KEI vows to continue battle over Bayh-Doyle restrictions after US Commerce Department suggests it may issue regulations to exclude pricing as a basis for requiring companies to license their patents.
The US Department of Commerce has left unresolved the exact circumstances in which the federal government can require a patent owner or licensee to share its patent rights with another party, but its suggestion that drug pricing is not likely to be a factor for pharma patents will surely drive further debate over the issue before regulations are implemented.
On 24 April, the Commerce Department's National Institute of Standards and Technology (NIST) issued a final Green Paper addressing the...
A government-backed program is working on improving the ability to run dementia clinical trials in the UK, and access to trials for participants.
Vinay Prasad’s exit from the US FDA reignited conversations about integrating its drugs and biologics centers under George Tidmarsh. Those plans appear to be shelved, but the leadership transition could be an opportunity to fully realize the vision for the Oncology Center of Excellence.
The Pink Sheet viewed Stealth's complete response letter and other documents indicating the FDA appears willing to grant accelerated approval to elamipretide before a confirmatory trial begins enrolling. But the company says it needs a two-month review of the NDA resubmission to survive.
