Recon: House Passes $2T Stimulus, Heads to Trump for Signature; Vertex Joins List of Drugmakers Halting New Studies

• House passes historic $2 trillion stimulus despite objections from GOP lawmaker (CNN) (WSJ)
• Irate House lawmakers scramble back to DC amid fears of coronavirus vote delay (Politico) (Reuters)
• The US Now Leads the World in Confirmed Coronavirus Cases (NYTimes)
• After Considering $1 Billion Price Tag for Ventilators, White House Has Second Thoughts (NYTimes)
• Could Obamacare save jobless Americans from coronavirus? (Politico)
• Internal Emails Show How Chaos at the CDC Slowed the Early Response to Coronavirus (ProPublica)
• Trump allies fear a premature victory lap against coronavirus (Politico)
• Orphan status for coronavirus drug caught health officials off guard (Axios)
• Sanofi, Translate Bio to work on COVID-19 vaccine (Reuters) (Endpoints) (Press)
• A Spur to the Biotech Century Ahead (WSJ)
• Ex-FDA commissioner says US coronavirus epidemic likely to be national (The Hill)
• FDA moots virtual AdComms but delays GSK, Intercept meetings (Fierce)
• Despite another delay, Intercept says its NASH drug remains on track (BioPharmaDive) (Fierce)
• Drugmaker Vertex to delay new clinical studies due to coronavirus (Reuters) (Endpoints)
• US government has 1.5 million expired N95 masks sitting in an Indiana warehouse (Washington Post)

• Study sees 'severe and acute' emergency for world in coronavirus pandemic (Reuters)
• Mapping the Coronavirus (Bloomberg)
• WHO chief urges G20 to boost production of protective gear against virus (Reuters)
• Italy’s coronavirus death toll tops 8,000 as EU leaders fail to present new stimulus (CNBC)
• COVID-19: Parliament approves crucial EU support measures (European Parliament)
• Italy suffers setback to hopes its coronavirus epidemic might be in retreat (Reuters)
• Roche urged to share info with Dutch corona test labs: FTM (DutchNews)
• Patents on new products could result in high prices and keep medicines and vaccines out of reach for people everywhere (MSF)
• South Korean test kit makers swamped as coronavirus cases explode in US, Europe (Reuters)
• A Singapore VC raises $200M for a new round, but will Covid-19 prevent it from raising the rest? (Endpoints)
• UK pledges 210 million pounds to global push for coronavirus vaccine (Reuters) (Fierce)
• Roche strikes a deal with Britain to increase coronavirus testing: Channel 4 news (Reuters)
• With U.S. hit by virus, China courts Latin America with medical diplomacy (Reuters)
• China to suspend entry of foreigners with visas, residence permits due to coronavirus (Reuters 1, 2)
• Email mix-up causes Britain to miss EU ventilator buying scheme (Reuters 1, 2)
• Boris Johnson, U.K. Prime Minister, Tests Positive for Coronavirus (NYTimes)

