Recon: Hydroxychloroquine flops in NIH-funded study; Senators question FDA over emergency authorizations

• Trump, Pence test negative after White House valet contracts coronavirus (Reuters)
• US coronavirus deaths exceed 75,000: Reuters tally (Reuters)
• Malaria drug touted by Trump for coronavirus fails another test (Reuters) (CNBC) (NEJM)
• States weigh what to do with millions of malaria pills (Roll Call)
• Warren, Murray want answers on FDA's emergency authorizations (Politico)
• US needs better technology to test for COVID-19: top health official (Reuters)
• Moderna CEO: Supply of vaccine will be limited, US to help decide who gets it first (CNBC)
• More than 1,000 clinical trials were stopped by the pandemic, dozens in PhIII (Endpoints)
• Orchard lays off a quarter of its staff amid major shift (BioPharmaDive) (Endpoints)
• Acknowledging the public role in private drug development: lessons from remdesivir (STAT) (STAT)
• Frustrated doctors push administration to reveal which hospitals are getting remdesivir — and why (Politico) (Reuters)

• China open to probe of origins of coronavirus, says envoy: report (Reuters)
• Teva generics benefit from COVID-19 bump––but the boom may not last (Fierce)
• Post-Coronavirus Warnings From EU Pharma Industry (Pink Sheet)
• Arthritis Drug Seen Helping Covid-19 Patients in Small Study (Bloomberg)
• Praluent Barred in Japan after Top Court Nixes Sanofi’s Patent Claim (PharmaJapan)
• EU actions to support availability of medicines during COVID-19 pandemic – update #5 (EMA)
• Coronavirus could kill up to 190,000 in Africa in first year if not contained: WHO (Reuters)
• Australia to provide Pacific nations rapid COVID-19 test kits (Reuters)
• UN Humanitarian Aid Request Due To COVID-19 More Than Triples (NPR)
• Falsified and contaminated Defibrotide identified in WHO regions of Western Pacific, Europe and Eastern Mediterranean (WHO)

• Wuhan market had role in virus outbreak, but more research needed – WHO (Reuters)
• Japan lowers bar to coronavirus testing, drops temperature guideline (Reuters)
• After Recovery From the Coronavirus, Most People Carry Antibodies (NYTimes)
• NIH doesn’t expect the coronavirus to rapidly mutate like the seasonal flu (CNBC)
• Regeneron says antibody for COVID-19 could be ready this year (PMLive)
• Cadila shutters Indian ingredients plant after 26 workers test positive for COVID-19: report (Fierce)
• Coronavirus May Lurk in Semen, Researchers Report (NYTimes)
• Becton Dickinson to boost testing capacity for potential second COVID-19 wave (Reuters)
• Exclusive: Large number of COVID-19 cases among Afghan medics spark alarm in Kabul (Reuters)
• False negative: officials say Russian virus tests often give wrong result (Reuters)
• Russia's coronavirus cases rise by more than 10,000 for sixth straight day (Reuters)

• Two years after a wrenching setback, Protagonist touts a slice of data and sets sights on pivotal trial in a surprising place: the blood (Endpoints)
• After trial failure, Enanta narrows its focus to NASH (BioPharmaDive)
• Biogen gears up Swiss manufacturing facility for potential aducanumab rollout (Fierce)
• Fresh off positive Nuplazid data, Acadia adds new clinical drug from Vanderbilt in milestone-heavy deal (Endpoints)
• Bristol Myers Squibb's blood thinner Eliquis soars on COVID-19 demand, but Opdivo could suffer: execs (Fierce)
• FDA isn't lifting the clinical hold on Solid Bio's Duchenne MD gene therapy just yet — but is there a silver lining? (Endpoints)
• Ovid's lead drug shows promising efficacy signal in Fragile X syndrome study, but optimal dosing regimen is unclear for path forward (Endpoints)
• Amid lab space scarcity, a life sciences complex to rise in South San Francisco hub (Endpoints)
• Rx Vial Size: FDA Stresses Safety Issues Amid Push To Find Savings For Payors (Pink Sheet)
• Ex-AstraZeneca exec Kristen Buck hops aboard Icon as CMO; Immunocore taps Brian DiDonato as CFO (Endpoints)
• COVID-19 Disruptions Could Lead To Sharp Slowdown In India Pharma Market (Scrip)
• Indian pharma exports miss target, stand at $20.58 bn in FY' 20 (Economic Times)
• Long-Range Planning (LRP): Reframed Leaders Require Purpose (LifeSciVC)
• FDA Grants Fast Track Designation For Omecamtiv Mecarbil In Heart Failure (Press)
• European Commission Approves Subcutaneous Formulation of Entyvio® (Vedolizumab) for use as Maintenance Therapy in Adults with Moderately to Severely Active Ulcerative Colitis or Crohn’s Disease (Press)
• FDA Stakeholder Engagement on ICH E6 Guideline for Good Clinical Practice, 4-5 June 2020 (FDA)

• Roundup: Q1 medtech reports give glimpse into coronavirus-era gains and losses (MedtechDive)
• 10 stories on the state of COVID-19 testing in the US (MedtechDive)
• FDA’s Popular CMMI Maturity Model Appraisal Program Soldiers On In Spite Of COVID-19 (MedtechInsight)
• Grifols ART System Nabs FDA Approval (GenomeWeb)
• Infections Associated with Resterilized Pacemakers and Defibrillators (NEJM)

• Maryland governor vetoes funding for a prescription drug affordability board (STAT)
• Importing Prescription Drugs from Canada — Legal and Practical Problems with the Trump Administration’s Proposal (NEJM)
• House Democrats urge FDA to revise policy limiting gay, bisexual men from donating plasma (The Hill)
• HHS Official Expects Probe Into Ex-Vaccine Chief's Ouster (Law360)
• Astellas, Indian Generic Cos. Settle IP Fight Over Bladder Drug (Law360)
• If At First You Don’t Succeed, Bring Another Lawsuit: PMRS Takes a Loss in Court (FDA Law Blog)
• Hologic, Inc. v. Minerva Surgical, Inc. (Fed. Cir. 2020) (Patent Docs)
• This Is The Correct Standard For Judging Predominance In Class Actions (Drug & Device Law)