Recon: Second patient death linked to Alzheimer’s drug lecanemab rocks Eisai, Biogen; Roche withdraws Tecentriq’s bladder cancer indication

ReconRecon | 29 November 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Roche withdraws Tecentriq from U.S. bladder cancer indication (Reuters) (Biospace) (Endpoints)
  • FDA rejects Crinetics' current PhII design for hyperinsulinism drug (Endpoints)
  • Piloting Real-World Evidence: US FDA RWE Demonstration Projects (Pink Sheet)
  • PhRMA, once invincible in Washington, has lost its edge (STAT)
  • Resistance to FDA’s opioid-disposal plan raises concerns about CADCA, a powerful advocacy group (STAT)
  • Fauci Says Covid Shows Endless Threat of Infectious Disease (Bloomberg)
  • HHS Proposes Rule to Ensure Better Care Coordination for Patients With SUD (MedPage Today) (Insider Health Policy)
  • Twitter stops enforcing COVID misinformation policy (The Hill)
In Focus: International
  • Mistakes at UK COVID testing lab may have led to deaths of 20 people (Reuters) (The Independent)
  • Collaboration Makes The (Real) World Go Round: Global Efforts Strive To Anchor RWE With Real-World Data Standards And Practices (Pink Sheet)
  • WHO Gives Strong Backing To Antimalarial Combo As New Resistance Strategy Kicks Off (Pink Sheet)
  • UK regulator calls for review of reactions in eyes to Sanofi asthma drug (Reuters)
  • Diphtheria infections rise in Britain, says UK health agency, citing migrant cases (Reuters)
  • Brazilian Regulator Consults On Improving Rules For Registering Biosimilars (Generics Bulletin)
  • Saudi FDA Finalizes Approach To Commercial Info In Public Assessment Reports (Pink Sheet)
Pharma & Biotech
  • Eisai, Biogen rocked by 2nd lecanemab death report ahead of Alzheimer’s data reveal (Fierce) (Reuters) (Bloomberg) (Biospace)
  • AstraZeneca jumps deeper into cell therapy 2.0 space with $320M biotech M&A (Endpoints) (Reuters) (Fierce)
  • Fosun Said to Mull Sale of India’s $3.8 Billion Gland Pharma (Bloomberg)
  • Bristol Myers has change of heart on cardiovascular gene therapy pact, terminating uniQure deal (Fierce) (Biospace)
  • GSK survey finds COVID, lack of early HCP conversations hitting lupus patients’ care (Fierce)
  • Sanofi welcomes 500 staffers to new Paris HQ after €30M renovation (Endpoints)
  • Almirall signs on for European clinical trial project to collect data for patients (Fierce)
  • mRNA startup Strand Therapeutics raises millions to test targeted cancer therapies (STAT)
  • Organon joins global push to prevent unintended pregnancies (Fierce)
  • Fierce Biotech Layoff Tracker: November Layoff wave persists amid culls, pipeline pivots (Fierce)
  • Stada to place $50M+ investment in a new facility in Romania (Endpoints)
  • One Step Closer to a Universal Flu Vaccine? (NYT)
Medtech
  • EU Plenary Debates How To Protech Orphan Devices From MDR Crisis (MedTech Insight)
  • EU Designates First Czech Notified Body Under MDR (MedTech Insight)
  • Swiss Parliament’s Vote For Medtech Innovation Succeeds (MedTech Insight)
  • Color Additive Risk Evaluation Tool Qualified As New Medical Device Development Tool (MedTech Insight)
  • Boston Scientific to buy Apollo Endosurgery for $417 million (Reuters)
  • Google Health licenses breast cancer detection AI to iCAD (MedTechDive)
  • Bionaut Labs secures $43M for its tiny, drug-carrying robots (Fierce)
Government, Regulatory & Legal
  • US seeks jail time for co-CEO of New England compounding center after deadly 2012 fungal outbreak (Endpoints)
  • Former Indivior CMO Challenges HHS’ Exclusion For ‘Responsible Corporate Officer’ Misdemeanor (Pink Sheet)
  • LabCorp, Whistleblowers Reach Settlement Ending Blood Draw Suit (Bloomberg)
Regulatory Recon is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
 
A story’s inclusion in Regulatory Recon does not imply endorsement by Regulatory Focus or RAPS.

 

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