Regulatory Focus™ > News Articles > 2022 > 5 > Recon: Senate user fee bill omits accelerated approval measures; NIH to study longer course of Paxlo

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Posted 18 May 2022 | By Joanne S. Eglovitch 

Recon: Senate user fee bill omits accelerated approval measures; NIH to study longer course of Paxlovid to combat reinfections

2898 Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • House committee unanimously advances FDA user fee legislation with accelerated approval tweaks (Endpoints)
  • Senate user fee reauthorization bill omits accelerated approval reforms, shows wide gaps with House version (Endpoints) (The Pink Sheet)
  • FDA lobbies Congress over rare disease court ruling with wide implications (Endpoints)
  • Confirmation for Head of New Research Hub Required in House Bill (Bloomberg)
  • National Academies report cites ‘urgent’ need to recruit more diverse participants for clinical trials (STAT) (Bloomberg)
  • FTC’s New Commissioner, Alvaro Bedoya, May Bolster Tougher Stance On Pharma Oversight (The Pink Sheet)
  • Pfizer’s Tight Paxlovid Rein Stymies Drug Combination Research (Bloomberg)
  • Proposed Cancer Institute Cuts Blamed on Timing, Not Priorities (Bloomberg)
  • What happens when the government stops buying Covid-19 vaccines? (STAT)
  • US to study whether longer Paxlovid course needed to combat reinfections (Reuters)
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  • As US COVID-19 cases rise, so does demand for antivirals (Reuters)
In Focus: International
  • WHO raises alarm about 'healthcare on a knife-edge' in Ukraine (Reuters)
  • Roche’s Eye Drug Scores First UK Approval Under Access Consortium (The Pink Sheet)
  • UK Lucentis Biosimilar Nod Offers Teva Potential First-Mover Advantage (The Pink Sheet)
  • World in no better place to fight pandemics than before COVID – review (Reuters)
  • EFPIA On How To Prepare EU For Future Health Crises (The Pink Sheet)
  • Mozambique detects first case of polio in 30 years (Reuters)
  • COVID shows need for better information sharing early in pandemics, UK's Javid says (Reuters)
  • When Africans asked for COVID shots, they didn't get them. Now they don't want them (Reuters)
Pharma & Biotech
  • Drugmakers use monopoly tactics to thwart lower-cost generic competition for inhalers, analysis finds (STAT)
  • Under-the-radar Chinese biotech scores $47M upfront in secretive Merck deal around cancer drug (Endpoints)
  • Ampio’s years of troubles come to a head with internal investigation, trio of COVID trial failures (Fierce)
  • Berkshire Hathaway pulls out of AbbVie, Bristol Myers Squibb investments (Endpoints)
  • A long time coming: GlaxoSmithKline officially changes name to GSK (Endpoints)
  • Axsome Takes New Approach, Targets NMDA Receptors to Treat Depression (Biospace)
  • High blood pressure pills are costly — but also hard to find — in some lower-income countries (STAT)
  • Researchers May Have Unlocked Mechanism Driving Inflammation in Rheumatoid Arthritis (Biospace)
Medtech
  • Watchdog Calls On FDA To Set Policy For Use Of Unauthorized Tests In Public Health Emergencies (MedTech Insight)
  • Medtronic links renal denervation to increased time below blood-pressure threshold (MedTech Dive)
  • First Polish Notified Body Designated Under The EU's Medical Device Regulation (MedTech Insight)
  • EU Notified Body Figures Demonstrate The Scale And Timing Of Capacity Shortfall (MedTech Insight)
  • Regulation, Digitization Mulled As Swiss Medtechs Look To An ‘EU+’ Vision For The Future (MedTech Insight)
Government, Regulatory & Legal
  • Federal judge weighs motion to dismiss HeLa lawsuit against Thermo Fisher (Endpoints)
  • Allergic Patient’s Suit Against Hospital Potentially Barred (Bloomberg)
  • Dental Monitoring Sues Get-Grin Over AI-Powered Imaging Tech (Bloomberg)
  • Medical Device Maker Sues Over Reused Rectal Sensor Allegations (Bloomberg)
  • Drugmakers Win Challenge to Medicaid Drug Price Rebate Rule (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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