Pfizer's Novel HIV/AIDS Treatment SELZENTRY™
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- Category: Pfizer
The U.S. Food and Drug Administration (FDA) has granted SELZENTRY™ (maraviroc) full (traditional) approval for use in treatment-experienced adults with CCR5-tropic HIV-1 in combination with other antiretrovirals. SELZENTRY was originally granted accelerated conditional approval in August 2007 based on 24-week data from pivotal Phase 3 studies. SELZENTRY now becomes the latest fully approved treatment for HIV.
AstraZeneca Settles US Pulmicort Respules Patent Litigation with Teva
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- Category: AstraZeneca
AstraZeneca has entered into a settlement agreement in its Pulmicort Respules patent infringement litigation against Ivax Pharmaceuticals, Inc., a wholly owned subsidiary of Teva Pharmaceuticals USA. The agreement settles the patent infringement litigation filed by AstraZeneca following Teva's submission to the United States Food & Drug Administration of an Abbreviated New Drug Application for a generic version of Pulmicort Respules.
Sandoz receives positive EU opinion for biosimilar filgrastim
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- Category: Novartis
Sandoz has received a positive opinion from European regulators for its third biosimilar medicine, filgrastim, marking another important milestone in its efforts to bring affordable high-quality biopharmaceuticals to patients worldwide.
Johnson & Johnson Announces Definitive Agreement to Acquire Omrix
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- Category: Financial
Johnson & Johnson (NYSE: JNJ) and Omrix Biopharmaceuticals, Inc. (NASDAQ: OMRI), a fully integrated biopharmaceutical company that develops and markets biosurgical and immunotherapy products, have announced a definitive agreement whereby Omrix will be acquired for approximately $438 million in a cash tender offer.
GSK and Neptunus form joint venture for the co-development of flu vaccines
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- Category: GlaxoSmithKline
GlaxoSmithKline (GSK) has signed an exclusive Cooperation Agreement with Shenzhen Neptunus Interlong Bio-Technique Co. Ltd. (NIBT) as a preliminary step in forming a Joint Venture (JV) between the two companies. The agreement outlines the proposed terms for establishing a JV company, which will seek to co-develop seasonal influenza vaccines and pre-pandemic/pandemic influenza vaccines, firstly targeting against strains of the virus specific to China, Hong Kong and Macau.
AstraZeneca to divest Nordic over-the-counter portfolio
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- Category: AstraZeneca
AstraZeneca has announced the divestment to GlaxoSmithKline of a portfolio of over-the-counter (OTC) products predominantly sold in Sweden. The decision reinforces AstraZeneca's strategy to focus on innovation in prescription medicines.
Pfizer withdraws its application to change the marketing authorisation for Viagra
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- Category: Pfizer
The European Medicines Agency (EMEA) has been formally notified by Pfizer Limited of its decision to withdraw its application for a change to the marketing authorisation for the medicine Viagra (sildenafil) 50 mg film-coated tablets.
More Pharma News ...
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- CRESTOR® is in line with other marketed statins - new data from the JUPITER study