Recon: Moderna requests vaccine EUA for children under 6; Pfizer to begin US trial of Duchenne gene therapy as FDA lifts hold

| 28 April 2022 | By Joanne S. Eglovitch 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Moderna files for US authorization of COVID shot for kids under 6 (Reuters) (Endpoints) (Biospace)
  • Pfizer can restart PhIII trial of Duchenne gene therapy, now on par for late-2023 FDA approval request  (Endpoints) (Reuters) (Fierce) (BioSpace)
  • IRS seeks more than $7B in back taxes and penalties from Amgen for shifting profits to Puerto Rico (Endpoints)
  • ACLA, AdvaMed urge Congress to immediately replenish COVID-19 testing fund (MedTech Dive)
  • Medicare Advantage Plans Often Deny Needed Care, Federal Report Finds (NYT)
  • FDA Moves to Ban Sales of Menthol Cigarettes (NYT) (STAT)
  • Merck raises 2022 forecast as COVID pill, cancer drug fuels profit beat (Reuters)
  • Lawmakers Dismiss McKinsey’s Apology on Opioid Crisis as ‘Empty’ (NYTimes)
  • Walmart, CVS Pharmacies Have Blocked or Delayed Telehealth Adderall Prescriptions (WSJ)
In Focus: International
  • Pay-For-Performance Deals Help Solve ATMP Access Barriers In Europe (The Pink Sheet)
  • How The EU Is Keeping Up With Innovation In Clinical Trials (The Pink Sheet)
  • EU can do more for patients with smart use of biosimilar medicines (Medicines For Europe)
  • Central & Eastern European patients have inequitable access to medicines for life-threatening conditions (Medicines For Europe)
  • Korea Regulatory Support Group To Speed Drugs, Vaccines For Public Health Crises (The Pink Sheet)
  • Montreal will be Moderna's next manufacturing venture — report (Endpoints)
Coronavirus Pandemic
  • WHO says pandemic justifies leader's pitch at Moderna meeting (Reuters)
  • How climate change could drive animal movements — and threaten more viral spillovers (STAT)
  • How Paxlovid came to be: From the germ of an idea to a vital tool against Covid (STAT)
Pharma & Biotech
  • With new diabetes drug data, Eli Lilly is taking aim at obesity (STAT) (Fierce) (Bloomberg)
  • EMA Consults On Protecting Personal & Commercial Data In New Clinical Trial System (The Pink Sheet)
  • Big Pharma CEOs assess the BD landscape in biotech: Staying the course, not seeing cheap targets, and going for it (Endpoints)
  • USP Exec On Onshoring, Impact Of War-Fueled Metals Turbulence On Pharma (Scrip)
  • After Amgen deal, Plexium maintains momentum with AbbVie neurological partnership (Fierce)
  • BioMarin plots comeback year, with plans to turn around profits and head back to the FDA with rejected gene therapy (Endpoints)
  • Novartis/BeiGene Likely To Struggle In Crowded PD-1 Space Despite Positive First-Line Data (Scrip)
  • Y-mAbs' longtime CEO steps down abruptly as FDA reviews second pediatric cancer drug (Endpoints)
  • After failing to secure more funds, a private gene therapy developer lays off staff (Endpoints)
  • The EU HTA Regulation: How It Threatens Device Launches And Where The Solutions Lie (MedTech Insight)
  • How The EU Needs To Address Conflicts Between AI And Medical Device Rules: Part 1 (MedTech Insight)
  • FDA Qualifies Facial PRO As New Medical Device Development Tool (MedTech Insight)
  • Medtronic’s Covidien has another Class I recall for PB980 ventilators (MedTech Dive)
  • Behind The Breakthroughs: FDA Releases Expedited Program Data For First Time (MedTech Insight)
  • Sensyne’s new CEO kicks off restructuring with potential mass layoffs, sale of several divisions (Fierce)
Government, Regulatory & Legal
  • Celgene Must Face Humana Suit on ‘Supracompetitive’ Drug Prices  (Celgene)
  • Balwani Recruited His Dermatologist As Lab Chief, Jury Told (Law360)
  • COVID-19 Cases Won't Stop SF's Opioid Bellwether Trial (Law360)
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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