• 'It’s a razor’s edge we’re walking': inside the race to develop a coronavirus vaccine (The Guardian)
• Italian scientists investigate possible earlier emergence of coronavirus (Reuters)
• Mystery In Wuhan: Recovered Coronavirus Patients Test Negative ... Then Positive (NPR)
• Coronavirus Pandemic Delays Testing of New Drugs (WSJ)
• Known Drugs Against the Coronovirus: Runner-Up Candidates (In the Pipeline)
• Emory-discovered antiviral is poised for COVID-19 clinical trials (C&EN)
• A.I. Versus the Coronavirus (NYTimes)
• ‘Drug development is a long, long process’: pharma CEO in Italy sounds a note of caution on Covid-19 (STAT)
• AGs Ask Feds To Allow Fetal Tissue Research For COVID-19 (Law360)
• The Drug Trials of the Century (WSJ)
• In Defense Of Coronavirus Testing Strategy, Administration Cited Retracted Study (NPR)
• How Monoclonal Antibodies Might Prove Useful Against The Coronavirus (NPR)
• How many Americans have coronavirus? New Reuters poll might offer a hint (Reuters)
• The next frontier in coronavirus testing: Identifying the full scope of the pandemic, not just individual infections (STAT)
• Blood Plasma From Survivors Will Be Given to Coronavirus Patients (NYTimes)
• New Orleans Faces a Virus Nightmare, and Mardi Gras May Be Why (NYTimes)
• Trump downplays need for ventilators as New York begs to differ (Politico)
• ‘The Other Option Is Death’: New York Starts Sharing of Ventilators (NYTimes)
• Not So Fast Using CPAPs In Place Of Ventilators. They Could Spread The Coronavirus. (KHN)
• Coronavirus could kill 81,000 in U.S., subside in June - Washington University analysis (Reuters)
• Significance of Pangolin Viruses in Human Pandemic Remains Murky (NYTimes)
• Trump says he will not cancel August Republican Convention (Reuters)
• What if hydroxychloroquine doesn’t work? What if it does? Right now, we don’t know (STAT)
• Prisma Health develops FDA-authorized 3D-printed device that lets a single ventilator treat four patients (TechCrunch)
• Congress pumps up NSF program to fast-track COVID-19 research (Science)
• Summary of FDA & EMA Global Regulators Meeting on Data Requirements Supporting First-in-Human Clinical Trials with SARS-CoV-2 Vaccines (FDA)
• Coronavirus (COVID-19) Update: Daily Roundup March 26, 2020 (FDA)
• Investigational COVID-19 Convalescent Plasma - Emergency INDs Frequently Asked Questions (FDA)
• Turkey struggles to ramp up tests as outbreak reaches critical phase (Reuters)
• Paris hospitals near coronavirus breaking point (Reuters)
• Chinese firm to replace exported coronavirus test kits deemed defective by Spain (Reuters)
• Spain reports 769 new coronavirus deaths but says daily rise stabilizing (Reuters)
• Iran's death toll from coronavirus rises to 2,378: Health Ministry (Reuters)
• Fresh From Iran’s Coronavirus Zone, Now Moving Across Afghanistan (NYTimes)
• Japan PM says lockdown of Tokyo would have severe impact on economy (Reuters)
• Russian PM urges all citizens to stay at home, calls for tougher measures: Interfax (Reuters)
• Russia says coronavirus cases surpass 1,000 in biggest daily rise (Reuters)
• Number of coronavirus cases in Germany rises to 42,288: RKI (Reuters)
• Germany takes in 47 coronavirus patients from Italy (Reuters)
• Germany looks at tracking patients to rein in coronavirus – reports (Reuters)
• UK to use firefighters to deliver food, collect bodies in coronavirus crisis (Reuters)

• Strategic Planning In Biotech During A Pandemic Crisis (LifeSciVC)
• Biotech in the time of the coronavirus: With China returning to work, preclinical companies ramping back up (STAT)
• Biotech’s balancing act amid Covid-19 delays (Evaluate)
• Allergenic Products Advisory Committee; Cancellation of Meeting - DBV Technologies (FDA)
• Could real-world evidence help shape the future of drug development? (STAT)
• After 'initial shock,' generics supply chain likely to weather COVID-19 blows: analyst (Fierce)
• Should Biogen's Spinraza for SMA be delayed amid COVID-19? No, say these parents (Fierce)
• Bluebird bio pushes back commercial launch of Zynteglo due to COVID-19 (PMLive)
• Struggling Unum execs are ready to consider a sale, merger or any deal that comes its way (Endpoints)
• Scientific Wave Pushes CBER Into Brighter Light (Pink Sheet-$)
• As share buybacks come under scrutiny, what's in store for the biopharma industry? (Endpoints)
• Jim Robinson takes over the reins at Urovant; Carlos Campoy moves to CytomX (Endpoints)
• VBL and its “gene therapy” cancer treatment are back — with a peek at PhIII potential (Endpoints)
• Call for Submissions: Journal of Law and Biosciences, “Law and Ethics in the Time of a Global Pandemic” (Harvard Bill of Health)
• Dr. Reddy's Laboratories Issues Voluntary Nationwide Recall of Phytonadione Injectable Emulsion USP, 10 mg/mL Single-Dose Ampules Due To Ampules Breaking And Shattering Upon Opening (FDA)

