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IGI Laboratories submits second abbreviated new drug application to FDA

IGI Laboratories, a New Jersey based formulation and manufacturing company, today announced that it has submitted its second abbreviated new drug application to the US FDA.

10 Jan 2011

Obama administration sides with drug companies in pricing lawsuit; Supreme Court agrees to hear case regarding use of prescription drug data

At issue are charges to public hospitals and clinics that treat a large number of poor patients and a Vermont law that restricts prescription drug data.

10 Jan 2011

Shionogi brings KAPVAY ADHD drug to the U.S market

Shionogi Inc., the U.S.-based group company of Shionogi & Co., Ltd., today announced a true milestone as it marks the first commercial availability for the non-central nervous system stimulant medication KAPVAY™, an extended-release oral formulation of clonidine for Attention Deficit Hyperactivity Disorder (ADHD) in children and adolescents.

10 Jan 2011

Neomend receives CE Mark for ProGEL PLATINUM Surgical Sealant

Neomend, Inc., an innovator in sealant and adhesion-prevention products for the surgical marketplace, announced it has received the European Union CE Mark for the company's ProGEL® PLATINUM Surgical Sealant.

10 Jan 2011

EffRx submits EX101 NDA for osteoporosis treatment to FDA

EffRx Pharmaceuticals SA, a Lausanne, Switzerland based drug delivery company announces the NDA submission of the company's lead project to the US Food and Drug Administration.

10 Jan 2011

Manhattan enters settlement and release agreement with Nordic and H Pharmaceuticals

Manhattan Pharmaceuticals, Inc. announced that on January 4, 2011, the company entered into a settlement and release agreement with Nordic Biotech Fund II K/S and H Pharmaceuticals K/S. Manhattan Pharmaceuticals and Nordic are partners in the H Pharmaceuticals joint venture for the development and commercialization of Hedrin®, a non-pesticide treatment for head lice.

10 Jan 2011

Pennsaid fourth quarter prescriptions increase 20% sequentially

Nuvo Research Inc., a specialty pharmaceutical company focused on the research and development of drug products that are delivered into and through the skin using its topical and transdermal drug delivery technologies, and on the development of its immune modulating drug candidate WF10, today announced it will be meeting with several U.S. investment bankers, analysts and fund managers during J.P. Morgan's 29th annual Healthcare Conference held from January 10th to January 13th, 2011, in San Francisco, California.

10 Jan 2011

New, paid prescriptions for Questcor's Acthar increase 66%

Questcor Pharmaceuticals, Inc. today reported a strong finish to 2010. The Company estimates that 353 new, paid Acthar prescriptions for the treatment of multiple sclerosis (MS) were filled and shipped during the quarter, up 66% from the year ago period and up 9% from the third quarter of 2010.

10 Jan 2011

Watson receives FDA approval for generic Fentora

Watson Pharmaceuticals, Inc. today announced that its subsidiary, Watson Laboratories, Inc., has received approval from the United States Food and Drug Administration (FDA) for Fentanyl Buccal tablets, USP, in the 0.1, 0.2, 0.4, 0.6 and 0.8 mg strengths, the generic equivalent to Cephalon's Fentora ® tablets.

10 Jan 2011

New study finds extending term of exclusive access can lead to higher drug costs in short term

A new study in the January 2011 issue of Health Affairs is the first to calculate the financial and social costs of limiting access to trial data — and finds that extending the term of exclusive access will lead to higher drug costs in the short term but also to more than 200 extra drug approvals and to greater life expectancy in the next several decades.

10 Jan 2011

Endo Pharmaceuticals receives FDA complete response letter for OPANA ER

Endo Pharmaceuticals today announced that it received a complete response letter from the U.S. Food and Drug Administration regarding the New Drug Application for its new formulation of OPANA® ER designed to be crush resistant.

10 Jan 2011

FDA warns public about extortion scam

The U.S. Food and Drug Administration is warning the public about criminals posing as FDA special agents and other law enforcement personnel as part of a continued international extortion scam.

10 Jan 2011

FDA approves Abstral drug for treatment of breakthrough pain in cancer patients

Orexo AB announces today that its partner ProStrakan Group plc has received approval from the US Food and Drug Administration for Abstral. Abstral is licensed for the treatment of breakthrough pain in cancer patients, 18 years of age and older, who are already receiving, and are tolerant to, opioid analgesics for their underlying persistent cancer pain.

10 Jan 2011

U.S. District Court grants injunction for Sensipar patents

A U.S. District Court in Delaware today granted an injunction preventing Teva Pharmaceuticals USA, Inc., Teva Pharmaceuticals Industries Ltd., and Barr Laboratories, Inc. from commercializing generic versions of Amgen's Sensipar® (cinacalcet) until expiration of the drug's U.S. patents.

10 Jan 2011

Abstral transmucosal tablets receive FDA approval, may help manage pain in cancer patients

The U.S. Food and Drug Administration today approved Abstral transmucosal tablets to manage breakthrough pain for adults with cancer.

9 Jan 2011

Old flu jabs from pandemic to combat this winter’s peak

With rise of incidence of flu this winter emergency stocks of the vaccine are being released. A review is to be carried out into whether vaccines should be purchased centrally next year in order to avoid shortages. At present the GPs can procure the jabs directly from manufacturers according to their estimates of patient requirement.

9 Jan 2011

Malaria drug makes cancer drug more effective

Scientists investigating the cancer-fighting properties of artesunate - a drug commonly used to treat malaria - have found early evidence that combining it with an existing cancer drug has the potential to make each drug more effective than when used alone. They also found that regular treatment breaks could improve success levels.

7 Jan 2011

NovaDel receives $500,000 milestone payment from Akrimax in connection with NitroMist agreement

NovaDel Pharma Inc. today announced that it has received a $500,000 milestone payment from Akrimax Pharmaceuticals. The milestone payment was received in connection with the license and distribution agreement, dated October 27, 2009, between NovaDel Pharma Inc. and Mist Acquisition, LLC, an affiliate of Akrimax Pharmaceuticals.

7 Jan 2011

FDA approved KOMBIGLYZE XR for type 2 diabetes mellitus now available in pharmacies

Bristol-Myers Squibb Company, and AstraZeneca today announced that KOMBIGLYZE™ XR (saxagliptin and metformin HCl extended-release), approved by the U.S. Food and Drug Administration (FDA) on November 5, 2010, is now available by prescription in pharmacies across the United States.

7 Jan 2011

Dendreon provides U.S. commercialization and European strategy updates for PROVENGE

Dendreon Corporation today announced several updates regarding the U.S. commercialization of PROVENGE® (sipuleucel-T), the European strategy for PROVENGE, and progress on its pipeline.

7 Jan 2011