Recon: FDA approves Axsome drug to treat agitation in Alzheimer’s patients; HHS appeals ruling on Kennedy’s vaccine policies

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

In Focus: US

• Securing NIH awards is getting more competitive — and confusing (STAT)
• US FDA approves Axsome's drug for Alzheimer's-related agitation (Reuters)
• HHS appeals ruling that stalled many of Kennedy’s vaccine policy changes (STAT)
• Supreme Court justices appear to signal ‘skinny labeling’ can survive (STAT)
• Democrats go hard on health care affordability (STAT)
• FDA revives oncology advisory panel to debate AstraZeneca drugs (Endpoints)

In Focus: International

• India's Dr Lal Path Labs posts quarterly profit fall on tax expense (Reuters)
• France reports two bird flu outbreaks after easing restrictions (Reuters)
• Baxter beats quarterly estimates, monitors effect from Middle East conflict (Reuters)
• Convicted former Harvard scientist rebuilds brain computer lab in China (Reuters)
• Medtronic secures CE mark for Stealth AXiS surgical system (MedTech Dive)

Pharma & Biotech

• Lilly lifts profit forecast as surging demand for weight-loss drugs offsets pricing pressure (Reuters)
• Merck beats quarterly sales expectations as Keytruda fuels growth (Reuters)
• What does Akeso’s primo plenary spot say about its survival data? (STAT)
• As excitement grows for Bristol Myers' pipeline, Krazati confirmatory study is a mystery (Endpoints)
• Novartis unveils North Carolina factory as final new build in $23B US expansion (Endpoints)
• As AbbVie posts more strong Skyrizi sales, Wall Street frets over J&J pill (Endpoints)
• LEO Pharma to buy U.S. drug developer Replay for $50 million upfront (Reuters)
• Bristol Myers beats quarterly profit estimates on blood thinner, cancer drug sales (Reuters)

Medtech

• New obesity tool aims to predict risk of 18 serious complications (STAT)
• Teleflex hires Jason Weidman as CEO (MedTech Dive)
• FDA advises users of Trividia glucometer to switch to alternatives (MedTech Dive)
• Surgeries are moving to ASCs. Distalmotion wants its robot to drive the shift. (MedTech Dive)
• TytoCare De Novo Could Transform ENT Diagnosis, Accelerating At-Home Care (MedTech Insight)
• CareDx To Acquire Naveris For Up To $260M, Expanding Into Cancer Molecular Testing (MedTech Insight)
• Zimmer Biomet Advances Monogram To FDA, Says Stryker Cyberattack Had No Q1 Impact (MedTech Insight)
• Three Deaths Linked To Early Alert For Bolton Medical RelayPro Thoracic Stent-Graft (MedTech Insight)

Food & Nutrition

• Food giants hit with consumer lawsuit calling ultraprocessed ingredients addictive (Food Dive)
• Banks fail to address meat and dairy’s rising methane emissions: report (Food Dive)

Government, Regulatory & Legal

• Google clinical director says AI can be a ‘bridge’ for people having a mental health crisis (STAT)
• Cigna will exit ACA individual markets next year, adding to tumult for patients (STAT)
• Why conversations around health AI may be evolving beyond hype (STAT)
• Congress must hold RFK Jr. accountable after hearings (STAT)
• CVS' healthcare delivery chief eyes potential in clinical AI (Endpoints)
• Cardinal Health's revenue miss clouds annual profit forecast raise (Reuters)
• FDA-Approved Marijuana Products and Those Subject to State-Issued Licenses Rescheduled; Marijuana Hearing Calendared; Dispensary Applications Accepted (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.