Product

Ranbaxy announces launch of Atorvastatin, generic Lipitor®, in the U.S.

Ranbaxy Pharmaceuticals Inc., a wholly owned subsidiary of Ranbaxy Laboratories Ltd. (RLL, NSE: RANBAXY, BSE: 500359) ("Ranbaxy"), today announced that it has received final approval from the U.S. Food and Drug Administration to manufacture and market Atorvastatin and has launched the product in the U.S. market.

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Forest Laboratories and Nycomed Receive Complete Response Letter for Roflumilast

Forest Laboratories, Inc.Forest Laboratories, Inc. (NYSE: FRX) and Nycomed announced that the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the New Drug Application (NDA) for roflumilast.

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Saudi Food and Drug Authority Suspends The Authorisation of Rosiglitazone (Avandia®)

The Saudi food and Drug Authority has reviewed the safety of Rosiglitazone (Avandia®) which used in treatment of type 2 diabetes mellitus and marketed in Saudi Arabia as Avandia®.

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Novel Drug for Chronic Management of Hyperuricemia in Gout Patients

Teijin Pharma Limited announced the European launch of TMX-67 (febuxostat), a novel drug discovered by Teijin Pharma for the treatment of hyperuricemia in patients with gout. Ipsen, a global biotechnology specialty care group and the TMX-67 licensee in Europe, and its sublicensee the Menarini Group, the first Italian pharmaceutical group in the world, have began marketing the product in Europe under the brand name ADENURIC(r).

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FDA Grants IBsolvMIR Orphan Drug designation in the treatment of diabetes patients in the U.S.

TikoMed AB, a biotechnology company focused on development and commercialization of innovative treatments for immune diseases and cell therapies, today announced that IBsolvMIR® has been granted orphan drug designation for the prevention of graft rejection of pancreatic islet transplantation by the U.S. Food and Drug Administration (FDA).

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Orphan Drug Designation for the treatment of patients with atypical Hemolytic Uremic Syndrome (aHUS)

Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) announced today that Soliris(R) (eculizumab), its first-in-class complement inhibitor, has been granted Orphan Medicinal Product Designation by the European Commission for the treatment of patients with atypical Hemolytic Uremic Syndrome (aHUS).

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Schering-Plough Announces European Filing of SYCREST(R) (asenapine)

Schering-Plough CorporationSchering-Plough Corporation (NYSE: SGP) announced that the European Medicines Agency (EMEA) has validated (accepted for review) the company's Marketing Authorization Application (MAA) for SYCREST(R) (asenapine) sublingual tablets for the treatment of schizophrenia and manic episodes associated with bipolar I disorder.

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Novo Nordisk and Aarhus University …

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Bristol-Myers Squibb Company (NYSE: BMY) and PsiOxus Therapeutics, Ltd. (PsiOxus) today announced an exclusive clinical collaboration agreement to evaluate the safety, to...

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Bristol-Myers Squibb acquires Cormo…

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Sanofi Pasteur signs research agree…

Sanofi and its vaccines global business unit Sanofi Pasteur announced today a Cooperative Research and Development Agreement with the Walter Reed Army Institute of Resear...

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FDA advances Precision Medicine Ini…

In support of the President’s Precision Medicine Initiative, the U.S. Food and Drug Administration has issued two draft guidances that, when finalized, will provide a fle...

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