Keeping Track: More Rx-To-OTC Switches On Deck After US FDA’s OTC Narcan Approval; Iovance Looks To Bring Cell Therapy To Melanoma
Executive Summary
The latest drug development news and highlights form the Pink Sheet’s US FDA Performance Tracker.
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Finance Watch: Impel’s Cash Has Nearly Run Out Despite Commercial Push
Restructuring Edition: Impel eliminated R&D spending earlier this year to focus on Trudhesa commercialization, but is examining all options, including bankruptcy, as its funding runs out. Also, Alaunos, BioXcel and others announce job cuts and strategic shifts during second quarter updates.
Senate Committee Passes Moderate PBM Reform, But Has Its Eyes On Stronger Policies
Delinking pharmacy benefits managers’ compensation from the prices of drugs received bipartisan rhetorical support at a HELP markup, but the panel only cleared less drastic PBM reforms along with generic and orphan-drug focused policies. Approved amendments tackled step therapy, pharma transparency and PBM gag clauses, among other topics.
How Sturdy Is PK/PD Bridge Between Epinephrine Injection Products And Nasal Spray?
FDA enumerates uncertainties in determining whether PK/PD results support a favorable risk-benefit assessment for use of ARS Pharmaceuticals’ epinephrine nasal spray for emergency treatment of allergic reactions, including anaphylaxis.