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November 18, 2024
by Jason Scott

Recon: FDA approves Syndax leukemia therapy; Boston Scientific completes $3.7B Axonics acquisition

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US
  • RFK Jr vow to purge FDA sets up collision with Big Pharma (Reuters)
  • What to know about RFK Jr.’s views on food, vaccines, abortion, and the FDA (STAT)
  • Syndax wins U.S. approval for leukemia treatment (STAT)
  • Q&A: American Heart Association president on GLP-1s and ‘common ground’ with the next White House (STAT)
  • Medicaid fuels US coverage of Novo, Lilly weight-loss drugs (Reuters)
  • Lilly sues US agency over blocking of drug-rebate program (Reuters)
  • Boston Scientific closes $3.7B Axonics deal after lengthy review (MedTech Dive)
  • VBI Vaccines recalls hepatitis B shot as it winds down operations (Fierce Pharma)
  • Cleanup for the IL-23 class in ulcerative colitis as new drugs 'rapidly gained significant momentum': report (Fierce Pharma)
In Focus: International                                                                                                       
  • Exclusive: Athena Countouriotis' Avenzo taps Shanghai biotech for ADC, adds new funds (Endpoints)
  • Novo Nordisk launches obesity drug Wegovy in China (Reuters)
  • Nigeria begins delayed mpox vaccination programme (Reuters)
  • Bangladesh deaths from dengue cross 400 as outbreak worsens (Reuters)
  • Bavarian Nordic has $340 mln orders for its mpox, smallpox vaccine in 2025 (Reuters)
Pharma & Biotech
  • Regenxbio says gene therapy strengthened boys with Duchenne muscular dystrophy (STAT)
  • Novo Nordisk readies trial results for next-generation weight-loss drug (The Financial Times)
  • A rare neurological disease is Sage’s last, best hope after failures in depression (Endpoints)
  • Eisai terminates Phase 3 trial of Dravet drug, citing recruitment challenges (Endpoints)
  • 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.
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