Recon: China to Begin Reporting Asymptomatic Coronavirus Cases; Amarin Loses Vascepa Patent Suit

• Trump says coronavirus guidelines may get tougher; one million Americans tested (Reuters)
• Restrictions Are Slowing Coronavirus Infections, New Data Suggest (NYTimes)
• Top US expert sees 'glimmers' social distancing dampening virus spread (Reuters)
• US coronavirus death toll rises past 3,000 on deadliest day (Reuters)
• US Congress eyes next steps in coronavirus response (Reuters)
• US panel outlines how doctors should ration care in a pandemic (Reuters)
• What we at the FDA are doing to fight Covid-19 (CNN)
• Agencies move at warp speed on coronavirus, drawing praise and scrutiny (Politico)
• J&J, Moderna sign deals to produce huge quantity of possible coronavirus vaccines (Reuters)
• Trump administration in talks with India to avoid US drug supply shortage (NBC)
• Amarin loses patent lawsuit on main drug, shares tumble (Reuters) (STAT) (Endpoints) (PMLive)
• Just in time to assure a decision before CVR deadline, Bristol Myers Squibb files NDA for Celgene/bluebird CAR-T (Endpoints) (BioPharmaDive) (Press)
• Ford, GE to produce 50,000 ventilators in 100 days (Reuters)
• The US Tried to Build a New Fleet of Ventilators. The Mission Failed. (NYTimes) (Medtronic)

• Coronavirus epidemic 'far from over' in Asia: WHO official (Reuters)
• Britain says need for global 'lessons learned' inquiry into pandemic (Reuters)
• No proof drug touted by Trump drug is effective against coronavirus: EU (Reuters)
• In France, controversial doctor stirs coronavirus debate (Politico)
• China to start reporting on asymptomatic coronavirus cases (Reuters 1, 2) (SCMP)
• China health commission says 1,541 asymptomatic coronavirus patients under observation (Reuters)
• Big drugmakers under pressure to share patents against coronavirus (Financial Times)
• Mylan offers concessions to address EU concerns about Pfizer deal (Reuters)
• German minister: We need a law to ensure supply of medicines in future (Reuters)
• France to ramp up domestic production of face masks, respirators: Macron (Reuters)
• Facing shortages, India bets on China for swift ramp-up of protective health gear: sources (Reuters)
• Bayer gets EU nod for prostate cancer drug Nubeqa (PMLive)
• Europe sells medicine to Tehran in first bypass of US sanctions, as Iran grapples with coronavirus outbreak (Independent)

• WHO Official Defends Guidance: 'We're Not Seeing' Airborne Transmission (NPR)
• We shouldn’t rush to use an unproven malaria drug to treat the coronavirus (STAT)
• ‘Panic Prescribing’ Untested Coronavirus Treatments: A Danger To Patients Today and Tomorrow (Health Affairs)
• Optimizing Ventilator Use during the COVID-19 Pandemic (US PHS)
• Covid-19 testing: overcoming challenges in the next phase of the epidemic (STAT)
• As coronavirus spreads, doctors in the ER warn ‘the worst of it has not hit us yet’ (STAT)
• Mass disinfections to combat coronavirus pose another health hazard (Reuters)
• Germany aims to launch Singapore-style coronavirus app in weeks (Reuters)
• Gates Foundation and Wellcome Trust to fund Covid-19 drug trials (Financial Times)
• Oxford firm to screen 15,000 drugs in search for coronavirus cure (The Guardian)
• Letter to Sponsors, Applicants and Regulated Entities on COVID-19 (FDA)
• Hospital Safety Rules Are Relaxed to Fight Coronavirus (NYTimes) (KHN) (HealthcareDive)
• It is 'kind of a proven technology': Hep B vaccine maker joins global hunt for coronavirus vaccine (Endpoints)
• Bay Area scientists hope coronavirus antibody tests reveal the key to immunity (San Francisco Chronicle)
• Brii Bio gets all hands on deck for Covid-19 antibody hunt, leveraging Chinese partners' work with recovered patients (Endpoints)
• Dosing Guidance Lacking For Leading COVID-19 Antiviral Therapies, ASHP Analysis Shows (Pink Sheet-$)
• QIAGEN Receives FDA EUA for QIAstat-Dx test kit, First and Only Syndromic Solution Integrating Detection of SARS-CoV-2 Coronavirus (Press)
• Rendu Biotechnology Gets Emergency Approval in China for Coronavirus Detection Kit (GenomeWeb)
• Kiniksa Announces Early Evidence of Treatment Response with Mavrilimumab in 6 Patients with Severe COVID-19 Pneumonia and Hyperinflammation (Press)
• Number of long-term care facilities with COVID-19 cases tops 400 nationwide (NBC)
• NIST Funding Manufacturing Institutes to Support Pandemic Response (NIST)
• Italy to extend coronavirus lockdown until Easter as new cases fall (Reuters)
• Italy coronavirus deaths rise by 812, number of new cases falls sharply (Reuters)
• Italy's coronavirus deaths could be underestimated in data: official (Reuters)
• Italy may be on wrong path in fighting coronavirus contagion: scientist (Reuters)
• California COVID-19 hospitalizations double in four days: governor (Reuters)
• Deaths, intubations swamp New Orleans doctors in coronavirus surge (Reuters)
• Tokyo records most new coronavirus cases in a day as pressure for lockdown builds (Reuters)
• Paris to transfer 38 coronavirus patients to other regions on Wednesday: officials (Reuters)
• Russia coronavirus cases jump to 2,337 in record daily rise (Reuters)
• Russian regions join coronavirus lockdown as toll rises (Reuters)
• Number of confirmed coronavirus cases in Germany rises to 61,913: RKI (Reuters)

