Recon: Oxford, Moderna push ahead with COVID-19 vaccine trials; Pfizer, Novartis post Q1 results

• The Secret Group of Scientists and Billionaires Pushing a Manhattan Project for Covid-19 (WSJ)
• WHO says US federal coronavirus plan is clear and science-based (Reuters)
• With more testing, White House prepares for outbreaks this summer ‘and beyond’ (Politico)
• Dr. Anthony Fauci warns US could ‘be in for a bad fall’ if coronavirus treatments don’t work (CNBC)
• FDA's Role In Coronavirus Testing Guidelines Released By White House (NPR)
• Moderna's coronavirus vaccine candidate advances to next stage of testing (MarketWatch) (Press)
• Trump cuts US research on bat-human virus transmission over China ties (Politico)
• California fines more than a dozen drug makers for not providing drug pricing data (STAT)
• Most Americans believe Trump has failed to make progress lowering drug prices (STAT)
• Pfizer’s quarterly sales fall 8% as it races to develop coronavirus vaccine (CNBC)
• Teva Wins Ruling on Patents for Bendeka Cancer Drug (Bloomberg)
• US medical testing, cancer screenings plunge during coronavirus outbreak - data firm analysis (Reuters)

• Indian Government may not press Gilead on potential Covid-19 drug (LiveMint)
• Italy, UK explore possible COVID-19 link to child inflammatory disease (Reuters 1, 2)
• In Race for a Coronavirus Vaccine, an Oxford Group Leaps Ahead (NYTimes) (Endpoints)
• Drugmakers race to scale up vaccine capacity (Financial Times)
• WHO warns on supply disruptions in coronavirus crisis, seeks more air capacity (Reuters)
• WTO Urges Members To Lift Trade Barriers On Virus Supplies (Law360)
• French scientists to test theory that nicotine combats COVID-19 (Reuters)
• Novartis sales, profits rise in first quarter on COVID-19 buying rush (Reuters)
• EC approves Shionogi's new antibiotic Fetcroja (PharmaTimes)

• US total death rate spiked above coronavirus death count in early weeks of pandemic: report (Washington Post)
• Trump hopes for 2 million tests per week by end of May — the low end of experts’ estimates of what’s needed to reopen (STAT)
• CVS, Walgreens ramp up COVID-19 testing capabilities (Reuters)
• Quest Diagnostics rolls out direct-to-consumer coronavirus antibody tests (CNBC)
• Abbott, DiaSorin coronavirus antibody tests get EUAs as lawmakers question others on market (MedtechDive)
• Pfizer restarts trial recruitment, speeds up antiviral work against COVID-19 (Fierce)
• U.S. coronavirus deaths projected at over 74,000 by August (Reuters)
• Novartis announces plan to initiate clinical trial of canakinumab for patients with COVID-19 pneumonia (Press)
• The world wants answers on Gilead’s Covid-19 drug. Experts worry next studies may increase uncertainty (STAT)
• Dr. Scott Gottlieb sees ‘some level’ of immunity for most people who had coronavirus (CNBC)
• US FDA says steps needed to stop people drinking hand sanitizer (Reuters)
• Banking on hope, swayed by hype? Hydroxychloroquine in the time of Covid-19 (Endpoints)
• Woodcock Warns Research Apparatus Could Be Overwhelmed If Coronavirus Trials Don’t Use Master Protocols (Pink Sheet)
• Anti IL-6 For Coronavirus Patients: Does It Work, or Not? (In The Pipeline)
• Russia overtakes China with coronavirus cases at 87,000 (Reuters)
• Faulty masks for pregnant women are latest problem for Japan's government (Reuters)
• UK on track for one of Europe's worst virus death tolls (Reuters)
• More than 2,200 Indonesians have died with coronavirus symptoms, data shows (Reuters)
• Germans urged to stay home as coronavirus infection rate edges back up (Reuters)
• Trump Disinfectant Remarks Echo Claims by Miracle-Cure Quacks (NYTimes)
• Coronavirus (COVID-19) Update: Daily Roundup April 27, 2020 (FDA)

• Vertex’s new cystic fibrosis drug needs to be far cheaper to be cost effective, analysis finds (STAT) (Endpoints)
• Weeks after FDA delay, Roche, PTC unveil another batch of positive risdiplam data in severe SMA patients (Endpoints)
• Roche Gives Update On Ocrevus Studies (Reuters) (Press)
• Portola Unruffled By NICE’s Rejection Of Ondexxya (Pink Sheet)
• NICE backtracks to approve Janssen's Stelara in ulcerative colitis (Pharmafile)
• It’s time to make ClinicalTrials.gov a better tool for patients. Here’s how (STAT)
• China has near-total control of the world’s antibiotic supply. Is America at risk as a result? (STAT)
• Astellas partners with Insilico, Harvard; Zambon gets FDA's fast track status for lung drug (Endpoints)
• Amid string of splashy pandemic IPOs, ADC returns for its millions (Endpoints)
• Exploring the US FDA's Upcoming Complex Generic Product-Specific Guidance Lists (Pink Sheet)
• Warning Letter - Health Solutions Pharmacy Center Inc dba Professional Compounding Pharmacy (FDA)
• Fresenius Kabi's Recall of Ketorolac Results In QuVa Pharma® Recall of Compounded Sterile Product (R.E.C.K.) (FDA)

• FDA says 18 deaths linked to intragastric weight loss balloons (MedtechDive) (FDA)
• 3M ticks up on Street-beating Q1 results (MassDevice)
• FDA Clears Cancer Genomic Profiling Kit From Personal Genome Diagnostics (Precision Oncology News)
• Cagent Vascular wins FDA clearance for balloon catheter (MassDevice)
• Class 1 Device Recall Langston Dual Lumen Catheter (FDA)

• FDA sets new date to talk future data strategy (MedtechDive)
• Amgen Sues Pfizer and Hospira for Patent Infringement related to Hospira’s Filgrastim Biosimilar (Big Molecule Watch)
• Fed. Circ. Bars Pfizer Appeal Over Roche Antibody Drug IP (Law360)
• Not So Smooth of a “Transition”: FDA Sued Over Deemed BLA Transitions – or Lack Thereof (FDA Law Blog)
• Judge Keeps EpiPen Expiration Date Suit Out Of MDL (Law360)
• Fed. Circ. Won't Revive Boston Scientific IP From Edwards IPR (Law360)
• Testing Laboratory Agrees to Pay Up to $43 Million to Resolve Allegations of Medically Unnecessary Tests (Department of Justice)
• Court Prohibits Dallas Wellness Center from Touting ‘Ozone Therapy’ as COVID-19 Treatment (Department of Justice)
• Additional safety protections relating to COVID-19 for faecal microbiota transplant (FMT) products (TGA)