Latest News About Regulatory Affairs!

Duska Therapeutics Submits Phase 3 ATPace(TM) Protocol To FDA For Comment

Duska Therapeutics, Inc. (OTC Bulletin Board: DSKA) ("Duska") announced that it has submitted for comment a synopsis of a proposed Phase 3 clinical study for its lead drug, ATPace(TM), to the U.S. Food and Drug Administration's (the "FDA") Division of Cardiovascular and Renal Products.

NCCN Updates Kidney Cancer Guidelines To Incorporate FDA Approval Of Everolimus

The National Comprehensive Cancer Network (NCCN) has updated the NCCN Clinical Practice Guidelines in Oncology(TM) for Kidney Cancer to reflect the recent FDA approval of everolimus (Afinitor(R), Novartis) for advanced renal cell carcinoma in patients whose disease has progressed after treatment with kinase inhibitors such as sunitinib (Sutent(R), Pfizer Inc.) and sorafenib (Nexavar(R), Bayer HealthCare).

First Centralised Authorisation To Be Moved To Non-prescription Status, Europe

The European Medicines Agency (EMEA) announced today[1] that a positive scientific opinion has been adopted for the first switch of a centrally authorised medicine to non-prescription status. "This is a breakthrough for European citizens. An innovative non-prescription medicine may thus become available in all 27 EU Member States at the same time.

ClinQua Inc. : The overall cost of clinical trials depends on an array of factors

In a progressive global market of supply and demand, it remains unthinkable to engage in practices that are ambitiously over-priced when there are endless opportunities to utilize more cost-efficient methods which would yield the same results. As per Mr. David Mills former ClinQua Clinical ...
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New FDA Regulation Of Tobacco Products Has Problems

New US legislation granting the Food and Drug Administration (FDA) jurisdiction over tobacco products represents a serious compromise on the part of tobacco control advocates, argues a new essay in this week's open access journal PLoS Medicine.

Cervical Cancer Prevention Efforts Should Prioritize Vaccinating Pre-Adolescent Girls And Continued Cervical Cancer Screening

Persistent infection with high-risk types of human papillomavirus (HPV), a sexually transmitted virus, is known to be a cause of cervical cancer. Current guidelines prioritize HPV vaccination of pre-adolescent girls, which has been shown to be cost-effective in previous studies, but the value of vaccinating boys in the United States has been unclear.

St. Jude Medical Announces Australian TGA Regulatory Approval For Libra Deep Brain Stimulation Systems For Parkinson's Disease

St. Jude Medical, Inc. (NYSE:STJ) announced Australian Therapeutic Goods Administration (TGA) approval of its Libra® and LibraXP™ deep brain stimulation (DBS) systems for treating the symptoms of Parkinson's disease, a neurological disorder that progressively diminishes a person's control over his or her movements.

ClinQua Inc: Regulatory Agencies Do Not Require Clinical Trials To Be Expensive!

Mr. David Mills former ClinQua Clinical Trials Inc. www.clinqua.com executive argues that the inevitable burden of clinical investigation is cost, and unfortunately, the weight of that burden falls onto consumers. Consequently, the clinical climate has seen unprecedented ...
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Antibiotic-Resistant Organisms Could Be Spread By The Transporting Of Broiler Chickens

Researchers at the Johns Hopkins Bloomberg School of Public Health have found evidence of a novel pathway for potential human exposure to antibiotic-resistant bacteria from intensively raised poultry - driving behind the trucks transporting broiler chickens from farm to slaughterhouse.

FDA Authorizes Emergency Use Of Intravenous Antiviral Peramivir For 2009 H1N1 Influenza For Certain Patients, Settings

The U.S. Food and Drug Administration announced that, in response to a request from the U.S. Centers for Disease Control and Prevention, it has issued an emergency use authorization (EUA) for the investigational antiviral drug peramivir intravenous (IV) in certain adult and pediatric patients with confirmed or suspected 2009 H1N1 influenza infection who are admitted to a hospital.

X-GEN Pharmaceuticals Receives FDA Approval For AcetaZOLAMIDE For Injection USP

X-GEN Pharmaceuticals announced that it will begin marketing Acetazolamide for Injection USP. The product is AP rated and equivalent to Diamox(R)(1) by Duramed Pharmaceuticals.

