Latest News About Regulatory Affairs!

Global Insight's Analysis Of Nice's Rejection Of Cancer Drug Erbitux For NHS Use, UK

Global Insight's Senior Analyst/Oncology Gustav Ando's note on NICE's rejection of cancer drug Erbitux for NHS use. "In another setback for patients in the U.K., an important new colorectal cancer treatment called Erbitux has been deemed too expensive to become readily available on the NHS.

Optimer Pharmaceuticals To Accelerate European Filing Of Fidaxomicin (OPT-80)

Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) announced that it plans to begin preparations to file a Marketing Authorization Application (MAA) with the European Medicines Agency (EMEA) for approval of fidaxomicin as an oral treatment for Clostridium difficile infection (CDI) based on the results from the company's first Phase 3 CDI trial.

Baxter Receives EMEA Positive Opinion For CELVAPAN H1N1 Pandemic Influenza Vaccine

Baxter International Inc. (NYSE:BAX) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) granted its "positive opinion" for CELVAPAN H1N1 pandemic vaccine using Baxter's Vero cell technology. This positive opinion confirms the acceptability of Baxter's regulatory submission to obtain final marketing authorization and licensure of the product.

Anestvise Inc. is Delivering Quality and Enabling Technology

Anestvice Inc. www.anestvice.com sponsors clinical trials towards manufacture of new medical devices. They work with medical professionals to design better equipment to meet their needs.We envision a modernization of the development and regulation processes for new medical devices. This ...
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China Sky One Medical, Inc. Obtains SFDA Approval For Diclofenac Sodium Eye Drops

China Sky One Medical, Inc. ("China Sky One Medical" or "the Company") (Nasdaq: CSKI), a leading fully integrated pharmaceutical company producing over-the-counter drugs in the People's Republic of China ("PRC"), announced that it obtained approval from the State Food and Drug Administration (SFDA) in China for the production of Diclofenac Sodium eye drops. The document number for the drug is 2009S02063.

Senate Will Vote On Tobacco Bill Today

The Senate is to vote on an extensive tobacco control bill expected to gain approval today. The bill would "give the Food and Drug Administration legal authority to regulate the sale, manufacturing and marketing of tobacco products" and "give the federal government broad new powers to monitor and change a toxic substance that contributes to some 400,000 deaths every year," according to the

FDA Warnings About Antidepressants Associated With Lasting, Unintended Changes In Diagnosis And Treatment

Government warnings about suicidality among children taking antidepressants appear to be associated with unintended and persistent changes in the diagnosis and treatment of depression in children and adults, according to a report in the June issue of Archives of General Psychiatry, one of the JAMA/Archives journals.

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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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.

Shire Announces FDA Approval Of Once-Daily INTUNIV™ Extended Release Tablets For The Treatment Of ADHD In Children And Adolescents Aged 6 To 17

Shire plc (LSE: SHP, NASDAQ: SHPGY), the global specialty biopharmaceutical company, today announced that it has received approval from the US Food and Drug Administration (FDA) for INTUNIV™ (guanfacine) Extended Release Tablets for the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children and adolescents aged 6 to 17 years. INTUNIV, a once-daily formulation of guanfacine, is the first selective alpha-2A adrenergic receptor agonist approved for the treatment of ADHD.

APP Pharmaceuticals Receives Approval For The First Generic Chlorothiazide Sodium 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 Chlorothiazide Sodium for Injection, USP. APP expects to launch Chlorothiazide Sodium for Injection, USP in the fourth quarter of 2009.

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 Approves First Additive Solution For Platelet Storage Up To 5 Days

The U.S. Food and Drug Administration approved InterSol, the first solution approved to replace a portion of plasma used when storing platelets for up to five days, allowing some of the donor plasma to be used for other purposes...

