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