As cardiomyopathy market expands, Alnylam offers look at Phase 1 data in healthy volunteers (Endpoints)
Intellia touts first clinical outcomes on CRISPR-based ATTR amyloidosis asset (Endpoints)
Aclaris makes a deal, aims to raise $80M; Emmecell’s Ph1 update in corneal edema (Endpoints)
Atlas Venture targets $450M for 14th biotech fund, the same size as its 2022 raise (Endpoints)
Novartis strikes radiopharma deal with Ratio worth up to $745M (Endpoints)
Cybin says its psychedelic drug can sustain remission in depression patients (Endpoints)
CVS adds four new board members in deal with Glenview as CEO pursues a turnaround (Reuters)
With new patient resource to close conversation gaps in rheumatic disease, AbbVie makes 'Rheum for Dialogue' (Fierce Pharma)
Eisai sunsets development, access program for withdrawn obesity med in Dravet syndrome (Fierce Pharma)
Amid Seattle downsizing, Gilead cuts 100+ positions at California HQ (Fierce Pharma)
Medtech
With rising cancer rates in younger adults, experts emphasize better tests (STAT)
The PFA race is heating up. Here’s where the market stands after J&J’s approval (MedTech Dive)
Boston Scientific’s Watchman could be new option for patients post ablation: study (MedTech Dive)
FDA warns providers on Getinge devices tied to 17 serious injuries (MedTech Dive)
Abbott Opens New Manufacturing Facility In Ireland For FreeStyle Libre 3 Production (MedTech Insight)
UK Kicks Off Seven-Week Pre-Market Regulatory Consultation (MedTech Dive)
Government, Regulatory & Legal
First U.S. case of new mpox strain detected in California (STAT)
Hospitals and insurers are optimistic Republicans will extend ACA subsidies (STAT)
How RFK Jr. could strip legal protections from vaccine makers as HHS Secretary (STAT)
Medical services provider CareMax files for Chapter 11 restructuring (Reuters)
Even in “Unprecedented” Times, There is Precedent (FDA Law Blog)
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.