Latest News in the pharma Industry

Policy & Regulation

Spectrum Submits IND Application for SPI-014

Spectrum Submits IND Application for SPI-014

6 Dec 2011

The company expects to commence Phase I studies of the drug candidate used for ESRD patients as soon as possible after FDA review.

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BIO Welcomes Senate Passage of SBIR Program Reauthorization

BIO Welcomes Senate Passage of SBIR Program Reauthorization

5 Dec 2011

SBIR grants are critical for supporting small companies with promising scientific innovation to continue critical research and development of medical advancements and breakthroughs.

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Russian Drugmakers Question Pricing Strategy

Russian Drugmakers Question Pricing Strategy

5 Dec 2011

Russian pharmaceutical industry has questioned the country's list of vital and essential drugs (ZHMVLP) that forbids price increases.

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Teva Wins Tentative Approval of Generic Lipitor

Teva Wins Tentative Approval of Generic Lipitor

2 Dec 2011

The FDA has granted tentative approval for the Company's Abbreviated New Drug Application for Atorvastatin Calcium Tablets.

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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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