Recon: FDA approves first drug for type 1 narcolepsy, mRNA flu vaccine; No merger talks between AstraZeneca-BMS

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

In Focus: US

FDA approves first drug to treat the full range of narcolepsy type 1 symptoms (FDA) (STAT)
FDA approves Moderna's mRNA flu vaccine (New York Times) (Moderna)
Caristo wins FDA authorization for cardiovascular risk predictor (MedTech Dive)
Federal regulators invite industry, researchers, and lobbyists to closed-door meetings on clinical AI (STAT)
New US FDA quantitative medicine initiative could advance non-animal testing, trial modeling (Pink Sheet)
Fine print is no fix: FDA says buried disclosures do not cure misleading promos (Pink Sheet)
US FDA’s IND reform pilot could use external partners to speed trial set-up (Pink Sheet)
US FDA details inspection ‘right-sizing’ approach (Pink Sheet)
Dengue spreads with Virginia's first local-exposure case (Bloomberg)

In Focus: International

Merger talks between AstraZeneca, Bristol Myers are off (Endpoints) (Reuters)
EU approval for Tavneos revoked over ‘misleading’ data as Amgen fights to keep drug on US market (Pink Sheet)
EMA drafts shortage prevention plan guidance ahead of new rules for industry (Pink Sheet)
Sanofi asked to change Dupixent ads after Galderma challenge (Fierce Pharma)
First EU joint clinical assessment reports could jeopardize advanced therapy development (Pink Sheet)
UK, Canada find common ground in joint pharmacovigilance inspections (Pink Sheet)
Sanofi pauses mid-stage lung study amid new CEO’s ‘rigorous portfolio prioritization’ (BioSpace)
Once again, child dies in gene-editing trial in China, rekindling debate on transparency and safety (STAT)
Ebola kills 1,700 in eastern Congo as the fastest-growing outbreak surges (AP News)

Pharma & Biotech

Gilead’s Yeztugo beats forecasts as HIV PrEP franchise exceeds $1B (Endpoints)
CVS Health launches Eli Lilly GLP-1 partnership, lifts outlook as profit increases (Wall Street Journal)
The FDA adcomm reboot part 1: Lessons from the meeting on Capricor’s deramiocel (FDA Law Blog)
DMD community presses FDA to broaden its view of benefit as deramiocel decision looms (Pink Sheet)
Chaotic adcomms threaten to derail FDA’s bid to renew trust after Makary, Prasad (BioSpace)
Aurora Therapeutics scraps plans to scale custom CRISPR therapies (STAT)
AstraZeneca, CSPC to form joint venture for biologics manufacturing (Fierce Pharma)
Compounding the problem: Peptides and the FDA advisory committee process (Pink Sheet)
Tarsus to expand eye disease pipeline with up to $800 million Alkeus acquisition (Reuters)
Amgen culls early-stage obesity candidate, makes pipeline updates (Endpoints)
Merck lifts guidance on life science, electronics (Bloomberg)
Lilly beats forecasts again as tirzepatide makes up nearly two-thirds of revenue (Endpoints)
Roche bets on Recursion Al to develop new neuroscience drug (Bloomberg)
Braveheart lands $383M IPO to take Hengrui cardio drug into Phase 3 (Endpoints)
Attovia extends biotech IPO streak with $289M listing for three I&I drugs (Endpoints)
LifeMine raises $263M for safer immunosuppressant (Endpoints)
Novo Nordisk eyes bolt-on deals as pipeline disappointments pile up (Endpoints)
Merck plans a sac-TMT combo trial with Keytruda as patent cliff looms (Endpoints)
Pfizer has already made its biggest deals, Bourla says (Endpoints)
Kenvue misses quarterly estimates as inflation, tariffs squeeze margins (Reuters)
Revolution Medicines preps for pancreatic drug launch, boosting expected 2026 expenses (Endpoints)
Arrowhead buys PRV for $215M; Twist hopes to raise $300M in public offering (Endpoints)
Novavax lifts annual revenue forecast as licensing bets offset weak vaccine demand (Reuters)
Vedanta gets $60M to finish phase 3 for C. diff microbiome therapy (Endpoints)
As FDA makes Lipfendra poster child of CNPV pilot, Merck charts long-term path for first PCSK9 pill (Fierce Pharma)
Could fecal microbiome transplant be the next treatment for food allergies? (STAT)

Medtech

FDA’s Koven warning letter flags supplier management and design change failures (Pink Sheet)
Danaher promotes Julie Sawyer Montgomery to CEO (MedTech Dive)
STAAR Surgical appoints Warren Foust as permanent CEO (MedTech Dive)
MRI is standard for diagnosing prostate cancer in most western countries. But most U.S. men don’t get them (STAT)

Food & Nutrition

Roche launches two new cyclospora tests as US outbreak widens (Reuters)
Fifteen states now linked to iceberg lettuce cyclospora outbreak, CDC says (AP News)
Mexican jalapenos tied to Salmonella outbreak in 27 US states (Reuters)

Government & Legal

Exemption of rare disease therapies in drug-pricing pilots would wipe out huge savings, analysis finds (STAT)
Atossa Therapeutics founder to be selected as NIAID director (Endpoints)
Erica Schwartz confirmed as CDC director, filling nearly yearlong vacancy (STAT)
Senate committee votes to hold Fauci in contempt for refusing to answer COVID questions (AP News) (US Senate)
Trump Administration Reveals New Guidelines for Autism Therapy (Wall Street Journal) (CMS)
Senate inquiry suggests Trump administration softened kratom and tobacco policies in quid pro quo (STAT)
Trump has another tariff plan to reshore generic drug production. Will it work? (Supply Chain Dive)
Claims can still be preempted if the drug is later withdrawn (Drug & Device Law)
Seventh Circuit reverses dismissal of zero sugar yogurt consumer deception lawsuit after FDA reverses its position on what constitutes sugar (Drug & Device Law)

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.