Recon: Japan approves remdesivir for COVID-19; Moderna cleared to start Phase 2 coronavirus vaccine trial

• Moderna expects mid-stage trials for COVID-19 vaccine to begin shortly (Reuters)
• Doctors lambaste federal process for distributing Covid-19 drug remdesivir (STAT)
• Stepping on BioMarin's turf, PTC Therapeutics picks up PKU drug for a song (Endpoints)
• Fauci's absence from hearing draws bipartisan rebuke from House lawmakers (The Hill)
• US plans to make ‘millions’ of ‘easy-to-use’ coronavirus tests by end of summer: Collins (CNBC)
• US shelves detailed guide to reopening country (AP)
• Generic Drug Maker to Admit to Fixing Prices for Cholesterol Medication (NYTimes)
• Alexion Pharmaceuticals Strikes Tentative $25 Million Bribery Settlement (WSJ)
• FDA approves Novartis drug for hard-to-treat type of lung cancer (Reuters) (Endpoints) (FDA) (Press)
• US Was Behind On Payments To WHO Before Trump's Cutoff (NPR)
• Remdesivir helps coronavirus patients — but at what cost? (Politico) (Reuters)

• Japan approves Gilead Sciences' remdesivir as COVID-19 drug (Reuters) (PharmaJapan)
• Japan Eyes May Approval for Avigan with Investigator-Led Study Data (PharmaJapan)
• Japan to Test Ivermectin for COVID-19: Prime Minister (PharmaJapan)
• GSK tests experimental drug to treat pneumonia from COVID-19 (Reuters)
• NICE gives thumbs-up to Roche's Kadcyla in HER2+ breast cancer sub-population (Pharmafile)
• WHO warns against rushed end to coronavirus lockdowns (Reuters)
• WHO guidelines for frontline PPE use designed to protect people, conserve gear (Reuters)
• WHO says it’s in talks to send mission to China to investigate source of coronavirus (CNBC)
• EU wants WHO review of lessons learnt from coronavirus crisis: draft (Reuters)

• Travel From New York City Seeded Wave of U.S. Outbreaks (NYTimes)
• Azar faulted workers' 'home and social' conditions for meatpacking outbreaks (Politico)
• Some US senators worry that without tests they could bring coronavirus home (Reuters)
• The TSA Hoarded 1.3 Million N95 Masks Even Though Airports Are Empty and It Doesn’t Need Them (ProPublica)
• Ford and 3M begin shipping respirators to front-line health workers fighting coronavirus pandemic (CNBC)
• New coronavirus adapts to populations; vaccine works in monkeys (Reuters)
• Giving blood thinners to severely ill Covid-19 patients is gaining ground (STAT)
• Amazon lends its expertise — and its cash — to Covid-19 research (STAT)
• The Conference Call to Cure Covid-19 (WSJ)
• Flagship-backed Evelo Biosciences joins Covid-19 hunt with proposal for bacteria trial (Endpoints)
• Africa disease centre rejects Tanzania's allegation that its coronavirus tests faulty (Reuters)
• Russia overtakes Germany, France after record rise in coronavirus cases (Reuters)
• Brazil hits record for coronavirus deaths, raising chances of lockdowns (Reuters)
• UK misses COVID-19 testing target for fourth day running (Reuters)
• Coronavirus: UK becomes first country in Europe to pass 30,000 deaths (BBC)
• Spain extends coronavirus state of emergency for two weeks (Reuters)

• Medical Research Is Locked Down, Too (WSJ)
• Clinical trials press on for conditions other than COVID-19. Will the pandemic’s effects sneak into their data? (Science)
• Pfizer tags 3 U.S. manufacturing sites for possible COVID-19 vaccine launch (Fierce)
• Bristol Myers Squibb Reports Strong First Quarter 2020 Financial Results (Press)
• Daiichi Sankyo Submits Supplemental New Drug Application for Trastuzumab Deruxtecan in Japan for Treatment of Patients with HER2 Positive Metastatic Gastric Cancer (Press)
• CGMP Requirements Apply To Remdesivir In COVID-19 Emergency – But Not To Chloroquine Or HCQ (Pink Sheet)
• Novo's diabetes drug also appears to work in NASH (BioPharmaDive)
• 'Deeply committed' Jim Wilson pours more of his life's work into Passage Bio — locking in more gene therapy programs, new tech (Endpoints)
• MacroGenics CEO Scott Koenig gets the pre-ASCO party started with some encouraging pipeline tidbits — leaving lots of questions for later (Endpoints)
• Tetraphase has two suitors, despite struggling market for antibiotics (Endpoints)
• Cigna's Express Scripts offers discounted drugs for U.S. newly unemployed (Reuters)

• Blood test for cancer detection company Grail rakes in $390M in latest round (Endpoints)
• Becton Dickinson Fiscal Q2 Revenues Up 1 Percent (360Dx)
• Becton Dickinson beats The Street in Q2 (MassDevice)
• Integra LifeSciences up despite missing on Q1 projections (MassDevice)
• FDA clears Nanobiotix to start cancer treatment trial (MassDevice)

• Fed. Circ. Reveals Why It Didn't Revive Boston Scientific IP (Law360)
• Fed. Circ. Says Thermo Fisher Can't Call Dibs On Injector IP (Law360)
• Roche Rails Against Bid To Void Del. Ruling On IP Rights Buy (Law360)
• Otsuka Nears Win Against Calif. Abilify Failure-To-Warn Suit (Law360)
• California Hand Sanitizer Company Ordered to Stop Marketing Unapproved New Drugs (DOJ)
• Promedical Equipment fined $63,000 for alleged unlawful advertising of a COVID-19 Rapid Test kit (TGA)
• Notice of final decisions to amend (or not amend) the current Poisons Standard, May 2020 (TGA)
• Senior Enforcement Advisor at UK Medicines Regulator warns against purchasing fake or unlicensed coronavirus (COVID-19) medicines (MHRA)