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)
- 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)
- 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)
- 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)
- 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)
- 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)
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