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)
- 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)
- 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)
- 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)
- 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)
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