Novo announces it will resubmit Tresiba to the FDA; WHO urges Europe to share cost-effectiveness data; J&J and Google partner to develop robotic surgery system
The Scottish Medicines Consortium gave a thumb's down to GSK's drug and a Boehringer COPD drug.
A greenlight could garner Pfizer $1B in sales.
Britain's National Institute for Health and Care Excellence has followed through on its Kadcyla objections and has said Roche's breast cancer drug will remain off the National Health Services formulary because it is too expensive.
Biogen Idec is seeing strong sales for blockbuster MS drug Tecfidera, especially overseas where it's beginning to catch fire this summer.
The MS pill saw rapid uptake in the US last year, but its overseas launch won't be as quick, CEO George Scangos conceded this week at an analyst conference.
Sanofi named in China corruption probe; GlaxoSmithKline starts a venture capital fund; and European non-profit AllTrials outlines its transparency goals
GSK seeks a new ovarian cancer indication for Votrient; a bill that would extend exclusivity for some combination drugs is introduced in Congress; Otsuka's tolvaptan gets a thumbs-down from an FDA advisory committee; NICE rejects Roche's Perjeta; India tosses Herceptin patents; and China revokes Gilead's patent on Viread
Regeneron says it will seek a diabetes macular edema indication for Eylea this year, potentially encroaching on yet another Lucentis market.
Companies are moving toward more access to clinical trial data. Despite their new stance, the internal battles haven't quite ended, some say.
CHMP recommended two Remicade biosimilars for approval. Its nod comes with an added shakeup: the European agency sanctioned the copies for indications beyond RA.
Sales slipped 9% during the quarter, compared to the same period last year, but analysts zeroed in on if and when the company will split and how arthritis pill Xeljanz will tackle Europe.
Should the FDA give the thumbs-up to J&J diabetes pill Invokana tomorrow, expect a blockbuster US marketing push, says CSD's Jerry Maynor.
The head of the European Medicines Agency has said it's a matter of how, not if, the body will mandate publication of clinical trials data—and that has pharmas on both sides of the Atlantic sweating the potential implications for global competitiveness.
The family-owned pharma cautioned that early 2012 success doesn't mean the second half will be a breeze.
The UK's Prescription Medicines Code of Practice Authority (PMCPA), which arbitrates drug industry self-regulation there, last week issued "informal guidance" on digital communications, and while it's more than FDA has offered, it's not much to go on.
PhRMA said the reasoning behind a sharp cap on samples mandated by its European counterpart doesn't apply in the US.
Wyeth enlisted actress and artist Jane Seymour for an unbranded rheumatoid arthritis campaign in Europe.
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- US pharma market value projected to be $550 billion in five years
- Biosimilar uptake will require companies to tell a trustworthy backstory
- Lawmakers propose allowing pharma companies to share some off-label information
- Apple's ResearchKit: Five Guidelines for Pharma
- Everyday Health buys rare-disease agency Cambridge BioMarketing