treatment, reduces patient inconvenience, and reduces treatment costs.<br /><br />Our partners have completed proof of concept and development of a proliposomal formulation for the model drug, calcitonin, which is used in the treatment of osteoporosis and thyroid cancer. <br /><br />Clinical trials are expected to begin at a number of centers across the United States, Canada and European Union. <br />Pharmalef Developments introduces several new products in Rheumatology, Immunology and Respiratory Diseases.With a focus on familiar, everyday health problems, Pharmalef Developments . www.pharmalef.com aims to develop and deliver products that meet the individual’s health care needs, developing a wide range of products.<br /><br />In addition to its established range of highly effective and distinctive products Pharmalef Developments will introduce several new products in new fields, including Rheumatology, Immunology and Respiratory Diseases.<br />Pharmalef Developments plays a vital role in proper documenting the drug development process.New drugs are the lifeblood of the pharmaceutical industry. Yet strict testing and documentation requirements mean only one in many drug candidates make it to market. <br /><br />Pharmalef Developments www.pharmalef.com can play a vital role in documenting the drug development process. By leveraging our expertise in business process management and the latest technologies, we can also help you develop a documentation process for clinical trials that is easy and efficient, while satisfying strict government requirements and regulations. <br />Pharmalef Developments is a home for team-oriented professionalsPharmalef Developments www.pharmalef.com is a home for team-oriented professionals and their aim is to be the first choice in the industry for licensing and academic collaborations that bring mutual benefits to each party.<br /><br />They entered into many collaborations with leading academic centers, CRO-s and biotechnology companies to complement our in-house R&D capabilities. <br /><br />They are always interested in forming new partnerships covering early-stage research, novel compounds or technologies and implementation of clinical trials.<br />CEREPROTEC Method for Neuroprotection with Glycoluril Derivatives Patent Application has been Published September 18, 2008<br /><br />A method for prevention, inhibition or treatment of neuronal degeneration caused by injury, disease, disorder or condition in the central nervous system (CNS) comprises administering a glycoluril derivative to an individual in need thereof. View document here: http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=/netahtml/PTO/srchnum.html&r=1&f=G&l=50&s1=20080227838.PGNR.&OS=DN/20080227838&RS=DN/20080227838<br /><br />1. A method for prevention, inhibition or treatment of neuronal degeneration caused by injury, disease, disorder or condition in the central nervous system (CNS), comprising administering to an individual in need thereof an amount effective to treat said injury, disease, disorder or condition, of a compound of the formula I:whereinR.sub.1, R.sub.2 and R.sub.3, the same or different, each is H or (C.sub.1-C.sub.6) alkyl;R.sub.4 is selected from the group consisting of (C.sub.1-C.sub.6) alkyl, --R.sub.5--COOR, --R.sub.5--OH, --R.sub.5--NH--CO--R and --R.sub.5--CO--NH--(CH.sub.2).sub.n--COOR;R.sub.5 is (C.sub.1-C.sub.6) alkylene;R is H or (C.sub.1-C.sub.3) alkyl;n is an integer of 1 to 6; or an enantiomer thereof or a pharmaceutically acceptable salt thereof.<br /><br />2. The method according to claim 1 wherein R.sub.1 to R.sub.3 each is H or (C.sub.1-C.sub.6) alkyl and R.sub.4 is (C.sub.1-C.sub.6) alkyl.<br /><br />3. The method according to claim 2, wherein R.sub.1 to R.sub.4 each is methyl.