Latest News in the pharma Industry

Policy & Regulation

European Medicines Agency provides plan to help deal with manufacturing-related medicine shortages

European Medicines Agency provides plan to help deal with manufacturing-related medicine shortages

30 Nov 2012

The European Medicines Agency has published a plan to help the European medicines regulatory network deal with supply shortages of medicines following manufacturing problems.

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Janssen announces cross-pharma clinical trial investigator databank

Janssen announces cross-pharma clinical trial investigator databank

26 Nov 2012

Janssen R&D has launched a new databank that should help pharmaceutical companies to identify appropriate clinical trial sites more efficiently.

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NPPA cuts price of diabetic drug glipizide, hikes rates of 4 other bulk drugs

NPPA cuts price of diabetic drug glipizide, hikes rates of 4 other bulk drugs

22 Nov 2012

The National Pharmaceutical Pricing Authority (NPPA) has brought down the prices of anti-diabetic bulk drug glipizide considerably, increased the prices of four other bulk drugs, and revised the prices of 92 formulations.

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New pharma policy to be ready by Nov 27 as GoM hammers out ‘consensus’ over possible pricing formula

New pharma policy to be ready by Nov 27 as GoM hammers out ‘consensus’ over possible pricing formula

22 Nov 2012

Pushed by the Supreme Court to finalise the National Pharmaceutical Pricing Policy before November 27, the Group of Ministers (GoM) on Wednesday claimed to have settled the differences among the key ministries over the pricing mechanism and vowed to an...

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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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