Latest News in the pharma Industry

Policy & Regulation

Transcept's Insomnia Therapy Wins FDA Approval

Transcept's Insomnia Therapy Wins FDA Approval

29 Nov 2011

The approval is backed by two placebo-controlled studies which evaluated the safety and efficacy of Intermezzo for the treatment of patients with insomnia.

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Novartis Receives European Approval for Rasitrio

Novartis Receives European Approval for Rasitrio

29 Nov 2011

The approval of Rasitrio is based on pivotal phase III data involving more than 1,181 high blood pressure patients.

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European Parliament Calls for Tighter Controls on Antibiotics

European Parliament Calls for Tighter Controls on Antibiotics

29 Nov 2011

The European Parliament has called for tighter controls on the use of antimicrobials to fight growing resistance to bacteria.

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EMA Launches New Review on Non-selective NSAIDs

EMA Launches New Review on Non-selective NSAIDs

28 Nov 2011

The EMA has launched a new review on whether non-selective NSAIDs (non-steroidal anti-inflammatory drugs) can damage cardiovascular health.

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India's Supreme Court to Hear Novartis Patent Case

India's Supreme Court to Hear Novartis Patent Case

28 Nov 2011

The case is the final act in a legal battle over the patentability of the salt form of the anti-cancer drug imatinib and section 3(d) of the Indian patent law that stretches back over five years.

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Takeda Submits NDA for Type 2 Diabetes Therapy

Takeda Submits NDA for Type 2 Diabetes Therapy

25 Nov 2011

Takeda submitted a New Drug Application to the FDA for the fixed-dose combination therapy alogliptin/metformin.

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EMA Recalls Ben Venue Cancer Drugs

EMA Recalls Ben Venue Cancer Drugs

24 Nov 2011

Four cancer drugs and the antiviral medicine Vistide have been recalled owing to problems in the sterilisation process.

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Mylan Settles Drug Lawsuit with Novartis

Mylan Settles Drug Lawsuit with Novartis

23 Nov 2011

Mylan has settled a patent litigation lawsuit with Novartis Pharmaceuticals related to Vivelle-Dot.

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NMP Expected to Enhance Indian Pharma Industry

NMP Expected to Enhance Indian Pharma Industry

23 Nov 2011

Drug pharmaceutical manufacturers, drug production industry experts opine that NMP would help to leverage the benefits from improved infrastructure, simplification of business regulations and skill upgrade measures.

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FDA Accepts NDA for Northera

FDA Accepts NDA for Northera

23 Nov 2011

The FDA will review and act on the application for the drug, designed to treat symptomatic neurogenic orthostatic hypotension, by 28 March 2012.

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FDA Approves Orphan Drug Erwinaze against Acute Lymphoblastic Leukemia

FDA Approves Orphan Drug Erwinaze against Acute Lymphoblastic Leukemia

21 Nov 2011

The approval is based on the results of clinical studies in 630 acute lymphoblastic leukemia patients.

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FDA Approves Eylea to Treat Eye Disorder

FDA Approves Eylea to Treat Eye Disorder

21 Nov 2011

The safety and effectiveness of Eylea was evaluated in two clinical trials involving 2,412 adult patients. The studies showed that Eylea was as effective as Lucentis in maintaining or improving visual acuity.

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