Recon: Ventilator Makers Boost Production; HIV Drug Combo Fails in COVID-19 Study

• Ventilator Makers Ramp Up Production Amid Coronavirus Crunch (NYTimes) (Reuters) (NPR)
• America Needed Coronavirus Tests. The Government Failed. (WSJ) (NYTimes)
• US coronavirus cases surpass 10,000, doubling in two days (CNBC)
• Trump signs coronavirus aid package with paid sick leave, free testing (The Hill) (Politico) (ProPublica)
• Intelligence Chairman Raised Virus Alarms Weeks Ago, Secret Recording Shows (NPR)
• 2 Members Of Congress Test Positive For COVID-19, Others Quarantine After Contact (NPR) (Politico)
• Younger Adults Make Up Big Portion of Coronavirus Hospitalizations in US (NYTimes)
• FDA turns to Twitter to help track testing supply shortages (Politico)
• Facing medical supply shortages, Trump invokes wartime law that could give government authority over private manufacturing (STAT)
• Roche test Actemra in coronavirus patients as firms re-purpose drugs (Reuters) (Fierce) (Press)
• Biogen Sues Over Sale of Alleged Copycat Alzheimer’s Antibody (Bloomberg Law)
• Pfizer puts off investor day, reports two late-stage study results in advance (Reuters) (Endpoints) (Press) (Press)
• Coronavirus delays Biogen's Spinraza for some patients (Reuters) (Endpoints)
• Biogen Sues Over 'Copycat' Alzheimer Treatment Products (Law360-$)
• Purdue Bankruptcy Shield Extended to Sacklers Through October (WSJ) (Law360-$)

• Rattled world 'at war' with coronavirus as deaths surge in Italy, France (Reuters)
• Patients with breathing, lung problems at highest risk with COVID-19 – study (Reuters)
• HIV drug combo fails as treatment for severe COVID-19 in China study (Reuters) (NYTimes)
• Faced with shortages, EU plans stockpiling medical gear (Reuters)
• UK faces 'massive shortage' of ventilators - Swiss manufacturer (Reuters)
• China reports no new local coronavirus transmissions for first time (Reuters)
• Israel OKs use of generic AbbVie drug to treat coronavirus despite patent (Reuters)
• WHO officials warn US President Trump against calling coronavirus ‘the Chinese virus’ (CNBC)
• Germany clears way for export of protective equipment to Italy (Reuters)
• Novartis posts pivotal data ahead of FDA decision on $9.7B bet (Fierce)
• Synairgen gets green light for coronavirus drug trial (Reuters)
• GSK quietly reveals just how much cash they used to buy a chunk of the Bay Area's buzziest startup (Endpoints)
• Japan approves Novartis' Zolgensma for SMA in patients under two years old (Pharmafile) (Press)
• WTO Forms Panel To Hear EU-Turkey Drug Production Case (Law360                -$)

• 'It's Not the Exact Same Virus Everywhere in the World' (Medpage) (medRxiv)
• Special Report: How Korea trounced US in race to test people for coronavirus (Reuters)
• Why Texas is so far behind other states on virus response (Politico)
• Complacency, Not Panic, Is the Real Danger (NYTimes)
• New York state likely has ‘tens of thousands’ of coronavirus cases, Gov. Cuomo says (CNBC)
• Turkey says it sent 500,000 coronavirus test kits to United States (Reuters)
• At the Front Lines of Coronavirus, Turning to Social Media (NYTimes)
• Wanted: People Willing to Get Sick to Find Coronavirus Vaccine (WSJ)
• US approves Abbott coronavirus test; company set to ship 150,000 (Reuters) (Press)
• Drug makers are racing to develop immune therapies for Covid-19. Will they be ready in time? (STAT)
• Biotech in the time of the coronavirus: Disruptions continue, but there’s some good news, too (STAT)
• A tropical disease doctor turns his sights on the coronavirus (Endpoints)
• COVID-19 Relief Bill Includes Protections For Face Masks (Law360)
• UK coronavirus deaths rise to 103, up from 71 (Reuters)
• Iran's death toll from coronavirus rises to 1,284: official (Reuters)
• Dutch confirmed coronavirus cases at 2,460: health authorities (Reuters)
• Dutch test blood donations for unseen coronavirus spread (Reuters)
• A Coronavirus Explosion Was Expected in Japan. Where Is It? (Bloomberg)
• Chad confirms first case of coronavirus: government statement (Reuters)
• Italy reports 475 new coronavirus deaths, lifting total death toll to 2,978 (Reuters)
• Nicaragua registers first case of coronavirus infection (Reuters)
• Russia reports its first coronavirus death (Reuters)
• Swiss cases of coronavirus rise to 3,880, with 33 deaths: government (Reuters)
• Malaysia reports 110 new coronavirus cases, total hits 900 (Reuters)
• Italy threatens to ban outdoor exercise as coronavirus deaths surge (Reuters)
• Netanyahu threatens Israeli lockdown orders in coronavirus crisis (Reuters)
• Mexico, former swine flu hub, tests nerves with coronavirus strategy (Reuters)
• Diabetic man becomes Mexico's first coronavirus death (Reuters)
• Bayer fires employee who was spotted breaking quarantine in China (Endpoints)
• Sick staff fueled outbreak in Seattle-area nursing homes, CDC reports (NBC)
• Qiagen Respiratory Panel With Coronavirus Targets Receives CE Mark (GenomeWeb)
• Lilly partners with Indiana State Health Department for coronavirus testing (PMLive)
• The First US Company Has Announced an Upcoming Home COVID-19 Test (Time)
• ACLA Calls on Congress to Ease Burdens on Labs Amid COVID-19 Outbreak (Letter)
• A serological assay to detect SARS-CoV-2 seroconversion in humans (medRxiv)
• 20/20 BioResponse to Launch Rapid Coronavirus Test Kits in U.S. following “Green Light” from FDA (Press)
• Medical Conferences Didn’t Cancel, Exposing Doctors Who Treat High-Risk Patients to Coronavirus (ProPublica)
• Global CRO Body Urges Sponsors To Focus On Key Risk Factors As Coronavirus Threatens To Upend Clinical Trials (Pink Sheet-$)
• Coronavirus: global crackdown sees a rise in unlicenced medical products related to COVID-19 (MHRA)

