Recon: FDA approves Edwards’ tricuspid valve repair device; Bayer wins Chinese approval for blood thinner asundexian
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- FDA launches new program to advance neuroscience medical product development (FDA)
- FDA wants to rewrite the Alzheimer’s prevention trial playbook (Pink Sheet)
- New US hepatitis B vaccine guidelines likely leave many infants vulnerable (Reuters)
- FDA’s rare disease framework could be ‘sandbox’ for wider drug development (Pink Sheet)
- FDA plans pilot program for Rx-to-OTC switches and other nonprescription drugs (Pink Sheet)
- Ex-staff returning to more normal FDA, but sponsors still should expect novice reviewers (Pink Sheet)
- CMS will face challenges in implementation of GLOBE model for MFN pricing (The Pharma Letter)
- US proposal to restrict China biotech investment leaves licensing in a gray area (Pink Sheet)
- Surgery Partners to be taken private by Bon Secours affiliate in $5.7 billion deal (Reuters)
In Focus: International
- China approves Bayer blood thinner asundexian (Reuters) (Bloomberg)
- UK approves J&J's oral psoriasis pill (Reuters)
- Japan halts Tavneos use in new patients, mulls revoking approval (Pink Sheet)
- Most cancer drugs approved by European regulators lack a high clinical benefit, analysis finds (STAT)
- Regeneron extends US agreement for additional supply of Ebola treatment (Reuters)
- Ebola scientists to probe Nigeria case origin, Africa CDC says (Reuters)
- Innovative drugs bound for Singapore could see wait for funding decisions halved (Pink Sheet)
- Takeda to seek Japan approval for gastric cancer drug next year (Reuters)
- Platform trials can be considered pivotal if sponsors plan ahead, says EMA (Pink Sheet)
- ‘You could generate an elephant’: EMA targets lengthy clock-stops in bid to speed drug reviews (Pink Sheet)
Pharma & Biotech
- Gilead strikes $1.3B upfront China deal for oral IL-23 drug (Endpoints)
- Merck drug extends survival in endometrial cancer trial, wins US priority review (Reuters)
- Roche taps Zymeworks in up to $813M deal for preclinical T cell engager (Endpoints)
- Moderna and Merck's cancer vaccine cuts risk of death but disappoints investors (Endpoints) (STAT)
- Genmab’s ADC beats survival expectations in phase 3 ovarian cancer trial (BioSpace) (Bloomberg)
- Bristol Myers reveals death in MS CAR-T trial, has answer for safety signal in lupus trial (Endpoints) (STAT)
- Amgen drug combined with immunotherapy extends survival in lung cancer trial (Reuters)
- Darolutamide cuts metastasis or death risk in high-risk prostate cancer (The Pharma Letter)
- Bristol Myers, SystImmune breast cancer drug cuts progression risk in study (Reuters)
- Akeso details ivonescimab's biliary cancer success, drawing Keytruda comparisons (Endpoints)
Medtech
- Edwards wins FDA approval for tricuspid valve repair device (MedTech Dive) (Medtech Insight)
- Smith & Nephew orthopaedics deal talks with J&J fail over CEO choice, source says (Reuters)
- If you change it, FDA will come: What the ON Diagnostics warning letter means for SaMD modifications (FDA Law Blog)
- Real-world evidence for medical devices: CDRH advice on Q-Submissions, data and bias (Medtech Insight)
- Former FDA officials in Boston offer device makers advice on inspections under new QMSR protocol (Medtech Insight)
- FDA’s new PCCP pages add case studies, instructions and a 240-device list (Medtech Insight)
- Most AI scribe companies don’t realize they’re making medical devices, says TGA (Medtech Insight)
- China’s pharma five-year plan targets 200 innovative medical devices by 2030 (Medtech Insight)
- Roche diagnostics says China drag is easing as it eyes return to mid-to-high single-digit growth (Medtech Insight)
- CMR Surgical chose agency over distribution to keep surgeons close, CEO says (Medtech Insight)
Food & Nutrition
- FDA warns fermented cabbage maker about pathogen risks, labeling violations (Food Safety News)
- FDA issues warning about cold smoked fish because of botulism risk; company refuses to recall product (Food Safety News)
Government & Legal
- NIH’s new vaccine injury center has broad goals beyond RFK Jr.’s focus on shots (STAT)
- The Trump administration moves to treat millions of mentally ill veterans with psychedelics (Politico)
- Exit of RFK Jr. ally widens rift in GOP tent (Politico)
- Bernie Sanders could soon get a powerful perch to help shape 2028 (Politico)
- Health care shakes up the Iowa election (Politico)
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.
