Recon: Moderna says coronavirus vaccine Phase II studies could start this spring; German vaccine makers want trial rules eased

• No 'magic pill': The fight over unproven drugs for coronavirus (Politico)
• Trump invokes Defense Production Act for ventilator manufacturing (CNBC) (MedtechDive)
• Do social distancing better, White House doctor tells Americans. Trump objects (Reuters)
• Opioid supply crunch for US coronavirus patients prompts appeal to relax limits (Reuters)
• FDA Relaxes Blood Donation Guidelines for Gay Men and Others (NYTimes) (NBC)
• Essential Drug Supplies for Virus Patients Are Running Low (NYTimes)
• CIA Hunts for Authentic Virus Totals in China, Dismissing Government Tallies (NYTimes)
• Trump Administration Officials Weigh How Far to Go on Recommending Masks (NYTimes)
• Americans should cover faces and also keep distance: Dr. Fauci (Reuters)
• FDA says it will allow imports of KN95 respirators, alternative to scarce N95 (BuzzFeed) (The Hill)
• Less than 10 percent of the N95 masks requested have been received by 5 states (Roll Call)
• Merck’s Keytruda beats chemo in first-line colorectal cancer (PMLive)
• Large employers could have saved money if more biosimilars had been prescribed (STAT)
• Phase 2 of coronavirus vaccine human trials may begin in spring, Moderna chairman says (CNBC)
• Potential COVID-19 vaccine shows promise in mouse study (Reuters)
• Boston Scientific cutting hours and pay as revenue drops (STAT)

• With over a million coronavirus cases, economic freefall looms (Reuters)
• World Bank approves initial $1.9B in emergency coronavirus funds (Reuters)
• German vaccine makers urge regulators to ease rules for virus (Financial Times) (Fierce)
• No quick deliveries of COVID-19 ventilators, EU says (Reuters)
• Countries fighting over Chinese masks: German health minister (Reuters)
• US big bucks turn global face mask hunt into 'Wild West' (Reuters)
• Google releases location data to show if coronavirus lockdowns working in 131 countries (Reuters)
• Sanofi can produce millions of doses of potential coronavirus drug – CEO (Reuters)
• France races to boost supplies of critical medications (Reuters)
• Japan’s Stimulus Package Likely to Support API Manufacturing Repatriation, Vaccine/Drug Development (PharmaJapan)
• Pfizer wins EU approval for MabThera biosimilar (PharmaTimes) (Press)
• Sanofi and Regeneron's Dupixent shows more encouraging results (Reuters) (Press)
• Fujifilm says new coronavirus test can produce results in two hours (Reuters)
• Medical aid marooned as Africa shuts borders amid coronavirus pandemic (Reuters)

• Coronavirus in the US: How Fast It’s Growing (NYTimes)
• Volunteer disinfectant sprayers help Wuhan prepare for a return to work (Reuters)
• Covid-19 and Health Care’s Digital Revolution (NEJM)
• One Reason Caregivers Are Wearing Trash Bags: A U.S. Firm Had to Recall 9 Million Surgical Gowns (ProPublica)
• You may be able to spread coronavirus just by breathing, new report finds (Science Mag) (NAS)
• Incyte, Novartis to test repurposed cancer drug in COVID-19 (BioPharmaDive) (Press)
• GSK allies with Innovax for COVID-19 vaccine R&D project (Fierce)
• New York State Pays Up to 15 Times the Normal Prices for Medical Equipment (ProPublica)
• New York has enough ventilators to last six days: governor (Reuters)
• These drugs don’t target the coronavirus—they target us (Science Mag)
• Georgia Gov. Brian Kemp admits he just learned asymptomatic people can spread coronavirus (NBC)
• Trump Touted Abbott’s Quick COVID-19 Test. HHS Document Shows Only 5,500 Are On Way For Entire US (KHN)
• Explainer: How an old tuberculosis vaccine might help fight the new coronavirus (Reuters)
• Touting Virus Cure, ‘Simple Country Doctor’ Becomes a Right-Wing Star (NYTimes)
• Britain looking at virus immunity certificates but more research needed (Reuters)
• How Tea Party Budget Battles Left the National Emergency Medical Stockpile Unprepared for Coronavirus (ProPublica)
• Hungary's Alkaloida says it can mass produce hydroxychloroquine for coronavirus use: media (Reuters)
• Britain's Prince Charles opens massive new field hospital to fight coronavirus (Reuters)
• 3D printers forge face shields for fight against the coronavirus (Reuters)
• Swiss government expands powers to force firms to make supplies to fight COVID-19 (Reuters)
• Swiss ease access to COVID-19 treatments with exceptional decree (Reuters)
• Italy looks to safeguard biomedical valley leading fight against COVID-19 (Reuters)
• HHS eases HIPAA enforcement on data releases during COVID-19 (Modern Healthcare)
• US officials redistribute protective gear seized from alleged hoarder (Reuters)
• UK coronavirus death toll rises to 3,605, up 23% in a day (Reuters)
• Dutch coronavirus deaths rise to 1,487: health authorities (Reuters)
• Canada faces 'critical week' in coronavirus crisis, death toll jumps (Reuters)
• UK's worst case coronavirus toll is 50,000 dead but UK is not on course for that – source (Reuters)
• FDA Commissioned Corps Officers on the Front Line of COVID-19 Response (FDA)
• Coronavirus (COVID-19) Update: Daily Roundup April 2, 2020 (FDA)

