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Regulatory Focus™ > News Articles > 2020 > 4 > Recon: WHO, WIPO eye patent workarounds amid COVID-19; Trump admin orders 167M respirators from 3M

Recon: WHO, WIPO eye patent workarounds amid COVID-19; Trump admin orders 167M respirators from 3M

Posted 07 April 2020 | By Michael Mezher 

Recon: WHO, WIPO eye patent workarounds amid COVID-19; Trump admin orders 167M respirators from 3M

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • House Democrats to hold conference call with Pence, Fauci, Birx on coronavirus response (CNBC)
  • Trade Adviser Warned White House in January of Risks of a Pandemic (NYTimes) (Axios)
  • Trump attacks HHS watchdog (Politico) (TPM)
  • Trump says he, others will be tested regularly (Reuters)
  • Trump speaks with pharma, biotech CEOs about coronavirus therapies (Reuters)
  • Trump’s ‘Hail Mary’ drug push rattles his health team (Politico) (NYTimes)
  • Trump Admin Orders 167 Million Respirators From 3M (WSJ) (Press)
  • Despite promises, testing delays leave Americans ‘flying blind’ (Reuters)
  • Outbreak shows signs of leveling off in New York, New Jersey, but vigilance urged (Reuters)
  • California to send ventilators to national stockpile: governor (Reuters)
  • Lilly lowers most insulin costs to $35 a month in response to Covid-19 (STAT) (Reuters)
  • Somerville N95 decontamination site opens with plans to disinfect up to 80k masks a day (WBUR)
  • Data for Gilead’s remdesivir are coming soon. Here’s what you need to know (STAT)
  • Former FDA chiefs outline plan to reopen the economy — when broad testing in place (Politico) (AEI)
In Focus: International
  • India allows limited exports of anti-malaria drug after Trump warns of retaliation (Reuters)
  • WHO warns against easing coronavirus measures too early (Reuters)
  • UN agency says coronavirus emergency could trump some patent rights (Reuters)
  • WHO DG endorses voluntary intellectual property pool to develop Covid-19 products (STAT)
  • Open letter asking 37 WTO Members to declare themselves eligible to import medicines manufactured under compulsory license in another country, under 31bis of TRIPS Agreement (KEI)
  • Masks should be prioritized for health workers to avoid shortage: WHO (Reuters)
  • Scientists Rush to Find Coronavirus Cure—but It Still Isn’t Fast Enough (WSJ)
  • WHO says coronavirus vaccine and treatment research has ‘accelerated at incredible speed’ (CNBC)
  • UK PM Johnson in intensive care, needed oxygen after COVID-19 symptoms worsened (Reuters)
  • UK rejects Trump's offer to help with Boris Johnson's coronavirus treatment (Business Insider)
  • Global regulators discuss observational studies of real world data for COVID-19 medicines (EMA)
  • Medical groups warn of serious shortages of hydroxychloroquine (Financial Times)
  • Global health fund calls for $8 billion to begin COVID-19 exit strategy (Reuters) (Financial Times)
  • Lockdowns: Saving lives, but ruining livelihoods in Africa (Reuters)
  • Fujifilm: shooting for a cure (Financial Times)
  • Takeda's Alunbrig outclasses Xalkori to secure EU approval in ALK+ advanced non-small cell lung cancer (Pharmafile)
Coronavirus Outbreak
  • Everything Must Go Right for Big Pharma’s Bet on a Fast Vaccine (Bloomberg)
  • School closures will have little impact on COVID-19 control, review finds (Reuters)
  • US Children With Coronavirus Are Less Hard Hit Than Adults, First Data Shows (NYTimes) (Reuters)
  • Former Novartis exec wants to repurpose generic drugs to fight Covid-19 (STAT)
  • HHS Announces Upcoming Funding Action to Provide $186 Million for COVID-19 Response (HHS)
  • Gottlieb joining Maryland governor's coronavirus response team (The Hill)
  • IQVIA launches new COVID-19 trial 'matching service' in US (Fierce)
  • Angiotensin and Coronavirus Infection: The Latest as of April 7 (In The Pipeline)
