Brazil Aims For Top 10 Spot In Clinical Research (Pink Sheet)
Pharma & Biotech
Bristol Myers will pay $4.1 billion for cancer startup RayzeBio (STAT)
Novartis Inks Potential $1.3B Gene Therapy Deal with Voyager to Target Neuro (Biospace)
AstraZeneca makes $1B deal for Gracell and its cell therapies, adding to China ties (Endpoints)
ImmunityBio Snags $320M Royalty Deal Ahead of FDA Decision in April (Biospace)
Regeneron scores Eylea patent win against Mylan, keeping biosimilar at bay (Endpoints)
Cytokinetics heart drug aficamten succeeds in pivotal study (STAT)
Medtech
Shunned by insurers, digital therapeutics startups look for other ways to get paid (Endpoints)
Roche to buy part of LumiraDx diagnostics platform for $295 million (Reuters)
Apple Watches Are Back On The US Market (MedTech Dive)
Philips pays $2.4 million for allegedly giving kickbacks to sleep labs (STAT)
Former Stimwave CEO Charged With Securities Fraud (MedTech Insight)
Government, Regulatory & Legal
US judge allows FTC to temporarily block IQVIA acquisition of DeepIntent (Reuters)
LumiraDx Appoints Administrators, Sells Platform to Roche (Bloomberg)
McKinsey to pay $78 million in US opioid settlement with health plans (Reuters)
LumiraDx Appoints Administrators, Sells Platform to Roche (Bloomberg)
Abortion, Guns, Jan. 6 Highlight Top Supreme Court Cases in 2024 (Bloomberg)
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.
The International Medical Device Regulators Forum (IMDRF) has released a guidance for manufacturers on how to choose, evaluate, and monitor suppliers throughout the life cycle of medical devices.