Latest News in the pharma Industry

Policy & Regulation

GSK Submits Additional Information for Combination Vaccine

GSK Submits Additional Information for Combination Vaccine

2 Dec 2011

GlaxoSmithKline has submitted additional information to the FDA in support of the Biologics License Application for its candidate meningococcal and Hib combination vaccine.

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USP Publishes First Ten Quality Standards in New Medicines Compendium

USP Publishes First Ten Quality Standards in New Medicines Compendium

1 Dec 2011

The newly-authorized quality standards have been approved by USP and will now offer a new vehicle for improving medicines quality around the world.

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India's NPPA Hikes Prices of Six Bulk Drugs

India's NPPA Hikes Prices of Six Bulk Drugs

30 Nov 2011

The six bulk drugs are frusemide, silver sulphadiazine, pentazocine, famotidine, carbamazepine and erythromycin.

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Komboglyze Receives EU Marketing Authorisation

Komboglyze Receives EU Marketing Authorisation

30 Nov 2011

The approval of KOMBOGLYZE is based on a saxagliptin development programme that involved 4,326 patients, including 2,158 individuals receiving saxagliptin plus metformin.

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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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