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

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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-$)
• SEC Suspends 3 More OTC Stocks Over COVID-19 Concerns (Law360)
• SEC Suspends Trading Of Company That Sold 'At-Home' COVID-19 Tests (NPR)
• FDA Warns More CBD Sellers About Bogus COVID-19 Claims (Law360)
• Valeant Pharmaceuticals Int'l v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2020) (Patent Docs)
• Texas Law Yields A Better Result On A Motion To Dismiss (Drug & Device Law)
• Pfizer and Eli Lilly defeat lawsuit over claims Viagra and Cialis cause cancer (Pharmafile) (Law360-$)

• 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)

• 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)