Recon: Baxter resumes IV solution production at hurricane-impacted facility; Teva hit with €463M antitrust fine over Copaxone practices
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- US FDA says lowest dose of Novo Nordisk's weight-loss drug now available (Reuters)
- Novo Nordisk’s Ozempic and Wegovy, long in shortage, are now listed as available by FDA (STAT)
- Purdue Pharma nears new bankruptcy deal with Sacklers, mediator says (Reuters)
- IQVIA lowers annual revenue forecast amid trial delays (Reuters)
- Baxter restarts IV solutions manufacturing line at hurricane-hit facility (Reuters)
- Mpox cases on African continent show 500% increase year-on-year (Reuters)
- Merck sees Gardasil China woes carrying into 2025 (Reuters)
- AstraZeneca’s China president is under investigation by authorities (STAT)
- Baxter exits China IV fluids market amid tough local competition, US shortage (Fierce)
- Bristol Myers earnings beat expectations, driven by sales of older drugs (Reuters)
- Japan's Takeda raises full-year profit forecast amid restructuring (Reuters)
- Teva fined $503 million for disparaging a rival and using patents to thwart competition (STAT)
- Regeneron shares drop as higher-dose Eylea drug misses sales estimates (Reuters)
- Haleon misses Q3 forecasts on stronger pound (Reuters)
- EMA Considers Cracking Down On Late Filings From Companies By Auto-Releasing Rapporteurs (Pink Sheet)
- AbbVie adds to T cell engager momentum, with EvolveImmune pact starting at $65M (Endpoints)
- Amgen makes pipeline cuts, but obesity plans remain the focus (Endpoints)
- National Academies calls to change how biomedical research uses race and ethnicity (STAT)
- Capricor and the FDA: A daring, risky filing strategy (STAT)
- Argenx reports Vyvgart sales streak, bolstered by launch in rare neuro disorder (Endpoints)
- Lexeo shares early data on Alzheimer’s gene therapy (Endpoints)
- Compass Pathways delays key Phase 3 psilocybin readouts, spurring 30% layoffs (Endpoints)
- Corcept misses primary endpoint in supportive Cushing's syndrome study (Endpoints)
- UCB's anti-tau Alzheimer's program fails Phase 2 primary endpoint, but highlights positive secondaries (Endpoints)
- Alvotech Petitions US FDA To Deny Interchangeability For Rival Stelara Biosimilars (Pink Sheet)
- AbbVie Slaps Mankind Away Until 2027 On US Lumigan Generic (Pink Sheet)
- Makena Active Ingredient Compounding Ban Gets US FDA Panel Nod (Pink Sheet)
- Teleflex shares slump as hurricane impact weighs on annual revenue forecast (Reuters)
- Siemens could reduce stakes in Healthineers, other companies to fund Altair deal (Reuters)
- Apple claims new AirPod hearing aid feature is ‘clinical grade.’ Is it? (STAT)
- TCT 2024: Valve under-expansion plagues Boston Scientific's head-to-head TAVR trial (Fierce)
- TCT 2024: J&J’s Abiomed clears pivotal study for shrinkable heart pump (Fierce)
- Roche collects more data to support blood tests for diagnosing Alzheimer’s disease (Fierce)
- Edwards, Medtronic and Inari share trial data at TCT conference (MedtechDive)
- Boston Scientific’s Acurate Neo2 inferior to rival TAVR valves in study (MedtechDive)
- Jazz Pharma Loses Lawsuit Over FDA Approval of Rival Sleep Drug (Bloomberg Law) (Endpoints)
- Two generic drugmakers pay $49 million to settle price-fixing charges (STAT)
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