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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Teva Announces Tentative Approval Of Generic Femara(R) Tablets

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Novartis' breast cancer treatment Femara® (letrozole) Tablets, 2.5 mg...

Smokefree Innotec, Inc. Addresses FDA Concerns About Electronic Cigarettes

Smokefree Innotec, Inc. (Pink Sheets: SFIO) issued a statement referring to articles in USA Today and The New York Times of Wednesday, July 22, and Thursday, July 23rd, regarding the FDA taking aim at electronic cigarettes.

Diagnostic HYBRIDS Gets FDA Clearance For The Detection Of Influenza A (H1N1)v Virus

Diagnostic HYBRIDS announced that the US Food and Drug Administration has cleared an additional claim for the company's D3 UltraTM DFA Respiratory Virus Identification Kit, which confirms that the assay can detect the 2009 influenza A (H1N1)v virus.

What the Title of Home-based Clinical Research Associate Really Means

The title of Clinical Research Associate is deceiving to some degree. Many people think of “associate” as a secondary low paying job. “Clinical Monitor” is a title that better describes what CRA job entails. A clinical research associate does not, in fact, assist anyone; the associate ...
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In Wake Of FTC Ruling Today, Lautenberg, Snowe Hail End Of Decades Of Tobacco Industry Lies, USA

After years of pressure from Sen. Frank R. Lautenberg (D-NJ), the Federal Trade Commission (FTC) today announced that tobacco companies are no longer allowed to use the outdated "FTC Method" of testing tar and nicotine levels as the basis for marketing claims of "light" and "low-tar" cigarettes. Sens. Lautenberg and Olympia Snowe (R-ME) have written legislation to prohibit the continuation of the FTC Method of rating tar and nicotine.

Nanotechnology: Shortcomings Of Current Federal Oversight

Nanotechnology will significantly change virtually every facet of the way we live. The next president has the opportunity to shape these changes and to ensure that nanotechnology's benefits will be maximized and its risks identified and controlled. A new report by former EPA official J.

IDM Pharma Provides Update On Mifamurtide (L-MTP-PE) Regulatory Status Following September Meeting Of European Committee For Medicinal Products

IDM Pharma, Inc.

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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ONGLYZAT (saxagliptin) Cardiovascular Profile Acceptable According To FDA Advisory Committee

Bristol-Myers Squibb Company (NYSE: BMY) and AstraZeneca (NYSE: AZN) announced that the U.S. Food and Drug Administration's (FDA) Endocrinologic and Metabolic Drugs Advisory Committee determined (by a vote of 10 to 2) that the data supporting the new drug application for ONGLYZAT (saxagliptin) for the treatment of adults with type 2 diabetes were sufficient to rule out unacceptable cardiovascular risk relative to comparators in the program.

OncoGenex Receives Confirmation From FDA On The Design Of A Second Phase 3 Trial Evaluating OGX-011 For The Treatment Of Advanced Prostate Cancer

OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced that the company has reached an agreement with the U.S. Food and Drug Administration (FDA) on the design of a second Phase 3 registration trial of OGX-011, its lead product candidate targeting castrate resistant prostate cancer (CRPC), via the Special Protocol Assessment (SPA) process.

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.

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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Positive Opinion From Committee For Medicinal Products For Human Use (CHMP) For EvicelT Liquid Fibrin Sealant (Human)

OMRIX Biopharmaceuticals, Inc. ("Omrix" or the "Company") (NASDAQ: OMRI), a fully-integrated biopharmaceutical company that develops and markets biosurgical and immunotherapy products, announced today that it has received a positive opinion for EVICELT Fibrin Sealant (Human) from the Committee for Medicinal Products for Human Use (CHMP). Omrix is seeking approval to market Evicel in Europe for the improvement of hemostasis in surgery.

Celsion's Global Phase III ThermoDox(R) Trial Expands To Malaysia And The Philippines

Celsion Corporation (NASDAQ: CLSN) announced that it has received approval from the regulatory agencies in the Philippines and Malaysia for its Pivotal Phase III primary liver cancer Clinical Trial Application. Celsion's global Phase III trial is evaluating the efficacy and safety of ThermoDox in combination with radiofrequency ablation (RFA) when compared to RFA alone.