FDA Warns Consumers Not To Eat Certain Mussel Products From Bantry Bay Seafood

The U.S. Food and Drug Administration (FDA) is warning consumers against eating certain frozen cooked mussel products made by Bantry Bay Seafoods, imported from Ireland, because they may be contaminated with azaspiracid toxins, a group of naturally occurring marine toxins known to cause nausea, vomiting, diarrhea, and stomach cramps. Azaspiracid toxins are odorless, tasteless, and cannot be destroyed or neutralized by freezing or cooking, including boiling.

Obama Nominates Former NYC Health Chief Hamburg For FDA Head, Baltimore Health Chief As Deputy

President Obama on Saturday announced his selection of former New York City Health Commissioner Margaret Hamburg as his nominee for FDA commissioner and Baltimore health commissioner Joshua Sharfstein as Hamburg's deputy, the AP/Arizona Daily Star reports (AP/Arizona Daily Star, 3/15). According to the

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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Green Genetic Engineering Joint Statement By German Science Organizations

Germany's Federal Minister for Food, Agriculture and Consumer Protection, Ilse Aigner, has banned the cultivation of genetically modified maize. The ban took effect immediately on 14 April. The minister noted that the ban is an isolated decision on a particular case, not a fundamental rejection of green genetic engineering. Europe's highest licensing authority, the EFSA, had previously expressed no reservations about the cultivation of genetically modified maize.

Meda: FDA Approval Of The First Once-Daily Nasal Antihistamine

The U.S. Food and Drug Administration (FDA) has approved Astepro (azelastine) nasal spray 0.15% for the treatment of the symptoms of seasonal and perennial allergic rhinitis. This new Astepro nasal spray 0.15% ("Astepro Once-Daily") is the first nasal antihistamine to offer convenient once-daily dosing for patients who suffer from seasonal allergies. Astepro Once-Daily is formulated with azelastine, a leading nasal antihistamine in the treatment of rhinitis in the U.S.

Genta Receives Complete Response Letter From FDA To Amended Application Of Genasense(R) In Patients With Chronic Lymphocytic Leukemia

Genta Incorporated (OTCBB: GNTA.OB) today announced that the Company has received a complete response letter from the Office of Oncology Drug Products (OODP) at the Food and Drug Administration (FDA) regarding the Company's amended New Drug Application (NDA) for the use of Genasense® plus chemotherapy in patients with chronic lymphocytic leukemia (CLL).

Clinical outsourcing and current trends: How are they affecting business?

The clinical research industries growth is skyrocketing, the portion of the market outsourced to CROs is said to have grown from US$1 billion dollars in the early 1990’s to over US$17 billion in 2007. Analysts predict that by the year 2010 the industry could see numbers well into and over ...
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FDA Advises Consumers Not To Use Certain Zicam Cold Remedies

The U.S. Food and Drug Administration advised consumers to stop using three products marketed over-the-counter as cold remedies because they are associated with the loss of sense of smell (anosmia). Anosmia may be long-lasting or permanent.

Anika Therapeutics Receives Health Canada Approval For MONOVISC™

Anika Therapeutics, Inc. (Nasdaq: ANIK), a leader in products for tissue protection, healing and repair based on hyaluronic acid (HA) technology, announced that it has received Health Canada approval for MONOVISC™, its single injection viscosupplement approved for the treatment of osteoarthritis of the knee. Anika expects to launch MONOVISC this month through its long-term ORTHOVISC® distribution partner in Canada, Rivex Pharma Inc.

Sol-Gel's IND Application For Rosacea Accepted By FDA

Sol-Gel Technologies announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of Sol-Gel's Investigational New Drug Application (IND) for DER45-EV Gel for the topical treatment of rosacea. This IND allows Sol-Gel to initiate Phase II studies with DER45-EV Gel in rosacea patients. DER45-EV Gel is an innovative topical product based on Sol-Gel's patented drug delivery system that is designed to enhance the efficacy, safety and stability of topical drugs.

Clinproxy is a CRO with a focus on the Investigator with aspects essential for validating a drug’s remedial benefits.

