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