Recon: Pfizer, BioNTech request booster EUA for children 5-11; Novartis confirms layoffs as part of global reorg

• Fauci: US no longer in ‘full-blown’ pandemic phase (Washington Post)
• Pfizer, BioNTech seek US authorization of COVID-19 booster shot for younger kids (Reuters) (NPR)
• Zolgensma for dementia? AviadoBio gains orphan tag for one-dose gene therapy (Fierce)
• Fennec looks for FDA approval for hearing loss drug haunted by manufacturing problems (Endpoints)
• Editas sees clinical promise with new FDA pediatric disease tag for another blood disorder (Fierce)
• US FDA’s Califf Says Publishing Complete Response Letters Could Help Fight Misinformation (The Pink Sheet)
• CDER director on accelerated approval reforms and a court decision that will 'send a chill' across rare disease drug development (Endpoints)
• More than half of Americans have had COVID infections, US study shows (Reuters) (Washington Post)
• Reports of Kids’ Mysterious Liver Ailment Expand in US (Bloomberg)
• States may need to tweak generic drug laws to increase access, researchers find (Endpoints)

• EU to move away from emergency phase of COVID pandemic (Reuters) (Bloomberg)
• EU estimates up to 80% of population has had COVID (Reuters)
• Measles cases jump 79% in 2022 after COVID hit vaccination campaigns (Reuters)
• GSK tops forecasts as consumer health spin-off nears (Reuters)
• Lost In Translation? Japan’s GMP Compliance Dilemma (The Pink Sheet)
• AstraZeneca Uses Priority Voucher To Speed Combo Towards Liver Cancer Approval (Scrip)
• Malaysian government enlists native Biocon for insulin supply deal (Endpoints)
• Congo starts Ebola vaccinations to stem outbreak in northwest, WHO says (Reuters)

• The ACT-Accelerator: Two years of impact (WHO)
• WHO chief says we are 'increasingly blind' on COVID transmission (Reuters)
• Global COVID-19 Access Program Facing ‘Financial Crisis’ (The Pink Sheet)
• After phase 2 flop, BerGenBio posts new data on COVID-19 prospect (Fierce)

• Thousands of jobs are on the chopping block as Novartis lays out restructuring plans, M&A hunt for deals up to $2B (Endpoints) (Fierce)
• Solid Bio joins slate of biotech layoffs, shedding 35% of its workforce (BioPharma Dive)
• Novartis records another tislelizumab win en route to bringing BeiGene's PD-1 to FDA's doors (Endpoints)
• Spying synthetic lethal promise, Pfizer bets $25M on Zentalis, will support cancer trials (Fierce)
• Firms Hope To Adapt COVID Vaccine Trial Design, FDA Communication Approaches To Other Diseases (The Pink Sheet)
• Symeres buys Organix to enter lipids market and grow in the US (Fierce)
• Cytovia inks SPAC merger to get natural killer cells prospects into the clinic (Fierce)
• Sanofi offloads French rights for antipsychotic to neighboring pharma (Endpoints)
• 2 become 1: Caladrius and Cend merge into tumor-focused Lisata Therapeutics (Fierce)
• ViiV, Pfizer and Roche lead list for pharma reputation ranked by patient group, annual survey finds (Endpoints)
• BridgeBio's chief strategy officer resigns as the company quietly embarks on another round of layoffs (Endpoints)

• European Commission Seeks To Extend Delegated Act Powers By Five years Having Not Used Its Powers Yet (MedTech Insight)
• Abiomed implants first patient with long-term, removable heart pump (Fierce)
• New FDA Supply Chain Program Aims To Prevent Device Shortages (MedTech Insight)
• Boston Scientific surges 10% in Q1 amid slew of FDA nods, company reorganization (Fierce)
• GE Healthcare hit by supply chain constraints, inflation pressures (MedTech Dive)
• Recalls And Multiple Market Challenges Test Philips’ Resilience Into Q1 (MedTech Insight)

• J&J sues to block sales of 'dangerous' counterfeit HIV drugs (Reuters) (Law360)
• AstraZeneca Sues Mylan Same Day New Symbicort Patent Is Issued (Bloomberg)
• Aetna Faces Modest Class Over Liposuction Coverage for Lipedema (Bloomberg)