Clinproxy, www.clinproxy.com is a CRO (Contract Research Organizations), who specializes in evaluating the burden of the trial and eliminating surplus protocols by focusing the Investigator on aspects critical for validating the drug’s remedial benefits. Efficiency is all about resource ...
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Cepheid Molecular Diagnostic Test For Positive Blood Culture Bottles Categorized 'Moderate Complexity' By FDA

Cepheid (Nasdaq: CPHD) announced the U.S. Food & Drug Administration (FDA) categorized Cepheid's Xpert(TM) MRSA/SA Blood Culture (BC) test as "Moderate Complexity" under the Clinical Laboratory Improvement Amendments (CLIA). The new test is designed for on-demand detection of Methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA), (typically Methicillin-sensitive) in positive patient blood culture bottles.

Highlighting The Need To Update The US Food Safety System

Over the next several weeks, the U. S. Senate has an historic opportunity to take a major step toward improving food safety for all Americans.

European Medicines Agency Recommends Update Of Product Information OfTysabri And Risk Of Progressive Multifocal Leukoencephalopathy (PML)

The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended that the product information for Tysabri (natalizumab) be updated to further increase awareness about the risk of progressive multifocal leukoencephalopathy (PML) in patients with relapsing-remitting multiple sclerosis (MS) who have been treated with the medicine. PML is a rare brain infection whose symptoms are similar to those of an MS attack.

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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Akorn, Inc. Announces FDA Approval Of Ciprofloxacin HCl Ophthalmic Solution USP, 0.3%

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 Ciprofloxacin HCl Ophthalmic Solution USP, 0.3%. Ciprofloxacin HCl Ophthalmic Solution is indicated for the treatment of infections caused by microorganisms in corneal ulcers and conjunctivitis. Annual sales for Ciprofloxacin HCl Ophthalmic Solution are approximately $20 million, according to IMS sales data.

Bayer Agrees To Stop Running Ads For Oral Contraceptive YAZ That FDA Says Are 'Misleading'

Earlier this week, the pharmaceutical company Bayer agreed to stop airing commercials for the oral contraceptive YAZ in response to an Oct. 3 warning letter from FDA telling the company that the advertisements overstate the benefits of the drug. According to the FDA letter, the commercials "broaden the drug's indication, overstate the efficacy of YAZ and minimize serious risks associated with the use of the drug.

Diazyme Introduces Liquid Stable Enzymatic Lithium Test

Diazyme Laboratories announced recently that the U.S. Food and Drug Administration (FDA) has granted Diazyme 510(k) clearance to market its liquid stable enzymatic lithium test kit for the quantitative determination of lithium levels in blood samples. Compared to existing methods, the new Diazyme lithium assay provides improved reagent stability and a reduced cost per test. The assay features excellent accuracy and precision and offers an extended reportable range of 0.

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

Biocomposites Granted SFDA Clearance For GeneX(R) In P.R.China

Biocomposites announced that the company's unique bone graft substitute geneX®, has been cleared for use by the State Food and Drug Administration (SFDA) of the People's Republic of China. geneX® is a synthetic bone graft material with a unique bi-phasic composition manufactured through a proprietary process that confers the product with a reproducible negative surface charge.

AVI BioPharma Files IND For Clinical Trial Of Marburg Virus Treatment

AVI BioPharma, Inc. (NASDAQ: AVII), a developer of RNA-based drugs, announced the filing of an Investigational New Drug application with the U.S. Food and Drug Administration for a clinical trial to evaluate the Company's antisense drug AVI-6003 for the treatment of Marburg virus infection. AVI plans to conduct the trial as part of its continued collaboration with the US Army Medical Research Institute of Infectious Diseases (USAMRIID).

FDA Issues Guidances For Industry To Improve The Safety Of Food, Feed And Drugs

The U.S. Food and Drug Administration issued three guidances designed to help ensure the safety of FDA-regulated products in the supply chain.