  • A $30 billion gamble: Pandemic expert calls for making Covid-19 vaccines before we know they work (STAT)
  • The dark side of ventilators: Those hooked up for long periods face difficult recoveries (Washington Post)
  • How New York City’s Emergency Ventilator Stockpile Ended Up on the Auction Block (ProPublica)
  • ER Staffing Company Reverses Benefits Cuts for Doctors and Nurses Fighting Coronavirus (ProPublica)
  • More than 700 employees at one Detroit hospital system test positive for coronavirus (The Hill)
  • China reports no new coronavirus deaths as cases decline (Reuters)
  • Belgium Imposes Selective Export Ban As COVID-19 Threatens Stocks (Pink Sheet-$)
  • Too much focus on hospitals in Europe's coronavirus fight – MSF (Reuters)
  • Spain's coronavirus deaths near 14,000 as pace ticks up again (Reuters)
  • France's coronavirus death rate accelerates, cases near 100,000 (Reuters)
  • Italy's Diasorin aims to launch COVID-19 antibody test by end-April (Reuters)
  • Scramble for masks as Italian region orders coronavirus cover-up (Reuters)
  • Chinese masks, or 'blue gold', arrive for Swiss hospitals (Reuters)
  • Russia's daily rise in coronavirus cases tops 1,000 for first time (Reuters)
  • Relief Therapeutics (RLF:SIX) Drug Aviptadil Enters FDA Trial at University of Miami, to Treat COVID-19-induced Respiratory Distress (Press)
  • Co-Diagnostics Gets FDA Emergency Use Authorization for Coronavirus Test (GenomeWeb)
  • Luminex Receives FDA Emergency Use Authorization for Second SARS-CoV-2 Assay (GenomeWeb)
Pharmaceuticals & Biotechnology
  • Biotech in the time of coronavirus: Pondering the future of ‘JPM Week’ (STAT)
  • Cancer Surgeries and Organ Transplants Are Being Put Off for Coronavirus. Can They Wait? (ProPublica)
  • Merck-partnered antibody maker readies $300M IPO as HKEX picks up pace (Endpoints)
  • International Orgs Rally To Preserve COVID-19 Supply Chain (Law360)
  • The Latest CMS Outlook for Drug Spending—And How COVID-19 Will Change It (Drug Channels)
  • Johnson & Johnson posts 'temporary' Tylenol shortage amid heightened demand (Fierce)
  • Pivotal failure crumbles stock for Michigan’s once-promising Millendo (Endpoints)
  • Existing Accelerated CMC, Advanced Manufacturing, and Inspection Initiatives are Supporting Regulators in Pandemic Response, FDA’s Cruse Explains in Recent Field Office Updates (IPQ)
  • Sidley: Considerations for Sponsors of Ongoing Clinical Trials in Light of COVID-19 (Part 1, 2)
  • Alzheimer’s trial screening data links high amyloid levels with early stage disease (NIH)
  • As millions lose their jobs—and insurance—Bristol Myers, Eli Lilly expand patient assistance (Fierce)
  • AbbVie, Pfizer, Novartis and more pledge millions in COVID-19 disaster relief (Fierce)
  • Immunomedics nabs new CEO as data revive hopes its troubled cancer drug can make the finish line (Fierce)
  • Highlights from FDA Meetings on 3 Opioid-Related New Drug Applications (Harvard Bill of Health)
  • Biopharma billionaires dominate Forbes' list of the world's top 10 wealthiest healthcare execs — and the pandemic hasn't hurt (Endpoints)
  • Another protein degradation biotech emerges, with the promise of a new approach from an old hand (Endpoints)
  • Who's doing deals in the midst of a crippling pandemic? Here are the top 10 players for March (Endpoints)
  • US FDA Requests Frequent Updates On Supply Chain Disruptions In COVID-19 Era (Pink Sheet-$)
  • Timber Pharmaceuticals Announces Award of Second Tranche of FDA Orphan Products Clinical Trials Grant (Press)
  • Elite Laboratories, Inc., et al.; Withdrawal of Approval of 23 Abbreviated New Drug Applications; Correction (FDA)
  • Information Pertaining to Additional Safety Protections Regarding Use of Fecal Microbiota for Transplantation -- Testing of Stool Donors for Enteropathogenic Escherichia coli and Shigatoxin-Producing Escherichia coli (FDA)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • Alnylam Completes Rolling Submission of New Drug Application to the U.S. Food and Drug Administration and Submits Marketing Authorization Application to the European Medicines Agency for Lumasiran for the Treatment of Primary Hyperoxaluria Type 1 (Press)
