Novartis study tries to temper regulatory onslaught in Europe

As European countries line up with ever-stricter rules designed to reduce the price they pay for pharmaceuticals, Novartis has commissioned a new report from a group of tech experts that draws a straight line between the strictness of the new regs and a reduction in R&D innovation. In clear and measured language, the European School of Management and Technology Competition Analysis note that a strict regulatory environment inevitably shifts the attention of drug developers to new therapies...

GSK chief backs a centralized European approval process

With European countries slamming the brakes on drug spending whenever possible, GSK chief Andrew Witty took the helm of the continent's pharma association calling for a "new dialogue" between the industry and government officials and cautiously backing a radical revamp of the European approval process. Currently, developers have to gain the endorsement of the EMA prior to seeking marketing approval from the 27 countries in the EU, which assess a product's cost effectiveness. Witty, though,...

Amgen’s D-mab wins blockbuster approval in Europe

Amgen (NASDAQ: AMGN) can soon start watching the cash roll in for denosumab. After testing the bone-loss drug in a battery of late-stage trials, the therapy--to be sold as Prolia--won its first regulatory approval in Europe. GlaxoSmithKline (NYSE: GSK) will now collaborate with Amgen on the commercialization work on the continent for a drug that is expected to earn billions of dollars a year and help position the big biotech for the decade ahead. Regulators approved the drug as a treatment...