<br /><br />4. The method according to claim 1, wherein R.sub.1 to R.sub.3 each is H or (C.sub.1-C.sub.6) alkyl, R.sub.4 is --R.sub.5---COOR, R.sub.5 is (C.sub.1-C.sub.6) alkylene and R is H or (C.sub.1-C.sub.3) alkyl.<br /><br />5. The method according to claim 1, wherein R.sub.1 and R.sub.3 each is methyl, R.sub.2 is H and R.sub.4 is --(CH.sub.2).sub.3COOH.<br /><br />6. The method according to claim 1, wherein said injury, disease, disorder or condition is selected from the group consisting of: (i) a neurological injury: (ii) brain damage caused by a cardiovascular event; (iii) a cerebrovascular disorder or disease; (iv) a neurodegenerative disease or disorder; and (v) a dementia.<br /><br />7. The method according to claim 6, wherein said injury is a neurological traumatic injury selected from the group consisting of head trauma injury and spinal cord injury.<br /><br />8. The method according to claim 7, wherein said head trauma injury is selected from the group consisting of blunt trauma, closed head injury and penetrating trauma injury.<br /><br />9. The method according to claim 8, wherein said head trauma injury is closed head injury.<br /><br />10. The method according to claim 6, wherein said injury, disease, disorder or condition is brain damage caused by a cardiovascular event.<br /><br />11. The method according to claim 10, wherein said cardiovascular event is cardiac arrest or cardiac surgery.<br /><br />12. The method according to claim 6, wherein said injury, disease, disorder or condition is a cerebrovascular disorder or disease.<br /><br />13. The method according to claim 12, wherein said cerebrovascular disorder is brain ischemia or stroke.<br /><br />14. The method according to claim 6, wherein said injury, disease, disorder or condition is a neurodegenerative disease or disorder.<br /><br />15. The method according to claim 14, wherein said neurodegenerative disease or disorder is selected from the group consisting of Alzheimer's disease, Parkinson's disease, facial nerve (Bell's) palsy, multiple sclerosis, glaucoma, Huntington's chorea, amyotrophic lateral sclerosis and macular degeneration.<br /><br />16. The method according to claim 6, wherein said injury, disease, disorder or condition is dementia.<br /><br />17. The method according to claim 16, wherein said dementia is Alzheimer's disease or a non-Alzheimer's dementia selected from the group consisting of senile dementia, Lewy body dementia, vascular dementia and a dementia caused by Parkinson's disease, Huntington's chorea, Creutzfeld-Jacob disease or HIV infection.<br /><br />18. A method for conferring neuroprotection to an individual afflicted with a neurological injury, which comprises administering to said individual a compound of formula I in claim 1 or an enantiomer or a pharmaceutically acceptable salt thereof in an amount effective to ameliorate the neurodegeneration associated with said neurological injury.<br /><br />19. The method according to claim 18, wherein said neurological injury is selected from the group consisting of head trauma injury and spinal cord injury.<br /><br />20. A method for conferring neuroprotection to an individual suffering from a neurological or neurodegenerative disease or disorder, which comprises administering to said individual a compound of formula I in claim 1 or an enantiomer or a pharmaceutically acceptable salt thereof in an amount effective to ameliorate the neurodegeneration associated with said neurological or neurodegenerative disease or disorder.<br /><br />21. The method according to claim 20, wherein said neurological or neurodegenerative disease or disorder is selected from the group consisting of Alzheimer's disease, Parkinson's disease, facial nerve (Bell's) palsy, multiple sclerosis, glaucoma, Huntington's chorea, amyotrophic lateral sclerosis, macular degeneration and dementia.

