Johnson & Johnson plans to shift 340B price concessions on Stelara and Xarelto to rebates for some hospitals beginning in October, allowing for more company oversight of claims.
That didn’t take long. Johnson & Johnson ignited a new 340B confrontation between pharmaceutical manufacturers and the Health Resources and Services Administration with its recently disclosed plan to shift up-front 340B discounts for Stelara and Xarelto to back-end rebates for certain types of hospitals.
The conflict between manufacturers and HRSA and 340B “covered entities” is a consequence of the 340B program outgrowing its original...
With the US BIOSECURE Act waiting for a Senate vote, there are signs it may be prompting some Chinese firms to look at their operations. In the meantime, two legal experts in China suggest a range of coping strategies for companies that may be deemed "of concern."
The US FDA Commissioner pushed for a rebalancing of the US’s pharmaceutical supply chains while also stressing that there is a role for US-China commerce that would be risky to compromise.
The UK regulator approved 16 medicines containing a new active substance in the first half of this year, while the European Commission issued marketing authorizations for 20 NAS-containing drugs.
Joint clinical assessment reports must be descriptive rather than reach definitive conclusions, and must not interfere with national decision making processes, according to new EU guidance.
Cardiovascular and Renal Drugs Advisory Committee will consider whether open-label extension data from a randomized trial that failed its primary endpoint, along with a historical control comparison, are enough to support approval in the ultra-rare disease.
Recent ODAC meetings suggest the FDA will expand focus beyond applications with pending approval decisions to refining trial designs and drug labels for competitors.
The agency also should explain the potential consequences for sponsors if enrollment goals are not met, stakeholders say in comments on the DAP draft guidance. Some commenters urged the FDA to apply waiver criteria flexibly, especially for rare diseases.
