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February 1, 2024
by Jason Scott

Recon: Hikma, ad firm settle US opioid suits for $500M; Novavax announces new layoffs

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

In Focus: US
  • Ad firm Publicis, drugmaker Hikma settle US opioid cases for $500 million (Reuters)
  • Biden administration makes opening offers in Medicare drug price negotiations (STAT) (Fierce Pharma)
  • Judge skeptical of arguments against Medicare drug price negotiation (STAT)
  • Methadone treatment gets first major update in over 20 years (STAT)
  • Merck still on the hunt for billion-dollar deals, citing Prometheus and Daiichi Sankyo as examples (Endpoints)
  • More than 40 House Republicans co-sponsor IRA fix to align small molecule and biologic negotiation periods (Endpoints)
  • FDA receives more reports of deaths linked to Philips’ recalled respiratory devices (MedTech Dive)
In Focus: International
  • Despite Roche's sharp COVID sales decline, eye drug Vabysmo powers major revenue win, CEO says (Fierce Pharma)
  • Due to ‘overwhelming demand,’ Sanofi and AstraZeneca’s RSV antibody to be in limited supply (Endpoints)
  • Sanofi Q4 earnings hit by weak dollar, generic competition (Reuters)
Pharma & Biotech
  • Novavax is on thin ice, and the latest update isn’t exactly encouraging (STAT)
  • Novavax announces another round of layoffs, lets go 12% of employees (Endpoints)
  • Raleigh-Durham challenges Boston as biomanufacturing hub of the future (STAT)
  • Sanofi expects RSV antibody to ⁠breach blockbuster status in 2024, even as supply hitch drags on (Fierce Pharma)
  • Can gene therapies make for a profitable business? Keep your eye on Bluebird Bio (STAT)
  • ‘120 pages of data’: Roche’s pipeline review leads to asset cuts, but also additions (Endpoints)
  • Schrödinger takes a step forward with AlphaFold in drug R&D, as biotech hits a pipeline 'inflection' (Endpoints)
  • Basking raises $55M; Seroba’s fourth fund; Vera upsizes its public offering (Endpoints)
  • In continuing its transformation, Teva confirms plan to sell off API business (Fierce Pharma)
  • Novo Nordisk doubles stock of Wegovy starter doses, but supply constraints persist: CEO (Fierce Pharma)
  • AGC Biologics warned for poor discrepancy investigation practices, quality control issues at Washington site (Endpoints)
Medtech
  • Where do we go from here on digital therapeutics? (STAT)
  • Clues from mice could help explain why women face a higher risk of autoimmune disorders (STAT)
  • Thermo Fisher mulls Irish site exit; Alvotech’s new Form 483; Catalent assists with Wegovy manufacturing (Endpoints)
  • Califf backs increased LDT oversight despite industry opposition (MedTech Dive)
  • Boston Scientific nets Farapulse approval, pushes back US TAVR launch (MedTech Dive)
  • BD partners with Techcyte to offer AI-enhanced cervical cancer screening (MedTech Dive)
  • The top medtech trends in 2024 (MedTech Dive)
  • Neuralink rival Synchron takes stake in medical component maker Acquandas (Reuters)
  • FDA extends deadline for comments on role of digital health in diabetes detection (MedTech Dive)
Government, Regulatory & Legal
  • General Catalyst wants to take over a safety-net health system in Akron. The city has questions (STAT)
  • Why I left the editorial board of the prestigious scientific journal NeuroImage — and helped start something new (STAT)
  • Lawsuit accuses UPenn and Jim Wilson of secretly profiting from former postdoc's work (Endpoints)
  • GSK inks another Zantac settlement ahead of trial in California (Fierce Pharma)
  • FDA slams Eugia with Form 483 and posts older reprimands for AGC, Baxter (Fierce Pharma)
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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