Recon: CBER official overruled Replimune melanoma drug rejection; AbbVie claims phase 3 win for multiple myeloma drug
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- CBER official overruled review team's rejection of new Replimune melanoma drug (Endpoints) (BioSpace)
- FDA is working with manufacturers to boost estrogen patch supply amid access concerns (Reuters)
- FDA conveys tougher clamp down of foreign trial data coinciding with China’s rise (Endpoints)
- A surprising bright spot at the FDA on regulating unproven stem cells (STAT)
- Updated FDA therapeutic equivalence guidance allows faster 505(b)(2) rating requests (Pink Sheet)
- OPDP’s latest reminder on preapproval promotion (FDA Law Blog)
- September Is back-to-school season at FDA: Half of upcoming goal dates include children (Pink Sheet)
- FDA pilot offers generative AI medical devices a path to patients before they are authorized (STAT)
- FDA seeks public input to advance development of botanical drug products (FDA)
In Focus: International
- English funding provisionally blocked for Ubeslo, Evlarco over evidence uncertainties (Pink Sheet)
- Acadia’s Daybu is among new EU approvals (Pink Sheet)
- PIC/S uses look-and-learn visits to build pharmacovigilance inspection consistency (Pink Sheet)
- Japan health ministry eyes AI investment for pharma innovation, regulation (Pink Sheet)
- Amgen disappointed by UK Tavneos suspension as study data scrutiny continues globally (Pink Sheet)
- GSK inks another Asia alliance, betting up to $1.3B for HUTCHMED’s cancer therapy (BioSpace)
- Aspen sees Mounjaro Africa sales above $124 million in 2027 (Reuters)
- Health officials turn to mobile-phone data to track Ebola spread in Congo (Reuters)
Pharma & Biotech
- AbbVie claims phase 3 win of multiple myeloma drug, seeking to enter crowded market (Endpoints) (Reuters)
- Summit, Akeso say ivonescimab clears OS bar in phase 3 lung cancer trial (Endpoints)
- Superluminal secures $60M for Phase 1 of genetic obesity drug (Endpoints)
- GSK to license Hutchmed’s dual-action cancer drug for $110M upfront (Endpoints)
- Ultragenyx’s Angelman therapy fails phase 3 trial in setback for company and patients (Endpoints) (STAT)
- Novartis telegraphs 130 job cuts amid biologics rethink in Switzerland (Fierce Biotech) (Novartis)
- Cellares downsizes New Jersey operations after losing BMS cell therapy contract (Fierce Pharma)
- ArsenalBio sacrifices ‘majority’ of staff in pivot to in vivo CAR T (BioSpace)
Medtech
- MiniMed submits new patch pump for FDA clearance (MedTech Dive)
- Abbott ablation device effective at 1 year in complex cases (MedTech Dive)
- Medtronic invests $700M in Cornerstone Robotics (MedTech Dive)
- Stryker to add rotator cuff repair tech with ZuriMED buy (MedTech Dive)
- Enovis inks eCential takeover to develop surgical ortho robots (MedTech Dive)
- Medtronic kicks off its fiscal year on a high note (MedTech Dive)
Food & Nutrition
- Nestle to build infant formula plant in Brazil as part of $393 million investment (Reuters)
- Canada assesses risks to imports after India raid finds fake labels on food products (Reuters)
- More than 1,700 fall sick from Indonesia free school meals in three days (Reuters)
- From hunger to obesity: Developing world faces growing threat to child health (Reuters)
Government & Legal
- Doctors groups release vaccination guidelines ahead of respiratory illness season (STAT)
- CDC director challenges Pennsylvania's report of two measles deaths (New York Times)
- House votes to temporarily block Trump plan to politicize federal grants (STAT)
- Pentagon issues clinical guidelines on troop testosterone screening to start immediately (Reuters)
- US to grant up to $125M for personalized RNA manufacturing innovation (BioSpace)
- Medicare’s GLP-1 bridge program off to fast start, but how will CMS manage demand? (Pink Sheet)
- BridgeBio’s MFN pact exempts orphan products, highlighting deals’ bespoke nature (Pink Sheet)
- How Trump’s latest pharma deals may undermine efforts to rein in drug costs (STAT)
- “Pilot trials” – the latest atextual MDL proposal (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.
