Recon: US Strategic Stockpile Running Out of Protective Gear; Teva Prevails in Patent Dispute Against Eli Lilly

• White House Projects 100,000 to 240,000 US Coronavirus Deaths (WSJ)
• Informal discussions begin on 9/11-style commission on coronavirus response (NBC) (WSJ) (The Hill)
• Rick Scott calls for congressional inquiry into WHO's coronavirus response (Politico)
• Pence task force freezes coronavirus aid amid backlash (Politico)
• Diabetes, lung and heart disease common in US coronavirus patients: CDC (Reuters)
• US emergency medical stockpile nearly out of protective gear as demand rises (Reuters 1, 2)
• India likely to soon ease some drug export curbs after US pressure (Reuters) (NBC)
• 3M to boost US production of respirator masks to 50 million as demand soars (Reuters)
• Becton Dickinson, BioMedomics launch test to detect past, current coronavirus exposure (Reuters) (MedtechDive) (Financial Times)
• China Concealed Extent of Virus Outbreak, US Intelligence Says (Bloomberg)
• A new Covid-19 problem: Shortages of medicines needed for placing patients on ventilators (STAT)
• US court rules for Teva in migraine patent dispute with Eli Lilly (Reuters)
• Motion denied: Gilead still on the hook for $1.5B in damages over CAR-T patent dispute with Bristol Myers Squibb (Endpoints)
• CDC Weighs Advising Everyone to Wear a Mask (NYTimes) (Reuters)
• Taxpayers Paid Millions to Design a Low-Cost Ventilator for a Pandemic. Instead, the Company Is Selling Versions of It Overseas. (ProPublica)

• Coronavirus Battle Creates a Global ‘Free-for-All’ to Find Masks (NYTimes)
• Mass testing, empty ICUs: Germany scores early against virus (AP)
• Japan 'on the brink' as it struggles to hold back coronavirus (Reuters)
• Britain working with industry on reagent shortage: PM's spokesman (Reuters)
• Daiichi Sankyo sinks $200M into new gene therapy tech from Ultragenyx (Endpoints)
• Coronavirus patents: for the greater good (Financial Times)
• Lilly cuts deal with UK’s Sitryx for autoimmune disease drugs (PMLive)
• First ventilators from new UK production run due this weekend (Reuters)
• Chinese scientists seeking potential COVID-19 treatment find 'effective' antibodies (Reuters)
• China clamps down on coronavirus test kit exports after accuracy questioned (Reuters)
• Canada coronavirus deaths jump by 35%, Quebec says equipment running low (Reuters)
• Worker crunch hits world's top medical glove maker as demand spikes (Reuters)
• British American Tobacco working on COVID-19 vaccine using tobacco leaves (Reuters) (Financial Times)

• Coronavirus - What will the impact be? (PharmaIntelligence)
• White House pressures FDA on unproven Japanese drug (Politico)
• Drugs Trump Touted for Covid-19 Treatment Added to Shortage List (Bloomberg)
• FDA's authorization of hydroxychloroquine and chloroquine for COVID-19 looks like political science (BioCentury)
• Rudy Giuliani wants FDA to fast-track a stem cell therapy for Covid-19; critics see political meddling (STAT)
• Everyone Thinks They’re Right About Masks (The Atlantic)
• What coronavirus tests does the world need to track the pandemic? (Financial Times)
• Private Labs Are Fueling a New Coronavirus Testing Crisis (The Atlantic)
• 'It's just impossible': tracing contacts takes backseat as virus spreads (Reuters)
• Europe to launch coronavirus contact tracing app initiative (Reuters)
• That viral story on FDA approving two-minute coronavirus test looks like a cruel April Fools' hoax (Washington Examiner)
• Infected but Feeling Fine: The Unwitting Coronavirus Spreaders (NYTimes)
• Blood Centers Will Collect Plasma From COVID-19 Survivors In Bid For Treatment (KHN)
• Frightened Doctors Face Off With Hospitals Over Rules on Protective Gear (NYTimes)
• Hospitals Tell Doctors They’ll Be Fired If They Speak Out About Lack of Gear (Bloomberg)
• Expired Respirators. Reused Masks. Nurses in the Nation’s Original Covid-19 Epicenter Offer Sobering Accounts of What Could Come. (ProPublica)
• Outbreak On U.S. Aircraft Carrier 'Accelerating,' Commander Warns Pentagon (NPR)
• Covid-19 TrialsTracker (Tracker)
• Clinical Trials Set To Determine If Anti-Malaria Drug Effective Against COVID-19 (NPR)
• Tesla plans to supply FDA-approved ventilators free of cost: Musk (Reuters)
• EU research-based industry unveils COVID-19 commitments (PharmaTimes)
• Israel tests coronavirus vaccine prototype on rodents at defense lab (Reuters)
• ‘Human experts will make the call’: Stanford launches an accelerated test of AI to help care for Covid-19 patients (STAT)
• The race to develop Covid-19 drugs and vaccines is on — here’s what’s happening in the UK (Endpoints)
• Joint Commission backs clinicians demanding freedom to bring their own PPE to work HealthcareDive)
• What FDA Has Done So Far In Response To COVID-19 (Law360-$)
• FDA to authorize single-laboratory COVID-19 tests (MassDevice)
• Genetic Signatures Gets CE Mark for Coronavirus Molecular Test (GenomeWeb)
• MHRA approves new life-saving breathing aid to help keep coronavirus (COVID-19) patients out of intensive care (MHRA)
• What Does It Mean That Oracle is Partnering with the Trump Administration to Study Unproven COVID-19 Drugs? (Harvard Bill of Health)
• The Trump Administration Is Leaving the Nation’s Emergency Backup Hospital System on the Sidelines (ProPublica)
• A Major Medical Staffing Company Just Slashed Benefits for Doctors and Nurses Fighting Coronavirus (ProPublica)
• Trump rejects opening ObamaCare special enrollment period amid coronavirus outbreak (The Hill)
• Texan spring break group tests positive for coronavirus after Mexico beach trip (Reuters)
• Cruise Ship Struggling With COVID-19 Headed To Florida (NPR)
• UK coronavirus deaths rise by 563 to 2,352 (Reuters)
• Spain reports more than 100,000 coronavirus cases, new daily death toll record (Reuters)
• Preliminary study finds UK lockdown is slowing spread of COVID-19 (Reuters)
• Iran's coronavirus death toll rises to 3,036: health ministry official (Reuters)
• Rikers Island Prisoners Being Offered Ppe And $6 An Hour To Dig Mass Graves (The Intercept)

