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

• 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)
• As US COVID-19 cases rise, so does demand for antivirals (Reuters)

• 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)

• 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)

• 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)

• 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)