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

| 27 April 2022 | By Joanne S. Eglovitch 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • 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)
In Focus: International
  • 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)
Coronavirus Pandemic
  • 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)
Pharma & Biotech
  • 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)
Government, Regulatory & Legal
  • 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)
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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