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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BSD Medical Corporation Reports FDA Review Of BSD-2000 Hyperthermia System Continues

BSD Medical Corporation (NASDAQ: BSDM) reported that the U.S. Food and Drug Administration (FDA) continues its review of the Company's Humanitarian Device Exemption (HDE) marketing submission for the Company's BSD-2000 Hyperthermia System.

FDA Clears Nexstim's Navigated Brain Stimulation For Non-invasive Cortical Mapping Prior To Neurosurgery

Nexstim Oy, a medical device company, announced that the U.S. Food and Drug Administration (FDA) has cleared the Navigated Brian Stimulation System for use in the assessment of the primary motor cortex for pre-procedural planning...

Bipolar Disorder - Eurand Announces FDA Approval Of EUR-1048 (Lamictal(R) ODT(TM)), Co-Developed With GlaxoSmithKline

Eurand N.V. (NASDAQ: EURX), a specialty pharmaceutical company that develops enhanced pharmaceutical and biopharmaceutical products based on its proprietary pharmaceutical technologies, announced that the U.S. Food and Drug Administration (FDA) has approved EUR-1048, to be marketed as GlaxoSmithKline's (NYSE: GSK) Lamictal(R) ODT(TM) (lamotrigine) Orally Disintegrating Tablets.

Pharmalef Developments is a home for team-oriented professionals

Pharmalef 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.They entered into many collaborations with leading ...
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FDA Awards Contract To Harvard Pilgrim To Develop Pilot For Safety Monitoring System

The U.S. Food and Drug Administration has awarded a contract to Harvard Pilgrim Health Care Inc. to develop a pilot of the FDA's Sentinel System, which will use automated health care data to evaluate medical product safety. Reports filed by hospitals, health care professionals, and industry account for much of information that the FDA relies on regarding medical product safety...

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...

European CHMP Issues Positive Opinion On Cymbalta For The Treatment Of Generalised Anxiety Disorder

Eli Lilly and Co (NYSE: LLY) and Boehringer Ingelheim announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) has issued a positive opinion supporting the approval of Cymbalta(R) (duloxetine hydrochloride) for the treatment of Generalised Anxiety Disorder (GAD).

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 ...
(613) 686-5745 Cerepotec Pharmalef

CVS Caremark Comments On FTC Investigation Into Anti-Trust Aspects Of Walgreens Proposal To Acquire Longs, USA

In response to the press release issued earlier today by Longs Drug Stores Corporation (NYSE:LDG) regarding the investigation by the Federal Trade Commission into the antitrust implications of a possible acquisition of Longs by Walgreens, CVS Caremark Corporation (NYSE:CVS) issued the following s

Teva Pharma B.V. Withdraws Its Marketing Authorisation Application ForClopidogrel Teva Pharma (clopidogrel Hydrobromide)

The European Medicines Agency has been formally notified by Teva Pharma B.V. of its decision to withdraw its application for a centralized marketing authorisation for Clopidogrel Teva Pharma (clopidogrel hydrobromide) 75 mg film-coated tablets. Clopidogrel Teva Pharma was developed as a generic medicine to be used for the prevention of atherothrombotic events in patients who have myocardial infarction, ischaemic stroke or established peripheral arterial disease.

FDA Approves Saphris Tablets (asenapine) To Treat Schizophrenia And Bipolar Disorder

The U.S. Food and Drug Administration has approved Saphris tablets (asenapine) to treat adults with schizophrenia, a chronic, severe and disabling brain disorder, and to treat bipolar I disorder in adults, a serious psychiatric disorder that causes shifts in a person's mood, energy, and ability to function. "Mental illnesses like schizophrenia and bipolar disorder can be devastating to patients and families, requiring lifelong treatment and therapy," said Thomas Laughren, M.D.

