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News Breaks
June 27, 2014
09:29 EDTRBXLY, NVSRanbaxy subsidiary to launch generic valsartan tablets
Ohm Laboratories, a wholly owned subsidiary of Ranbaxy Laboratories (RBXLY), announced that Ohm has received approval from the Food and Drug Administration to manufacture and market valsartan 40 mg, 80 mg, 160 mg, and 320 mg tablets on an exclusive basis. The Office of Generic Drugs, U.S. Food and Drug Administration, has determined the Ohm formulations to be bioequivalent and have the same therapeutic effect as that of Novartis' (NVS) branded drug Diovan. The company said, "Ohm is pleased to announce this first-to-file FDA approval for Valsartan tablets, which will be introduced to all classes of trade, with 180-days marketing exclusivity, as soon as sufficient supplies are manufactured to meet the needs of the market. Valsartan will be manufactured at the Ohm facilities located in New Brunswick, New Jersey."
News For RBXLY;NVS From The Last 14 Days
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September 29, 2014
08:07 EDTNVSPhase 2 trial of binimetinib in NRAS melanoma shows promising clinical activity
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September 26, 2014
07:30 EDTNVSNovartis drug Signifor LAR recommended by CHMP for EU approval
The Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency, or EMA, adopted a positive opinion for Signifor long acting release, or LAR, formulation to treat adult patients with acromegaly for whom surgery is not an option or has not been curative and who are inadequately controlled on treatment with a first-generation somatostatin analogue, or SSA. If approved in the EU, this next-generation SSA could fill a current unmet need, providing a new therapeutic option for the approximately 45% of acromegaly patients whose growth hormone, or GH, or insulin-like growth factor-1, or IGF-1, levels remain inadequately controlled despite treatment with currently available SSAs.
September 25, 2014
05:28 EDTNVSNovartis AIN457 meets primary endpoint in two Phase III studies
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September 22, 2014
16:07 EDTNVSAnacor announces commercial launch of KERYDIN topical solution in U.S.
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September 16, 2014
07:31 EDTNVSEuropean Association for Study of Diabetes to hold annual meeting
50th Annual Meeting of EASD to be held in Vienna, Austria on September 15-19.

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