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October 31, 2024
by Michael Mezher

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)
In Focus: International
  • 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)
Pharma & Biotech
  • 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)
Medtech
  • 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)
Government, Regulatory & Legal
  • 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)
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.
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