Recon: Abbott profits triple with OTC test launch; Good news for bluebird

| 20 April 2021 | By Kari Oakes 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • Large clinical trial to study repurposed drugs to treat COVID-19 symptoms (NIH)
  • Q&A with Acting FDA Commissioner Janet Woodcock on the Future of the FDA (BioSpace)
  • Covid cases, vaccinations remain elevated as U.S. nears Biden’s 200 million goal (CNBC)
  • U.S. CDC expands COVID-19 vaccine eligibility to 16 and older (Reuters)
  • Johnson & Johnson reports $100 million in quarterly sales from Covid vaccine (CNBC)
  • U.S. Covid vaccination obstacle shifts towards lack of demand from scarce supply, warns doctor (CNBC) (Vox)
  • Women turning out more than men for COVID-19 vaccines (The Hill)
  • Abbott Profits Triple As Over-the-counter Covid-19 Tests Hit Drugstore Shelves (Forbes) (Reuters)
In Focus: International
  • Europe Orders 100 Million More Doses of Pfizer/BioNTech Vaccine (FDA News)
  • WHO director-general says pandemic can be brought under control within months (PMLive)
  • UK launches human challenge trial on COVID-19 reinfection (Biopharma Reporter)
  • Swiss Biotechs May Get SPAC Listing Option Soon (Scrip)
  • NICE sets out plans for ‘ambitious’ five-year strategy (PMLive)
  • Enhertu now available via Cancer Drugs Fund following NICE decision (Pharmafile)
Coronavirus Pandemic
  • We know a lot about Covid-19. Experts have many more questions (STAT)
  • AZ And J&J’s Problems Fuel Demand For Pfizer and Moderna COVID-19 Vaccines (Scrip)
  • Op-Ed: Can Statisticians Save the J&J Vaccine? (MedPage Today)
  • Covid vaccines and the race to understand blood clots (FT)
  • Rapid COVID-19 Tests Are Coming to the Home (MD+DI)
  • More than half India’s population could be immune by September, says hospital executive (CNBC)
  • US to expand 'do not travel' warning to 80 percent of countries amid COVID-19 spike (The Hill)
Pharma & Biotech
  • Biden officials met privately with 3M, AmerisourceBergen, PhRMA, and more to debate shoring up the national stockpile (STAT)
  • A Tecfidera Comeback? Investors Await More On Patent Plans From Biogen (Scrip)
  • Researchers In Europe, U.S. Team Up for First Ever 5-MeO-DMT Psychedelic Training Program (Forbes)
  • Long COVID’s long R&D agenda (Nature Reviews Drug Discovery)
  • PPD-backed siteless trial specialist Medable reels in $78M as the pandemic continues to push its biz forward (Fierce)
  • Vertex pays CRISPR $900M to take control of sickle cell partnership, betting they can beat bluebird (Endpoints)
  • Blue­bird says it has more good news for its gene ther­a­py safe­ty, but a pric­ing dis­agree­ment in Ger­many will spur lay­offs (Endpoints)
  • Biogen Reports New Spinraza Data in SMA (Global Genes)
  • Janssen will not seek regulatory approval for Erleada plus Zytiga in prostate cancer (PMLive)
  • US FDA pauses work on Anixa's novel CAR-T cell candidate (Pharmaletter)
  • FDA slaps a hold on KalVista's PhII study of an HAE drug, raising a red flag on preclinical results (Endpoints)
  • Breakthrough designation granted for Amgen’s bemarituzumab (PharmaTimes)
  • Express Scripts 2020 Update: Utilization Drove Drug Spending Growth—While Maximizers Gained Further Traction (Drug Channels)
  • Biotech Funding Tops The Charts Again (Life Sci VC)
  • Rezolute Enters $30 Million Debt Agreement to Advance Rare and Metabolic Disease Pipeline (Global Genes)
  • Forbion closes final European life sciences funding round at €360M with help from Eli Lilly (Fierce)
  • The Battle Over an Alzheimer’s Treatment (WSJ)
  • Gene therapy shows promise in initial trial for patients with childhood blindness (EurekAlert)
  • Opioid vaccine in the works (EurekAlert)
  • Once-a-week insulin treatment could be game-changing for patients with diabetes (EurekAlert)
  • Virta Health Raises $133M to Reverse Type 2 Diabetes (MD+DI)
  • BD Alaris pump recall again labeled Class I event by FDA (Medtech Dive)
  • Oxford University & Prenetics to collaborate on global rapid testing tech (Pharmafile)
  • As at-home Covid-19 testing rose, so did demand for other tests (MedCity News)
  • Australian addiction support platform eyes US expansion after closing $1.9M seed round (MobiHealth News)
  • Renovia raises $17M to help tackle female pelvic floor disorders (MobiHealth News)
  • Our Quest to Understand the Human Brain Is Limited by Ethics, Not Science (Slate)
  • Tiny implantable tool for light-sheet imaging of brain activity (EurekAlert)
Government & Regulatory
  • $50B Opioid Trial Starts With Warring Views Of Drug Marketing (Law 360)
  • FTC’s challenge to Illumina’s vertical merger with Grail is all wrong (STAT)
  • The Ongoing Step Therapy Debate (Bill of Health)
  • Senators Want Expert Panel To Guide $100B Plan For R&D (Law360)
  • A new book traces the roots of the opioid crisis through the secretive Sackler family (STAT)
  • Lower Reimbursement For Accelerated Approval Drugs May Get Push From ICER (Pink Sheet)
  • AdvaMed pushes CMS to implement MCIT final rule without further delay (Medtech Dive)
  • The 'burn' of ranitidine recall: current insights and mitigation strategies (PubMed)
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.


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy