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
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- 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)
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