Recon: FDA Clears Roche, NY State Coronavirus Tests for Emergency Use; Roche Bags EU Approval for CLL Combo

• Trump declares national emergency over coronavirus pandemic (NYTimes)
• The Trump administration announces steps to speed up testing. (NYTimes) (Reuters) (Politico)
• FDA works to speed coronavirus tests with Roche, New York approvals (Reuters) (WSJ) (Bloomberg) (FDA) (Press)
• 'It is a failing. Let's admit it,' Fauci says of coronavirus testing capacity (NBC)
• Trump set to meet with major lab company executives on coronavirus testing (Reuters)
• US health agency to fund two diagnostic tests for coronavirus (Reuters) (HHS) (Press)
• Despite entry of large private labs, coronavirus tests remain scarce in US (Reuters)
• Trump officials did sound the coronavirus alarm. They just don’t work there anymore. (Politico)
• Experimental Drug Helps Some Americans Ride Out Coronavirus, NIH Doctor Says (WSJ)
• New paper about Gilead drug to combat coronavirus has some analysts skittish (STAT)
• A quarantined Ted Cruz proposes to speed approvals for coronavirus drugs and vaccines (STAT)
• US communities must act 'proportionately' on coronavirus: Fauci (Reuters)
• Pelosi and Mnuchin closing in on a deal on coronavirus aid package (Politico) (Reuters)
• Senate will delay recess, work on coronavirus bill next week: McConnell (Reuters)
• What Happens When Coronavirus Hits Congress? (Politico)
• Novartis sidesteps Europe travel ban to provide CAR-T drug Kymriah to patients (Fierce)
• Two dead, four hospitalized after receiving OpenBiome stool transplants (STAT) (Endpoints)
• Eli Lilly, AbCellera Biologics to co-develop coronavirus therapies (Reuters) (Endpoints)
• What the Medicare insulin plan does (and doesn't do) to costs (Politico) (STAT)

• The World Has a Plan to Fight Coronavirus. Most Countries Are Not Using it. (NYTimes)
• WHO, UN Foundation and partners launch COVID-19 solidatiry response fund (WHO)
• As Virus Spreads, Drugmakers Are On the Case (WSJ)
• China sends medical supplies, experts to help Italy battle coronavirus (Reuters)
• Germany discussing its medical export restrictions with EU partners (Reuters)
• Canadian government to suspend Parliament (Politico)
• Canada's Trudeau to be in isolation after wife tests positive for coronavirus (Reuters)
• WHO officials rethink epidemic messaging amid pandemic debate (Reuters)
• Bavencio from Merck KGaA, Pfizer encounters yet another trial setback (Endpoints) (Press)
• EU grants approval for Venclyxto/Gazyvaro combo in CLL (PMLive)
• UK court bars Edwards TMVR sales, gives Abbott win in patent spat (MassDevice) (Law360-$)

• Anthony Fauci: Talking with patients about COVID-19 (NEJM)
• The Worst-Case Estimate for US Coronavirus Deaths (NYTimes)
• Why COVID-19 'death rates' are not what they seem (Reuters)
• Life upended for Americans as US scrambles to contain coronavirus threat (Reuters)
• How 4 Big States Are Preparing to Vote as the Coronavirus Spreads (NYTimes)
• Coronavirus hits politicians, sports and showbiz stars as it spreads across globe (Reuters)
• Coronavirus Is an Even Worse Threat to More Than Half of Americans (NYTimes)
• How one company made $208 million on an untested coronavirus vaccine (STAT)
• Spying on coronavirus: A little-known US intel outfit has its most important mission yet (NBC)
• Johns Hopkins develops its own coronavirus test (CBS)
• Pentagon developing tests to detect coronavirus faster (Financial Times)
• New York will begin its first ‘drive-through’ testing center for coronavirus in New Rochelle (CNBC)
• Cleaning product makers race to labs to bolster coronavirus claims (Reuters)
• Hospitals plan for 'COVID cabanas,' conference rooms to house patients (Reuters)
• The FDA Is Forcing the CDC to Waste Time Double Testing Some Coronavirus Cases (ProPublica)
• Brazilian Official Who Met Trump Last Weekend Tests Positive For Coronavirus (NPR)
• UK's Johnson to talk to world leaders on coronavirus response: spokesman (Reuters)
• Canada may soon advise against foreign travel - PM Trudeau (Reuters)
• China's coronavirus epicenter reports just five cases; Beijing tomb-sweepers urged to stay back (Reuters)
• Iran's coronavirus death toll 514 on over 1,000 new cases: state TV (Reuters)
• UK coronavirus cases rise 35% to 798 in a day (Reuters)
• Number of coronavirus cases in Ireland rises to 70 from 43 (Reuters)
• Dutch coronavirus infections rise by 190 to 804, deaths double to 10 (Reuters)
• Belarus has 27 cases of coronavirus: health ministry (Reuters)
• Spain's coronavirus tally jumps to 4,209 cases, 120 dead (Retuers)
• Indonesia's confirmed coronavirus cases more than double, to 69 (Reuters)
• Scottish coronavirus cases almost double to 60 in one day (Reuters)
• Coronavirus cases in Germany surge past 2,000: Koch Institute (Reuters)
• South Korea reports more recoveries than coronavirus cases for the first time (Reuters)
• Philippines confirms 12 new coronavirus cases (Reuters)
• Egypt reports 13 new coronavirus cases including one death (Reuters)
• Hong Kong records fourth coronavirus-related death - hospital spokeswoman (Reuters)
• Saudi Arabia detects 17 cases of coronavirus, brings total to 62: SPA (Reuters)
• Ethiopia confirms its first case of coronavirus (Reuters)
• Sudan reports first coronavirus case (Reuters)
• Coronavirus triggers sharp rise in price of pain relief medication (The Guardian)
• Tackling COVID-19: EFPIA welcomes proactive and regular dialogue with Commissioners on the supply of medicines (EFPIA)

