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Regulatory Focus™ > News Articles > 2020 > 10 > Recon: AstraZeneca’s COVID vaccine packs a wallop; Merck KGaA, partners link for COVID mAbs

Recon: AstraZeneca’s COVID vaccine packs a wallop; Merck KGaA, partners link for COVID mAbs

Posted 23 October 2020 | By Kari Oakes 

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)
  • 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.

Tags: coronavirus, EMA, EU, FDA, US

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