European regulators launch speedier drug approval process: AbbVie and Boehringer Ingelheim to partner on psoriasis drug; the FDA approves hemophilia B drug
Physicians criticize pricing of Orkambi, Vertex's new cystic-fibrosis drug; the EU approves Amgen's PCSK9 inhibitor Repatha; PhRMA boosts lobbying spending in the second quarter
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.
Click here to learn about the Agency Issue.
- When it comes to professional ads, print makes its comeback
- Amgen takes issue with yet-to-be published multiple-myeloma drug report
- How Watson for Oncology is advancing cancer care
- Creative partners should push pharma clients to tell better stories
- Following positive outcomes data, a new diabetes class is on the rise