Recon: FDA weighs new deputy commissioner posts; Trump set to reveal more MFN drug pricing deals

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

In Focus: US

• HHS plans new FDA deputy commissioner roles for technology and drugs, sources say (CNBC) (Fierce Pharma)
• Trump set to reveal MFN pricing deals with mid-sized companies (Fierce Pharma) (Bloomberg)
• FDA approves new pancreatic cancer drug expected to usher in new era of treatment (STAT) (FDA)
• FDA approves ViiV's HIV treatment for newborns (Endpoints) (ViiV)
• Abbott receives FDA nod for dual-analyte sensor (MedTech Dive)
• FDA’s 510(k) route is clearing thousands of AI devices with no proven patient benefit (Medtech Insight)
• FDA authorizes Abbott’s glucose-ketone monitor (Medtech Insight)
• Paradromics gets FDA approval to embed BCI software in personal devices (Medtech Insight)

In Focus: International

• EMA targets faster, more streamlined data standards in draft framework (Pink Sheet)
• China's drug regulator accepts Novo Nordisk's application for oral Wegovy (Reuters)
• CEPI backs Minapharm's experimental Ebola vaccine with up to $16.5 million funding (Reuters) (Bloomberg)
• Nine animal-free drug tests win UK funding (Pink Sheet)
• Akeso, Summit hail ivonescimab's biliary tract cancer win in China-only phase 3 trial (Endpoints)
• Egypt cracks down on non-compliant drug ads with public naming and sanctions (Pink Sheet)
• India’s device rule changes draw fire from domestic makers over EU waiver and sterilizer labeling (Medtech Insight)
• What could a US-Germany drug pricing deal look like? (Pink Sheet)
• Could USTR German pricing investigation lead to policy misfire and damaged trading relations? (Pink Sheet)
• WHO says Ebola outbreak in Uganda is over, as cases rise in Congo (Reuters)

Pharma & Biotech

• Lilly's move to hide phase 1 pipeline draws mixed reviews (Endpoints)
• After recall, Vitruvias closes down; Baxter pulls more product batches (Fierce Pharma)
• Generate:Biomedicines discloses early respiratory drug data after congress poster leak (Endpoints)
• Alnylam’s heart drug troubles take center stage at a cardiology conference (STAT)
• AstraZeneca-Amgen asthma drug succeeds in late-stage esophagus disease trial (Reuters) (BioSpace)
• Biohaven strikes $795M deal for commercial partner in epilepsy (Endpoints)
• An uncertain future for Aurora, the first startup dedicated to custom CRISPR therapies (Endpoints)
• Spyre drops rheumatoid arthritis hopes for anti-TL1A drug after modest phase 2 data (Endpoints) (BioPharma Dive)
• Newer shingles vaccine linked to lower heart disease risk, ‘natural experiment’ shows (STAT)
• Nearly 1/4 dealing with long-term unemployment call it quits on biopharma job searches (BioSpace)
• Can AI chop clinical trial timelines in half? Faro raises $37M to find out (Endpoints)

Medtech

• Sword Health plans to buy Headspace, filing says (Endpoints) (STAT)
• Boston Scientific’s ordering, shipping disrupted in cyberattack (MedTech Dive) (Medtech Insight)
• Metriport raises $26M to help doctors retrieve patient data (Endpoints)
• Surgical Science launches novel simulator for point-of-care ultrasound training (Medtech Insight)

Food & Nutrition

• Jalapeno ranch dip recalled because of undeclared eggs (Food Safety News)
• More than 80 patients reported in new Salmonella outbreak (Food Safety News)
• Nestle wants India to consult on food-labelling rules amid debate on packaging warnings (Reuters)

Government & Legal

• Cassidy criticizes FDA oversight of abortion pill manufacturers in new report (STAT)
• A bill is supposed to protect U.S. biotech from Chinese competition. But there’s a loophole (STAT)
• A costly 180: The DC circuit flips FDA’s forfeiture playbook (FDA Law Blog)
• US lawmakers question Health Secretary Kennedy on vaccine settlement disclosures (Reuters)
• Kennedy advisers propose doubling US autism spending on care, family support (Reuters)

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.