EU’s Future Regulatory Priorities Will Soon Be Solidified So Medtech Must Engage Now (MedTech Insight)
France Consults On Best Practice Guidelines For Decentralized Trials (MedTech Insight)
Industry Applauds AUD18.8m Funding For Australia’s ‘One Stop Shop’ For Clinical Trials (MedTech Insight)
Pharma & Biotech
Weight-loss drug forecasts jump to $150 billion as supply grows (Reuters)
Airway disease drug from Insmed succeeds in one of the year’s most anticipated trials (STAT)
Duchenne muscular dystrophy drug from Nippon Shinyaku fails in rare confirmatory trial (STAT)
Gene therapies for deafness dredge up an old question: Do deaf people want a ‘cure’? (STAT)
Merus drug, with immunotherapy, boosts tumor response in patients with head and neck cancer (STAT)
NewAmsterdam says former Amgen cardio drug reduces heart disease risk factor (Endpoints)
Joe Panetta to step down as Biocom California CEO (Endpoints)
After 14 years calling partnering shots at Genentech/Roche, James Sabry is headed back into the biotech fray (Endpoints)
Second engineered B cell therapy enters the clinic, promising to do in hemophilia B what gene therapies can't (Endpoints)
Agios sells rights to glioma drug to Royalty Pharma; Cargo’s $110M placement (Endpoints)
Takeda to lay off 640 workers in Massachusetts as part of multiyear overhaul (Endpoints)
Duchenne muscular dystrophy drug flunks Phase 3 confirmatory trial (Endpoints)
Corrected: AstraZeneca, Daiichi Sankyo’s TROP2 ADC boosts survival in Phase 3 lung cancer subgroup (Endpoints)
Novartis rides IgAN trioka to 2 trial wins in rare kidney diseases (Fierce Pharma)
Medtech
Achieving telehealth equity for people with hearing loss (STAT)
JPA Health continues expansion with acquisition of medical comms agency BioCentric (Fierce Pharma)
J&J’s Nisha Johnson on Ethizia wound-sealing patch, biosurgery market (MedTech Dive)
New products take center stage in medtech’s latest earnings season (MedTech Dive)
Government, Regulatory & Legal
Dark money group runs ads on China biotech bill (STAT)
At Las Vegas conference, methadone clinics blast idea of doctors prescribing directly (STAT)
Explainer: What does Louisiana's new abortion pill law mean for patients? (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.
Adam Fisher, the staff director of the Office of Pharmaceutical Quality in the Center for Drug Evaluation and Research (CDER) at the US Food and Drug Administration (FDA), reported that the agency has approved 17 pharmaceuticals that utilize continuous manufacturing in their production.
The European Medicines Agency (EMA), in partnership with the European Commission (EC) and the Heads of Medicines Agencies (HMA), has published the first quarterly report on the state of clinical trials conducted in the EU and the European Economic Area (EEA). The report is intended to shed light on the progress being made to attract more clinical trials to the region and increase access to new treatments as part of the targets set by the EU in 2025.
An official from the US Food and Drug Administration (FDA) on Monday presented three case studies demonstrating how sponsors effectively utilized real-world evidence (RWE) and real-world data (RWD) to secure approval for their products.