Latest News in the pharma Industry

Policy & Regulation

Successful inspection by FDA of Penn Pharma’s development and production facility

Successful inspection by FDA of Penn Pharma’s development and production facility

9 Oct 2012

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EMA publishes list of substances monitored by lead member states

EMA publishes list of substances monitored by lead member states

8 Oct 2012

A list of EU member states with lead responsibility for monitoring the safety of active substances has been published online by the EMA.

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European Medicines Agency enhances cooperation with EU drug-monitoring agency on psychoactive and abused medicines

European Medicines Agency enhances cooperation with EU drug-monitoring agency on psychoactive and abused medicines

17 Sep 2012

The exchange of information on new psychoactive substances and abused medicines has been enhanced today, thanks to an amended working arrangement signed in Lisbon by the directors of the European Medicines Agency (EMA) and the European Monitoring Centr...

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FDA approves Lucentis (ranibizumab injection) for treatment of diabetic macular edema

FDA approves Lucentis (ranibizumab injection) for treatment of diabetic macular edema

6 Sep 2012

Roche announced that Lucentis (ranibizumab injection) was approved by the U.S. Food & Drug Administration (FDA) for treatment of diabetic macular edema (DME), an eye condition in people with diabetes that causes blurred vision, severe vision loss and s...

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EU Drug Approvals 'Should Require Comparative Efficacy Evidence'

EU Drug Approvals 'Should Require Comparative Efficacy Evidence'

14 Aug 2012

An article in the BMJ argues that demonstrating a new drug's lack of inferiority to existing alternatives should be a formal requirement of the approvals process.

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New Rules Should Improve Chinese Pharmaceutical Market

New Rules Should Improve Chinese Pharmaceutical Market

7 Aug 2012

A senior Chinese medical official insists that a new regulation will help to regulate the pharmaceutical excipients industry.

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GSK Announces Submissions in the EU and US for Dabrafenib and Trametinib

GSK Announces Submissions in the EU and US for Dabrafenib and Trametinib

6 Aug 2012

GSK has announced regulatory submissions in the EU and US related to single-agent use of its BRAF inhibitor dabrafenib and MEK inhibitor trametinib.

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EMA Approves Isis Manufacturing Facility

EMA Approves Isis Manufacturing Facility

6 Aug 2012

The EMA's approval of the Isis manufacturing facility in California allows Isis to supply Genzyme with KYNAMRO? drug substance to support commercial launch in Europe.

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EMA Sees Benefits of Interaction with Japanese Regulators

EMA Sees Benefits of Interaction with Japanese Regulators

1 Aug 2012

The Agency has increased its level of interaction and cooperation with medicines regulatory authorities in Japan over the past three years.

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Pharmaceutical Approvals Set to Fall This Year

Pharmaceutical Approvals Set to Fall This Year

31 Jul 2012

Fitch Ratings predicts a fall in the number of new drug approvals in 2012.

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EMA Publishes Policy on Changing Scope of PIPs

EMA Publishes Policy on Changing Scope of PIPs

30 Jul 2012

The new policy allows the scope of a previously agreed PIP to be extended or merged if the company wishes to apply for marketing authorisation for more than one condition at the same time.

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FDA Clears Roche's Vitamin D Laboratory Test

FDA Clears Roche's Vitamin D Laboratory Test

26 Jul 2012

Roche has received clearance from the FDA for a fully automated vitamin D test for use on cobas? modular platforms.

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