American Heart Journals Publishes Results From ERATO Trial Showing Dronedarone (Multaq(R)) Improves Ventricular Rate Control

The ERATO study published in the American Heart Journal demonstrated, for the first time in patients with permanent atrial fibrillation, that dronedarone (Multaq(R)) significantly reduces mean 24 hour ventricular rate, on top of other rate control agents. The mean heart rate reduction was 11.7 beats per minute (p

Head-to-head Trial Demonstrates Viramune®`s Similar Efficacy And Superior Effect On Lipid Profile Compared To Atazanavir/ritonavir

Results from the ARTEN trial presented at the 5th International AIDS Society (IAS) conference in Cape Town, South Africa demonstrated non-inferiority regarding efficacy between Viramune® (nevirapine) and ritonavir boosted atazanavir (atazanavir/r) both combined with tenofovir and emtricitabine (Truvada ®).

FDA Ends Maryland Seafood Processor's Pattern Of Sanitary Violations

The FDA announced that a Maryland seafood processor delivering fresh, frozen, and ready-to-eat seafood in Virginia, Pennsylvania, and New Jersey, and Washington, D.C., is to stop processing and distributing adulterated fish and seafood because it is not compliant with federal food safety laws. The Congressional Seafood Company Inc. of Jessup, Md...

Understanding the Importance of ICH GCP is Vital to the Continued Safety of Clinical Patients.

Several Kriger www.krigerinternational.com course sessions are dedicated to understanding concepts and principles that have helped mold the industry into what it is today. This gives each student the opportunity to understand how the industry is progressing, so that when they take their place ...
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CNSBio Inc. To Present Latest Clinical Trial Data For CNSB015 At Neuropathic Pain Conference In San Francisco

CNSBio Inc. will present recent Phase IIa proof-of-concept clinical trial data for CNSB015, an orally administered potassium channel modulator used in combination with opioids for the treatment of neuropathic pain, at the 12th International Conference on the Mechanisms and Treatment of Neuropathic Pain on November 20-21, 2009 in San Francisco, CA. Dr.

Information Field Theory Enables Astronomers, Medical Practitioners And Geologists To Look Into Places Where Their Measuring Instruments Are Blind

A bit of imagination on the part of a measuring instrument wouldn't be a bad thing. It could help to add data from areas where the instrument is unable to measure. However, it must do so constructively. In order to infer missing data in an astronomical measurement with more than just imagination, physicists at the Max Planck Institute for Astrophysics have formulated a theory of spatial perception called information field theory.

Symptoms Of Toxicity Are Markers Of Breast Cancer Treatment Success

An article published early online and in the December edition of The Lancet Oncology reports that if breast cancer patients who receive endocrine treatment develop hot flushes, vasomotor symptoms (such as cold and night sweats), and joint symptoms, then they have a lower likelihood of cancer recurrence. That is, the toxicity of the treatment is acting as an indicator of treatment success.

Biopharmaceutical companies focus their attention on outsourcing

In the world of clinical trails it is crucial that the process in which a product goes through the testing and regulatory process be swift at the same time remaining within the budget.This expedited process is achieved when pharmaceutical companies make the decision to outsource ...
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WellNet Launches Online Social Networking Program For Health Care Coordination

WellNet Healthcare this month will launch a test version of Point to Point Healthcare, a social network linking users' physicians, pharmacists and insurance benefit managers, the Washington Post reports.

BioMS Medical's Phase III U.S. Multiple Sclerosis Trial Receives Positive Safety Review From Data Safety Monitoring Board

BioMS Medical Corp. (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced that the independent Data Safety Monitoring Board (DSMB) for the Company's U.S. pivotal phase III MAESTRO-03 trial of dirucotide in patients with secondary progressive MS has completed a safety analysis and recommended that the trial continue as per the protocol.

Sales Of Painkillers - Help For Retailers

The Medicines and Healthcare products Regulatory Agency (MHRA) launched new guidance on the best practice for the sale of pain relief medication. The guidance outlines that no more than two packs should be sold in one transaction and discourages retailers from promoting offers that encourage the sale of more than one pack at a time...

Volunteers Respect Accurate and Personalized Information From Study Results

Many CRO’s and investigators believe that even though volunteer patients in clinical trials expose themselves to a great deal of risk, there is no legal mandate for investigators to inform them of study results. However, Clinproxy, www.clinproxy.com as well as many investigators have ...
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Technique For Eliminating Reblockage Of Arteries Developed By Hebrew University Scientist

An easily implementable technique to avoid reblockage of arteries that have been cleared through angioplasty and stent insertion has been developed by researchers led by Prof. Boris Rubinsky of the Hebrew University of Jerusalem.

