Recon: Neurocrine’s schizophrenia drug posts mixed results in Phase 2 study; BioMarin to lay off 225 of its staff
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.In Focus: US
- Biden cap on drug costs will save US seniors over $1,000 a year, study finds (Reuters)
- The weight loss drug shortage is driving patients to Hims. What happens when the shortage ends? (STAT)
- Eli Lilly’s lauded discount of its obesity drug Zepbound comes with caveats (STAT)
- Merck ends two Phase 3 studies of Keytruda, including an early-stage non-small cell lung cancer trial (Endpoints)
- How an upstart pharmacy benefit manager has been winning over companies like TikTok and Zoom (Endpoints)
- UK government partners with pharma on new £400M life science infusion (Endpoints)
- Pharma Warming Up To Benefits Of Australia’s Teletrials Initiative (Pink Sheet)
- Global Regulators Zero In On Pediatric Extrapolation To Speed Up Drug Access (Pink Sheet)
- Drugmaker Mundipharma's China unit sale fails to find buyer, sources say (Reuters)
- EU Needs Feedback On Draft Requirements For Seven High-Risk IVD Test Categories (MedTech Insight)
- Catalent beats revenue estimates ahead of deal close with Novo Holdings (Reuters)
- Genentech is shedding even more employees (STAT)
- Neurocrine reports mixed results on schizophrenia therapy in mid-stage trial (STAT)
- Recursion nears ‘moment of truth’ with first key data, kicking off 18-month flurry of readouts (Endpoints)
- Pfizer's Direct-To-Consumer Digital Platform Not Limited To Its Own Treatment Options (Pink Sheet)
- J&J heads to FDA for Vyvgart competitor; Tokyo conglomerate launches venture fund (Endpoints)
- BioMarin lays off 225 employees as it cuts spending on gene therapy rollout (Endpoints)
- Preclinical team hit hardest in Repare's R&D prioritization, layoffs (Endpoints)
- Navigating The Legal Risks Of Using AI To Optimize The Pharma Supply Chain (Pink Sheet)
- AI In Drug Development: Regulatory Clarity Needed On Inspections, Human Role (Pink Sheet)
- Continuous glucose monitoring for the masses is here. Are we ready for it? (STAT)
- Penumbra axes virtual reality division, will lay off 71 people (MedTech Dive)
- Qiagen, AstraZeneca expand companion diagnostic pact beyond cancer (MedTech Dive)
- Johns Hopkins, CareFirst, Techstars launch healthcare AI accelerator (MedTech Dive)
- Illumina wins FDA approval for companion diagnostic cancer test (MedTech Dive)
- Early Diagnosis Law Targeting Risk Factors Is Answer To Germany’s Spiralling CVD Costs (MedTech Insight)
- EU Launches Call For Regulatory Sandbox Initiative To Accelerate Medtech Innovation (MedTech Insight)
- Truvian CEO Confident Blood-Testing Benchtop Could Be ‘Any Place You Go’ (MedTech Insight)
- California To Ban DEHP In IV Bags, Tubing With Phased Compliance Deadlines (MedTech Insight)
- Tylenol maker defeats lawsuit over labeling (Reuters)
- Glucose monitors, mpox vaccine inequity and effects of LGBTQ+ restrictions (STAT)
- Smokers under 30 need photo IDs to buy tobacco products, US FDA says (Reuters)
- UnitedHealth pledged a hands-off approach after buying a Connecticut medical group. Then it upended how doctors practice (STAT)
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.
