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Recon: Pfizer identifies coronavirus drug candidate; Gilead swaps endpoint, boosts enrollment goal for remdesivir trials

Posted 09 April 2020 | By Michael Mezher 

Recon: Pfizer identifies coronavirus drug candidate; Gilead swaps endpoint, boosts enrollment goal for remdesivir trials

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • Most New York Coronavirus Cases Came From Europe, Genomes Show (NYTimes)
  • Pfizer clinches coronavirus vaccine deal, sees potential in antiviral treatment (Reuters) (WSJ) (STAT) (Press 1, 2)
  • Gilead supersizes remdesivir trials, changes primary endpoint (Endpoints) (Fierce) (Evaluate)
  • Fujifilm to start phase II clinical trial of Avigan for COVID-19 patients in US (Reuters)
  • FDA commissioner: Mitigation is working (Fox)
  • Fate Of 'Interim Emergency' Relief Bill Uncertain As Parties Debate Size, Timing (NPR)
  • US to seize exports of masks and gloves amid coronavirus crisis (Reuters)
  • NIH clinical trial of hydroxychloroquine, a potential therapy for COVID-19, begins (NIH) (Henry Ford)
  • Essential workers exposed to coronavirus should take precautions returning to jobs: CDC head (Reuters)
  • Pfizer gets Array deal payoff as FDA approves Braftovi (PMLive) (Press)
  • U.S. fines Rite Aid over improper sales of pseudoephedrine (Reuters)
  • Medtronic wins US approval for ventilator, plans launch in May (Reuters)
  • GM, Philips to supply 73,000 US ventilators in $1.1 billion effort (Reuters)
  • A Company Promised Cheap Ventilators to the Government, Never Delivered and Is Now Charging Quadruple the Price for New Ones (ProPublica)
In Focus: International
  • WHO's new funding appeal for coronavirus fight to top $1B: diplomats (Reuters)
  • Trump faulted the WHO’s coronavirus response. But it’s guided by rules the US helped write (STAT)
  • While the World Spends on Coronavirus Bailouts, China Holds Back (NYTimes)
  • Euro countries are trying once again to agree on coronavirus stimulus after failed talks (CNBC)
  • EU urges states to lift drug export bans to prevent shortages (Reuters)
  • Europe's coronavirus export bans raise concern over insulin supplies (Reuters)
  • No sign Europe's COVID-19 epidemic is at peak, EU disease monitoring agency says (Reuters)
  • EU to provide 20 billion euros for Africa and Latin America to fight coronavirus (Reuters)
  • PM Johnson 'getting better' in intensive care as UK extends overdraft (Reuters)
  • A bruised Circassia offloads debt by returning COPD drugs to AstraZeneca (Endpoints) (PharmaTimes)
  • France more than doubles crisis budget package to 100 billion euros (Reuters)
  • Regeneron licenses lymphoma drug to China’s Zai Labs (PMLive)
  • Italy's daily coronavirus death toll falls, but new cases accelerate (Reuters)
  • In Scramble for Coronavirus Supplies, Rich Countries Push Poor Aside (Reuters)
  • Brazil turns to local industry to build ventilators as China orders fall through (Reuters)
  • Some African countries heading for peak in coronavirus cases in weeks: WHO official (Reuters)
Coronavirus Outbreak
  • More Coronavirus Vaccines and Treatments Move Toward Human Trials (NYTimes)
  • What AIDS Taught Coronavirus Leaders: You Can’t Bank on a Fast Vaccine (WSJ)
  • The COVID-19 vaccine development landscape (Nature)
  • Bill Gates urges rich countries to fund coronavirus vaccine search (Financial Times)
  • Lockdowns shouldn't be fully lifted until coronavirus vaccine found, new study warns (CNN)
  • When will life return to normal? Expert says US testing is too far behind to know, expects second wave of cases (USA Today)
  • Safety concerns over vaccine for coronavirus still remain, says expert (CNBC) (SPGlobal)
  • GAVI to disburse $29 million to help COVID fight in 13 countries (Reuters)
  • Key China coronavirus hospital says HIV drug beneficial to patients (Reuters)
  • In the Race for Coronavirus Drugs, This Scientist Urges a Slower Pace (NYTimes)
  • Scientists weigh in on coronavirus drugs: What we know, what we don’t (CBS)
  • Haywire Immune Response Eyed In Coronavirus Deaths, Treatment (WSJ)
  • J&J HIV drug already in Covid-19 clinical trials flunks in vitro study (MedCityNews)
  • International trial uses AI to rapidly identify optimal Covid-19 treatments (STAT)
  • U.S. nurses who can't get tested fear they are spreading COVID-19 (Reuters)
  • Federal Support Ends For Coronavirus Testing Sites As Pandemic Peak Nears (NPR)
  • Natural killers are coming for Covid-19 and the therapy, experts say, could make things worse (Endpoints)
  • Over 90% of 1M Abbott coronavirus tests sitting idle, White House official says (MedtechDive)
  • UK Doctors call for relaxation of ‘Shipman’ end-of-life drugs rules (Financial Times)
  • Relief Therapeutics (RLF:SIX) Drug Aviptadil Enters FDA Trial at Thomas Jefferson University Hospital in Philadelphia, to Treat COVID-19-induced Acute Respiratory Distress (Press)