Class Of Diabetes Drugs Carries Significant Cardiovascular Risks

A class of oral drugs used to treat type 2 diabetes may make heart failure worse, according to an editorial published online in Heart Wednesday by two Wake Forest University School of Medicine faculty members. "We strongly recommend restrictions in the use of thiazolidinediones (the class of drugs) and question the rationale for leaving rosiglitazone on the market," write Sonal Singh, M.D., M.P.H., assistant professor of internal medicine, and Curt D. Furberg, M.D., Ph.D.

Da Vinci(R) Surgical System Robot And Blue Man Group To Invade This Year's Boston FIRST Robotics Competition

The Boston FIRST (For Inspiration and Recognition of Science and Technology) Robotics Committee today announced that Intuitive Surgical's da Vinci(R) Surgical System, which allows surgeons to perform procedures remotely with the use of robotic technology, will be on display and demonstrated at this year's robotics competition. This year's competition will be held March 6 & 7 at Boston University's Agganis Arena. Dr.

Ground breaking companies within the CRO industry

With over 1200 companies within the CRO industry Limdato www.limdato.com is one who is able to utilize cutting edge technology and innovations to ensure complete success for your clinical trial. During the 1970’s the industry was extremely limited to the services it could provide for ...
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Stanford University To Limit Pharmaceutical Industry Financing Of Continuing Medical Education

Stanford University officials on Tuesday plan to announce a new policy under which pharmaceutical and medical device companies no longer will have the ability to select continuing medical education courses that they seek to finance for physicians at the university's School of Medicine, the

CTRC-AACR San Antonio Breast Cancer Symposium Continues To Expand

Now in its 32nd year, the CTRC-AACR San Antonio Breast Cancer Symposium continues to attract the best in breast cancer science and world leaders from industry and academia with the goal of eradicating breast cancer. This year, more than 8,500 scientists and other professionals will gather at the Henry B. Gonzales Convention Center in San Antonio from Dec. 9-13, 2009...

Novo Nordisk A/S: Regulatory Approval

Novo Nordisk announced that the Japanese Ministry of Health, Labour and Welfare has approved Victoza® for the treatment of type 2 diabetes. Victoza® is the brand name for liraglutide, the first Glucagon-Like Peptide-1 (GLP-1) analogue approved in Japan, developed for the treatment of type 2 diabetes...

It is recommended that sponsor companies should first check what budget they can allocate, and then seek Clinqua Inc. expertise in achieving their goal.

