Recon: AbbVie wins FDA approval for 24-hour Parkinson’s infusion treatment; FDA expands use of Avadel’s narcolepsy drug to children 7 and older

• Top HHS official doesn’t think the election will impact AI rules (STAT)
• How invisible medical groups are powering telehealth’s GLP-1 ‘gold rush’ (STAT)
• FDA approves AbbVie's 24-hour Parkinson's infusion therapy after two CRLs (Endpoints)
• BenevolentAI CEO is out after less than a year on the job (Endpoints)
• FDA expands label for Avadel's narcolepsy drug into children (Endpoints)
• Baxter to import 18,000 tons of IV products to US by year-end (Reuters)
• Health officials outline industry role in AI oversight in JAMA article (MedTech Dive)
• Hurricane-related IV fluid shortage could hurt medical device makers (Reuters)
• Novartis loses latest bid to block generic version of blockbuster heart drug (Reuters)

• Eisai to ask Australia to reconsider rejection of Alzheimer's drug Leqembi (Endpoints)
• Merck KGaA eyes more manufacturing M&A as it faces headwinds in China (Endpoints)
• Canadian CDMO broadens CGT footprint with new $145M facility (Endpoints)
• Evonik winds down German site, lays off 260 workers; Chiesi’s €400M facility (Endpoints)
• Nigeria rolls out new Oxford R21 malaria vaccine (Reuters)
• CDMO SpectronRx homes in on completion of European plant to crank out key radiopharma isotope (Fierce Pharma)

• Meet the 2024 STAT Wunderkinds (STAT)
• Sage shakes up senior management, slashes pipeline, sheds 33% of staff (Endpoints)
• Viatris, Lexicon ink licensing deal; Capricor’s $75M offering (Endpoints)
• Tarsus’ Xdemvy tackles a ‘mitey problem’ in 1st DTC TV ad (Fierce Pharma)
• Kezar to discontinue mid-stage trial for lupus treatment (Reuters)
• More evidence on GLP-1s and opioid addiction (STAT)
• Ahead of public meeting, FDA signals flexibility in evaluating smoking cessation treatments (STAT)
• NIH study shows Bavarian Nordic's mpox shot elicits immune response in teens (Fierce Pharma)
• Eli Lilly shows how public restroom rarity affects ulcerative colitis patients (Fierce Pharma)
• Viatris makes good on CEO's dealmaking promise with $25M licensing pact for Lexicon's heart med Inpefa (Fierce Pharma)

• Medicare Advantage insurers ramped up use of technology to deny claims, Senate investigation shows (STAT)
• For this cancer-focused digital health startup, an FDA rejection meant the end of the road (STAT)
• Buoyed by clinical success, Onward Medical charts future of neurostimulation (STAT)
• Lawsuits To Stop FDA From Overseeing LDTs Could Create Chaos, Panelist Says (MedTech Insight)
• Legacy medical devices keep regulators up at night (MedTech Dive)
• CMR Surgical gets FDA de novo nod for Versius robot (MedTech Dive)
• FDA labels Cue’s recall of COVID tests as Class II, revokes EUAs (MedTech Dive)
• Abbott CEO sees ‘mass market potential’ for CGMs (MedTech Dive)

• Eli Lilly chief scientist Daniel M. Skovronsky: Beware elected leaders who would weaken patents (STAT)
• A former top Trump health official lays out how the GOP should revisit fights over drug pricing and the ACA (STAT)
• Former UnitedHealth doctors detail what changed at their clinics after takeovers (STAT)
• Inside UnitedHealth’s strategy to pressure physicians: $10,000 bonuses and a doctor leaderboard (STAT)
• Hospitals gush about new AI note-taking tools. It may leave the human medical scribes who originated the roles behind (Endpoints)