Recon: Alzheimer’s drugmakers undeterred on accelerated approval despite Aduhelm coverage decision; Japan cancels a third of its AstraZeneca vaccine order

ReconRecon | 11 April 2022 | By

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • FDA's Califf on accelerated approval: 'In God, we trust, everyone else must bring good evidence' (Fierce)
  • ‘Precedents are important’: Aduhelm coverage restrictions could shape the future of accelerated approval (STAT)
  • Alzheimer's drugmakers seek accelerated FDA review despite U.S. coverage decision (Reuters)
  • Pfizer taps David Denton from Lowe's as CFO (Reuters)
  • Walgreens trial over its part in Florida opioid crisis set to begin (Reuters)
  • Biotechs take a beating in first round of #AACR22 as weak data cripple share prices (Endpoints)
In Focus: International
  • Moderna recalls thousands of COVID vaccine doses in Europe (Reuters)
  • Drugmakers pledge speedier European market launches to avert stricter regulation (Reuters)
  • India's COVID-19 vaccine prices cut as booster program is extended (Reuters)
  • Taiwan orders Pfizer's COVID-19 pill as infections rise (Reuters)
  • Japan cancels a third of contracted AstraZeneca vaccine purchase (Reuters)
  • ICH Statement on the situation in Ukraine (ICH)
Coronavirus Pandemic
  • WHO says it is analysing two new Omicron COVID sub-variants (Reuters)
  • Demand for Covid vaccines falls amid waning appetite for booster shots (FT)
  • Germany agrees deal with CureVac, GSK for mRNA vaccines until 2029 (Reuters)
  • Vaccine group Gavi secures $4.8 billion in funding pledges for COVAX (Reuters)
  • Incomplete data likely masks a rise in U.S. Covid cases as focus on infection counts fades (NBC)
  • There’s an uptick in U.S. vaccinations, and older Americans are the reason (NBC)
Pharma & Biotech
  • AACR: Bristol Myers details Opdivo's presurgery lung cancer win, with an early sign of survival benefit (Fierce)
  • AACR22: Amgen reveals new long-term data for Lumakras, looking to keep pressing market advantage over Mirati (Endpoints)
  • AACR22: Affimed's NK cell therapy produces more patient responses — and more durability questions (Endpoints)
  • An mRNA vaccine boost may help CAR T-therapy treat solid cancers (STAT)
  • Flagship-backed microbiome company Kaleido Biosciences shuts down (Endpoints)
  • Scoop: AbbVie drops IBS drug Viberzi in Canada, 'devastating' patients (Endpoints)
  • Exclusive: Flagship snags another CEO-partner, on a personal mission, to lead its tRNA boat (Endpoints)
Medtech
  • Fitbit tails Apple Watch with FDA-cleared algorithm to passively check for afib (Fierce) (TechCrunch)
  • FDA official: Draft cybersecurity guidance has 'teeth' (MedtechDive)
  • Pfizer to drop $74M for COVID cough-screening smartphone app developer (Fierce)
Government, Regulatory & Legal
  • Seagen scores $41.8M in Enhertu patent case against Daiichi Sankyo (Fierce) (Law360)
  • Vanda Sues US FDA For Documents Backing Complete Response For Hetlioz Jet Lag Indication (Pink Sheet)
  • When Congress Seeks Cos.' Nonpublic Info From Regulators (Law360)
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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