It is an undesirable reality, but the development of pharmaceutical drugs is a costly undertaking. Yet, these costs are necessitated by the substantial investment of both time and resources of the companies in question. It stands to reason that if a company is willing to invest millions of ...
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Cereprotec Inc. and Institute of Applied Chemistry at Hebrew University are working together to synthesise new Glycoluril Derivatives with Possible Neuroprotection Effects.According to report of Institute of Applied Chemistry they have performed the third step as it appears in the synthesis route scheme. This took much longer than the other steps, after all, this reaction doesn't appear in any literature and in the end only took two and half weeks. This research is fully sponsored by Cereprotec Incorporated www.cereprotec.com a US company that already runs clinical tests of their first drug Cereprotex .<br />In the reaction between compound II and III, one gets two main products, three additional compounds in small quantities plus unreacted starting materials and one main side product. All together there were 8 compounds in the reaction mixture. <br /><br />One of the main materials precipitated out from the mixture and was removed via filtration from the reaction mixture. This material was cleaned up via crystallization but turned out not to be the desired compound. <br />The second main material was separated via silica gel column chromatography. Unfortunately, this main material came off at the same Rf value as another material. They tested out several solvents and found that ethyl acetate was able to crystallize out the main material. <br /><br />Using NMR and elemental analysis, Institute of Applied Chemistry were able to prove that the crystallized out material is indeed Compound III. Yield was 17%. Two grams of material was obtained, enough to try out Stage IV. <br /><br />This step can be repeated in the future in order to produce more of compound III. <br />Cereprotec Inc. Phase II clinical study of efficacy and safety of Cereprotex as preventive treatment of cognitive dysfunction as a complication of coronary artery bypass graft (CABG) surgery.Cerebral dysfunction is a significant complication of coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass (CPB).While overt neurological dysfunction occurs in 3% of patients, cognitive dysfunction is detectable in most patients early after CABG and in up to half of patients at six months.<br /><br />Cereprotec Inc. www.cereprotec.com proposes to use Cereprotex prior to and after CABG procedures in order to minimize or eliminate entirely the effects of neuro-impairment. Based on the successful animal trials Cereprotec Inc. believes that the human trials will show significant reduction in neuro-impairment. <br /><br />At this moment Cereprotec Inc. www.cereprotec.com is prepared to start clinical trials and is actively seeking serious investors.<br />Cereprotec Inc: Cerebral dysfunction is a significant complication of coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass (CPB). Cerebral dysfunction is a significant complication of coronary artery bypass graft (CABG) surgery using cardiopulmonary bypass (CPB). Cognitive dysfunction is detectable in up to 70% of patients.<br /><br />In Phase II Cereprotec Inc. www.cereprotec.com study patients will undergo a standard battery of 10 cognitive tests performed by one examiner before surgery and at 7 and one month after CABG. Four tests (auditory verbal learning test (AVLT), adult memory and information processing battery (AMIBP), trail-making test B (TMTB), and verbal fluency test (VFT)) will be used to calculate a composite cognitive index.<br />US Patent Application No.11/723,011 to be assigned to CEREPROTEC INC. Method for Neuroprotection with Glycoluril DerivativesCereprotec Incorporated www.cereprotec.com is a US company involved in the development of neuroprotective drug Cereprotex. <br /><br />This company is also developing a family of other promising novel chemical compounds. <br /><br />Proof of efficacy of these compounds has been obtained in three animal studies including hypoxia in both mice and rats and brain trauma in mice. The proof of neuroprotection concept has been shown not only for prevention (hypoxia model), but also for the treatment paradigm post brain trauma which reflects a potential realistic situation in humans. <br />Professor Esther Shohami has joined the board of advisors of Cereprotec IncorporatedProfessor Esther Shohami has joined the board of advisors of Cereprotec Incorporated. Her research interests include: Pathophysiology of brain injury - mediators of delayed neuronal damage e.g., prostaglandins, reactive oxygen species, cytokines, cannabinoids, and the cholinergic system in rat and mouse models of injury (closed head injury, CHI). Evaluation of potential therapeutic strategies. CHI as a risk factor for delayed onset of Alzheimer's disease. Genetic manipulations (cytokines or apoE knockouts, acetylcholine-esterase transgenics, and more) as tools for investigating the role of specific mediators in traumatic brain injury. Interrelationship between traumatic brain injury and bone remodeling. Role of endocannabinoids in blood-brain barrier function and in bone remodeling after brain trauma. Mechanisms of neuroprotection induced by pre-conditioning (ischemic or heat acclimation). In vitro model for stretch injury that simulates traumatic conditions in astrocytes.