FDA Wants Suicide Warnings On Epilepsy Drugs

A panel of independent experts that advises the US Food and Drug Administration (FDA) is meeting this Thursday in Beltsville, Maryland, to review evidence of increased suicide risk for patients on anti-seizure drugs, and is expected to agree to the FDA's recommendation that these drugs carry the highest level of warning, the so-called "Black Box" label.

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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FDA Approves Expanded Label For CANCIDAS(R) As The 1st And Only Echinocandin Therapy For Pediatric Patients With Indicated Fungal Infections

Merck & Co., Inc. announced that the U.S. Food and Drug Administration (FDA) has approved an expanded label for CANCIDAS®, which makes it the first and only echinocandin therapy approved in the United States for the treatment of pediatric patients aged 3 months to 17 years with indicated fungal infections.

Sabril Approved By FDA To Treat Spasms In Infants And Epileptic Seizures

Sabril (vigabatrin) Oral Solution has been approved by the U.S. Food and Drug Administration to treat infantile spasms in children ages 1 month to 2 years. Sabril is the first drug in the United States approved to treat the disorder, characterized by a severe type of seizure that usually appears in the first year of life, typically between ages 4 months and 8 months. The disorder can be debilitating because of the frequency of difficult-to-control daily seizures.

Second Edition Of 'Medical Ultrasound Safety' Released By AIUM

The American Institute of Ultrasound in Medicine is pleased to announce the release of Medical Ultrasound Safety, Second Edition. All operators of ultrasound systems with an output display should review the information in this publication. The book consists of 3 parts: Bioeffects and Biophysics, Prudent Use, and Implementing ALARA (as low as reasonably achievable).

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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FDA Approves Left Ventricular Assist System For Severe Heart Failure Patients

The U.S. Food and Drug Administration today approved the HeartMate II, a continuous-flow, left ventricular assist system as a support for severe heart failure patients who are not acceptable candidates for heart transplantation. The HeartMate II is already FDA-approved for use in patients awaiting further, perhaps more complex treatment, such as transplants...

HSP90 Inhibitor To Advance To Clinical Development - Prominent In Tumor Cells Where It Promotes Activity Of Proteins Controlling Growth And Survival

Exelixis, Inc. (Nasdaq:EXEL) announced today that it has submitted an investigational new drug (IND) application to the U.S. Food and Drug Administration for XL888, a novel anticancer compound. XL888 is an orally available small molecule inhibitor of HSP90, which is a chaperone protein that promotes the activity and stability of a range of key regulatory proteins, including kinases.

Bayer's Novel Oral Anticoagulant Xarelto(R) (Rivaroxaban) Gets European Licence

Today the UK's 160,000 elective hip and knee replacement patients1 will be eligible to receive Bayer Schering Pharma's new oral anticoagulant, rivaroxaban. This follows European Commission authorisation of its licence for the prevention of venous thromboembolism (deep vein thrombosis (DVT) and pulmonary embolism (PE)), in patients undergoing elective hip or knee replacement surgery.

Contract Research Organizations Facing New Challenges

The biggest challenge facing CROs in the current industry are strict regulatory requirements. Global regulatory bodies increasingly require more detailed safety control of drug candidates to ensure safety and to avoid product recalls. In order to comply with these regulations CROs must ...
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FDA Approves Drug That Boosts Stem Cell Yield For Bone Marrow Transplants

The U.S. Food and Drug Administration approved Mozobil (plerixafor), a drug that helps increase the number of blood stem cells for bone marrow transplantation in patients with certain forms of blood cancer. Mozobil is intended to be used in combination with the growth factor granulocyte-colony stimulating factor (G-CSF), for treatment of adults with multiple myeloma or non-Hodgkin's lymphomas.

FDA Taking Steps To Improve Contact Lens Safety

The U.S. Food and Drug Administration is taking steps to improve contact lens safety by reminding consumers of the importance of following proper cleaning and storing procedures. Consumers who do not follow instructions for contact lens care and use increase their risk of serious eye infections that can lead to blindness. To support proper cleaning and storage, the FDA has developed a new video on contact lens safety, which can be found on the FDA's Web site (

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...

