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Recon: Congress reaches deal on $10B COVID bill; Gilead’s remdesivir fails to show benefit in European trial

ReconRecon | 05 April 2022 |  By 

Recon: Congress reaches deal on $10B COVID bill; Gilead’s remdesivir fails to show benefit in European trial

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • FDA convenes committee of vaccine experts to consider a flu-like path for Omicron-specific boosters (Endpoints)
  • Congress announces deal on $10 billion in COVID-19 funding (Reuters) (Bloomberg) (Inside Health Policy)
  • 'About as true as saying the earth is flat': Alzheimer's expert picks apart Biogen's Aduhelm manuscript (Endpoints)
  • High Drug Prices Spur New Call to Probe Impact of IP Rights (Bloomberg)
  • Wyden wants details on Merck’s US taxes as part of expanding probe into pharma practices (STAT) (Bloomberg)
  • FDA tees up a snap review for Dupixent as Sanofi, Regeneron hunt 4th approval for megablockbuster (Endpoints)
  • CDC announces revamp plans, hires outside official for review (Reuters) (Bloomberg) (NYT)
In Focus: International
  • Gilead's remdesivir fails to show benefit in European trial; no fetus risk seen with first trimester vaccination (Reuters)
  • UK Regulator Tests Using Consultancy Firms To Monitor GMP, GDP Compliance (The Pink Sheet)
  • Carogra, Xenpozyme Among Japan World-First Approvals (The Pink Sheet)
  • Mismatched Tech And Demand Behind Korea’s Slow Pharma AI Progress (Scrip)
Coronavirus Pandemic
  • IMF calls for $15 billion this year to manage long-term risks of COVID (Reuters)
  • Global groups propose pandemic plan costing $10 billion a year (Reuters)
  • COVAX, African Union decline to buy more doses of Moderna's COVID shots (Reuters) (Bloomberg)
  • Third Covid Shot Protects Against Omicron for Months, Study Says (Bloomberg)
  • Omicron sub-variant BA.2 makes up 72% of COVID variants in U.S. – CDC (Reuters)
  • Moderna Puts $50 Million Into Foundation for Covid’s Hardest-Hit (Bloomberg) 
Pharma & Biotech
  • Late-Stage Pipeline Blooming At Boehringer As R&D Spend Soars (Scrip)
  • Gilead's landmark CAR-T approval leaves Bristol Myers Squibb scrambling for second place (Endpoints)
  • Through ‘serial de-risking,’ Sage is getting closer to building an Alzheimer’s contender (Fierce)
  • Bluebird, troubled gene therapy maker, to lay off employees and reduce costs (STAT)
  • Spotlighting subgroup analysis, Theravance tries to carve out 'narrow, but critically important' market for failed drug (Endpoints)
  • Takeda’s gene therapy hunger not yet quelled as Evozyne pact extended for $400M in biobucks (Fierce)
  • New targets could better immunotherapy for colon cancer (Fierce)
  • With newly discovered cell type, Penn scientists propose COPD drug development strategy (Fierce)
Medtech
  • Abbott picks up the pace with FDA approval of revvable, long-lasting leadless pacemaker (Fierce)
  • Minute Insight: Abbott’s Aveir VR To Take On Medtronic’s Micra In US Leadless Pacemaker Market (MedTech Insight)
  • Recall Gives New Cleaning Instructions For Karl Storz Endoscopes (MedTech Insight)
  • Medtronic self-expanding TAVR shows durability benefit over surgery at 5 years, analysis shows (MedTech Dive)
  • Nearly 80% of patients with infection following cardiac implant not treated appropriately: study (MedTech Dive)
Government, Regulatory & Legal
  • Geron Investors Win Class Status in Bone Marrow Cancer Drug Suit (Bloomberg)
  • Inovio Board Accused of Covid Vaccine Hype, Insider Sales (Bloomberg)
  • West Virginia says J&J, drugmakers created 'tsunami' of opioid addiction (Reuters) (Law360)
  • Mallinckrodt’s $1.75 Billion Opioid Plan in Effect During Appeal (Bloomberg)
  • Biden administration funnels one of the largest-ever pay increases to Medicare Advantage insurers (STAT)
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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