<br /><br />Dr. Roman Kamburg CEO of Cereprotec and the registered owner of 1125 shares in CEREPROTEC Incorporated (the "Corporation") www.cereprotec.com a corporation incorporated in and under the laws of the State of Delaware, having its registered office at 108 West 13th Street, Wilmington, Delaware, transfered to Dr. Esther Shohami 40 Shares of Common Stock, for no consideration, to be held by the Transferee, her administrators and assignees, subject to all the terms and conditions on which such shares were held by the Transferor, and Transferee agreed to receive such shares.<br />Pharmalef Inc. is starting collaboration in development of new oral delivery platformPharmalef Inc. www.pharmalef.com is starting collaboration in development of new oral delivery platform offers pharmaceutical companies the ability to extend the shelf life and stability of medicinal compounds.<br /><br />Moreover, oral delivery improves patient compliance, improves treatment, reduces patient inconvenience, and reduces treatment costs.<br /><br />Our partners have completed proof of concept and development of a proliposomal formulation for the model drug, calcitonin, which is used in the treatment of osteoporosis and thyroid cancer. <br /><br />Clinical trials are expected to begin at a number of centers across the United States, Canada and European Union. <br />Pharmalef Developments introduces several new products in Rheumatology, Immunology and Respiratory Diseases.With a focus on familiar, everyday health problems, Pharmalef Developments . www.pharmalef.com aims to develop and deliver products that meet the individual’s health care needs, developing a wide range of products.<br /><br />In addition to its established range of highly effective and distinctive products Pharmalef Developments will introduce several new products in new fields, including Rheumatology, Immunology and Respiratory Diseases.<br />Pharmalef Developments plays a vital role in proper documenting the drug development process.New drugs are the lifeblood of the pharmaceutical industry. Yet strict testing and documentation requirements mean only one in many drug candidates make it to market. <br /><br />Pharmalef Developments www.pharmalef.com can play a vital role in documenting the drug development process. By leveraging our expertise in business process management and the latest technologies, we can also help you develop a documentation process for clinical trials that is easy and efficient, while satisfying strict government requirements and regulations. <br />Pharmalef Developments is a home for team-oriented professionalsPharmalef Developments www.pharmalef.com is a home for team-oriented professionals and their aim is to be the first choice in the industry for licensing and academic collaborations that bring mutual benefits to each party.<br /><br />They entered into many collaborations with leading academic centers, CRO-s and biotechnology companies to complement our in-house R&D capabilities. <br /><br />They are always interested in forming new partnerships covering early-stage research, novel compounds or technologies and implementation of clinical trials.<br />CEREPROTEC Method for Neuroprotection with Glycoluril Derivatives Patent Application has been Published September 18, 2008<br /><br />A method for prevention, inhibition or treatment of neuronal degeneration caused by injury, disease, disorder or condition in the central nervous system (CNS) comprises administering a glycoluril derivative to an individual in need thereof. View document here: http://appft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=/netahtml/PTO/srchnum.html&r=1&f=G&l=50&s1=20080227838.PGNR.&OS=DN/20080227838&RS=DN/20080227838<br /><br />1. A method for prevention, inhibition or treatment of neuronal degeneration caused by injury, disease, disorder or condition in the central nervous system (CNS), comprising administering to an individual in need thereof an amount effective to treat said injury, disease, disorder or condition, of a compound of the formula I:whereinR.sub.1, R.sub.2 and R.sub.3, the same or different, each is H or (C.sub.1-C.sub.6) alkyl;R.sub.4 is selected from the group consisting of (C.sub.1-C.sub.6) alkyl, --R.sub.5--COOR, --R.sub.5--OH, --R.sub.5--NH--CO--R and --R.sub.5--CO--NH--(CH.sub.2).sub.n--COOR;R.sub.5 is (C.sub.1-C.sub.6) alkylene;R is H or (C.sub.1-C.sub.3) alkyl;n is an integer of 1 to 6; or an enantiomer thereof or a pharmaceutically acceptable salt thereof.<br /><br />2. The method according to claim 1 wherein R.sub.1 to R.sub.3 each is H or (C.sub.1-C.sub.6) alkyl and R.sub.4 is (C.sub.1-C.sub.6) alkyl.<br /><br />3. The method according to claim 2, wherein R.sub.1 to R.sub.4 each is methyl.