Recon: Califf nomination timeline slips after Biden admin misses paperwork deadline; Canada fully approves J&J COVID vaccine

| 24 November 2021 | By Michael Mezher 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • FDA nomination slips after Biden admin fails to send papers to Congress (Politico)
  • Califf, Biden’s pick to lead FDA, has millions invested in pharma and tech companies (STAT)
  • FDA Approves Takeda's drug for post-transplant CMV infection (Reuters) (FDA)
  • CVS, Walgreens and Walmart Fueled Opioid Crisis, Jury Finds (NYTimes)
  • Elizabeth Holmes Points Fingers at Others and Says She Was a Believer (NYTimes)
  • Elizabeth Holmes admits she added drugmakers’ logos to Theranos reports (CNBC)
  • Pfizer says former employee stole trade secrets on megablockbuster COVID-19 vaccine (Fierce)
In Focus: International
  • A vision for use of real-world evidence in EU medicines regulation (EMA)
  • Canada gives full approval to J&J's single-shot COVID-19 vaccine (Reuters)
  • South Africa delays COVID vaccine deliveries as inoculations slow (Reuters)
  • In major shift, EU says vaccine boosters should be considered for all adults (Reuters)
  • WHO on EU booster recommendation: "Focus on the unvaccinated and high-risk groups" (Reuters)
  • 'False sense of security' around vaccines as Europe again COVID epicentre – WHO (Reuters)
  • German government-to-be eyes retroactive drug price cuts (Reuters)
  • EU loosens defence of pharma groups on Covid vaccine patents (FT)
Coronavirus Pandemic
  • Swiss strike deal for COVAX to get 1 mln Moderna doses more quickly (Reuters)
  • Three OTC COVID-19 Tests Win FDA Clearance After Template Updates (MedtechInsight)
Pharma & Biotech
  • AstraZeneca to run more clinical trials in people’s homes to improve diversity (The Guardian)
  • EMA Moves To Ensure ‘Smooth’ Evaluation Of Drug Approval Dossiers (Pink Sheet)
  • The deal for BeiGene's massive new US manufacturing and R&D site is complete, and it plans to pour in 'several hundred million dollars' soon (Endpoints)
  • BeiGene gets the ball rolling on its 3rd IPO — and this one is expected to fetch $3B (Endpoints)
  • FDA halts phase 1b Kura Oncology trial in acute myeloid leukemia following patient death (Fierce)
  • Chasing Regeneron, Pfizer posts data on $250M cardiovascular bet (Fierce)
  • NICE approves hormone drug which could prevent 1,200 miscarriages each year (PharmaTimes)
  • EC grant Trodelvy marketing authorisation for treatment of breast cancer (PharmaTimes)
  • US FDA ‘Quietly Working Hard’ To Develop Advanced Manufacturing Framework (Pink Sheet)
  • Dragonfly gets Merck on second TriNKET candidate since 2018 collab; Chinese eye gene therapy developer nabs $60M (Endpoints)
  • FDA’s New Inspections Council Whipping Up Policy Around Remote Regulatory Assessments (MedtechInsight)
  • Philips debuts AI-equipped MRI machines plus spectral angio-CT combination scanners (Fierce)
  • European Council gives the go-ahead to new healthtech assessment rules (MobiHealthNews)
  • Medtronic's surgery robot rollout hits supply chain speed bumps (Fierce)
  • Comments Invited on European Commission Vision For IVDR EU Reference Laboratories (MedtechInsight)
Government, Regulatory & Legal
  • Paying for Drugs in Medicare Part D Under Current Law and Under Proposals to Redesign the Program (CBO)
  • Sun Pharma loses bid to drop Ranbaxy antitrust case; jury trail set for January (Fierce)
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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