France’s medicine regulator, Agence française de sécurité sanitaire des produits de santé (Afssaps), has approved the gene therapy product, Cerepro (sitimagene ceradenovec), for use on a named-patient basis in France.
The new chief executive officer of Pharming Group NV has outlined a strategy for the Dutch company that involves building up a broadly based portfolio of products in the fields of biotechnology, biomaterials and bionutritionals. The purpose is to reduce the group’s dependence on any one product. Pharming’s lead product for acute attacks of hereditary angioedema (HAE), Rhucin, encountered regulatory obstacles in 2008.
The European Medicine Agency’s Paediatric Committee has approved plans from 11 companies to investigate their new drugs for use in children.
The German molecular diagnostics company, Epigenomics AG, has raised €5.18 million in a share placement with two of its existing institutional investors. The proceeds will be used to finish the development and commercialisation of its most advanced product, a blood-based molecular diagnostic test for the early detection of colorectal cancer.
Sanofi-aventis reported higher sales and earnings in the fourth quarter and full year in 2008 on an adjusted basis. But expressed under International Financial Reporting Standards (IFRS), sales and earnings in 2008 showed a decline.
Elan Corporation Plc said that its previously-announced review of strategic options, including a possible sale of shares to a minority investor, is underway. But shareholders representing 37% of the company’s stock say that the possible sale of a stake to another pharmaceutical company would be unacceptable.
H. Lundbeck A/S of Denmark will substantially broaden its pipeline of central nervous system (CNS) products following the acquisition of the US-based specialty pharmaceutical company, Ovation Pharmaceuticals, Inc.
The all-cash acquisition, which is valued at up to $900 million, was announced on 9 February 2009. It is expected to close in March.
Crucell NV, the Dutch vaccine developer and producer, reported its first ever annual profit in 2008, which was driven by strong fourth quarter sales of its paediatric, travel and endemic vaccines as well as higher license revenue.
GlaxoSmithKline Plc is expanding its restructuring programme to include the elimination of more jobs and to support a change in its business model
Roche Holding AG reported stagnant sales and earnings in 2008 because the strength of its accounting currency, the Swiss franc, wiped out gains in local currencies.