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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Abbott Receives FDA Approval For TRILIPIXT, First And Only Fibrate Indicated For Use In Combination With A Statin For Cholesterol Management

Recently, the U.S. Food and Drug Administration (FDA) approved Abbott's TRILIPIXT (fenofibric acid) delayed-release capsules for use along with diet to help lower triglycerides and LDL cholesterol, and to raise HDL cholesterol in patients with lipid problems. TRILIPIX is the first and only fibrate to be approved for use in combination with a statin. In certain patients, treatment guidelines recommend the combination of a fibrate with a statin to further improve lipid levels.

Nutra Pharma Completes FDA Submission For Nyloxin OTC And Nyloxin Rx - Over-the-Counter And Prescription Treatments For Chronic Pain

Nutra Pharma Corp...

Allergan Receives FDA Approval For ACUVAIL™ Ophthalmic Solution For The Treatment Of Pain And Inflammation Following Cataract Surgery

Allergan, Inc. (NYSE: AGN) announced that the United States Food and Drug Administration (FDA) has approved ACUVAIL™ (ketorolac tromethamine ophthalmic solution) 0.45%, an advanced, preservative-free formulation of ketorolac, a nonsteroidal anti-inflammatory drug (NSAID) indicated for the treatment of pain and inflammation following cataract surgery.

Outsourcing of R&D functions is reshaping the drug development services industry.

As per Esploron www.esploron.com executive management the cost of drug development has soared during the past ten years compelling pharmaceutical and biotechnology companies to look for new, smarter ways of conducting clinical research. Driven by mounting market pressures, ...
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Pharmion Ltd Withdraws Its Marketing Authorisation Application For Orplatna (satraplatin), Europe

The European Medicines Agency (EMEA) has been formally notified by Celgene Europe Ltd of Pharmion Ltd's decision to withdraw the application for a centralised marketing authorisation for the medicine Orplatna (satraplatin) 10 mg and 50 mg capsules. Orplatna was expected to be used, in combination with prednisone and prednisolone, in the treatment of patients with metastatic hormone-refractory prostate cancer who have failed prior chemotherapy.

Stem Cells Guided To Damaged Tissue By Nanomagnets

Microscopic magnetic particles have been used to bring stem cells to sites of cardiovascular injury in a new method designed to increase the capacity of cells to repair damaged tissue, UCL scientists haved announced.

Possibilities For HHS Secretary, FDA Commissioner In Obama Administration Discussed

Democratic congressional staffers and others have begun "floating names for top health posts" in the administration of President-elect Barack Obama that include several possibilities for HHS secretary, the Wall Street Journal's "

Pharmalef Inc. is starting collaboration in development of new oral delivery platform

Pharmalef 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.Moreover, oral delivery improves patient compliance, improves treatment, ...
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Teva Announces Approval And Launch Of Generic Solodyn(R) Extended-Release Tablets

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced that the U.S. Food and Drug Administration has granted final approval for the Company's Abbreviated New Drug Application (ANDA) to market its generic version of Medicis Pharmaceutical Corporation's acne treatment Solodyn® (Minocycline HCl) Extended-Release Tablets, 45 mg, 90 mg and 135 mg. Shipment of this product has commenced.

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.

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,

In the United States, CROs receive an estimated 60% of the clinical research outsourced from pharmaceutical companies.

Typically, large CROs compete on the basis of medical and scientific expertise in specific therapeutic areas; the ability to manage large-scale trials on a global basis with strategically located facilities, by providing medical database management capabilities, providing statistical and ...
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Greyson's Trilexon(R) System Receives Trademark Approval

GREYSON INTERNATIONAL, INC. (GYSN.PK) has been awarded trademark approval for Trilexon®, a new delivery system which will improve the effectiveness of virtually every topical application in today's cosmetic market and every over-the-counter topical drug application. The first products featuring the Trilexon® system are skin-care products that are currently in the preparation stage to be sold in the marketplace.

Samaritan's HIV Drug Granted IND From FDA

Samaritan Pharmaceuticals (OTCBB:SPHC), a biopharmaceutical company committed to commercializing new innovative therapeutic drugs, announced that it has filed an IND (Investigational New Drug) application for SP-6310 in the treatment of HIV-infected patients with abnormal cortisol levels. Following discussions and protocol agreement with U.S.

