Recon: MHRA AI Airlock candidates selected; Gilead tests yearly anti-HIV shot
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Pfizer’s blockbuster Ibrance slows tumor progression in another type of breast cancer (STAT)
- I used to do health insurance company PR. Here’s what I think the backlash is missing (STAT)
- Prices for 5 drugs were hiked without proof of new benefits, costing the U.S. $815M in 2023, report finds (STAT)
- Gilead to test once-a-year HIV prevention shot (STAT)
- US FDA identifies cases of liver injury after treatment with Intercept's drug (Reuters)
- Public-Private Partnerships Praised Amid Criticism of COVID-19 Response (MedTech Insight)
- After M&A rumors sparked stock volatility, Bausch + Lomb confirms it's exploring a sale (Fierce Pharma)
- Europe allows Novo to include reduction of kidney disease in Ozempic label (Reuters)
- First victims of UK blood scandal offered compensation (Reuters)
- Lonza seeks deals as it exits health and ingredients to focus on contract development (Reuters)
- Five AI Technologies Selected For UK MHRA’s AI Airlock Pilot (MedTech Insight)
- UK Medtechs Fear Government Tax Rise Will Push Them Over The Edge (MedTech Insight)
- Arcellx won the battle of BCMA CAR-T therapies (STAT)
- What I’ve learned — the hard way — about AI in bio (STAT)
- Why Stoke Therapeutics’ Dravet syndrome drug is worth watching (STAT)
- Keros shares plunge as safety doubts prompt dosing pause in blood pressure drug trial (Reuters)
- Elevation to pay up to $368M in ADC deal; Bavarian Nordic closes San Diego site (Endpoints)
- Eli Lilly and Ro’s unlikely relationship (Endpoints)
- Pleno raises $25M for multiomics testing, names new CEO (Endpoints)
- CRO Ora showcases key role music plays in the blind community (Fierce Pharma)
- Inside Isomorphic Labs: Demis Hassabis’ lab-free vision for biotech’s AI future (Endpoints)
- Labcorp closes takeover of Ballad Health outreach laboratory services (MedTech Dive)
- Patterson, a dental products distributor, agrees to $4.1B sale to healthcare investor (MedTech Dive)
- Masimo lays off 75 employees in California (MedTech Dive)
- Artivion says cybersecurity incident has disrupted order, shipping processes (MedTech Dive)
- Penetration Testing Strengthens Medical Device Security Against Emerging Threats (MedTech Insight)
- Thermo Fisher’s Allergen Farm: The ‘Secret Sauce’ Driving Its Diagnostic Progress (MedTech Insight)
- Deloitte 2025 Life Sciences Outlook Report Finds Medtech Leaders Focus On AI, GenAI Adoption Across Value Chain To Increase Efficiencies, Cut Costs (MedTech Insight)
- In a threat to patient trust, Texas hospitals must ask ‘Are you a U.S. citizen?’ (STAT)
- Health insurer Centene forecasts upbeat 2025 profit amid cost pressures (Reuters)
- Padlock shareholders sue Bristol Myers over milestone dispute after 2016 acquisition (Endpoints)
- After a Hiatus, the BLOCKING Act is Back! (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.
