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August 20, 2024
by Jason Scott

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)
In Focus: International                                                                                                       
  • 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)
Pharma & Biotech
  • 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)
Medtech
  • 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)
Government, Regulatory & Legal
  • 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)
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.
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