Policy
In a Cabinet meeting, Health Secretary Robert F. Kennedy Jr. said the website could go live “probably in the next 10 days,” but an exact launch date remains unclear.
FEATURED STORIES
An inconsistent boom-and-bust cycle funding environment for early-stage biotech innovations and burdensome regulation threaten the U.S.’s half-century-long dominance in the biotech sector.
Acadia Pharma’s Catherine Owen Adams is one of the founders of a group of small- to mid-cap biotechs advocating against a ‘peanut butter blanket’ approach to drug pricing for small companies.
Former European Trade Commissioner Phil Hogan and former U.S. Senator Richard Burr, speaking on a panel at the J.P. Morgan Healthcare Conference, pushed to see a larger picture beyond the Trump administration’s year of chaos and confusion.
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With a priority review voucher in hand, Teva is expecting the FDA to rule on its new migraine treatment fremanezumab by June.
United Therapeutics Corporation will pay $210M to resolve U.S. claims that the drugmaker used a charity as a conduit to illegally cover Medicare patients’ out-of-pocket drug costs in order to eliminate price sensitivity and to boost sales.
North Carolina sued Insys on Thursday, accusing the pharmaceutical company of illegally pushing a powerful fentanyl-based cancer pain medicine called Subsys to boost profits amid the U.S. opioid epidemic.
Shares of Agile plunged more than 62 percent in early trading after the company announced this morning the FDA rejected its low-dose hormonal contraceptive patch called Twirla.
The lawsuit, filed in the U.S. District Court for Eastern Pennsylvania, alleges that Mario Schackelman jumped ship for Zimmer Biomet on Oct. 31 after a decade of selling for Synthes despite clauses in his contract barring him for working for a competitor for two years.
France’s competition authority finedJ&K $29.6M on Wednesday after it ruled the company had deliberately slowed market access to generic copies of its painkiller Durogesic.
The lawsuit filed by Margo Polett claimed that she re-injured her knees while making a Zimmer promotional video, after a double knee replacement procedure in 2006 using the company’s Gender Solutions device.
Last month Align Tech filed formal patent infringement complaints against medical device maker 3Shape.
The FDA has acknowledged that the resubmission is a complete, class 2 response to the CRL received on May 5, 2017 for TX-004HR.
The FDA continues to hand out some early Christmas presents to pharma companies.