EuroPharma Today

Rx Class Action Suits May Come To France In Response To Mediator Scandal

A bill in the French upper house of parliament, the Senate, aimed at averting conflicts of interest in the pharmaceutical sector now has a section that could in fact encourage conflict by creating potentially painful class action cases against firms.

European Regulatory Round-Up: Research Partners And Parallel Traders

The EU Innovative Medicines Initiative, the world’s largest public-private partnership in health R&D, in July called for proposals across seven new health care areas.

Mediator Scandal Provokes Flurry of French Health Reforms But Impact Is Hard To Gauge Until The Dust Settles

France is facing various reforms to its health care system as a direct result of the scandal involving Servier’s diabetes drug Mediator (benfluorex), which may have caused up to 500 deaths.

J&J vs. Merck: The Race Is On As Incivek Passes First EU Regulatory Hurdle

Four days after the European Commission approved Merck & Co.'s protease inhibitor for hepatitis C, Victrelis (boceprevir), the European Medicines Agency has given the nod to its rival, Johnson & Johnson subsidiary Tibotec's Incivek (telaprevir).

European Commission Drops Boehringer Case And Lauds Itself For Receding Patent Abuse

On July 6, the European Commission announced that it had resolved its antitrust investigation into alleged weak patent filings by Boehringer Ingelheim GmbH.

UK's top regulator knighted; elected chair of EMA's management board

The head of Prof. Kent Woods, chief executive of the UK drugs regulator, the MHRA, must be spinning. Over the past week, he has been elected by his peers to chair the management board of the European Medicines Agency. And on Saturday, June 11, it was announced that he had received a knighthood in the UK Queen's Birthday Honors List.

Woods takes over the management board chair from Pat O'Mahony, chief executive of the Irish Medicines Board, having played a role in nominating the head of the Italian Medicines Agency, Guido Rasi, to fill the vacant position of executive director of EMA.

Woods, who continues as chief executive of the MHRA, has a three-year mandate at the management board, which oversees EMA and has 37 members, drawn from all the regulatory agencies in Europe, the European Commission and Parliament, patient and physician groups.

He qualified in medicine from Cambridge, UK, studied at Harvard School of Public Health, and was director of the National Health Services's health technology assessment program immediately prior to taking up his post at the MHRA in 2004.

Wood was knighted along with 20 others, including Dr Hugh Pelham, director of the MRC's Laboratory of Molecular Biology in Cambridge, a source of numerous biotech breakthroughs, and the IVF pioneer, Prof. Robert Edwards.

Also receiving a CBE in this honors list was Kevin Young, executive vice president, commercial operations, at the US biotech Gilead Sciences, for services to the development and marketing of life changing medicines. He joined Gilead in 2004, having previously worked at Amgen and AstraZeneca. Young is also a board member of ReSurge,  a humanitarian organization providing reconstructive plastic surgery in developing countries.

John  Davis (j.davis@elsevier.com)

 

 

Guido Rasi nominated as next head of the European Medicines Agency

 
After a six-month delay, and an embarrassing re-run of the selection process, the management board of
the European Medicines Agency has finally picked the person it wishes to be the next executive director of the agency, the head of the Italian Medicines Agency, Guido Rasi.

Europe wants reassurance that Japanese medicines are not radioactive

Europe's regulators at the European Medicines Agency are seeking assurances that medicines imported from Japan are not radioactive.

Following the radiation leaks from the Fukushima Daiichi nuclear power plant in east Japan in March, EMA said May 3 that it was to take a precautionary approach to whether medicines manufactured close by the plant were contaminated.

European Spec Pharma Testing New Niches: Emerging Markets, Novel Products

Many struggling European specialty pharma companies are grappling with whether to move outside the traditional business mold by venturing beyond Europe, including into emerging markets, and how to develop differentiated products with potential for transformative growth.

Rawlins Rides Again at NICE, For One More Year

Professor Sir Michael Rawlins has received a special exemption – again – to continue to serve as chairman of the U.K.'s costs regulator, the National Institute for Health and Clinical Excellence.

In ordinary circumstances, appointments to chair U.K. public bodies, like NICE, last for a maximum of 10 years.