Recon: Pfizer seeks EUA for COVID vaccine for kids under 5; Regeneron buys rights to Sanofi cancer drug for up to $1.1B

ReconRecon | 02 June 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Pfizer seeks U.S. authorization of COVID vaccine for young children (Reuters) (Bloomberg) (Washington Post)
  • Sanofi earns breakthrough nod in hemophilia A as it continues to play catch-up with Roche's Hemlibra (Endpoints) (Fierce)
  • FDA's Peter Marks lays out plans to support gene therapies for ultra-rare diseases (Endpoints)
  • FDA lifts hold on Legend Biotech's follow-up CAR-T targeting CD4+ (Endpoints)
  • Alzheimer’s Evidence Accelerator Modeled On FDA COVID Project Floated By USAgainstAlzheimer’s (The Pink Sheet)
  • Federal agency to review FDA response to baby formula recall (Reuters)
  • US Baby Formula Shortages Hit 74% Despite Biden Action (Bloomberg)
  • Covid Boosters, Like Flu Shots, Need a Yearly Schedule (Bloomberg)
In Focus: International
  • Canada authorizes Pfizer COVID-19 booster for 16 and 17-year-olds (Reuters)
  • Moderna delays COVID vaccine deliveries to EU by several months (Reuters)
  • Swiss drugmaker Novartis resumes Ukraine business (Reuters)
  • EU drugs watchdog in talks with Bavarian Nordic over wider use of smallpox vaccine (Reuters)
  • Italian authorities fine drugmaker for ‘excessive’ pricing of a rare disease drug (STAT)
  • Outbreaks of diseases such as monkeypox becoming more frequent, warns WHO (Reuters)
  • New vaccine plant in Senegal gets 75 million euros from EIB (Reuters)
  • COVID cases rise in the Americas, nations must also monitor other viruses -PAHO (Reuters)
  • Africa's COVID deaths to fall by 94% in 2022, WHO analysis shows (Reuters)
  • UAE achieves 100% COVID vaccination target -state news agency (Reuters)
  • More Than Two-Thirds of People Have Covid Antibodies, WHO Says (Bloomberg)
Pharma & Biotech
  • Regeneron Buys Sanofi Cancer Drug for Up to $1.1 Billion (Bloomberg) (Reuters)
  • GSK bets $3.3B on a buyout, jumping into a blockbuster showdown with Pfizer and Merck (Endpoints)
  • FDA compliance vet heads to India-based Lupin after long public career (Endpoints)
  • Bristol Myers triples-down on Immatics, bringing deal to $4.2B total biobucks. Why not just buy it? (Fierce)
  • Teva UK introduces first generic oral anticoagulant (PharmaTimes)
  • Industry Middlemen driving up prices of generic drug prescriptions as much as 20 percent: research (The Hill)
  • AbbVie in position to become largest pharma by 2028, narrowly edging out Roche — report (Endpoints)
  • Companies can’t make CAR-T cells for cancer treatment quickly enough. Here’s what they’re doing about it (STAT)
  • Evonik to build $220 mln U.S. production site for mRNA lipids (Reuters)
  • PARADIGME shift: Nordic Nanovector reviews stuttering cancer trial as enrollment grinds to a halt (Fierce)
  • Cambrex secures acquisition in Ireland, increasing their European footprint (Endpoints)
  • Migraine Patch Developer Zosano Goes Bankrupt, Will Sell Assets (Bloomberg)
  • There’s still no HIV vaccine. The science behind coronavirus shots may help. (Washington Post)
  • Minute Insight: Stryker And Si-Bone Receive US FDA Clearances For Spine Surgery Guidance System (MedTech Insight)
  • Diabeloop rounds up €70M to take AI-powered insulin delivery tech global (Fierce)
  • Ear 3D-printed from a patient’s own cells implanted successfully in first-in-human trial (Fierce) (NYT)
  • FDA’s Draft QMSR: 3 Experts Read More Stakeholder Comments So You Don’t Have To (MedTech Insight)
Government, Regulatory & Legal
  • Justice Department says sweeping lab test fraud in Texas involved dozens of doctors and front companies (STAT)
  • Ionis Board Members Stuffed Their Own Pockets, Lawsuit Alleges (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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