Recon: Medicare pricing could thwart promising therapies; LDT rule could be first to receive scrutiny post-Chevron

• 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)