EuroPharma Today

Merck: Poised to be THE biosimilars pioneer

Find out how they’ll do it and what it means for the rest of the industry in this FREE article just published in “The Pink Sheet” DAILY:
Merck Prepares To Test Drive Biosimilar Pathway In The U.S.

DOWNLOAD FREE HERE: http://www.elsevierbi.com/mktg/HTML/pdwtl610.html

Latest CHMP positive opinions include Pharming and Archimedes Products

Two small European biotech companies, Pharming and Archimedes, had their lead products, Ruconest and PecFent respectively, recommended for approval by the EU’s Committee for Medicinal Products for Human Use at its monthly meeting on June 21-24.

Finding The Future Value In Medicines - What Are The Most Promising Bets To Make?

It is clear that the pharmaceutical industry needs to evolve, but in which direction and how quickly? One thing is certain: Rewards will be great for companies that tap into new opportunities and align their business models and strategies for the future. In this complimentary webinar (Thursday, June 24), pharmaceutical industry strategist Robin Arnold, vice president of IMS Health’s Product and Portfolio Strategy practice, will reveal insights from the company’s recent global study of pharmaceutical market growth opportunities over the next decade. 

Win An Apple® iPad Just By Telling Us What You Think!

We need your input. How interested are you and your company in European biopharmaceutical news and analysis?

New head for Germany’s medicines watchdog, IQWiG

Professor Juergen Windeler has been appointed director of Germany’s Institute for Quality and Efficiency (IQWiG), succeeding Dr Peter Sawicki.

Almirall to sell Basilea's eczema drug in 10 European countries

Switzerland's Basilea Pharmaceutica has signed up Spain's Almirall to be the exclusive distributor of Basilea's eczema treatment Toctino (alitretinoin) in 10 European markets and Mexico.

Europroduct update: Benlysta & Axanum filings

GlaxoSmithKline has just submitted its novel lupus therapy, Benlysta (belimumab) for EU approval, while at the end of last week, fellow UK company AstraZeneca submitted Axanum (esomeprazole plus aspirin), for EU approval.

A fraught few months for UK biotech in the offing

The next few months will be fraught for UK biotech, which is waiting to see if R&D tax credits, patent boxes, innovation passes and the like will survive cost-cutting by the new coalition government.

 

UK regulatory grievance procedure rarely used

How often are grievances against the UK regulatory authority, the Medicines and healthcare products Regulatory Agency, taken to a higher, non-legal, authority?

Not often, judging from the annual report of the Regulation of Medicines Review Panel. However, the hefty £10,000 fee payabe by applicants for a review might have something to do with that.

The annual report, the first to be produced by the Panel, is only three pages long, and contains brief anonymised details of two cases referred to it during 2009. The first involved a marketing application for a generic and the second the granting of a wholesaler dealer's license. In both cases the Panel sided with the regulatory authority

The panel has five members who are independent of the regulatory authority, the MHRA, and the pharmaceutical industry.

John Davis (j.davis@elsevier.com)

Click here to start your 30-day, risk-free trial of "The Pink Sheet" – The leading provider of biopharma insight and analysis for more than 70 years.

Michael Cann elected chairman of UK generics association

The British Generic Manufacturers Association (BGMA) has elected Michael Cann chairman, replacing Kim Innes who will now be vice-chair for a year. Mr Cann is Director of Generics at the UK subsidiary of Actavis.

Michael Cann of Actavis UK.

Around 65% of all medicines dispensed by the UK National Health Service are generics, but they only account for 26% of the NHS drugs bill, the BGMA says. The average cost to the NHS of a generic medicine is £3.83, while the average cost of a branded medicine is £20, the BGMA claims.