<br /><br />4. The method according to claim 1, wherein R.sub.1 to R.sub.3 each is H or (C.sub.1-C.sub.6) alkyl, R.sub.4 is --R.sub.5---COOR, R.sub.5 is (C.sub.1-C.sub.6) alkylene and R is H or (C.sub.1-C.sub.3) alkyl.<br /><br />5. The method according to claim 1, wherein R.sub.1 and R.sub.3 each is methyl, R.sub.2 is H and R.sub.4 is --(CH.sub.2).sub.3COOH.<br /><br />6. The method according to claim 1, wherein said injury, disease, disorder or condition is selected from the group consisting of: (i) a neurological injury: (ii) brain damage caused by a cardiovascular event; (iii) a cerebrovascular disorder or disease; (iv) a neurodegenerative disease or disorder; and (v) a dementia.<br /><br />7. The method according to claim 6, wherein said injury is a neurological traumatic injury selected from the group consisting of head trauma injury and spinal cord injury.<br /><br />8. The method according to claim 7, wherein said head trauma injury is selected from the group consisting of blunt trauma, closed head injury and penetrating trauma injury.<br /><br />9. The method according to claim 8, wherein said head trauma injury is closed head injury.<br /><br />10. The method according to claim 6, wherein said injury, disease, disorder or condition is brain damage caused by a cardiovascular event.<br /><br />11. The method according to claim 10, wherein said cardiovascular event is cardiac arrest or cardiac surgery.<br /><br />12. The method according to claim 6, wherein said injury, disease, disorder or condition is a cerebrovascular disorder or disease.<br /><br />13. The method according to claim 12, wherein said cerebrovascular disorder is brain ischemia or stroke.<br /><br />14. The method according to claim 6, wherein said injury, disease, disorder or condition is a neurodegenerative disease or disorder.<br /><br />15. The method according to claim 14, wherein said neurodegenerative disease or disorder is selected from the group consisting of Alzheimer's disease, Parkinson's disease, facial nerve (Bell's) palsy, multiple sclerosis, glaucoma, Huntington's chorea, amyotrophic lateral sclerosis and macular degeneration.<br /><br />16. The method according to claim 6, wherein said injury, disease, disorder or condition is dementia.<br /><br />17. The method according to claim 16, wherein said dementia is Alzheimer's disease or a non-Alzheimer's dementia selected from the group consisting of senile dementia, Lewy body dementia, vascular dementia and a dementia caused by Parkinson's disease, Huntington's chorea, Creutzfeld-Jacob disease or HIV infection.<br /><br />18. A method for conferring neuroprotection to an individual afflicted with a neurological injury, which comprises administering to said individual a compound of formula I in claim 1 or an enantiomer or a pharmaceutically acceptable salt thereof in an amount effective to ameliorate the neurodegeneration associated with said neurological injury.<br /><br />19. The method according to claim 18, wherein said neurological injury is selected from the group consisting of head trauma injury and spinal cord injury.<br /><br />20. A method for conferring neuroprotection to an individual suffering from a neurological or neurodegenerative disease or disorder, which comprises administering to said individual a compound of formula I in claim 1 or an enantiomer or a pharmaceutically acceptable salt thereof in an amount effective to ameliorate the neurodegeneration associated with said neurological or neurodegenerative disease or disorder.<br /><br />21. The method according to claim 20, wherein said neurological or neurodegenerative disease or disorder is selected from the group consisting of Alzheimer's disease, Parkinson's disease, facial nerve (Bell's) palsy, multiple sclerosis, glaucoma, Huntington's chorea, amyotrophic lateral sclerosis, macular degeneration and dementia.

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And a pair of them on 800notes.com. pharmaceutical company you hope to one day work for. Similar to comments bearing the same signature and left elsewhere, it includes talk of defamation, and “offensive or harassing content” removing this blog trinity includes a recruiting agency, a pharma company, and a school

INSTITUTIONS THAT OFFERS A PRACTICAL ORIENTED COURSE IN CLINICAL RESEARCH.ClinfoSource online GCP training courses WARN OF ONE INSTITUTE. STAY AWAY. they will help you find a job in India. certificates courses, numerous spelling and grammar mistakes. Looking for clinical research staff nation-wide to prepare and initiate clinical trials. report a fraud. report this scam. moving forward in their clinical trial as it was approved.Espoir and PharmAlef are a complete and utter fraud

qualified for any clinical trials-related positions, but we highly recommend you get a clinical trials certificate. QA experience: GMP, GLP and GCP certificate through the training and certification  programs accredited by the International Biopharmaceutical Association. Certificate form Kriger and Bachelor's degree in science and clinical research experience preferred. I am still interested in pursuing a career in clinical research. 613-686-5745

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