• Cell And Gene Therapies Are Driving M&A Deal Activity (Law360-$)
• FDA Says Stop SGLT2 Inhibitors for Diabetes Prior to Surgery (Medscape)
• How to rebrand a clinical trial? For one study, Instagram influencers and a dash of wit go a long way (STAT)
• Coronavirus disruption scuppers Curium Pharma sale (PMLive)

• In NIH trial, selumetinib shrinks tumors, provides clinical benefit for children with NF1 (NIH)
• Janssen Submits Ponesimod New Drug Application to the U.S. FDA for Treatment of Adults with Relapsing Multiple Sclerosis (Press)
• Dicerna Receives Orphan Drug Designation From U.S. Food and Drug Administration for DCR-A1AT for Treatment of Alpha-1 Antitrypsin Deficiency (Press)
• Soligenix Announces Positive Top-line Results for its Pivotal Phase 3 FLASH Trial Evaluating SGX301 in Treatment of Cutaneous T-Cell Lymphoma (Press)
• NantKwest Doses First Patient in Phase 2 Single-Arm Trial of Metastatic Merkel Cell Carcinoma Therapy With Off-the-Shelf CD16 Natural Killer Cells (Press)
• BELLUS Health Announces Completion of Enrollment in Phase 2 RELIEF Trial of BLU-5937 for the Treatment of Refractory Chronic Cough (Press)
• Japan grants orphan drug designation to Lynparza for BRCA+ unresectable pancreatic cancer (Pharmafile)

• CME America Recalls BodyGuard Microset Infusion Sets for the BodyGuard Infusion Pump System Due to Risk of Under-Infusion (FDA)
• Complete List of Donor Screening Assays for Infectious Agents and HIV Diagnostic Assays (FDA)

• The Trump Administration’s Buy American Drug Mandate Is A Costly Mistake (Forbes)
• Bill to Cut Out Role of Benefit Managers Clears Legislature (AP)
• Personal Injury from Mismailed Drugs (Drug & Device Law)
• Federal Circuit Denies Hospira’s Petition to Rehear Safe Harbor Ruling in Epoetin Biosimilar Dispute (Big Molecule Watch)
• NECC Execs Push 'Legal Impossibility' Defense In 1st Circ. (Law360-$)
• Bayer Asks Ill. Justices To Boot 160 Claims From Essure Suits (Law360-$)
• Gilead Knowingly Peddled Dangerous HIV Drugs, Suit Says (Law360-$)
• ‘Pharma Bro’ Suit Proceeds By Phone As COVID-19 Spreads (Law360-$)

• COVID-19- European Commission's recommendation on conformity assessment and market surveillance procedures (JDSupra)
• The use of state-of-the-art standards in the absence of harmonised standards under the IVD and Medical Devices Regulations (IVDR/MDR) (MedtechEurope)
• State of play of joint assessments of Notified Bodies in the medical device sector (EC)
• Class 4 FMD Medicines Information: WDA(H) 50340 HMS Wholesale Limited, Multiple Products, (EL (20)A/17) (MHRA)
• Professor Gillian Leng appointed NICE Chief Executive (EPR)
• Swiss vote on EU free movement accord falls victim to virus (Reuters)

• Price Freezes And Postponed Inspections: Philippines Responds To Coronavirus (Pink Sheet-$)

• Coronavirus outbreak makes a compelling case to declare API as strategic sector (Economic Times)
• Shredded documents and trick cameras: FDA knocks Indian drugmaker Windlas for brazen errors (Fierce)

• Australia closes borders to coronavirus, pumps $56 billion into economy (Reuters)
• TGA suspends overseas GMP inspections and QMS audits until further notice (TGA)
• Limits on dispensing and sales of prescription and over-the-counter medicines (TGA)
• COVID-19 limits on dispensing and sales at pharmacies (TGA)