• Impact of COVID-19 on Regulatory Enforcement and Approvals – Part 3 – FDA Adds Resources to Facilitate COVID-19 Research (Eye on FDA)
• Coronavirus Demanding Focus Of US FDA’s Antiviral, Other Divisions (Pink Sheet-$)
• CDER’s Woodcock On COVID-19: Missed User Fees Unlikely, But Some Work Will Be ‘Set Aside’ (Pink Sheet-$) (Interview)
• Guest Editorial: We Should Expect Drug Shortages to Get Worse (PDALetter-$)
• Recommendations for Hydroxychloroquine and Chloroquine Usage (American College of Rheumatology)
• CRISPR Therapeutics braces for ‘severe impact’ from COVID-19 crisis (Fierce)
• The biotech scorecard for the second quarter: 18 stock-moving events to watch (STAT)
• Biosimilars could disappear if the Supreme Court overturns the ACA (STAT)
• The small-cell lung cancer drug market (Nature)
• A small NASH drugmaker finds positive data, but coronavirus makes for a 'tricky' path forward (BioPharmaDive)
• FDA puts pediatric aGVHD drug on priority review lane — will they go virtual with the adcomm? (Endpoints)
• Flexion secures China deal for osteoporosis drug; Struggling to find a buyer, Akorn throws in the towel (Endpoints)
• A quiver of arrows for immune disorders: Pandion scores $80M in fresh funding (Endpoints)
• ITeos nabs $125M as they prep Keytruda combination trial — if Covid-19 will let them (Endpoints)
• ‘There was a growing weariness’: Rushing against a pandemic clock, Aspen Neurosciences secures $70M Series A (Endpoints)
• NIH researchers discover gene for rare disease of excess bone tissue growth (NIH)
• Paratek Pharmaceuticals Announces Initiation of Funding from BARDA for Security Requirements and U.S. Onshoring of the Manufacturing Supply Chain for NUZYRA• (omadacycline) (Press)

• AVEO Oncology Announces Submission of New Drug Application to U.S. FDA for Tivozanib in Patients with Relapsed or Refractory Renal Cell Carcinoma (Press)
• Concert Pharmaceuticals Announces Plans for CTP-543 Phase 3 Trials in Alopecia Areata (Press)
• OrphoMed Pauses Recruitment for Phase 2 Adaptive Design Study of ORP-101 for Treatment of IBS-D (Press)
• A Randomized, Controlled Trial of Liraglutide for Adolescents with Obesity (NEJM)

• The promise of digital therapeutics (McKinsey)
• FDA makes technical amendments to medical device regulations (FDA 1, 2)
• Microbiology Devices: Reclassification of Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Assay Devices, To Be Renamed Nucleic Acid-Based Hepatitis C Virus Ribonucleic Acid Tests (FDA)
• Microbiology Devices: Reclassification of Certain Hepatitis C Virus Antibody Assays Devices, To Be Renamed Hepatitis C Virus Antibody Tests (FDA)

• Genentech Loses Eye-Drug Patent Rights Over Agent's Error (Law360-$)
• PTAB Extends Time For Insulin Glargine IPR Decision (Big Molecule Watch)
• Merck Can't Trim Dozens Of Suits From Zostavax MDL (Law360-$)
• Breast Implant Preemption (the Sequel) (Drug & Device Law)
• Ex-Theranos CEO Wants Trial Prep OK'd Amid Pandemic (Law360-$)
• Indivior Again Fails To Dodge Feds' Opioid Marketing Case (Law360-$)
• FDA Seeks Extension Of Vape App Deadline Due To COVID-19 (Law360-$)
• Vulnerability in medication dispensing system flagged again by DHS cyber team (MedtechDive)
• FTC Data Shows Jump in Coronavirus-related Complaints from Consumers (FTC)

• EU recommendations for 2020/2021 seasonal flu vaccine composition (EMA)
• Regulatory information - 1.6% increase in fees from 1 April 2020 (EMA)
• Spinal implant: All MAGEC Systems – supply suspended to the UK (MDA/2020/011) (MHRA)
• Russia May Cap Drug Prices In Fight Against COVID-19 (Pink Sheet-$)

• Daiichi Sankyo submits NDA in Japan for Gilead’s CAR-T drug (PharmaLetter-$)
• Biocon says probe on Malaysia manufacturing unit ends (Economic Times)

• Medical devices to be regulated as drugs for quality control, price monitoring: Government (Economic Times)
• Maharashtra orders private labs to stop sample collection (Economic Times)
• Covid-19 battle: Govt suggests ‘off label’ use of combo drugs (Economic Times)

• Summary: Guidance Document Questions and Answers: Plain Language Labelling Regulations for Non-prescription Drugs (Health Canada)

• Cannabis scientists are chasing the perfect high (NYTimes)
• Fresenius Medical Care working with dialysis providers in US to tackle coronavirus (Reuters)