Keeping Track: More Rx-To-OTC Switches On Deck After US FDA’s OTC Narcan Approval; Iovance Looks To Bring Cell Therapy To Melanoma
The latest drug development news and highlights form the Pink Sheet’s US FDA Performance Tracker.
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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.
Green Light For First OTC Naloxone In US After FDA Raises Caution Flag During Advisory Panel
Sponsor Emergent revealed single-panel display of instructions at February advisory panel without testing in OTC human factors study. While different naloxone formulations and dosages will remain Rx-only, generics of the Narcan 4-mg nasal spray must transition to OTC, FDA says.