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19 April 2015

 
17 April 2015

The generic medicines industry associations in the US (GPhA) and Canada (CGPA) have both launched new divisions focusing on the biosimilars industry 1 ,2 . Areas of focus for the GPhA's new biosimilars arm will include education, access, the ...

17 April 2015

John Castellani announced on16 April that he plans to step down as CEO of US drug industry association Pharmaceutical Research and Manufacturers of America (PhRMA) at the end of the year. The revelation at the drug industry lobbying group's board ...

17 April 2015

The Transatlantic Trade and Investment Partnership (TTIP) could lead to common standards in areas like the safety of medicines and medical devices, but it must not "sacrifice certain European safeguards on the altar of free trade", an influential ...

17 April 2015

The European Medicines Agency's recommendation that hundreds of generic medicines whose European marketing authorizations relied on clinical studies performed by Indian contract research organization GVK Biosciences be suspended in Europe has been ...

17 April 2015

The generic medicines industry associations in the US (GPhA) and Canada (CGPA) have both launched new divisions focusing on the biosimilars industry 1 ,2 . Areas of focus for the GPhA's new biosimilars arm will include education, access, the ...

17 April 2015

John Castellani announced on16 April that he plans to step down as CEO of US drug industry association Pharmaceutical Research and Manufacturers of America (PhRMA) at the end of the year. The revelation at the drug industry lobbying group's board ...

17 April 2015

The Transatlantic Trade and Investment Partnership (TTIP) could lead to common standards in areas like the safety of medicines and medical devices, but it must not "sacrifice certain European safeguards on the altar of free trade", an influential ...

17 April 2015

The European Medicines Agency's recommendation that hundreds of generic medicines whose European marketing authorizations relied on clinical studies performed by Indian contract research organization GVK Biosciences be suspended in Europe has been ...

17 April 2015

The European Medicines Agency's recommendation that hundreds of generic medicines whose European marketing authorizations relied on clinical studies performed by Indian contract research organization GVK Biosciences be suspended in Europe has been ...

16 April 2015

The lower house of the French parliament has approved the bill on the reform of the healthcare system, which among other things will introduce new provisions on dealing with drug shortages and bring French legislation into line with the new EU ...

16 April 2015

Australia's Therapeutic Goods Administration is seeking comments on whether or not to adopt two of the European Medicines Agency's overarching biosimilar guidelines as well as eight other EU guidelines covering drugs 1 . The two biosimilar ...

16 April 2015

The World Health Organization has amended its final statement on the disclosure of results from drug and medical device clinical trials to bring it in line with internationally accepted reporting timelines, and to clarify that researchers should ...

17 April 2015

John Castellani announced on16 April that he plans to step down as CEO of US drug industry association Pharmaceutical Research and Manufacturers of America (PhRMA) at the end of the year. The revelation at the drug industry lobbying group's board ...

17 April 2015

The Transatlantic Trade and Investment Partnership (TTIP) could lead to common standards in areas like the safety of medicines and medical devices, but it must not "sacrifice certain European safeguards on the altar of free trade", an influential ...

15 April 2015

As evidence accumulates on the use of biosimilars in the real-world setting, it looks as if regulatory agencies in Europe may be softening their stance on interchangeability after the Dutch regulator the MEB came out in favor of allowing patients ...

14 April 2015

Later this year pharmaceutical firms should find out exact details of the safety features they will have to affix to their prescription drugs in order to comply with EU legislation aimed at preventing falsified medicines entering the legitimate ...

23 March 2015

A US District Court has ruled that Novartis unit Sandoz did nothing wrong by not engaging in the disclosure and dispute resolution process laid out by the Biologics Price Competition and Innovation Act ? the law that established the abbreviated ...

11 March 2015

The Court of Justice of the European Union has delivered a preliminary ruling on defective medical devices that could introduce new costs for manufacturers. The CJEU ruled that where a medical device has a potential defect based on quality control ...

26 January 2015

The judgement by a High Court judge that the launch by Actavis of a generic version of Pfizer's Lyrica (pregabalin) in the UK would not infringe a patent held by Pfizer company Warner-Lambert on one of the three uses for which Lyrica is approved 1,2 ...

 
02 April 2015
Ian Schofield
News that the French regulatory agency ANSM has formally launched an internal inquiry into claims that former members of two committees responsible for decisions on drug approval and reimbursement held secret meetings with pharmaceutical companies ...
 
07 November 2014
Maureen Kenny
The appointment of Professor Sir Michael Rawlins as chair of the UK Medicines and Healthcare ...
 
14 April 2015
Adam Sherlock discusses a recent life science industry survey that shows how companies are ...
02 April 2015
Daniel Kracov and Rosemary Maxwell explain how the 21 st Century Cures initiative proposes to ...
01 April 2015
There are now three bases on which clinical data can be disclosed in the EU. Elisabethann Wright, ...
 
 
12 November 2013
Joint assessments by national designating authorities in the EU of notified bodies active in the medical device area are relatively new. A voluntary ...
28 August 2013
Ken Daly looks to the US to predict what could happen in Europe if the European Commission's recommendation for an EU-wide class action system is ...
05 July 2013
The French medtech market is already highly regulated and complex and is becoming more so. While the CE marking should act as a single passport to ...
 
The EMA at 20, what's it all about?
17 April 2015
 
New MITA regulatory director to promote imaging standards adoption The US Medical Imaging & Technology Alliance has appointed Megan Hayes as its regulatory and standards director 1 . In her ...
UK MHRA appoints chairman for new medtech advisory committee The UK Medicines and Healthcare products Regulatory Agency has appointed Peter Nightingale as chairman of its ...
 
   
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