  • Merck Receives Priority Review from FDA for Second Application for KEYTRUDA® (pembrolizumab) Based on Biomarker, Regardless of Tumor Type (Press)
  • Blaze Bioscience Announces FDA Has Granted Fast Track Designation to BLZ-100 (tozuleristide) for Pediatric Central Nervous System Tumors (Press)
  • BELLUS Health Announces Completion of Dosing in Phase 2 RELIEF Trial with BLU-5937 for the Treatment of Refractory Chronic Cough (Press)
  • FDA-Approved Randomized Controlled Feasibility Study Finds InGeneron's Regenerative Cell Therapy to Significantly Reduce Pain and Improve Shoulder Function Over Corticosteroid Injection to Address Symptomatic Partial-Thickness Rotator Cuff Tears (Press)
  • Can-Fite Reports Positive Top Line Results from its Phase II NASH Study with Namodenoson (Press)
Medical Devices
  • The need for a system view to regulate artificial intelligence/machine learning-based software as medical device (Nature)
  • Use of menstruation and fertility app trackers: a scoping review of the evidence (BMJ)
  • Boston Scientific Corporation Recalls Imager II Angiographic Catheters Due to Tip Detachment (FDA)
  • Non-surgical Device for BPH Wins De Novo from FDA (MDDI)
  • Has FDA relaxed its human factors expectations in response to the COVID-19 pandemic? (Emergo)
  • Digital health rakes in record $3.1B in Q1, but COVID-19 slump could loom (MedtechDive)
  • Allurion Technologies Announces Submission of US Premarket Approval (PMA) Application for its Flagship Elipse® Gastric Balloon (Press)
US: Assorted & Government
  • US Patent Office Extends Certain Deadlines Under CARES Act (Big Molecule Watch)
  • MiMedx Group Inc. Agrees to Pay $6.5 Million to Resolve False Claims Act Allegations of False Commercial Pricing Disclosures (DOJ)
  • High Court Won't Hear Respiratory Treatment Patent Suit (Law360-$)
  • Key CARES Act Implications For Health And Life Sciences (Law360)
  • DOJ OKs Medical Supply Partnership For COVID-19 Response (Law360)
  • Mylan Gets PTAB To Nix Sanofi's Lantus Patent Claim (Law360-$)
  • LA City Atty Settles Suit Over Fake At-Home COVID-19 Tests (Law360)
  • NIH’s process for removing reviewers remains a mystery, watchdog finds (Science Mag)
  • Innovator Liability and Personal Jurisdiction – From Theory to Reality (Drug & Device Law)
  • USPTO Answers FAQs on Extension of Patent Deadlines under CARES Act (Patent Docs)
  • State COVID-19 Response: Medical Marijuana and Telemedicine (FDA Law Blog)
Upcoming Meetings & Events
  • Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests – 8 April 2020
Europe
  • Coronavirus: Commission and European Investment Fund (part of EIB Group) unlock €8 billion in finance for 100,000 small and medium-sized businesses (EC)
  • Adapting to COVID: Defending the Public Interest in Vaccine and Medical Development (EU Ombudsman)
  • Commission launches “COVID-19 Clinical Management Support System” (EC)
  • Ordinance on Measures to Combat the Coronavirus (COVID-19) (Swissmedic)
  • COVID-19 claims Cancer Research UK funding cuts, forecasting major shortfall (Fierce)
  • Class 2 Medicines Recall: Emerade 300 micrograms solution for injection in pre-filled syringe, PL 33616/0014 (EL(20)A/20) (MHRA)
  • Guidance for manufacturers and Good Practice (GxP) laboratories on exceptional flexibilities for maintenance and calibration during the coronavirus COVID-19 outbreak (MHRA)
India
  • Natco launches cut-price copies of AstraZeneca's patented anti-diabetes drug (Economic Times)
Australia
  • COVID-19 point-of-care tests (TGA)
  • Ventilator for COVID-19 use in Australia (TGA)
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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