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.
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.
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.
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.
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.