rf-fullcolor.png

 

August 29, 2024
by Jason Scott

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)
In Focus: International                                                                                                       
  • 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)
Pharma & Biotech
  • 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)
Medtech
  • 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)
Government, Regulatory & Legal
  • 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)
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.
×

Welcome to the new RAPS Digital Experience

We have completed our migration to a new platform and are pleased to introduce the updated site.

What to expect: If you have an existing login, please RESET YOUR PASSWORD before signing in. After you log in for the first time, you will be prompted to confirm your profile preferences, which will be used to personalize content.

We encourage you to explore the new website and visit your updated My RAPS page. If you need assistance, please review our FAQ page.

We welcome your feedback. Please let us know how we can continue to improve your experience.