Recon: Novo Holdings slated to buy Catalent for $16.5B; Amgen, Regeneron pursuing GLP-1 class obesity drugs
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Regeneron is interested in obesity treatments that combat muscle loss (STAT)
- Can Arena Bioworks upend the traditional scientific research model in the U.S.? (STAT)
- FDA website shows limited availability of some doses of Lilly's Mounjaro (Reuters)
- Merck to buy Elanco's aqua health business for $1.3 billion (Reuters)
- FDA sets date for high-profile CAR-T adcomm for Bristol's Abecma, J&J's Carvykti (Fierce Pharma)
- J&J's immune disorder drug succeeds in mid and late-stage studies (Reuters)
- Draft 340B reforms include user fees, clarity around contract pharmacies (Endpoints)
- End of Aduhelm’s road; Janet Woodcock exit interview; Stuart Schreiber's $500M experiment; Vertex's pain breakthrough; and more (Endpoints)
- Califf Touches On A Range Of Issues And Priorities During Fireside Chat (MedTech Insight)
- Exclusive: Novartis in the lead to acquire cancer drug developer MorphoSys-sources (Reuters)
- EU Creates Manufacturer Vigilance Template And Cardio And Breast Implant Reporting Tables (MedTech Insight)
- EU AI Act Final Text Approved By European Member States (MedTech Insight)
- EU ‘Pathfinder’ Project Aims To Improve Cancer Drug Development & Assessment (Pink Sheet)
- EMA: Should The Comparative Efficacy Requirement Be Waived For Biosimilars? (Pink Sheet)
- Novo Holdings to purchase drug manufacturer Catalent for $16.5 billion, a deal that could expand Wegovy production (STAT)
- Wegovy is usually taken indefinitely. Amgen wants a version that can be tapered down (STAT)
- Promising early data details on Amgen weight-loss drug published (Reuters)
- The top 10 biopharma M&A deals of 2023 (Fierce Pharma)
- Valneva sells chikungunya vaccine priority review voucher for $103 mln (Reuters)
- Gene editing startup Metagenomi finally sets IPO range, as preclinical biotech eyes $87M (Endpoints)
- Pliant’s chronic liver disease drug has consistent safety across dose ranges, PhII data show (Endpoints)
- 4D Molecular Therapeutics' gene therapy cuts Eylea use in wet AMD patients, biotech divulges plans for pivotal studies (Endpoints)
- Abecma sales disappoint again as BCMA competition ramps up, FDA adcomm looms (Endpoints)
- Bristol Myers CEO outlines transition strategy featuring 11 key brands, more dealmaking (Fierce Pharma)
- Amgen, Astellas backed group wants patients to test their biomarkers in new stomach cancer campaign (Fierce Pharma)
- BMS runs first branded TV spot for Camzyos, focusing on moments its $13B heart disease drug makes (Fierce Pharma)
- Aduhelm’s Goodbye: ENVISION Confirmatory Study To End In May, With BLA Withdrawal In November (Pink Sheet)
- Medical devices with screens aren’t accessible to the blind. Congress has chance to change that (STAT)
- Edwards receives FDA approval for first transcatheter tricuspid valve replacement treatment (MedTech Dive)
- Usability challenges for at-home devices top ECRI’s 2024 hazards list (MedTech Dive)
- CVRx names Kevin Hykes as CEO (MedTech Dive)
- News We’re Watching: CDRH Announces Cybersecurity Collaboration, Electrostim Faces Lawsuit, FDA Recalls And Approvals (MedTech Insight)
- FDA Phones a Friend: Joint Statement with CMS Eschews CLIA Modernization and Supports FDA Oversight of LDTs (FDA Law Blog)
- Juul spent big to court Black leaders to promote its e-cigarettes, new documents show (STAT)
- A scholar of the patient ‘revolution’ tracks the arc from powerlessness to influence (STAT)
- Hikma to pay $115M in cash, $35M in donations to settle opioid claims (Endpoints)
- Real Humira competition may not arrive until 2026, AbbVie execs tell investors (Endpoints)
- Rick Gonzalez lays out plan for internal candidate to take over as AbbVie's CEO (Endpoints)
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