POZEN Submits New Drug Application For VIMOVOT (PN 400)

POZEN Inc. (NASDAQ:POZN), announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the marketing approval of VIMOVOT (PN 400), the combination of enteric coated (EC) naproxen and immediate release esomeprazole. POZEN and AstraZeneca entered into a global co-development agreement for VIMOVO in August 2006.

Pharmalef Inc. is starting collaboration in development of new oral delivery platform

Pharmalef 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.Moreover, oral delivery improves patient compliance, improves treatment, ...
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FDA Announces Second Annual Science Writers Symposium

Science is a key foundation for the decisions FDA makes daily on a wide-range of products affecting human and animal health-from the most common food ingredients, to complex medical and surgical devices, to lifesaving drugs. The Second Annual Science Writers Symposium on Nov. 4 and 5, 2009, at the FDA's White Oak campus in Silver Spring, Md., will highlight how the FDA applies novel scientific approaches to critical public health issues and the products it regulates.

Explaining NCRP Report No. 160 On Increased Average Radiation Exposure Of The US Population

Scientists at the American Association of Physicists in Medicine (AAPM) are offering additional background information to help the public avoid misinterpreting the findings contained in a report issued by the National Council on Radiation Protection and Measurements (NCRP), a non-profit body chartered by the U.S. Congress to make recommendations on radiation protection and measurements.

FDA Panel Recommends Approval Of New, Less Costly Female Condom

An FDA advisory panel on Thursday voted 15-0 to recommend approval of the new, less costly version of the female condom developed by the Female Health Company, Reuters reports.

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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ABRAXANE For Metastatic Breast Cancer Approved In Australia

Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated, global biotechnology company, and Specialised Therapeutics Australia Pty Ltd, today announced that approval has been received from the Therapeutic Goods Administration (TGA) in Australia to market ABRAXANE® (nanoparticle albumin-bound paclitaxel) 100 mg powder for injection (suspension) for the treatment of metastatic carcinoma of the breast after failure of anthracycline therapy.

Kaiser Daily Health Policy Report Feature Highlights Recent Blog Entries

"Blog Watch" offers readers a roundup of health policy-related blog posts.The American Prospect's Ezra Klein looks at different options Senate Democrats might attempt for budget reconciliation.

Oral Laquinimod For Multiple Sclerosis Granted Fast Track Status By FDA

Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI) today announced that oral laquinimod, an investigational treatment for relapsing-remitting multiple sclerosis (RRMS), has received a Fast Track designation from the U.S. Food and Drug Administration (FDA).

Clinproxy recommends that sponsors use their expertise in creating a budget within their means.

It is a reality that the development of pharmaceutical drugs is a very expensive task. Yet, these costs are necessary due to the substantial investment of both resources and time of the companies in question. If a company is willing to invest millions of dollars it is a given they would seek ...
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NIH And FDA Announce Collaborative Initiative To Fast-Track Innovations To The Public

The U.S. Food and Drug Administration and the National Institutes of Health unveiled an initiative designed to accelerate the process from scientific breakthrough to the availability of new, innovative medical therapies for patients...

FDA Approves Orphan Drug Status For Revolutionary Cancer Drug For Children

The Cure Our Children Foundation, a nonprofit charitable foundation dedicated to children, announced that the U.S. Food and Drug Administration (FDA) has approved the Orphan Drug Designation of the foundation's unique drug product for children with Ewing's Sarcoma cancer. The efforts to develop this drug were made possible by the generous volunteers and researchers in private industry and at two universities.


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

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FDA, FSIS, CDC Collaborate On Methods To Measure Success Of Food Safety Programs

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Understanding Your Liability and Confidentiality in Clinical Trials

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Alcon To Purchase Ophthalmic Pharmaceutical Assets From Sirion

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LA Biomed Study Finds Medication Improves Health Of Patients With Pulmonary Arterial Hypertension

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

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(613) 686-5745 Cerepotec Pharmalef

FDA Warns Web Sites Against Marketing Fraudulent H1N1 Flu Virus Claims

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Kellogg To Stop Immunity Claims On Rice Krispies, US

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FDA Seeks Recall Of 25 Weight Loss Pills With Potentially Unsafe Ingredients

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ClinQua Inc. : The overall cost of clinical trials depends on an array of factors

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Bayer Welcomes The Proposed EMEA Labeling Changes For Moxifloxacin

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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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