Latest News in the pharma Industry

Policy & Regulation

European Patent Office Grants Patent for Sativex

European Patent Office Grants Patent for Sativex

18 Nov 2011

The European Patent Office has granted a patent for endocannabinoid modulator Sativex with an exclusivity period until August 2023.

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FDA Approves First Drug to Treat Myelofibrosis

FDA Approves First Drug to Treat Myelofibrosis

18 Nov 2011

Jakafi has become the first drug approved to specifically treat patients with the bone marrow disease.

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EMA Accepts MAA for PBA Therapy

EMA Accepts MAA for PBA Therapy

18 Nov 2011

The MAA is based on comprehensive clinical data from Avanir's controlled phase 3 studies of NUEDEXTA in patients with PBA.

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FDA Approves Anti-depressant CPI-300

FDA Approves Anti-depressant CPI-300

17 Nov 2011

CPI-300 is a single dose 450mg formulation of bupropion hydrochloride for the treatment of major depressive disorder.

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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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