Recon: House lawmakers push FDA to probe clinical studies conducted in China; J&J to buy V-Wave for up to $1.7B
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- J&J to buy heart failure implant maker V-Wave for up to $1.7B (MedTech Dive) (Endpoints)
- Congressional probe questions clinical trials run in China, citing Army involvement (STAT)
- What to know about Alnylam’s upcoming readout on its heart drug (STAT)
- Abortion rights and drug pricing program take spotlight at first night of DNC (STAT)
- Q&A: How the FDA could use AI for drug and device safety surveillance (STAT)
- Big employers are spending even more money on pharmacy costs, driven by GLP-1s and other high-cost therapies, survey says (Endpoints)
- FDA Disruption: If Trump Wins, Could Big Changes Be Coming? (Pink Sheet)
- AstraZeneca’s Imfinzi Squeezes Through: Is FDA Reversing Course Or In A Transition Period? (Pink Sheet)
- Improving the FDA-EMA parallel scientific advice program to advance complex generics (STAT)
- Emergent joins broader efforts for mpox vaccine drive in Africa (Endpoints)
- UK Medicines Agency Wants ‘Up To Five Years’ Notice Of New Applications (Pink Sheet)
- ICH Explores New Platform To Facilitate Global Evaluation Of CMC Changes (Pink Sheet)
- EU Warns Of Anaphylaxis With MS Drug ‘Months Or Years’ After Start Of Treatment (Pink Sheet)
- Brexit & Covid Impact On UK Cancer Trials ‘Dissipating’ (Pink Sheet)
- Does Ozempic increase the risk of suicidal thoughts? A new study muddles the picture (STAT)
- Lilly’s Zepbound slashed risk of developing diabetes (STAT)\
- Kymera seeks to raise $225M; Adcendo, Multitude's new ADC deal (Endpoints)
- TCGX and JPM help Pathalys raise $105M to go up against Amgen in subset of kidney disease (Endpoints)
- FDA rebukes another troubled Eugia production site with a warning letter (Fierce Pharma)
- Medtronic: Diabetes strategy hasn’t changed amid Abbott partnership (MedTech Dive)
- Histosonics raises $102M for noninvasive treatment to destroy tumors (MedTech Dive)
- Edwards continues M&A spree with Genesis’ TAVR tech (MedTech Dive)
- FDA OKs first at-home syphilis test (MedTech Dive)
- DuPont acquires Donatelle Plastics for $313M (MedTech Dive)
- European Commission Publishes Links To Notified Bodies’ Medtech Fees (MedTech Insight)
- Neptune Medical Leans Into GI Robotics, Spins Out Jupiter Endovascular (MedTech Insight)
- Moximed Secures $91M To Scale Commercialization Of MISHA Knee System (MedTech Insight)
- Cresilon’s FDA-Cleared Traumagel Stops Severe Bleeding Instantly, Available In US In Late 2024 (MedTech Insight)
- Teamwork is good for science — but maybe not for young researchers’ careers (STAT)
- Teva faces fresh Copaxone kickbacks case from Medicare providers as it defends against DOJ claims (Fierce Pharma)
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