Pharmacyclics, Inc.
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Latest From Pharmacyclics, Inc.
Breakthrough Bounceback Looks Unlikely At US FDA’s CDER, But CBER Is Riding Wave Of RMATs
Only two breakthrough-designated novel agents remain on the US FDA drugs center’s 2023 user fee calendar, while CBER stacks up on vaccines and gene therapies under both BTD and RMAT programs.
Keeping Track: Regeneron’s Bispecific Bid, More Regenerative Medicine BLAs, And Vadadustat Returns
Highlights of recent submissions for approval from the Pink Sheet’s US FDA Performance Tracker
Medicare Drug Pricing In Court: Judge Praises ‘Zealous Advocacy’ Of Attorneys In First Hearing On IRA
DOJ and Chamber of Commerce attorneys argue over whether Chamber has standing to sue and whether AbbVie has suffered harm meriting a preliminary injunction to halt the program. With Medicare’s Oct. 2 deadline looming, Judge Newman said he would issue a decision ‘as quickly as we can.’
Court Could Pause Medicare Drug Price Negotiation Process Following First Hearing In IRA Litigation
Ahead of Friday’s hearing on US Chamber of Commerce's suit against HHS, attorneys discuss potential remedies and carveouts to Inflation Reduction Act's drug price negotiation provisions, harms to industry that may support a preliminary injunction, and what would prompt Supreme Court review.
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