Latest News in the pharma Industry

Policy & Regulation

FDA Issues Orphan Drug Status for Santen Sirolimus Drug

FDA Issues Orphan Drug Status for Santen Sirolimus Drug

16 Nov 2011

The FDA has granted orphan drug designation to the Japanese pharmaceutical company's sirolimus drug.

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FDA Nods for Cord Blood Therapy

FDA Nods for Cord Blood Therapy

16 Nov 2011

The FDA has approved Hemacord for the treatment of blood forming disorders or cancer.

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Amgen Announces EU Approval for Vectibix

Amgen Announces EU Approval for Vectibix

16 Nov 2011

Amgen announced that the European Commission has approved to extend the therapeutic indications for Vectibix, a therapy to treat colorectal cancer.

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India's DoP Considers Anti-dumping Duty on API Imports from China

India's DoP Considers Anti-dumping Duty on API Imports from China

16 Nov 2011

The DoP is learnt to have taken up the matter with the Ministry of Commerce for imposing anti-dumping duty. However, the Commerce Ministry is still studying the matter and a decision would be taken up after analysing all related aspects, sources said.

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ISPE to Publish Updated Water and Steam Systems Guide

ISPE to Publish Updated Water and Steam Systems Guide

15 Nov 2011

The new edition includes tools to help pharmaceutical manufacturers meet safety requirements while avoiding unnecessary cost.

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FDA Grants Fast-track Designation to Opexa Tovaxin Drug

FDA Grants Fast-track Designation to Opexa Tovaxin Drug

14 Nov 2011

The FDA has granted fast-track designation to Opexa Therapeutics' Tovaxin drug candidate against secondary progressive multiple sclerosis.

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Merck Receives Two FDA Rejections

Merck Receives Two FDA Rejections

14 Nov 2011

Merck has received two rejections from the US FDA. The company plans to discuss the rejections with the FDA.

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Affymax & Janssen Biotech Settle Patent Dispute

Affymax & Janssen Biotech Settle Patent Dispute

10 Nov 2011

The settlement is to end the arbitration and litigation related to certain intellectual property emerging from a 1992-1995 research collaboration.

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FDA Approves Drug against Late-stage Head and Neck Cancer

FDA Approves Drug against Late-stage Head and Neck Cancer

8 Nov 2011

The FDA has approved Erbitux for use with chemotherapy to treat patients with late-stage head and neck cancer.

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FDA Accepts NDA Filing for Obesity Treatment

FDA Accepts NDA Filing for Obesity Treatment

7 Nov 2011

The FDA indicated that an advisory committee of the Division of Metabolism and Endocrinology Products (DMEP) will meet to discuss the Qnexa NDA in the first quarter of 2012.

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GSK Agrees to Settle US Drug Dispute for $3Bn

GSK Agrees to Settle US Drug Dispute for $3Bn

4 Nov 2011

GSK has agreed to pay $3bn to settle all US investigations into the way the company marketed and developed its products.

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India to Extend Price Control of Essential Medicines

India to Extend Price Control of Essential Medicines

4 Nov 2011

India is to extend its price control of essential medicines from the current 34 to at least 400 drugs.

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