Recon: Boston Scientific buys urology devicemaker Axonics for $3.7 billion; J&J, Merck announce purchases of cancer therapy developers
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Boston Scientific acquires Axonics, urology company, for $3.7 billion (STAT)
- The ADC hot streak continues: J&J to buy cancer drug developer Ambrx Biopharma (STAT)
- Merck to acquire Harpoon Therapeutics for $680 million (STAT)
- Drugmakers kick off industry conference with two cancer deals (Reuters)
- HHS names inaugural chief competition officer (STAT)
- Cerevel failed to draw Pfizer into a bidding war, but got AbbVie to up its price anyway, filing shows (Endpoints)
- Moderna's 2023 prelim COVID vaccine sales meet target (Reuters)
- Regeneron reports preliminary Q4 U.S. sales of Eylea at $1.46 bln (Reuters)
- Walgreens to pay $360 million to Humana in drug pricing settlement (Reuters)
In Focus: International
- Novartis licenses two cardiovascular RNAi drugs from Chinese biotech for $185M upfront (Endpoints)
Pharma & Biotech
- Former Sage executives join biotech VC Cure Ventures (STAT)
- No pain data yet from Vertex, and sky high deal expectations at JPM 2024 (STAT)
- Vertex pauses diabetes islet cell therapy study after two patient deaths it says are unrelated to drug (Endpoints)
- Novartis strikes $250M buyout for Merck Serono spinout's autoimmune 'pipeline-in-a-drug' (Endpoints)
- Bayer’s $425M non-hormonal therapy for menopause symptoms clears first PhIII test (Endpoints)
- Affimed cuts up to 50% of employees to support clinical projects, CEO departs (Endpoints)
- New David Liu study details virus-like delivery system for prime editing (Endpoints)
- Exclusive: Alphabet's Isomorphic inks first pharma deals with Eli Lilly and Novartis for $83M upfront, $2.9B in milestones (Endpoints)
- Allogene to cut 22% of its workforce (Reuters)
Medtech
- Execs On The Move: December 2023 (MedTech Insight)
- Americans are obsessed with health and fitness tracking. It’s time for a data diet (STAT)
- Backed by Mayo Clinic and Microsoft, a nonprofit forms to test AI tools used in health care (STAT)
- Insitro, biotech AI’s quiet unicorn, unveils efforts in ALS, liver disease, and cancer at JPM (STAT)
- Abbott, Tandem launch new hybrid closed-loop insulin delivery system (MedTech Dive)
- ‘Healthy pullback’: GSR Ventures’ Sunny Kumar on normalizing digital health funding, accelerating M&A in 2024 (MedTech Dive)
- Thermo Fisher to lay off 74 California workers in restructuring (MedTech Dive)
- Nanowear gets FDA clearance for undergarment that estimates blood pressure (MedTech Dive)
- News We’re Watching: Synovo Hip Warning, 23andMe Lawsuit, Public Citizen Co-Founder Dies (MedTech Insight)
- Arik Ishay Is Marching To The Biobeat Of His Own Drum (MedTech Insight)
- ResMed Says Magnetic Masks Could Interfere With Implanted Devices, Provides Updated Safety Instructions (MedTech Insight)
Government, Regulatory & Legal
- Cost isn’t the only reason Medicare doesn’t cover Wegovy (STAT)
- US Supreme Court rejects new Intel challenge to federal patent policy (Reuters)
- New FDA List Shows 18 COVID-19 Tests With Traditional Authorization (MedTech Insight)
- Why are Post-Approval Pregnancy Studies Post-Marking Requirements Rather Than Post-Marketing Commitments? (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.
