Latest News in the pharma Industry

Policy & Regulation

EMA Reviews Cardiovascular Risks of Non-selective NSAIDs

EMA Reviews Cardiovascular Risks of Non-selective NSAIDs

24 Oct 2011

NSAIDS have been the subject of several European reviews in relation to gastrointestinal and cardiovascular safety and the occurrence of serious skin reactions.

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India's CDSCO Delegation to Inspect Manufacturing Sites in China

India's CDSCO Delegation to Inspect Manufacturing Sites in China

24 Oct 2011

A three-member delegation of the Central Drugs Standard Control Organization will leave for China next month to inspect a total of six diagnostics and bulk drug units there.

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Oxford BioMedica Wins IND Approval for Gene-based Therapy

Oxford BioMedica Wins IND Approval for Gene-based Therapy

21 Oct 2011

The Phase I/IIa study will enroll around 18 patients with Usher syndrome type 1B and assess three dose levels of UshStat for safety, tolerability and aspects of biological activity.

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India Considers Special Financial Package to Boost Pharma Exports

India Considers Special Financial Package to Boost Pharma Exports

21 Oct 2011

India is considering the need for special financial package to boost the exports of pharma products from India.

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ISPE Releases New Guidance on Pharmaceutical Commissioning & Qualification

ISPE Releases New Guidance on Pharmaceutical Commissioning & Qualification

20 Oct 2011

The new guidance describes how firms can move from established baseline practice to a more efficient science- and risk-based framework.

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European Court of Justice Bans Patents for Embryonic Stem Cell Research

European Court of Justice Bans Patents for Embryonic Stem Cell Research

20 Oct 2011

The European Court of Justice has banned the issuing of patents for embryonic stem cell research, in a case that could have major implications for medical research.

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India's Pharma Industry May Move Court on Barcoding Issue

India's Pharma Industry May Move Court on Barcoding Issue

20 Oct 2011

India's pharma industry may move court against the union commerce ministry's notification dated 10th January, 2011 under which barcoding was made mandatory for pharma exports, if the government does not amend the notification to make it exporter friend...

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Lux Biosciences Withdraws Marketing Authorisation Application for Luveniq

Lux Biosciences Withdraws Marketing Authorisation Application for Luveniq

19 Oct 2011

The company stated that they were unable to demonstrate to the satisfaction of the CHMP an overwhelming effect showing that the benefits of Luveniq outweigh its risks, and thus would qualify for a recommendation for authorisation with one pivotal study...

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NICE New Draft Guidance Recommends against Ipilimumab Use

NICE New Draft Guidance Recommends against Ipilimumab Use

18 Oct 2011

New draft guidance from the NICE recommends against the use of ipilimumab for advanced malignant melanoma in people who have received prior chemotherapy.

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Watson Files ANDA with FDA for Generic Daytrana

Watson Files ANDA with FDA for Generic Daytrana

17 Oct 2011

Watson Laboratories has filed an Abbreviated New Drug Application with the U.S. FDA for the marketing approval of Methylphenidate Transdermal System.

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India to Reimburse Product Registration Fees to Pharma Exporters

India to Reimburse Product Registration Fees to Pharma Exporters

14 Oct 2011

The move is considered to be a measure to motivate and encourage Pharmexcil members in export trade of pharmaceuticals.

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FDA Adds Warning to Leukemia Drug Sprycel

FDA Adds Warning to Leukemia Drug Sprycel

13 Oct 2011

The FDA said the drug can increase the risk of pulmonary arterial hypertension. The potential risk has been added to the warnings and precautions section of Sprycel's label.

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