Recon: European Patent Office invalidates Moderna mRNA patent; Nvidia and Genentech ink AI deal
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
In Focus: US
Delay of eye drop recall highlights FDA’s impotence on the issue (STAT)
FDA warns against using Cardinal's syringes (Reuters)
Going to 11: New Subsections at CDER’s Office of Pharmaceutical Quality Are Important Piece of FDA’s Inspection and Enforcement Strategy (FDA Law Blog)
‘Essential’ Drug Coverage Including Obesity Treatments Make Sense For ACA Plans, CMS Says (Pink Sheet)
Confirmatory Trials: Comprehensive Development Plan, Early Communication Will Help Reduce Delays, US FDA Says (Pink Sheet)
With filing in Sanofi and Mylan insulin lawsuit, FTC amps up scrutiny on pharma’s patent tactics (Fierce Pharma)
In Focus: International
UK's NHS hands U.S.-based Palantir contract for patient data software (Reuters)
Flagship launches first UK-based startup to uncover genes that make cells vulnerable or resistant to disease (Endpoints)
European Patent Office declares Moderna mRNA patent invalid (Reuters)
BeiGene to buy global rights to Ensem's experimental cancer therapy (Reuters)
Indian researchers find no link between sudden death and COVID shots (Reuters)
Hemgenix: European Countries Start Joint HTA Of Another Costly Gene Therapy (Pink Sheet)
Australia’s TGA Offers Drug Sponsors Better Access To Adverse Event Data (Pink Sheet)
Pharma & Biotech
Bayer’s new CEO was dealt a duo of ‘clearing events.’ Tough choices lie ahead (STAT)
Flagship Pioneering launches Quotient, a new biotech, in two countries (STAT)
Mixed study results for MorphoSys blood-cancer drug raise questions about approval (STAT)
Novo rations Ozempic starter kits amid surge in use for weight loss (Reuters)
Updated: Merck commits up to $610M to buy out preclinical biotech and its neurodegenerative disease work (Endpoints)
MorphoSys marches ahead with plans to file myelofibrosis drug despite mixed PhIII results (Endpoints)
Former college roommates combine health and tech backgrounds to raise $58M for new fund (Endpoints)
Medtech
How the CEO of the largest medical device accelerator molds medtech startups (STAT)
GSK boosts low-carbon inhaler development with PhIII trials, investment in French manufacturing facility (Endpoints)
Medtronic shrugs off concerns over newer weight-loss drugs to raise annual forecast (Reuters)
Nvidia signs deal with Genentech to pair drugmaker's machine learning with chip supplier's tech (Endpoints)
Visana Health To Scale Virtual Women’s Health Clinic To Provide ‘Whole Human Being’ Care (MedTech Insight)
Government, Regulatory & Legal
Texas AG sues Pfizer over quality-control lapses in kids’ ADHD drug (Reuters)
Premarket Dose Optimization Precedent In Oncology Likely Not Available Yet (Pink Sheet)
Teva granted pretrial appeal in high-stakes Copaxone kickbacks case (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.
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.