Recon: FDA approves Zenbexus for multiple myeloma; NSAI seeks buyer for its MDR notified body business
In Focus: US
- US FDA approves Lantheus' brain-imaging agent for Alzheimer's assessment (Fierce Biotech) (Reuters)
- Bristol Myers wins ‘milestone’ FDA approval of myeloma drug acquired from Celgene (BioPharma Dive) (FDA)
- FDA office leadership overruled clinical review team to approve Replimune’s Tudriqev (Pink Sheet)
- FDA modernizes drug product packaging assessments with risk-based framework (Pink Sheet)
- CDRH sets September meeting to address AI, digital health regulatory science gaps (Medtech Insight)
- FDA proposes Class I status for seven device accessories (Medtech Insight)
- FDA oncology chief highlights ‘resilience’ in changing times (Pink Sheet)
- FDA loses key PFDD figure with Theresa Mullin’s departure (Pink Sheet)
- Was PDUFA VIII A Better ‘America First’ Vehicle Than GDUFA IV? (Pink Sheet)
In Focus: International
- Tavneos trial flagged for 'serious breaches' of protocol as EU regulators dissect market withdrawal decision (Fierce Pharma)
- EMA accepts Pfizer/Valneva’s Lyme disease vaccine filing in global first (Pink Sheet) (Pharmaceutical Business Review)
- Pharvaris’s Deucrictibant for HAE among nine new EU filings (Pink Sheet)
- Sandoz to license three biosimilar drugs from Shanghai Henlius Biotech (Reuters)
- EMA signals support for large MS data network for post-approval safety studies (Pink Sheet)
- New Zealand broadens lifetime labeling exemptions to ease regulatory burden and boost access (Pink Sheet)
Pharma & Biotech
- Swiss drug launches sacrificed due to US MFN, industry group warns (Pink Sheet)
- AstraZeneca cans late-stage bispecific trial after lung cancer setback (Endpoints)
- AZ's blood pressure newcomer Baxfendy fails to meet cost-effectiveness bar, ICER says (Fierce Pharma)
- Argenx declares phase 3 win for Vyvgart Hytrulo in autoimmune myositis (Endpoints) (Reuters)
- EyePoint's drug for age-related eye disease fails late-stage trial, shares tank (Reuters)
- Fulcrum to merge with Slate in all-stock deal after drug setback (Reuters)
- Appeals court resurrects Celgene investor lawsuit against BMS (Fierce Pharma)
- J&J hands lymphoma bispecific CAR T back to AbelZeta (BioSpace)
- Celcuity awaits FDA review for second factory to launch cancer drug (Endpoints)
- Capricor shares soar as potential FDA lifeline revives Duchenne drug hopes (Reuters)
Medtech
- MHRA quarantines six uncertified medical devices (Medtech Insight)
- Cook Medical discloses cyber incident stemming from a scam (MedTech Dive)
- Low demand causes TÜV NORD Scandinavia bankruptcy just seven months after purchase (Medtech Insight)
- NSAI will make ‘orderly exit’ from MDR notified body business (Medtech Insight)
- Thermo Fisher closes $1.1B sale of microbiology unit to PE firm (MedTech Dive)
- CHAI creates work group to counter frontier AI model cybersecurity risks (MedTech Dive)
- AMS secures shareholder support for planned sale to H.B. Fuller (MedTech Dive)
- EU PPWR labeling for medtech: New symbols, old space problem (Medtech Insight)
- Ambient AI blurs regulatory line between record and medical device (Medtech Insight)
- Philips authorizes largest shareholder to increase stake to 22% (MedTech Dive)
Food & Nutrition
- Michigan cyclosporiasis cases rise 11% in a week, even as new cases slow (Reuters)
- Nestle looks to develop new products to serve users of weight-loss drugs (Reuters)
Government & Legal
- Controversial drug-testing lab sues group that develops drug standards over criticism (STAT)
- FDA turns the spotlight on regulatory science: what medical device developers need to know (FDA Law Blog)
- RAPID device coverage: A narrow bridge over Medicare’s coverage gap (FDA Law Blog)
- Recent FDA development warrants revisiting tampon preemption (Drug & Device Law)
- Personal jurisdiction, arbitration, and Class II device preemption in Michigan (Drug & Device Law)
- Trump officials falsely connect COVID vaccines to miscarriage (New York Times)
- Fauci declines request to appear before a second Senate panel after GOP contempt vote (AP News)
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.
