Recon: Kerfuffle over WHO's Wuhan mission; BMS inks $1.3 B cancer deal

ReconRecon | 15 February 2021 |  By 

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
In Focus: US
  • New, Daily Coronavirus Cases Drop Below 100K For First Time In Months (NPR)
  • U.S. Continues To Accelerate Vaccination Strategy (NPR)
  • Seven coronavirus variants potentially similar to UK type have been detected in US: study (The Hill) (NYT)
  • Fauci Awarded $1 Million Israeli Prize For 'Speaking Truth To Power' Amid Pandemic (NPR)
  • Pentagon approves 20 additional COVID-19 vaccination teams (The Hill)
  • Three Men Are Accused in Scheme to Sell Covid-19 Vaccines (NYT) (DOJ)
  • COVID-19 leads to explosion in cyberattacks, data breaches (MedTech Dive)
  • Four potential COVID-19 therapeutics enter Phase 2/3 testing in NIH ACTIV-2 trial (NIH)
  • What Life Sci Attys Think Of Biden's Pace Choosing FDA Boss (Law360)
In Focus: International
  • WHO Wuhan probe finds signs original outbreak more widespread than previously thought: report (The Hill) (Reuters)
  • 'Politics was always in the room.' WHO mission chief reflects on China trip seeking COVID-19’s origin (Science)
  • U.S. 'gravely damaged' coronavirus cooperation, China says as feud erupts over WHO probe (NBC)
  • Can Covax deliver the vaccines much of the world needs? (Financial Times)
  • You Think The U.S. Has Vaccine Issues? 130 Countries Haven't Even Started Vaccinating (NPR)
  • Pan-European consortium seeks big pharma partner for COVID-19 shot (Reuters)
  • Ebola vaccination campaign begins in Democratic Republic of Congo (Reuters)
  • Israeli study finds 94% drop in symptomatic COVID-19 cases with Pfizer vaccine (Pharmafile) (Reuters)
  • February Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights (European Pharmaceutical Review)
  • Norwegian language requirement will apply following MDR implementation (Emergo)
  • India may approve Russia's Sputnik V vaccine within next few weeks: Report (Economic Times)
  • COVID-19 vaccines touch down in Australia, New Zealand, inoculations to start (Reuters)
Coronavirus Pandemic
  • Protecting the Most Vulnerable by Vaccinating the Most Active (RAND)
  • Pfizer exec 'confident' in ability to deliver 2 billion coronavirus vaccine doses this year (The Hill)
  • Can Pfizer and Moderna End the Pandemic by Sharing Their Vaccine Designs? It’s Not that Simple (KHN)
  • Half Doses of Moderna Produce Neutralizing Antibodies (Marginal Revolution)
  • One dose of COVID-19 vaccine provokes strong immune response in those previously infected (PharmaNews)
  • AZ/Oxford to trial COVID-19 vaccine in children (BioPharma Reporter)
  • U.K. Covid Variant Is Likely 30-70% Deadlier, New Research Finds (Forbes)
  • A machine-learning approach to finding treatment options for Covid-19 (MIT)
  • Researchers propose that humidity from masks may lessen severity of COVID-19 (NIH)
  • From A to Z, Supplements Fail for COVID-19 (MedPage Today)
Pharma & Biotech
  • EU Fast-Track Fail For Another BMS CAR-T Cell Therapy (Pink Sheet)
  • A gene therapy pipeline takes shape for a cluster of rare diseases (BioPharma Dive)
  • Recombinant Zoster Vaccine (Shingrix) real-world effectiveness in the first two years post-licensure (PubMed)
  • NICE rejects Lilly’s Verzenios for advanced breast cancer (PharmaTimes)
  • Therapeutic proteins and oral vaccines market to surpass $300,000 million by 2027 (European Pharmaceutical Review)
  • Molecular Templates signs cancer deal with BMS worth up to $1.3bn (Pharmafile)
  • Novel ionic liquid enables uniform chemotherapy delivery in solid tumours (European Pharmaceutical Review)
  • FDA Grants Rare Pediatric Disease and Orphan Drug Designations to Rescindo’s Treatment for Kabuki Syndrome (Rare Daily)
  • New Drug OK'd for Chemo-Induced Myelosuppression in SCLC (MedPage Today)
  • Precision medicine in human heart modeling : Perspectives, challenges, and opportunities (PubMed)
  • Home testing for COVID-19: Benefits and limitations (PubMed)
  • How is the FDA maintaining digital health safety standards? (PharmaLetter)
  • Longeviti CEO Talks Neurosurgical Implants and COVID-19 (MD+DI)
  • Blockchain could accelerate drug development: Bloqcube (Outsourcing Pharma)
  • Dexcom launches first VC fund (MedCity News)
  • STAT-Harris Poll: 1 in 4 Americans were unable to get a Covid-19 test when they wanted one (STAT)
Government & Regulatory
  • Against Regulatory Nationalism (Marginal Revolution)
  • Congressional Democrats File Amicus Brief in ACOG v. FDA (Dianne Feinstein)
  • Walgreens Revealed As Investor In Subsidiary Of Health Insurance Company Under Federal Investigation (Forbes)
  • Zantac Chronicles – No Innovative, or Innovator, Liability (Drug and Device Law Blog)
  • The Toolgen Interference: Broad Preliminary Motions List (Patent Docs)
  • 7 False Claims Act Enforcement Trends To Watch (Law360)
  • US appeals court confirms Amgen's patent claims on PCSK9 antibodies invalid (PharmaLetter)
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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