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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3-D Software To Give Doctors, Students A View Inside The Body Developed By Iowa State Engineers

James Oliver picked up an Xbox game controller, looked up to a video screen and used the device's buttons and joystick to fly through a patient's chest cavity for an up-close look at the bottom of the heart. And there was a sight doctors had never seen before: an accurate, 3-D view inside a patient's body accessible with a personal computer. A view doctors can shift, adjust, turn, zoom and replay at will. Software that uses real patient data from CT and MRI scans.

FDA Approves ACIPHEX(R) (rabeprazole Sodium) 20 Mg For Short-Term Treatment Of GERD In Adolescents

Eisai Corporation of North America, a wholly-owned subsidiary of Tokyo-based Eisai Co., Ltd., announced that the Food and Drug Administration (FDA) has approved ACIPHEX (rabeprazole sodium) 20 mg for the short-term (up to eight weeks) treatment of gastroesophageal reflux disease (GERD) in adolescents ages 12 and above. Included in the submission was a 12-week, multi-center, open-label, randomized, parallel-group study of 111 adolescent GERD patients.

FDA Approves New Huntington's Drug

The US Food and Drug Administration (FDA) announced on Friday that it has approved Prestwick Pharmaceuticals Inc's new drug Xenazine (generic name tetrabenazine) for the treatment of chorea in people with Huntington's disease, heralding the first treatment to receive US approval for any of the disease's symptoms. Huntington's is a rare inherited neurological disorder characterized by chorea or jerky, uncontrolled movements.

Limdato: Patient recruitment is essential to the accelerated success of a clinical trial.

Often one of the biggest burdens facing clinical trials is patient recruitment. The act of recruiting patients for a trail can be tedious at the best of times and often results in missed deadlines and an incredible hit to the sponsor’s budget. Limdato www.limdato.com along with its team of ...
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Merck Serono Submits New License Application For Erbitux In 1st-Line Non-Small Cell Lung Cancer In Europe

Merck Serono announced that it has submitted an application to the European Medicines Agency (EMEA) to license Erbitux (cetuximab) for the 1st-line treatment of epidermal growth factor receptor (EGFR) expressing, advanced or metastatic non-small cell lung cancer (NSCLC). The submission is supported by data from the Phase III FLEXa study presented this year at a plenary session of the American Society of Clinical Oncology (ASCO) Annual Meeting.

Sepracor's STEDESAT (Eslicarbazepine Acetate) New Drug Application Formally Accepted For Review By The FDA

Sepracor Inc. (Nasdaq: SEPR) today announced that it has been notified by the U.S. Food and Drug Administration (FDA) that the New Drug Application (NDA) for STEDESAT (eslicarbazepine acetate) has been accepted for filing and is now under formal review. As previously announced, the NDA for STEDESA was submitted to the FDA on March 31, 2009 for adjunctive therapy in the treatment of partial-onset seizures in adults with epilepsy.

Certain Cold Remedies Linked To Loss Of Sense Of Smell Warns FDA

The US Food and Drug Administration (FDA) advised consumers yesterday not to use certain cold remedies under the Zicam label because they have received over 100 reports linking the products to loss of sense of smell (anosmia) which can be long-lasting or permanent.

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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Announcement Of EMEA Authorisation Of Celgene's VIDAZA (Azacitidine) For Treatment Of MDS And AML

The granting by EMEA of full marketing authorisation for Celgene's VIDAZA will bring new hope to MDS patients, particularly those with high risk forms of these diseases that historically have been associated with a bleak outlook.

Big Tobacco Favored In Regulation Of Tobacco Products Making US Farms Less Stable

In an attempt to reinvent itself as a "responsible corporate citizen," tobacco company Philip Morris supports regulation of tobacco products by the U.S. Food and Drug Administration.

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.

Esploron is one of the innovative companies within the CRO industry.

