MUMBAI - Stung by strictures on Indian companies routing drug consignments through the European Union, the Indian government is considering drastic measures in a bid to control further damage to India's pharmaceutical trade.
Continue reading "India Opposes Seizure Of Drugs By EU Even As Dr. Reddy’s Labs Brings Its Goods Back" »
LONDON - Back in 2003 a government-funded team of experts outlined its vision for UK biotech--one in which the sector occupied a leading place on the global stage, with a strong clinical trial infrastructure, early patient acess to innovative drugs, and all built around a critical mass of companies "in the mould of Amgen".
Continue reading "UK Biotech: Shattered Dreams?" »
Novartis has launched in Europe what may be described as the first authorized biogeneric: a new branded version of Bayer-Schering's multiple sclerosis therapy Betaferon.
Continue reading "New Brand, Same MS Drug: Novartis Launches Extavia In Europe" »
European regulators are recommending that physicians ration Genzyme's Pompe Disease biologicMyozyme (alglucosidase alfa) due to continuing production constraints that will limit supply of the product until a 4000 L production scale is approved.
Continue reading "Rationing Of Genzyme’s Myozyme In Europe Likely Through April Due To Supply Constraints" »
LONDON - It appears that Janssen-Cilag feels a lot better now about its pay-for-performance scheme around multiple myeloma drug bortezemib (Velcade) than it did when the program was introduced in 2007.
Continue reading "More Velcade-Style Risk-Sharing In The UK?" »
LONDON - NICE doesn’t set drug prices in the UK, companies do. But the agency’s influence on pricing, if indirect, will nevertheless grow considerably given the UK’s new Pharmaceutical Price Regulation Scheme, published late last year following a surprise renegotiation of the agreement.
Continue reading "NICE's Growing Influence On UK Drug Pricing" »
UCB's buyback option-based oncology deal with Wilex, disclosed Jan. 9, takes research costs for two small molecules and three antibodies off the books until decision time, and will cost UCB just euro 10 million (US$13.46 million) and another euro 10 million when the first program reaches Phase I trials.
Continue reading "UCB Inks Buyback-Option Deal With Wilex For Oncology Lineup" »
LONDON - Tackling counterfeit drugs is one pillar of the European Commission's package of new proposed pharmaceutical legislation. It will mean higher costs for most drug firms, while significant loopholes will remain.
Continue reading "EU Tackles Counterfeits, But Parallel Trade Poses Tough Issues" »
Perceptions that U.S. FDA is more conservative in its approval standards than its European regulatory counterpart are misguided and largely overblown, FDA Office of New Drugs Director John Jenkins said.
Continue reading "FDA Not More Conservative Than EU, Jenkins Says; Investors Not Convinced" »