Recon: AbbVie purchases Immunogen for $10 billion to boost cancer portfolio; Cigna and Humana merger talks underway
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- AbbVie buys Immunogen, maker of targeted cancer drugs, for $10 billion (STAT)
- Cigna, Humana in Talks for Blockbuster Merger (Wall Street Journal)
- Vivos receives FDA 510(k) clearance for oral devices to treat severe sleep apnea (MedTech Dive)
- GE HealthCare gets 510(k) clearance for algorithm to detect collapsed lungs (MedTech Dive)
- ‘Fire, smoke, burns’: FDA warns about new safety risks for Philips CPAP machines (MedTech Dive)
In Focus: International
- With latest tranche, U.K. Biobank has genome sequences from 500,000 people available for research (STAT)
- Turkey launches investigation into 19 pharma companies (Reuters)
- GSK CEO says RSV vaccine revenue to top 1 bln pounds in first year (Reuters)
- Philips investor Exor: company's problems are "solvable" (Reuters)
- India's Tata Technologies valued at $6.4 bln after smashing debut (Reuters)
- Medtech Industry Weighs In On EMA’s AI Regulation Proposals (MedTech Insight)
- Latest Notified Body Designated Under the EU’s MDR Is A Software Specialist (MedTech Insight)
- EU Member States Call For Action Over High-Risk IVDs And Eudamed Medical Device Database (MedTech Insight)
Pharma & Biotech
- Do GLP-1s have a future treating alcoholism? (STAT)
- Cell manufacturing company raises $19M Series A to increase capacity, staff numbers (Endpoints)
- Cybin gears up for registrational trial of psilocybin analog in major depression after PhII success (Endpoints)
- Charles River works on rare disease gene therapy; Emergent gets $75M for anthrax vaccine; EuroAPI hires new COO (Endpoints)
- Flagship aims to raise $3B; Phenomic inks another pharma deal; Oncovita gets €8M for cancer vaccine (Endpoints)
- CRO Fortrea 'disputes the accuracy' of Acelyrin's claims about immunology drug trial conduct (Endpoints)
- Xenon offers $300M in shares after touting path ahead for MDD program despite PhII miss (Endpoints)
- Orna Therapeutics trims staff in ‘defensive reduction’ despite large financing hauls (Endpoints)
- Health tech stands out as a top area for early-stage VC funding in Q3 (Endpoints)
- Neuro startup stock craters after PhIII study marred with ‘significant deviation’ from trial protocol (Endpoints)
- No, I Am Spartacus – Embecta Joins The Quell Against GLP-1 Hype (MedTech Insight)
Medtech
- Diagnostic tests for rare conditions present a mathematical conundrum (STAT)
- Boehringer Ingelheim and IBM team up to make antibodies with generative AI (Endpoints)
- J&J heats up LAA closure competition with $400M Laminar buy (MedTech Dive)
- 3 medtech spinoffs that reshaped the industry in 2023, and what to expect next (MedTech Dive)
- Cleveland Clinic, Canon to establish medical imaging research center (MedTech Dive)
Government, Regulatory & Legal
- The surprising environmental cost of rapid testing, mosquito nets, and other lifesaving health products (STAT)
- How artificial intelligence could make pregnancy discrimination in employment more common (STAT)
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.
