Recon: FDA denies Hengrui-Elevar liver cancer drug for the third time; GSK to pursue FDA nod for Jemperli for rectal cancer
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
- Nominee for key federal health role has a history of questioning vaccines (STAT)
- HHS presses ahead with effort to curb antidepressant use (STAT)
- FDA returns to releasing pharma rejection letters with 14 new CRLs (Endpoints)
- FDA rejects Hengrui-Elevar liver cancer drug combo for third time (Endpoints)
- FDA's latest onshoring move homes in on streamlined facility registration, foreign plant scrutiny (Fierce Pharma)
- US FDA urges infant-formula makers to tighten supplier oversight after product recalls, botulism outbreaks (Reuters)
- US FDA Promotes Deputy To Acting Chief Information Officer (Pink Sheet)
In Focus: International
- 'We're paranoid.' As China biotech competition heats up, American drugmakers get more secretive (Endpoints)
- Mylan to sell up to $363 million stake in India's Biocon, term sheet shows (Reuters)
- Oxford begins first human trial of Bundibugyo Ebola vaccine (Reuters)
- Germany approves controversial healthcare reform package (Fierce Pharma)
- Apollo inks €3B equity deal for stake in Bayer's contraceptives business (Fierce Pharma)
- South East Asian Countries Consider EU Joint Clinical Assessment Model (Pink Sheet)
- Speedy Review For UK Phase I Trial Applications Imminent Under MHRA Economic Growth Goals (Pink Sheet)
- EU, Japan And US Pharmacopeias Test Prospective Harmonization With AstraZeneca’s Tagrisso (Pink Sheet)
Pharma & Biotech
- A breakthrough in pancreatic cancer has experts excited — and braced for what’s to come (STAT)
- Biopharma's 'extraordinary year' for M&A sets tone as earnings season begins (Endpoints)
- GSK's Jemperli meets main goal in mid-stage rectal cancer trial (Reuters)
- China innovative drug out-licensing deal value reaches new high in first half of 2026, says CCTV (Reuters)
- Star Padcev-Keytruda combo expands bladder cancer reach with FDA approval, pressuring AstraZeneca (Fierce Pharma)
Medtech
- J&J wins FDA approval for dual-energy ablation catheter (MedTech Dive)
- Medicaroid wins Europe’s CE mark for Hinotori surgical robot (MedTech Dive)
- Whoop tests wearable platform in joint replacement recovery (MedTech Dive)
- Illumina builds out C-suite with 2 new execs (MedTech Dive)
- Tariffs Meant To Reshore Medtech Would Send It Offshore, Industry Tells USTR (MedTech Insight)
Food & Nutrition
- JBS axes 2040 net-zero goal, citing ‘immense’ execution challenges (Food Dive)
- FDA warns Florida supplement maker about sanitation and allergen risks (Food Safety News)
Government, Regulatory & Legal
- Pesticide makers stack wins against US environmental, public health groups (Reuters)
- India seeks to quash Adani airport's nicotine pouch court challenge citing illegality, health risk (Reuters)
- Quadria-backed India's Maxivision hires IPO bankers, sources say (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.