  • OncoImmune Receives FDA Approval for COVID-19 Clinical Trial (Press)
  • For survivors of severe COVID-19, beating the virus is just the beginning (Science Mag)
  • China seeks to contain new coronavirus 'silent carriers' (Reuters)
  • Speed of coronavirus deaths shock doctors as New York toll hits new high (Reuters)
  • New York hospital sends some 'borderline' COVID-19 patients home with oxygen monitors (Reuters)
  • From fine to flailing - rapid health declines in COVID-19 patients jar doctors, nurses (Reuters)
  • French lockdown helped slow coronavirus but too soon to lift it, PM says (Reuters)
  • Germany's coronavirus cases rise by 4,974, deaths by 246: RKI (Reuters)
  • Japan state of emergency mutes nightlife but cities still open as infections rise (Reuters)
  • Ethiopia and Liberia declare states of emergency to curb coronavirus (Reuters)
  • Gaza runs out of coronavirus tests, Palestinian health officials say (Reuters)
  • FDA Warns Seller Marketing Dangerous Chlorine Dioxide Products that Claim to Treat or Prevent COVID-19 (FDA 1, 2)
  • FDA Virtual Town Hall Series #2– Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests (Transcript)
Pharmaceuticals & Biotechnology
  • Biotech venture capital had a record-breaking quarter, but isn’t out of the woods yet (STAT)
  • Qiming raises $1B fund, continuing big burst of VC activity (Fierce)
  • FDA approves generic to commonly used inhaler as demand surges due to coronavirus (Reuters) (FDA)
  • Novel drug targets in 2019 (Nature)
  • Biosimilar Market Updates (Big Molecule Watch)
  • Opioid-overdose prescriptions may go unfilled due to the cost (STAT)
  • Principles for COVID-19 Healthcare Communications – 2 – The Virtual Medical Meeting (Eye on FDA)
  • How a Seattle Genetics cancer drug could help lupus patients with kidney damage (Fierce)
  • US FDA Facility Compliance Actions Could Speed Up Despite Inspections Freeze (Pink Sheet-$)
  • Informative censoring — a neglected cause of bias in oncology trials (Nature)
  • Tango Therapeutics nabs $60M in CRISPR-based hunt for hidden cancer genes (Endpoints)
  • How Can the US Address Coronavirus Drug Shortages? (Harvard Bill of Health)
  • Frederic Pla enlisted as COO at the Parker Institute; Former Alkermes exec named CMO at Seres Therapeutics (Endpoints)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • Hunting a full OK for Bavencio in frontline bladder cancer, Pfizer, Merck KGaA receive VIP treatment at FDA (Endpoints)
  • Tenax Therapeutics Announces Last Patient Completes Final Visit in its Phase 2 “HELP Study” of Levosimendan for Pulmonary Hypertension and Heart Failure with Preserved Ejection Fraction (Press)
  • FirstWave Bio to Initiate Phase 2a/2b Study of FW-1022, a Proprietary Form of Niclosamide, to Treat COVID-19 (Press)
  • Bridge Biotherapeutics Discloses Interim Results from the First Cohort of Phase 2a Study of BBT-401, an Experimental Drug for Ulcerative Colitis (Press)
Medical Devices
  • Embolism risk prompts FDA to treat Boston Scientific recall as Class I event (MedtechDive)
  • Harvard, INSEAD authors pitch systemic regulatory approach to AI/ML devices (MedtechDive)
  • Coronavirus chaos ripe for hackers to exploit medical device vulnerabilities (MedtechDive)
  • FDA Grants Vapotherm® Oxygen Assist Module (OAM™) Breakthrough Device Designation (Press)
  • FDA Grants Breakthrough Device Designation to DNAe’s Sequencing Diagnostic (Press)
US: Assorted & Government
  • COVID-19 Countermeasure Protections Are Not Absolute (Law360)
  • J&J Unit Beats Suit Over Defective Breast Implants (Law360-$)
  • Juno Awarded Over $1.1B In Final Judgment For IP Case (Law360-$)
  • NY AG Seeks Additional Sackler Family Financial Info (Law360-$)
  • SEC Suspends 3 More OTC Stocks Over COVID-19 Concerns (Law360)
  • SEC Suspends Trading Of Company That Sold 'At-Home' COVID-19 Tests (NPR)
  • FDA Warns More CBD Sellers About Bogus COVID-19 Claims (Law360)
  • Valeant Pharmaceuticals Int'l v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2020) (Patent Docs)
  • Texas Law Yields A Better Result On A Motion To Dismiss (Drug & Device Law)
  • Pfizer and Eli Lilly defeat lawsuit over claims Viagra and Cialis cause cancer (Pharmafile) (Law360-$)
Europe
  • UK Antitrust Regulator Suspends Drug Price Probes Amid Virus (Law360)
  • Approval of GxP documents when working from home during the coronavirus (COVID-19) outbreak (MHRA)
  • New MDCG guidance on temporary extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions (MedicalDevicesLegal)
India
  • Zydus Cadila gets USFDA nod to market generic cancer drug (Economic Times)
  • Cipla gets final approval from USFDA for Albuterol Sulfate Inhalation Aerosol (Economic Times)
  • Granules India gets USFDA approval for Butalbital, Acetaminophen, Caffeine capsules (Economic Times)
  • Aurobindo Pharma gets USFDA nod for generic antidepressant tablets (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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