Recon: Medicare unveils discounted drug prices after first round of negotiation; FDA approves Gilead’s primary biliary cholangitis drug
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Medicare announces drug prices for historic first round of negotiations (STAT) (Endpoints)
- US expects billions in savings from Medicare drug price cuts of up to 79% (Reuters)
- Gilead gets US FDA approval for inflammatory liver disease drug (Reuters)
- Medicare drug price negotiation didn’t benefit Biden — but it may help Harris (STAT)
- Eli Lilly’s billions: Can the world’s most valuable pharma company keep inventing drugs at this pace? (STAT)
- NIH says SIGA’s antiviral didn’t improve resolution in mpox lesions in the DRC (Endpoints)
- Biden administration says IRA negotiations will result in $6B in 2026 Medicare savings (Endpoints)
- CMS Issues Proposed Rule on the Medicare Part B and Part D Inflation Rebate Program; HPM Issues Detailed Summary (FDA Law Blog)
- Merck signs MoU with Indian CDMO; Scorpius delays public offering (Endpoints)
- Zealand joins next-gen club aiming to ‘accelerate’ obesity drug development (Endpoints) (Reuters)
- Insulet unveils $200M insulin delivery device production site in Malaysia (Fierce Pharma)
- EMA Overhauls Guidance On Risk Minimization Activities (Pink Sheet)
- EU To Donate Mpox Vaccines To Africa As Public Health Emergency Is Declared (Pink Sheet)
- Vaccine group Gavi has up to $500 million in funds for mpox shots (Reuters)
- Bavarian Nordic to donate mpox vaccine doses following African emergency declaration (Reuters)
- Stereotaxis earns CE mark for new surgical robot (MedTech Dive)
- Astellas' gastric cancer therapy gets UK regulator's nod (Reuters)
- Boston’s lab market is in rough shape (STAT)
- Syros shares battered after it stops leukemia trial (STAT)
- AstraZeneca's Imfinzi gets FDA priority review for type of lung cancer (Reuters)
- Lilly demands doctors stop selling copycat weight-loss drugs (Reuters)
- Bluebird's slow sickle cell launch forces rework of loan, putting cash runway at risk (Endpoints)
- Doctors struggle to get Wegovy for older Americans with heart disease (Reuters)
- Incyte gets another graft-versus-host disease drug approval, this time with partner Syndax (Endpoints) (Reuters)
- CDMOs must look to leadership diversity, retention and specialized skills to stay on top: report (Fierce Pharma)
- Casgevy, Lyfgenia Medicare Add-On Payments In Sickle Cell Are Not Conditioned On Outcomes-Based Contracting (Pink Sheet)
- ALS patient lived with a brain-computer interface for 7 years. Here’s what researchers learned (STAT) (Reuters)
- Can AI help ease medicine’s empathy problem? (STAT)
- In a reality check for the field, AI underwhelms in Leash Bio's binding contest: 'No one did well' (Endpoints)
- Tandem warns iPhone app still draining insulin pump batteries (MedTech Dive)
- Neuronetics inks Greenbrook merger to acquire treatment centers (MedTech Dive)
- Grail to shed 350 workers in restructuring (MedTech Dive) (Reuters)
- Otsuka Precision Health launches first digital therapeutic for depression (MedTech Dive)
- FDA warning letter targets doctor who worked on a Takeda Phase 3 study (Endpoints)
- B. Braun, Baxter launch separate recalls over particulate concerns and excess endotoxin levels, respectively (Fierce Pharma)
- Existing Innovative Trial Design, Endpoint Tools Could Be Help Ultra-Rare Sponsors Need (Pink Sheet)
- J&J near disclosing support for talc settlement, sources say (Reuters)
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
