Recon: CDC says pandemic drove US deaths from antibiotic resistant superbugs; Biden officials mulling expanding second booster to all adults

ReconRecon | 12 July 2022 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • US deaths from antibiotic resistant 'superbugs' rose 15% in 2020 (Reuters) (Washington Post)
  • Biden officials push to offer second booster shots to all adults (Washington Post) (Bloomberg)
  • White House to prioritize boosters, testing for Omicron BA.5 subvariant (Reuters)
  • 'Approvability has been put to bed': Aldeyra says eye drop clears three dry eye signals en route to FDA (Endpoints)
  • Curb Your Enthusiasm For Continued Use Of Pandemic Clinical Trial Flexibilities, US FDA Says (The Pink Sheet)
  • CBER’s Goal To Reach Normal Ops In 2023 Includes Clearing IND, Meeting Backlogs In 2022 (The Pink Sheet)
  • U.S. CDC director: BA.5 estimated to represent 65% of circulating COVID-19 variants (Reuters)
  • A Bipartisan Case Against US FDA User Fees? (The Pink Sheet)
  • Non-Inferiority Trials, Please, US FDA Implores Rheumatoid Arthritis Sponsors (The Pink Sheet)
  • US Medicare Payment Schedule Targets Mental Health And Underserved Areas (MedTech Insight)
  • ‘Organize. Align’: Women in biotech see Roe v. Wade as a call to action (Fierce)
In Focus: International
  • Health Union: HERA delivers list of top-3 health threats to prepare against (European Commission)
  • EU DARWIN Project To Catalog Real-World Data Sources (The Pink Sheet)
  • India, South Africa, Others Push Robust TRIPS Discussion Schedule (Inside Health Policy)
  • WHO says COVID-19 remains a global health emergency (Reuters)
  • Scottish HTA Requests More Data For Orphan Drugs (Pink Sheet)
  • Japan Lists Eight Infectious Diseases For Focused Vaccine Development (The Pink Sheet)
  • Russia registers first case of monkeypox (Reuters)
Pharma & Biotech
  • Vertex absorbs ViaCyte and its stem cell-based diabetes treatment for $320M, clearing out competition (Fierce) (Scrip)
  • $350M Funding Breaths New Life into Former ALS Compound for Asthma (Biospace)
  • Roche hands over $55M for licensing rights to Ionis’ kidney disease candidate (Fierce)
  • Sanofi, still on CEO Paul Hudson’s quest to slim down, offloads 17 brands to Neuraxpharm (Fierce)
  • Flagship unwraps new AI biotech that looks to predict variants before they’re here (Endpoints)
  • Amgen's blockbuster hopeful Lumakras sees slower than expected sales in latest data, analyst says (Endpoints)
  • Novo Nordisk Touts Potential Hemophilia Treatment at London Meeting (FDAnews)
  • Moderna mRNA Portfolio on Track to Hit 2025 Goal with Nipah Virus Trial Launch (Biospace)
  • Verve Therapeutics begins human tests of first ‘base editor,’ aiming at heart disease (STAT)
  • After building new plant and signing on with AbbVie, Regenxbio enters commercial phase (Fierce)
  • Verve Tests First One and Done Gene Editing Treatment for Hereditary Killer (Biospace)
  • Struggling biotech sells its API manufacturing arm to narrow its focus (Endpoints)
  • The Top 12 Biopharma Companies Hiring Now (Biospace)
  • FDA clears’s smartphone-based AI test for early-stage kidney disease  (Fierce)
  • Philips scores FDA clearance for faster MRI scanning powered by AI (Fierce)
  • Medtronic recalls over 1M dialysis catheters due to malfunction (MedTech Dive) (Fierce)
  • Abbott’s personalized brain stimulator earns FDA breakthrough tag for treating depression (Fierce)
  • Hologic, Thermo Fisher roll out respiratory panels for Europe ahead of cold and flu season (MedTech Dive)
  • CMS makes ‘market-moving proposals’ to some medtech Medicare rates: analysts (MedTech Dive)
  • Health tech funding is down. Here’s what investors make of the market (STAT)
Government, Regulatory & Legal
  • New York AG accuses Teva of lying over opioid crisis to evade legal action (Endpoints)
  • CureVac’s patent infringement case against BioNTech has $500M of ‘potential upside’: analyst (Fierce)
  • Sanofi’s New Jevtana Patent Claims Should Be Barred, Judge Says (Bloomberg)
  • San Francisco reaches $54 million opioid settlement with Teva and Allergan (Reuters)
  • Mylan $264 Million Epipen Price-Gouge Deal Gets Final Court Nod (Bloomberg)
  • Abbott, Abbvie Beat Appeal in Lupron Bone, Joint Injury Suit (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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