• It May Not Be the Virus That Kills Me (WSJ)
• The E100 biotech survey: Execs are hunkering down for the pandemic, worried about longterm fallout — but eager to see biopharma make a difference (Endpoints)
• Top companies and drugs by sales in 2019 (Nature)
• Mending the broken social contract for pharmaceutical pricing and innovation (STAT)
• Comment Period Extended: Drug Products Labeled as Homeopathic; Draft Guidance (FDA)
• Biogen signs on to manufacture clinical supplies for Vir's COVID-19 antibodies (Fierce)
• Running Your Pharma Company Out Of A Starbucks: Drug Discovery Moves To The Cloud (Forbes)
• Partnered with Gilead and Sanofi, protein degradation specialist Nurix bags $120M to chart its own clinical path (Endpoints)
• One-time biotech unicorn Rubius gets slaughtered as lead program is scrapped, highlighting lingering trouble (Endpoints) (Fierce)
• Aldeyra halts trials, focuses on ocular assets to stretch runway (Fierce)
• US FDA details problems that led to Biocon’s Form 483 (InPharmaTechnologist)
• Long-term cancer survival rates improve among US teens, young adults (Reuters)
• CureVac founder back at the helm; Merck extends immunomodulatory drug discovery program with Sutro (Endpoints)
• Prescription unfilled? These 30 drugs are in short supply in the US right now (USA Today)
• J&J says demand for consumer products higher due to coronavirus (Reuters)
• Biological Product Deviation Reporting for Blood and Plasma Establishments; Guidance for Industry; Availability (FDA)

• Potential universal flu vaccine shows efficacy in clinical trial (PMLive)
• FDA green lights study of phage-based drug for resistant infections (PMLive) (Press)
• Five Prime Therapeutics Announces Publication of the Phase 1 Bemarituzumab Study in the Journal of Clinical Oncology (Press)
• Sensorion provides update on SENS-401 SSNHL Phase 2 AUDIBLE-S trial enrollment (Press)
• PharmaCyte Biotech Addresses Submission of IND and Recent FDA-Required Testing (Press)

• TransMedics to get FDA expert review for heart transplant device PMA (MedtechDive)
• Philips touts new cybersecurity testing certification (MassDevice)
• J&J’s Janssen, Thermo Fisher Scientific to collaborate on oncology diagnostic (MassDevice)
• DePuy Synthes wins CE Mark for hip replacement dual mobility system (MassDevice)
• TransEnterix Receives FDA Clearance for First Machine Vision System in Robotic Surgery (Press)
• OSSIO Receives FDA 510(k) Clearance for OSSIOfiber® Hammertoe Fixation System (Press)

• Explainer: What happens if Trump declares coronavirus an emergency? (Reuters)
• Mylan and Partner Biocon Win on Insulin Ruling (Big Molecule Watch)
• Ohio Gov., AG Unveil Opioid Settlement Framework (Law360-$)
• Gadolinium Plaintiff Runs Into Preemption Wall in Louisiana (Drug & Device Law)
• CBD Gets the Slow-Walk (FDA Law Blog)

• Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting – 8 May 2020

• UK: NICE Wins Argument Over Appraisal Of BioMarin Rare Disease Drug (Pink Sheet-$)
• UK Experimental AMR Payment Program “On Track” (Scrip-$)

• Cardinal Health settles China bribery case for $8.8 million (MassDevice)

• National Pharmaceutical Pricing Authority seeks drug stock, pricing data (Economic Times)
• Pharma department tells companies to step up manufacture of anti-HIV drugs (Economic Times)
• Covid-19: China stalls supplies, India faces anti-retroviral shortage (Economic Times)
• NPPA asks state regulators to ensure masks, sanitisers not sold above MRP (Economic Times)
• CDSCO declares 38 samples as NSQ and 1,233 samples as SQ in random sampling for February 2020 (Pharmabiz)

• Court proceedings commenced against Evolution Supplements Australia and its sole director for alleged advertising breaches (TGA)
• Consider the whole picture when testing troponin levels (TGA)
• Planning vital when using patient handling slings (TGA)
• Surgical staplers: TGA reviews device incident reports (TGA)
• Updated cleaning instructions for long-term nasogastric tubes (TGA)
• 2020 seasonal influenza vaccines (TGA)

• High Blood Pressure in Young Adulthood May Be Bad for Your Brain (NYTimes)
• Freedom, Measles, and Freedom from Measles (NEJM)