Amsterdam Molecular Therapeutics BV's potential gene therapy, Glybera (alipogene tiparvovec), may have been rejected for approval by Europe's top scientific advisory panel, CHMP, on Oct. 21, but the closeness of the vote - there was only one dissenting voice - suggests it won't be long before a gene therapy product clears the committee and reaches the European market.
Merck KGaA's pharmaceuticals division, Merck Serono, has returned global rights to the late-stage Parkinson's disease therapy safinamide to the Italian biotech Newron Pharmaceuticals SPA. The surprise decision comes just a week before Newron's shareholders were due to vote on its proposed merger with Finland's Biotie Therapies Corp.
The biggest changes in the European Commission's revised proposals on how pharmaceutical manufacturers can provide information to patients don't have to do with communications to patients at all - they address reporting safety concerns to regulators.
Teva Pharmaceuticals Industries Ltd. has succeeded in piercing the market exclusivity surrounding GlaxoSmithKline PLC's inhaled asthma products with a "first-to-market" launch on Oct.7 in the U.K. of a salmeterol xinafoate inhaler.