• FDA Accepts Genentech’s New Drug Application for Xofluza for the Treatment of Influenza in Children (Press)
• CStone submits new drug application for the targeted therapy avapritinib in Taiwan for the treatment of adults with advanced PDGFRA exon 18 mutant gastrointestinal stromal tumor (Press)

• Modifications to the List of Recognized Standards (FDA)
• What Device Manufacturers Need to Know at This Time about FDA’s Exercise of Emergency Authority in Response to COVID 19 (FDA Law Blog)
• In Pre-Cert 1st, FDA clears app-based treatment for chronic insomnia (MedtechDive)
• Small PAMA victory in aid package, but labs remain in 'untenable situation' (MedtechDive)
• UnitedHealth says self-swabbing study spurred FDA coronavirus policy change (MedtechDive)
• Continuing to make progress on human factors work during the COVID-19 pandemic (Emergo)

• Inside The COVID-19 Bill: Breaking Down The Pharma Policy Provisions (Pink Sheet-$)
• Drug Industry Perks Mostly Dropped From COVID-19 Bill, But A Big One Remains (Pink Sheet-$)
• Senate stimulus plan includes $155 million for HIV care (NBC)
• Genentech Says It Shouldn't Lose Patent Rights Over Error (Law360-$)
• Ariad Exec's Spouse Can't Shake Insider Trading Conviction (Law360-$)
• Abbott Wins Test Strip Suit After Supplier's Discovery Fraud (Law360-$)
• Guest Post – Is Artificial Intelligence a “Product”? The Third Circuit Says, “No.” (Drug & Device Law)
• Impact of COVID-19 Pandemic on Patent Offices and Federal Courts -- March 26 UPDATE (Patent Docs)
• Grantee Institutions' Actions To Strengthen Policies in Response to Concerns Regarding Potential Foreign Influence on NIH-Funded Research (HHS OIG)

• Antitrust: Joint statement by the European Competition Network (ECN) on application of competition law during the Corona crisis (ECN)
• UK Court Ruling Ends Novartis/Bayer Crusade Against Avastin In AMD (Pink Sheet-$)
• EMA accepts Arvelle’s cenobamate MAA (PharmaTimes)
• Thermo Fisher Scientific COVID-19 Test Receives CE Mark, Expanded FDA EUA (GenomeWeb)

• Alvotech Enters Partnership for Commercializing Adalimumab Biosimilar in Asia-Pacific Markets (Big Molecule Watch)
• Fosun Long March Gets Chinese Regulatory Approval for Coronavirus MDx Kit (GenomeWeb)

• DGFT allows export of 13 restricted APIs & their formulations under advance licences (PharmaBiz)
• COVID-19: NPPA asks states, UTs to ensure unobstructed movement of stock, manpower (Economic Times)
• Lockdown will soon hit medicine supplies in the country: Chemists and Druggists lobby (Economic Times)
• COVID-19 lockdown: Health Ministry allows doorstep delivery of essential medicines (Economic Times)

• Summary: Guidance Document - Administrative Processing of Submissions and Applications Involving Human or Disinfectant Drugs (Health Canada)

• Physical samples for batch release not required: a reminder for sponsors of biosimilars and biological medicines (TGA)
• Appropriate use of disinfectants: Information for consumers, health professionals and healthcare facilities (TGA)
• Regulation of cleaners and disinfectants: Information for sponsors and manufacturers (TGA)
• COVID-19 testing in Australia - information for health professionals (TGA)
• Oxymed Australia Pty Ltd fined $63,000 for alleged advertising breaches (TGA)

• Israel's Generic COVID-19 Drug Licensing Lacks Due Process (Law360)