Esploron www.esploron.com is one of the innovative companies within the CRO industry. This industry has evolved from providing limited clinical trial services in the 1970s to a full-service industry that today encompasses the entire drug development process, including preclinical evaluations, ...
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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 Approves Toviaz, A New Drug To Treat Overactive Bladder

The U.S. Food and Drug Administration has approved a new drug to help patients suffering from overactive bladder (OAB). Toviaz (fesoterodine fumarate) works by relaxing the smooth muscle tissue of the bladder, thus reducing the urinary frequency, urge to urinate, and sudden urinary incontinence (leakage of urine), that are characteristic symptoms of OAB.

FDA Clears First Automated Whole Blood Processing System In U.S.

Gambro BCT, Inc., soon to be known as CaridianBCT, a leading global provider of technology, products and services in automated blood collections, therapeutic systems, whole blood processes and pathogen reduction technologies, announced that it received FDA clearance for the commercial sale of Atreus® Whole Blood Processing system in the United States. The Atreus system is the first self-contained, automated manufacturing system cleared for distribution in the U.S.

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 ...
(613) 686-5745 Cerepotec Pharmalef

U.S. Grown Jalapeno And Serrano Peppers Not Connected To Salmonella Saintpaul Outbreak

The U.S. Food and Drug Administration is advising consumers that jalapeno and Serrano peppers grown in the United States are not connected with the current Salmonella Saintpaul outbreak. However, the FDA continues to advise consumers to avoid raw jalapeno peppers--and the food that contains them--if they have been grown, harvested or packed in Mexico.

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.


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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Bipolar Disorder - Eurand Announces FDA Approval Of EUR-1048 (Lamictal(R) ODT(TM)), Co-Developed With GlaxoSmithKline

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

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Clinproxy is a CRO with a focus on the Investigator with aspects essential for validating a drug’s remedial benefits.

Clinproxy, www.clinproxy.com is a CRO (Contract Research Organizations), who specializes in evaluating the burden of the trial and eliminating surplus protocols by focusing the Investigator on aspects critical for validating the drug’s remedial benefits. Efficiency is all about resource ...
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Internet Drugs Survey Shows 1 In 4 GPs Has Treated Patients For Complications, UK

A UK survey of GPs found that one in four had treated patients for complications linked to use of drugs they had bought over the internet, prompting doctors, regulators and pharmacists to warn patients to be careful about buying drugs online, of which many may be fake.

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FDA Issues Draft Guidance On Risk Evaluation And Mitigation Strategies

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Kriger's Instructors Provide A Sound Foundation For Anyone Wishing To Seek A Meaningful Career In The Clinical And Biopharmaceutical Industry

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Drive For Good Quality Medicines, Foods Reinforced By USP Agreements With Chinese Drug Authorities

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FDA Commissioner-Nominee Hamburg Would Face 'Several Crises' At Start Of Tenure, Wall Street Journal Reports

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Almirall Aims To File Once Daily Aclidinium Bromide For COPD In Europe In Early 2010

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Clinical Trials Do Not Need To Be Expensive!

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European Medicines Agency Update On Safety Of Insulin Glargine

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UCB Pharma Withdraws Its Marketing Authorisation Application For Lacosamide Pain UCB Pharma, Europe

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HHS Preparing To Open FDA Offices In China, India, Europe, And Latin America This Year

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European Medicines Agency Recommends Authorisation Of Two Vaccines For Influenza Pandemic (H1N1) 2009

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FDA Requests Labeling Change For Leukotriene Modifiers

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Talecris Biotherapeutics Receives Orphan Drug Designation For Aerosolized Form Of Alpha1-Antitrypsin (AAT) From The European Commission

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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.

613-686-5745 Clinical training is not a Scam, you should take training courses that are not a scam. Not a clinical trial scam for training in the clinical trail industry. Clinical Research Associate Courses maybe not a scam but not really a scam you learn alot about Clinic trials. Don't tell me its a scam as I think it does not work. Opinions of Clinical Training seem to say these courses are a scam. This is not truly a scam, scams are not good and clinical trails is not one of them. Take Clinical courses and you won't be scammed. Is Clinical Research Associates Training a scam? 613-686-5745

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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