Novavax fast-tracks phase 1 testing of coronavirus vaccine (PMLive)
How the CARES Act affects COVID-19 test pricing (Brookings)
The Pandemic Will Cleave America in Two (The Atlantic)
Coronavirus now leading cause of death in US (The Hill)
It’s difficult to grasp the projected deaths from Covid-19. Here’s how they compare to other causes of death (STAT)
HHS Rolls Out Initial $30 Billion for Hospitals From CARES Act (Bloomberg Law)
Checkpoints, Curfews, Airlifts: Virus Rips Through Navajo Nation (NYTimes)
Adapting cancer research to coronavirus (Politico)
Doctors ‘keep an open mind’ about unproven coronavirus drug, but worry it could do more harm than good (STAT)
Thousands of coronavirus tests are going unused in US labs (Nature)
Hydroxychloroquine Abuse Up Since Trump First Mentioned Drug, US Poison Center Data Says (Forbes)
Brazil minister resists calls for wider use of hydroxychloroquine (Reuters)
Indian manufacturers set to double production of hydroxychloroquine to meet rising demand (Pharmabiz)
Faulty N95 Masks Hamper Hospitals on Coronavirus Front Line (WSJ)
BioCryst starts COVID-19 trial of broad-spectrum antiviral (Fierce)
As fever checks become the norm in coronavirus era, demand for thermal cameras soars (Reuters)
We Need True Positives, True Negatives: Doggett and DeLauro Press FDA for Data on the Accuracy of COVID-19 Tests (DeLauro)
On Russian border, China scrambles to contain coronavirus influx (Reuters)
China's Wuhan to keep testing residents as coronavirus lockdown eases (Reuters)
Once the biggest outbreak outside of China, South Korean city reports zero new coronavirus cases (Reuters)
California governor encouraged by drop in ICU placements (AP)
'You can't relax': Vigilance urged as New York sees signs of coronavirus progress (Reuters)
Japan's coronavirus infections surpass 6,000 cases: NHK (Reuters)
Tokyo seeks shop shutdowns, Kyoto warns tourists away as coronavirus threatens Japan economy (Reuters)
Spain's coronavirus death toll curve flattening at last (Reuters)
Number of French people in ICU for coronavirus falls for the first time (Reuters)
Moscow, in U-turn, to assume all pneumonia patients may have coronavirus (Reuters)
Early testing helps Canada's British Columbia fight coronavirus, cases elsewhere soar (Reuters)
Georgia Resident Arrested for Selling Illegal Products Claiming to Protect Against Viruses (DOJ)
Approval Tests and Standards for Air-Purifying Particulate Respirators (HHS)
'It Tortures Me That I'm Not There Helping.' Former FDA Commissioner Scott Gottlieb on the Fight Against COVID-19 (Time)
Pharmaceuticals & Biotechnology
How will the pandemic shape biotech in the months ahead? An industry analyst weighs in (STAT)
States Can Use the Coronavirus Response to Go After Insulin Price Gougers (Slate)
COVID-19 Trial Changes Are “Propulsive Force” For Digital Adoption (Pink Sheet-$)
The Path Towards a Tailored Clinical Biosimilar Development (BioDrugs)
Eye drug side effects are real, Novartis confirms in new warning (BioPharmaDive)
Pharma operations: Creating the workforce of the future (McKinsey)
Biopharma portfolio strategy in the era of cell and gene therapy (McKinsey)
Arix cuts costs, changes leadership team to hunker down (Fierce)
Digital Doublespeak: The Language Barrier When Tech Companies Meet Regulators (Pink Sheet-$)
Nonresearch Pharmaceutical Industry Payments to Oncology Physician Editors (The Oncologist)
Information Pertaining to Additional Safety Protections Regarding Use of Fecal Microbiota for Transplantation - Screening Donors for COVID-19 and Exposure to SARS-CoV-2 and Testing for SARS-CoV-2 (FDA)
Temporary Policy Regarding Non-Standard PPE Practices for Sterile Compounding by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency (FDA)
Policy for the Temporary Use of Portable Cryogenic Containers Not in Compliance With 21 CFR 211.94(e)(1) For Oxygen and Nitrogen During the COVID-19 Public Health Emergency Guidance for Industry (FDA)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
Arrowhead Pharmaceuticals Files for Regulatory Clearance to Begin Phase 1/2a Study of ARO-ENaC for Treatment of Cystic Fibrosis (Press)
Astellas Announces Acceptance of XOSPATA® (gilteritinib) for Regulatory Review in China by the National Medical Products Administration (Press)
Medical Devices
Medtechs adapt to new sales reality amid halt on elective surgeries, hospitals' financial stress (MedtechDive)
US: Assorted & Government
Court’s Construction of the Term “Original New Drug Application” Formerly in Medicaid Rebate Statute Offers Rebate Relief for Some Drugs Approved Under Literature-Based NDAs (FDA Law Blog)
Court sides with Nevro over Boston Scientific in pain device patent dispute (MedtechDive)
Part D Redesign: MedPAC Finalizes Recommendations To Congress But COVID-19 Will Get In The Way (Pink Sheet-$)
COVID-19: All haemofiltration systems including machines and accessories – serious risks if users don’t follow manufacturer instructions for set-up (MDA/2020/013) (MHRA)
Asia
New China Drug Regulation Legalizes Emergency Approval Mechanism (Pink Sheet-$)
India
Health ministry equipped with only two notified labs to test and certify huge quantum of PPE procured in the country (Pharmabiz)
Supply chain issues hit testing ramp-up: Roche Diagnostics India MD Shravan Subramanyam (Economic Times)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
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