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March 17, 2025
by Jason Scott

Recon: AstraZeneca extends cancer drugs reach with EsoBiotec $1B purchase; Top 10 US drugs losing exclusivity this year

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US
  • Pfizer Has a New Playbook for Reviving Sales—and It’s Starting to Pay Off (The Wall Street Journal)
  • At NIH, ‘everyone is on edge’ as they brace for deep cuts and more centralized control (STAT)
  • Novartis is watching US reciprocal tariff policy 'very carefully', CEO says (Reuters)
  • The top 10 drugs losing US exclusivity in 2025 (Fierce Pharma)
  • Small vaccine maker names Operation Warp Speed leader as chairman, raises $110 million (STAT)
In Focus: International                                                                                                       
  • These 12 Chinese companies are poised to transform CRISPR gene-editing (STAT)
  • U.K. plan to require drugmakers to pay higher rebates draws criticism from industry group (STAT)
  • Otsuka's Taiho buys Swiss startup Araris with three ADCs nearing the clinic (Endpoints)
  • EU Pushes Faster Route For Innovative And Orphan Devices (MedTech Insight)
  • Novo Nordisk membership in UK pharma body restored after suspension (Reuters)
Pharma & Biotech
  • AstraZeneca boosts cancer therapies push with $1 billion EsoBiotec buy (Reuters)
  • Purified T cell transplant lowers risk of immune reaction for blood cancer patients, study shows (STAT)
  • Altimmune to study obesity drug in alcohol use disorder, following Eli Lilly (STAT)
  • OPKO and Entera partner to develop obesity pill (Reuters)
  • Stada plans to launch IPO as soon as Wednesday, sources say (Reuters)
  • Incyte's skin disease drug fails to impress in late-stage studies (Reuters)
  • Exclusive: KKR-Warburg Pincus group submit non-binding bid for Gerresheimer, sources say (Reuters)
  • Curevo gets $110M for a shot against Shingrix, gets Moncef Slaoui and Tal Zaks on board (Endpoints)
  • George Church spinout developing genomically recoded organisms cuts most employees (Endpoints)
  • AstraZeneca spotlights first-in-human data for B7-H4-targeting ADC in endometrial cancer (Endpoints)
  • HC Bioscience, a tRNA biotech backed by ARCH and Takeda, shuts down (Endpoints)
  • Sutro slashes workforce in half, changes CEO and closes factory (Endpoints)
Medtech
  • New Stanford tool evaluates AI models on tasks that actually matter in health care (STAT)
  • Q&A: How AI can fail people with disabilities (STAT)
  • FDA adds hemodialysis devices to shortage list amid B. Braun disruption (MedTech Dive)
  • Dr. Oz stresses need for faster Medicare coverage of new devices during confirmation hearing (MedTech Dive)
  • Vicarious Surgical appoints Sarah Romano as CFO (MedTech Dive)
  • Careology And Entia Partner To ‘Enhance’ Remote Monitoring For Patients With Cancer (MedTech Insight)
  • Study: Nearly 30% Of Device Adverse Event Reports Don’t Meet Deadline (MedTech Insight)
Government, Regulatory & Legal
  • Dr. Oz pledges Medicare Advantage scrutiny: ‘There is a new sheriff in town’ (STAT)
  • Howard Dean: Sympathy, not sanctimony, is the right response to vaccine fears (STAT)
  • HIPAA can’t keep up with health care’s security crisis (STAT)
  • US reports first outbreak of deadly H7N9 bird flu since 2017 (Reuters)
  • ACI’s 21st Annual Paragraph IV Disputes (FDA Law Blog)
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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