Latest News in the pharma Industry

Policy & Regulation

NICE Approves AstraZeneca's Brilique

NICE Approves AstraZeneca's Brilique

31 Oct 2011

NICE approved the drug for use for up to 12 months as a treatment option for patients who have had a hear attack or an episode of unstable angina.

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EMA Simplifies SME Assignment Process

EMA Simplifies SME Assignment Process

31 Oct 2011

The new process is expected to reduce the administrative burden on companies and to speed up the SME assignment and renewal process.

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Atox Bio Granted Orphan Drug Designation for AB103

Atox Bio Granted Orphan Drug Designation for AB103

31 Oct 2011

The drug candidate has completed a Phase I study and expects to go into a Phase II proof-of-concept study to assess its clinical benefit.

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FDA Nods for Sagent Bupivacaine Hydrochloride Injection

FDA Nods for Sagent Bupivacaine Hydrochloride Injection

27 Oct 2011

Sagent Pharmaceuticals' bupivacaine hydrochloride injection wins FDA approval and will be available in six single-dose and two multi-dose latex-free vials.

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WHO Working Group to Hold Session against Counterfeit Medical Products

WHO Working Group to Hold Session against Counterfeit Medical Products

25 Oct 2011

The working group of the World Health Organisation will held its second meeting on the issue of spurious drugs from October 25 to 28 at Geneva.

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EU Antitrust Regulators Investigate Suspected Deal between J&J and Novartis

EU Antitrust Regulators Investigate Suspected Deal between J&J and Novartis

25 Oct 2011

EU regulators have launched investigation focused on a suspected agreement between Johnson & Johnson and Novartis to delay the sale of a generic painkiller in the Netherlands.

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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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