• ‘It’s the disparity in who gets affected’: A sickle cell doctor tracks dollars and drug development (STAT)
• How Johnson & Johnson companies used a ‘super poppy’ to make narcotics for America’s most abused opioid pills (Washington Post)
• Creatures in this underwater forest could save your life one day (NYTimes)
• Pandemic sees one-quarter of investigators halting trial enrollment: poll (Fierce)
• Merck's search for growth outside Keytruda may not end in heart disease (BioPharmaDive)
• Myovant grabs $40M upfront in regional deal for relugolix; Akero announces NASH success but Covid-19 delays (Endpoints)
• Can a pair of top AveXis alumni steer a new gene therapy upstart to R&D glory? 3 VCs bet $60M on it (Endpoints)
• ACC: MyoKardia's mavacamten reduces heart stress signs in targeted biomarker study (Fierce)
• Fast-fail trial shows new approach to identifying brain targets for clinical treatments (NIH)
• Axsome Plans to Try Again After Failure in Treatment-Resistant Depression (Xconomy)
• Biohaven’s Acute Migraine Drug Bests Placebo in Prevention Study (Xconomy)
• Undeterred by a pandemic, Gilde Healthcare raises their largest fund yet (Endpoints)
• Eli Lilly antes up $60M gamble on a discovery deal with GSK-backed biotech (Endpoints) (Fierce)
• COVID-19 not expected to 'significantly delay' Genfit's phase 3 NASH readout (Fierce)
• Amgen sees no 'significant delays' from pandemic to novel KRAS cancer drug (Fierce)
• Unfazed by disruptions, Cowen backs AM-Pharma's $176M pivotal plan around lethal condition (Endpoints)
• Covid-19 and weak data force pipeline revamp at Reata, but the best trials go forward — with some creative adaptions (Endpoints)
• Boost for base editing to treat inherited blood disorders (Nature)

• FDA Accepts Investigational New Drug Application for CRISPR/Cas9-Based Sickle Cell Disease Therapeutic Candidate Developed Under Collaboration with Intellia Therapeutics (Press)
• OrphoMed Pauses Recruitment for Phase 2 Adaptive Design Study of ORP-101 for Treatment of IBS-D (Press)
• Mimetogen Pharmaceuticals Completes Enrollment of MIM-728 Phase 3 Trial for Tavilermide for Dry Eye Disease (Press)
• BiomX Announces Positive Topline Data from Phase 1 Study for Lead Candidate BX001 for Acne-Prone Skin (Press)

• AdvaMed wary of Trump's use of DPA to boost ventilator production (MedtechDive)
• Zoll Medical wins FDA nod for second-gen TherOx system (MassDevice)
• Second Sight Medical laying off most of its workers, winding down (MassDevice)
• Smith & Nephew expects Q1 revenue to be down 8% amid coronavirus (MassDevice)
• High-risk devices with expedited reviews more likely to be recalled, research suggests (MedtechDive)
• Stenting matches bypass surgery in 10-year study of left main patients (MedtechDive)
• Low-risk TAVR: Edwards results taper in 2nd year, Medtronic targets bicuspid market (MedtechDive)
• Medtronic Recalls Pipeline Flex Embolization Devices Due to Risk of Device Fracture (FDA)
• FDA Clears Siemens Healthineers RAPIDPoint 500e Blood Gas Analyzer Used for Critically Ill Patients in Acute Care Settings (Press)

• Biopharma COVID-19 Collaborations May Avoid Antitrust Hurdles, FTC And DOJ Suggest (Pink Sheet-$)
• Medical Diagnostic Device Maker Settles Allegations that it Misled Consumers about its Participation in the EU-US Privacy Shield (DoJ)
• After 4-year delay, DEA will review dozens of requests to grow marijuana for research (Science Mag)
• COVID-19 Bonanza: Stimulus Hands Health Industry Billions Not Directly Related To Pandemic (KHN)
• US Trustee Says Melinta Plan Releases Go Too Far (Law360-$)
• CBD Buyers Say They Shouldn't Have To Wait For FDA Action (Law360-$)

• Ophthalmic Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting – 9 June 2020

• EU Trade Chief Defends Medical Export Restrictions (Law360)
• Smiths Group to produce 10,000 ventilators for the UK Government (Smiths)
• Fees payable to MHRA for 2020 to 2021 (MHRA)
• Status of Phase 1 clinical trials in response to coronavirus (COVID-19) (MHRA)

• Myriad Genetics Seeks Japan Approval for Advanced Pancreatic, Prostate Cancer Companion Diagnostic (Precision Oncology News)
• Astellas Corporate Position on COVID-19 and Clinical Trials (Press)

• Maharashtra FDA resolves over 20 cases of inconsistent drug supply through its upgraded toll free helpline (Pharmabiz)

• Expedited COVID-19 medical device application process (TGA)
• Clinical Trial Processes: Information Relating to COVID-19 (TGA)

• Updated: Notice - Notification of Safety Labelling Changes to the Product Monographs of Pharmaceutical Drug Products (Health Canada)

• The World Pushes Back Against E-Cigarettes and Juul (NYTimes)