Recon: Medicare pricing could thwart promising therapies; LDT rule could be first to receive scrutiny post-Chevron
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Medicare drug pricing rules will delay access to promising therapies (STAT)
- Deep dive on pay packages; Lilly strikes $3.2B buyout; Pfizer’s R&D head to depart; and more (Endpoints)
- Lilly says lupus drug dropped from pipeline failed to show efficacy (Endpoints)
- How SCOTUS' decision in Chevron could change the way the FDA regulates biopharma (Endpoints)
- House committee tells FDA to suspend lab developed test rule (MedTech Dive)
- Opinion: Congress Must Reauthorize FDA Program for Pediatric Rare Diseases (BioSpace)
- U.K. pharma increasingly violates voluntary industry marketing codes, and probes are taking longer (STAT)
- GSK HQ officially returns to central London after decades in city’s suburbs (Endpoints)
- WHO Launches 'One-Stop Shop' For Global Information On Medical Devices (MedTech Insight)
- EMA Tightens Clock-Stop Rules To Address Impact On Drug Approval Timelines (Pink Sheet)
- Uptake Of Innovation Is UK’s ‘Biggest Hurdle’ In Life Sciences Competitiveness (Pink Sheet)
- In Vitro Triumph: European Pharmacopoeia Abolishes Rabbit Pyrogen Test (Pink Sheet)
- Early data from Lexeo’s gene therapy for rare heart disease shows promise (STAT)
- Revolution Medicines' RAS inhibitor shows promise in early-stage pancreatic cancer trial (Endpoints)
- Indivior axes schizophrenia drug and shrinks revenue guidance (Endpoints)
- Two healthcare SPACs go public, with several more on the hunt for deals (Endpoints)
- J&J’s CAR-T partner Legend Biotech reportedly receives buyout offer (Fierce Pharma)
Abecma competition, Sotyktu pricing pressure and IRA: Analysts outline Bristol Myers’ top challenges (Fierce Pharma) - Akebia unveils IRA-driven price tag for kidney disease drug Vafseo, ends CSL collab (Fierce Pharma)
- 5 Neuro Data Readouts to Watch in the Second Half of 2024 (BioSpace)
- Edwards to acquire Innovalve, stake in Affluent Medical (MedTech Dive)
- Hamilton recalls ventilators that may fail to restart (MedTech Dive)
- J&J limits use of Megadyne electrodes due to burn risk (MedTech Dive)
- AI Act Is Officially Published: Implementation Challenges Ahead For Medtech (MedTech Insight)
- Cumulus Neuroscience Joins Transatlantic Hunt For Alzheimer’s Blood And Digital Biomarkers (MedTech Insight)
- Sanford Health aims to shake off a run of failed deals by snapping up a $3 billion Wisconsin health system (STAT)
- Top FDA officials weighing regulation of ultra-processed foods, internal documents show (STAT)
- FDA finalizes guidance on studying opioid use disorder treatments (MedTech Dive)
- News We’re Watching: Roche Patent Suit, Dental Device Guidance Docs, Edwards Partners With Affluent Med (MedTech Insight)
- Pharmas are underutilizing social media to communicate with doctors and patients, HCPs say (Fierce Pharma)
- Netflix and ill: ‘Supacell’ taps streaming giant for ‘super’ sickle cell awareness (Fierce Pharma)
- Through the Looking Glass? Loper Bright Will Force FDA to Change Its Approach to Litigation and Advocacy (FDA Law Blog)
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe. Regulatory Recon is published each week on Monday, Tuesday and Thursday.
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
