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

• 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)

• 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)

• 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)

• 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)