Recon: AstraZeneca’s COVID vaccine packs a wallop; Merck KGaA, partners link for COVID mAbs
Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
Facing vaccine doubts, US grapples with building confidence in coronavirus shots (BioPharma Dive )
FDA shows signs of cold feet over emergency authorization of Covid-19 vaccines (STAT )
How pandemic fatigue and polarization led to Wisconsin’s massive Covid-19 outbreak (Vox ) (NPR )
Report finds coronavirus pandemic leading to 'unacceptable' shortage of US drug supplies (The Hill )
Former FDA Commissioner Discusses Updates On COVID-19 Vaccine Research Efforts (NPR )
BARDA enlists Current Health in COVID-19 monitoring (Outsourcing Pharma )
Did Trump Confuse the Public Option With ‘Medicare for All’? (KHN )
A health care debate full of big problems and vague solutions (Politico )
In Focus: International
WHO's Tedros says countries on "dangerous track" in pandemic (Reuters )
Canada to invest up to C$214 million for research into domestic-made vaccines: PM Trudeau (Reuters )
UK Authorizes Use Of Unlicensed Flu Vaccine (Pink Sheet ) (MHRA )
New UK Portal Should Streamline Reporting Of Drug Shortages (Pink Sheet )
African Nations Plan To Roll Out Coronavirus Rapid Testing; African Export Import Bank Readies Fundraising For Vaccines (KFF )
Gilead shares rise after United States approves remdesivir as COVID-19 drug (Reuters )
Merck, Pfizer pneumonia vaccines running low in EU as researchers fight COVID-19: report (Fierce Pharma ) (Reuters )
Deaths rattle South Korea's seasonal flu vaccination, but authority presses ahead with free scheme (Fierce Pharma )
ICR urges change as NICE rejects Keytruda plus chemotherapy (Pharma Times )
EMA accepts application for ranibizumab biosimilar from Samsung Bioepis (GaBI online )
Coronavirus Pandemic
Columbia report: US could have avoided 130,000 COVID deaths with better response (The Hill ) (NYT ) (STAT )
US reaches second-highest daily total of over 75,000 coronavirus cases (The Hill ) (NBC ) (NPR )
Trump Says “We’re Rounding the Turn” the Same Day the U.S. Approaches Record Number of New Coronavirus Cases (Slate )
Researchers Find Doubts About COVID-19 Vaccine Among People Of Color (NPR )
Europe warned COVID spreading more quickly, further curbs loom (Reuters )
Convalescent plasma fails phase 2 in moderate COVID-19 patients (Fierce Biotech )
Why the approval of remdesivir to treat Covid-19 obscures bigger scientific failures (STAT )
WHO says it will have advice on remdesivir in three-four weeks (Reuters )
Germany grapples with coronavirus spike months after it was hailed for good practice (NBC )
Aspirin could protect patients from severe COVID-19 complications (European Pharmaceutical Review )
Merck KGaA, IAVI and Serum Institute link up to develop COVID-19 mAbs (PharmaTimes )
SARS-CoV-2 antibodies detectable up to seven months post COVID-19 onset, shows new Portuguese study (AAAS )
Roche Forges Deal With Atea for COVID-19 Antiviral Pill (FDANews ) (Roche )
Why plexiglass alone can’t prevent Covid-19 (Vox )
AstraZeneca’s COVID-19 Vaccine Delivers Strong Immune Response, Study Confirms (FDANews )
Pharma & Biotech
CRISPR Therapeutics Reports Positive Phase 1 Data for CAR-T Treatment (FDANews )
Ultragenyx expands into Duchenne gene therapy with Solid Bio deal (BioPharma Dive )
BMS partners with Sensyne Health for rare blood disease research (Pharma Times )
Adicet Wins FDA Investigational Drug Clearance for NonHodgkin’s Lymphoma Cell Therapy (FDANews )
Retrophin buys up Orphan Technologies, spending $90M on rare disease drug (Fierce Biotech ) (Endpoints )
How To Manage Pharmacovigilance Inspections In A Globalized World (Pink Sheet )
With Disarm deal, Atlas returns to Lilly to take neuro program forward (BIocentury )
Scientists use gene therapy and a novel light-sensing protein to restore vision in mice (NIH )
A global sense of urgency: Collaborating to advance the conduct of clinical trials (ACRO )
Ionis Begins Clinical Trial of ALS Antisense Therapy Designed to Treat Broad ALS Population (Global Genes )
FDA Issues Grants for Clinical Trial Research for Orphan Diseases (Big Molecule Watch )
Sirnaomics nabs a major $105M funding round for next stage of its RNA work (Fierce Biotech )
Bain execs Adam Koppel and Jeffrey Schwartz line up $125M for their first blank check deal as Wall Street continues to embrace biotech (Endpoints )
Medtech
FDA highlights the need to address bias in AI (HIMSS )
Remote Patient Monitoring Sets Up Big Tech to Revolutionize Telemedicine and Healthcare (Health Care Blog )
Nasal drug delivery technology market to grow at CAGR of 5.1 percent (European Pharmaceutical Review )
Imaging analysis AI startups announce 510(k)s for prostate cancer, incidental pulmonary embolism algorithms (Mobihealth News )
Could a language test diagnose Alzheimer's? IBM is laying the groundwork (Fierce Biotech )
Government & Regulatory
Former Indivior CEO gets 6 months in jail for role in Suboxone marketing scheme (Fierce Pharma ) (Endpoints )
Walmart Sues Feds To Get Ahead Of Possible Opioid Suit (Law360 )
Federal COVID-19 Response Unlawfully Blocks State Public Health Efforts (Harvard Law/Petrie-Flom )
St. Jude Medical, LLC v. Snyders Heart Valve LLC (Fed. Cir. 2020) (Patent Docs )
TAVR Pioneer Edwards Lifesciences Wows Analysts with Q3 Results (MD+DI )
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.