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Vertex submits NDA for telaprevir for treating hepatitis C

Vertex Pharmaceuticals Incorporated announced that it has completed the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for telaprevir, Vertex's investigational treatment for people with hepatitis C.

23 Nov 2010

Radical change to Alzheimer’s management

The first disease-modifying drugs are expected to launch from 2013, radically changing the way Alzheimer’s disease is treated. With the potential to successfully slow or halt the progression of Alzheimer’s, blockbuster revenues are beckoning for such pipeline drugs, claims independent market analyst, Datamonitor.

23 Nov 2010

UnitedHealthcare introduces Pharmacy Saver program to provide affordable prescription drugs

UnitedHealthcare, a UnitedHealth Group company, announced a new program that will enable enrollees in the company's market-leading Medicare plans to save money on hundreds of prescription medications in 2011.

23 Nov 2010

Ziconotide could promote suicidal tendencies: Study

The active agent ziconotide, the synthetic toxin of the cone snail (Conus magus), was acclaimed a safe alternative to morphine when it was introduced six years ago. Now it is increasingly suspected of causing patients to commit suicide. Researchers working under the auspices of Prof. Christoph Maier (Director of the Pain Clinic Bergmannsheil at the Ruhr University in Bochum) presume that ziconotide not only suppresses the transmission of pain stimuli, but also deteriorates the frame of mind and could simultaneously reduce anxiety and impulse control.

23 Nov 2010

Genzyme issues Award of Excellence to Shanghai ChemPartner

ShangPharma Corporation a leading China-based pharmaceutical and biotechnology research and development outsourcing company, today announced that its wholly-owned contract research subsidiary, Shanghai ChemPartner, received an Award of Excellence from Genzyme.

23 Nov 2010

AADA releases updated position statement on isotretinoin usage

The American Academy of Dermatology Association (AADA) recently updated its position statement on the use of isotretinoin. The position continues to state that patient safety is dermatologists' primary concern and that the AADA is committed to the safe and responsible use of isotretinoin, which is the most effective treatment for severe acne.

23 Nov 2010

HIV drugs lead to insulin resistance

The same powerful drugs that have extended the lives of countless people with HIV come with a price - insulin resistance that can lead to diabetes and cardiovascular disease.

23 Nov 2010

USPTO issues patent for neurotherapeutic pharmaceutical formulation

Rexahn Pharmaceuticals, Inc., a clinical stage pharmaceutical company developing and commercializing potential best in class oncology and CNS therapeutics, today announced that the U.S. Patent & Trademark Office has issued U.S. Patent 7,833,998 entitled, Oral Neurotherapeutic Cephalosporin Sulfoxide and Sulfone-containing Compositions.

23 Nov 2010

Soligenix receives U.S patent for modified immunogen in RiVax vaccine

Soligenix, Inc., a late-stage biopharmaceutical company, announced today that the United States Patent and Trademark Office has granted patent #7,829,668, entitled Compositions and methods for modifying toxic effects of proteinaceous compounds.

22 Nov 2010

Confidisc introduces new anti-illegal drug syringe

ConfiDisc's anti-illegal drug syringe is an integral part of its syringe injection system. The disc, which is attached to the hub of a syringe device, acts as a physical barrier.

22 Nov 2010

Is the decade long flirtation with vaccines over?

In light of increasing competition, saturation of key vaccine sectors and a lack of innovative late-stage vaccine candidates, maintaining the strong growth of the last decade will be a major challenge for the vaccines industry suggests independent market analyst, Datamonitor.

22 Nov 2010

Impax initiates challenge of patents relating to WELCHOL

Impax Laboratories, Inc. today confirms that it has initiated a challenge of patents listed by Daiichi Sankyo, Inc. in connection with its WELCHOL® (Colesevelam HCl) for Oral Suspension, 3.75 gm/packet and 1.875 gm/packet.

22 Nov 2010

FDA grants Impax tentative approval for generic Cymbalta NDA

Impax Laboratories, Inc. confirmed that the U.S. Food and Drug Administration (FDA) has granted tentative approval of the Company's Abbreviated New Drug Application for generic version of Cymbalta® delayed-release (duloxetine hydrochloride) 20, 30 and 60 mg capsules.

22 Nov 2010

Grifols launches Flebogamma 10% DIF intravenous immune globulin in the U.S.

Grifols today announced availability of its recently approved Flebogamma® 10% DIF intravenous immune globulin. Grifols is a global healthcare company specializing in bioscience medicines derived from human plasma. Approval from the US Food and Drug Administration (FDA) for Flebogamma® 10% DIF was obtained in July 2010 and final approval in Europe is expected before the end of the year. Today's announcement signals widespread product availability to the US market.

22 Nov 2010

Spectral enters distribution agreement with Toray to market TORAYMYXIN in Canada

Spectral Diagnostics Inc., today announced that it has signed a long-term, exclusive distribution agreement with Toray Industries, Inc. and Toray Medical Co., Ltd. of Japan (collectively "Toray") to market and sell Toraymyxin™ in Canada. Toraymyxin™ is a therapeutic hemoperfusion device that removes endotoxin, which can cause sepsis, from the bloodstream. This product and Spectral's EAA™ diagnostic, which measures endotoxin and identifies patients for treatment, are already approved for sale by Health Canada.

22 Nov 2010

Convergence enters drug discovery collaboration with Selcia for chronic pain treatment

Convergence Pharmaceuticals Limited, the new company focused on the development of novel and high value analgesic medicines, and Selcia Limited, a contract research organisation, today are pleased to announce that they have entered into a drug discovery collaboration to identify and develop high quality candidate molecules for the treatment of chronic pain.

22 Nov 2010

Best Practices study: Mock review helps effective approach for preparing team for NDA advisory committee meeting

Pharmaceutical companies with good track records of approvals and first approvals are characterized not only by strong science but also strong working relationships with the FDA. Regulatory Affairs is the function that oversees and guides interactions with the FDA it's a job that comes with a plethora of responsibilities related to New Drug Applications (NDA).

20 Nov 2010

Surveyed cardiologists, PCPs perceive Crestor comparable to Lipitor in ability to reduce mortality

Decision Resources, one of the world's leading research and advisory firms for pharmaceutical and healthcare issues, finds that in the treatment of dyslipidemia, surveyed cardiologists and primary care physicians (PCPs) now perceive AstraZeneca's Crestor's ability to reduce mortality comparable to Pfizer's Lipitor. This finding has changed from Decision Resources' 2009 analysis in which surveyed cardiologists viewed Lipitor as significantly better on this end point.

20 Nov 2010

Vical to present results of Vaxfectin adjuvant at Conference in Hungary

Vical Incorporated today announced that the company is presenting an overview of results for its patented Vaxfectin adjuvant at the Modern Veterinary Vaccines & Adjuvants conference.

20 Nov 2010

Xanodyne to withdraw propoxyphene-containing products from the U.S. market

Xanodyne Pharmaceuticals, Inc. announced today that the company will voluntarily withdraw its Darvon, Darvon-N and Darvocet-N products from the U.S. market in consultation with the U.S. Food and Drug Administration (FDA).

20 Nov 2010