• COVID-19 is bad news for new drug launches. Which will suffer most? (Fierce)
• US FDA User Fee Renewals Remain On Schedule Despite Coronavirus (Pink Sheet-$)
• Lilly Asia Ventures co-leads $100M+ round for Chinese biotech and its late-stage lupus drug (Endpoints)
• Emergent to produce Novavax's flu vaccine under CDMO deal (BioPharmaDive)
• Virus Heightens Importance Of Drug Shortage Reports To FDA (Law360)
• Investing in the time of coronavirus: the good, the bad and the hopeful, as biotech VC firms close funds worth $3B (Endpoints)
• Biosimilar partnership updates (Big Molecule Watch)
• A small, obscure biotech just won big with their IPO. In this market. Are you kidding me? (Endpoints)
• Drug discovery in the age of coronavirus (Endpoints)
• J&J gives pioneering stem cell biotech its first Big Pharma deal, partnering on iPSC CAR-T and CAR-NK (Endpoints)
• Servier bags an antibody specialist in its latest oncology M&A deal with plans to add the platform tech (Endpoints)
• GSK vaccine chief heads for AIDS vaccine initiative; Pfizer enlists Sue Desmond-Hellmann to its board of directors (Endpoints)
• Ahead of US IPO, Legend Biotech adds $150M, top-tier investors to back CAR-T pipeline (Endpoints)
• Confessions Of A Planner (LifeSciVC)
• NIH-funded research leads to pediatric labeling updates for doxycycline, clindamycin and caffeine citrate (NIH)
• Compass Therapeutics' immuno-oncology prospect clears solid tumors in mice (Fierce)

• GlaxoSmithKline's chronic disease treatment study meets late-stage main goals (Reuters) (Endpoints)
• Asciminib in Relapsed Chronic Myeloid Leukemia (NEJM)
• IVERIC bio Announces Fast Track Designation from FDA for Zimura® for the Treatment of Geographic Atrophy Secondary to Dry Age-Related Macular Degeneration (Press)
• UroGen Announces Positive Interim Data from Phase 2b Study of UGN-102 in Patients with Low-Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer (Press)

• Coronavirus products or not, medtech navigates shifts in regulatory operations (MedtechDive)
• LeMaitre Vascular Inc. Recalls LeMaitre Over the Wire Embolectomy Catheter Due to Balloon Deflation and Separation Issue (FDA)

• Industry – 3, FDA – 0: Will the Agency Finally Throw in the Towel? (FDA Law Blog)
• Merck, Takeda Unit Beat Off-Label FCA Kickbacks Suit (Law360-$)
• Dems Want Rule Comment Periods Paused Amid Outbreak (Law360)
• 'Pharma Bro' Shkreli Aims Another Blow At Kidney Drug Suit (Law360-$)
• Melinta Gets OK For Ch. 11 Equity Swap Plan With Creditor (Law360-$)
• United States wants to end most payouts for leading vaccination-related injury (Science Mag)
• Impact of COVID-19 Pandemic on Patent Offices and Federal Courts – April 2 UPDATE (Patent Docs)

• EMA releases its regulatory strategy for next five years (EPR)
• Information for hospital blood banks during the coronavirus (COVID-19) outbreak (MHRA)
• Blood: authorisations and safety reporting (MHRA)
• AbbVie Brings In Non-EU Kaletra To Bolster Dwindling French Supplies (Pink Sheet-$)

• MHLW Allows Online IRB Meetings for Coronavirus Trials (PharmaJapan)
• Gilead-Sponsored Remdesivir Trial Expected to Start This Month: Minister (PharmaJapan)

• NPPA notifies all medical devices as drugs under DPCO-2013 for quality control & price monitoring (PharmaBiz)
• Mylab partners with Serum Institute of India and AP Globale for testing kits (Economic Times)
• Covid-19: Indian pharma companies want government to airlift APIs from China (Economic Times)

• Summary Safety Review - Direct-acting antivirals (DAAs) – (Health Canada)

• Notice of an amendment to the current Poisons Standard under paragraph 52D(2)(a) of the Therapeutic Goods Act 1989 – Hydroxychloroquine (TGA)