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