Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.

In Focus: US

• FDA advisory committee votes against plan for broad use of prostate cancer drug (Endpoints) (FDAnews) (MedPage Today) (Pink Sheet) (Reuters)
• FDA Greenlights First Bi-Monthly Injectable for Schizophrenia, Bipolar 1 Disorder (BioSpace) (Bloomberg) (Endpoints)
• FDA Revises Pfizer Covid Jab EUA for Immunocompromised Under 5 (Bloomberg)
• US FDA declines to approve Ascendis’ hormone disorder therapy (Reuters)
• FDA to review Takeda’s BLA resubmission for subcutaneous UC drug Entyvio after 2019 rejection (Endpoints) (FDAnews)
• Keeping Track: Showers Of Approvals In US FDA’s May Forecast (Pink Sheet)
• Biden admin seeks to pause order blocking Obamacare preventive care mandate (Reuters)
• In a small new study, scientists working on an AI ‘brain decoder’ inch closer than ever to reading minds (STAT)
• One-third of US nurses plan to quit profession – report (Reuters)

In Focus: International

• Agreement On EU’s Radical Pharma Reform Plans ‘Could Take Three Years’ (Pink Sheet)
• Pfizer, BioNTech propose EU pays half for each cancelled COVID dose, Financial Times reports (Reuters)
• EU Commission expects agreement on AI this year (MedWatch)
• EU CHMP Opinions and MAA Updates (Pink Sheet)
• EU Reforms Offer Mixed Blessings For Generics And Biosimilars (Pink Sheet)

Pharma & Biotech

• Astellas keeps the big buyouts rolling, inking $5.9B Iveric takeover ahead of FDA eye disease ruling (Fierce) (Bloomberg) (Endpoints)
• Biopharma firm Acelyrin seeks $1.5 bln valuation in US IPO (Reuters)
• Roche, ViiV and Horizon most reputable pharmas in the world last year, say patient groups (Fierce) (Endpoints)
• Sanofi bets $750M to enter glycogen-lined Maze deal with lead asset waiting in the middle (Fierce)
• Company founded by ex-Novartis execs inks $477M in-license deal (Endpoints)
• Sanofi, Flatiron Health in pact to redesign oncology clinical studies (Fierce)
• Astellas Pharma: Xtandi Plus Leuprolide Cut Metastasis Risk 58% (Bloomberg) (Fierce)
• The Top 12 Biopharma Companies Hiring Now (BioSpace)
• Hikma Sees Signs Of A Bounceback For Generics (Generics Bulletin)
• Amgen Falters In Core Immunology Business, But Help Is On The Horizon (Scrip)
• Still under partial hold, Sanofi makes case for safety of MS med from Principia buyout (Fierce)
• Struggling Biogen paid its two CEOs more than $57M last year, including $30.6M to new chief Viehbacher (Fierce)

Medtech

• UK MHRA Gives CE-Marked Devices More Breathing Space In GB (Medtech Insight) (MedTech Dive)
• As Digital Medtech Innovations Speed Ahead, How Can The UK Regulator Keep Up? (MedTech Insight)
• Digital Health Technologies: Use In Clinical Studies Comes With Practical Challenges (Pink Sheet)
• Minute Insight: Quest Diagnostics To Acquire Haystack Oncology For $300M In Cash (MedTech Insight)
• Medtronic ramps up competition for leadless pacemakers with newly approved devices (MedTech Dive)
• ResMed CEO on Philips’ return to CPAP market: ‘Game on’ (Fierce)
• Expert Insights on Process Validation for Devicemakers (FDAnews)
• Abbott rolls out artificial pancreas to UK with Ypsomed, CamDiab (Fierce)

Government, Regulatory & Legal

• Federal judge rules against Moderna in vaccine IP suit (Endpoints)
• Merck Discloses $573 Million Settlement in Zetia Antitrust Suit (Bloomberg)
• Eli Lilly Shareholders Fend Off Abortion, Diversity Proposals (Bloomberg)
• Plastic Surgeon, Son Agree to Settle False Claims Allegations (Bloomberg)

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.