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April 10, 2020
by Michael Mezher

Recon: CanSino moving COVID-19 vaccine into Phase II; Damages in BMS, Gilead patent case boosted to $1.2B

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • CDC Director: 'Very Aggressive' Contact Tracing Needed For US To Return To Normal (NPR)
  • The coming White House coronavirus clash (Politico)
  • Three US local governments to adopt coronavirus contact tracing app: MIT (Reuters)
  • Biogen sues life science supplier over ‘brazen’ Alzheimer’s knockoff (Boston Business Journal)
  • Bristol-Myers Patent Win Over Gilead Grows to $1.2 Billion (Bloomberg) (Reuters)
  • Gilead Rips Merck's New Bid To Restore $2.5B Patent Verdict (Law360-$)
  • Data for Regeneron arthritis drug in coronavirus could come in weeks (STAT) (Reuters)
  • A Perspective on the FDA’s COVID-19 Response (FDA)
In Focus: International
  • China's CanSino Bio advances COVID-19 vaccine into phase 2 on preliminary safety data (Fierce)
  • Covid-19 drugs could be made for $1 per day, say academics (Financial Times) (Reuters)
  • A New Front for Nationalism: The Global Battle Against a Virus (NYTimes)
  • Sanofi will donate 100 million doses of hydroxychloroquine to 50 countries (Reuters)              
  • India set to ship drug sought by Trump for coronavirus (Reuters) (Economic Times) (NPR)
  • UK PM Johnson leaves intensive care, remains under observation (Reuters)
  • Iceland’s ‘Test Everyone’ Goal Has Skeptics, but It May Be Working (Reuters)
  • China imposes more checks on mask exports to ensure quality control (Reuters)
  • South Korea reports recovered coronavirus patients testing positive again (Reuters)
  • EU Finance Ministers Reach $590 Billion Coronavirus Rescue Deal (NPR)
  • Malaysian firms led by world's top glove maker prioritise medical supplies (Reuters)
  • Drones take Italians' temperature and issue fines (AFP)
Coronavirus Outbreak
  • Searching for an effective Covid-19 treatment: promise and peril (STAT)
  • At the Center of a Storm: The Search for a Proven Coronavirus Treatment (NYTimes)
  • Oxford recruits 2,700 virus patients for fast-growing drugs trial (Financial Times)
  • 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-$)
  • Nonresearch Pharmaceutical Industry Payments to Oncology Physician Editors (The Oncologist)
  • Information Pertaining to Additional Safety Protections Regarding Use of Fecal Microbiota for Transplantation - Screening Donors for COVID-19 and Exposure to SARS-CoV-2 and Testing for SARS-CoV-2 (FDA)
  • Temporary Policy Regarding Non-Standard PPE Practices for Sterile Compounding by Pharmacy Compounders not Registered as Outsourcing Facilities During the COVID-19 Public Health Emergency (FDA)
  • Policy for the Temporary Use of Portable Cryogenic Containers Not in Compliance With 21 CFR 211.94(e)(1) For Oxygen and Nitrogen During the COVID-19 Public Health Emergency Guidance for Industry (FDA)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • Arrowhead Pharmaceuticals Files for Regulatory Clearance to Begin Phase 1/2a Study of ARO-ENaC for Treatment of Cystic Fibrosis (Press)
  • Astellas Announces Acceptance of XOSPATA® (gilteritinib) for Regulatory Review in China by the National Medical Products Administration (Press)
Medical Devices
  • Medtechs adapt to new sales reality amid halt on elective surgeries, hospitals' financial stress (MedtechDive)
US: Assorted & Government
  • Court’s Construction of the Term “Original New Drug Application” Formerly in Medicaid Rebate Statute Offers Rebate Relief for Some Drugs Approved Under Literature-Based NDAs (FDA Law Blog)
  • Court sides with Nevro over Boston Scientific in pain device patent dispute (MedtechDive)
  • Part D Redesign: MedPAC Finalizes Recommendations To Congress But COVID-19 Will Get In The Way (Pink Sheet-$)
  • On Promoting Off-Label Use II (Drug & Device Law)
  • COVID-19 Test Maker Hits 'Nefarious' Co. With TM Suit (Law360)
  • Daiichi Says Court Should Decide Drug Patent Fight Venue (Law360-$)
  • Pfizer v. J&J Remicade Antitrust Trial Deadlines Extended Due to COVID-19 Pandemic (Big Molecule Watch)
  • BASF Corp. v. SNF Holding Co. (Fed. Cir. 2020) (Patent Docs)
Europe
  • COVID-19: All haemofiltration systems including machines and accessories – serious risks if users don’t follow manufacturer instructions for set-up (MDA/2020/013) (MHRA)
Asia
  • New China Drug Regulation Legalizes Emergency Approval Mechanism (Pink Sheet-$)
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.
 
Need to contact the editor of Regulatory Reconnaissance? Email us at [email protected].
 
A story's inclusion in Regulatory Reconnaissance does not imply endorsement by Regulatory Focus or RAPS.
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