Recon: FDA Approves AZ’s Imfinzi for Untreated Small-Cell Lung Cancer; Merck, Bayer Drug Shows Promise in Heart Failure

• Trump backs off plan to reopen businesses by mid-April amid coronavirus warnings (Reuters)
• US health experts pushed strongly for Trump to extend coronavirus restrictions: Fauci (Reuters)
• Dr. Birx predicts up to 200,000 US coronavirus deaths 'if we do things almost perfectly' (NBC)
• Lawmakers’ coronavirus response means delays for drug pricing legislation (STAT)
• Johnson & Johnson says testing of coronavirus vaccine to begin by September (Reuters 1, 2)
• Sanofi, Regeneron expand testing of potential coronavirus treatment (Reuters) (Endpoints)
• AstraZeneca's Imfinzi gets FDA nod to target small-cell lung cancer (Reuters) (Endpoints) (Press)
• Inside GM’s Race to Build Ventilators, Before Trump’s Attack (NYTimes) (Reuters)
• Abbott wins US approval for test that can detect coronavirus in minutes (Reuters) (Bloomberg)
• White House Airlifts Medical Supplies From China in Coronavirus Fight (NYTimes)
• Medtronic Publishes Design Specs for Ventilator to Combat Coronavirus (WSJ)
• National coronavirus response: A road map to reopening (AEI)
• Coronavirus May Add Billions to the Nation’s Health Care Bill (NYTimes)

• WHO officials enroll first patients from Norway and Spain in ‘historic’ coronavirus drug trial (CNBC)
• WHO says early data shows some drugs ‘may have an impact’ on coronavirus, but more research is needed (CNBC)
• Pressure mounts to widen access to medical products that may combat Covid-19 (STAT)
• Roche backpedals and agrees to provide a solution for Covid-19 tests in the Netherlands (STAT)
• UK cannot confirm when coronavirus antibody test will arrive (Reuters)
• AstraZeneca scores win as diabetes drug shown to slow kidney disease (Reuters) (Endpoints) (Press)
• New drug from Merck, Bayer reduces hospitalizations for heart failure patients (STAT) (Endpoints)
• Lundbeck drops Parkinson’s drug acquired in €905m deal (PMLive) (Endpoints)
• 'Just one case': fears coronavirus may spread like wildfire in world's refugee camps (Reuters)
• China will step up prevention and control of asymptomatic coronavirus cases (Reuters)
• China Created a Fail-Safe System to Track Contagions. It Failed. (NYTimes)
• Taiwan says WHO not sharing coronavirus information it provides, pressing complaints (Reuters)

• The Lost Month: How a Failure to Test Blinded the U.S. to Covid-19 (NYTimes)
• ‘Red Dawn Breaking Bad’: Officials Warned About Safety Gear Shortfall Early On, Emails Show (KHN)
• Century-Old Vaccine Investigated as a Weapon Against Coronavirus (Bloomberg)
• Confirmed Coronavirus Cases Is an ‘Almost Meaningless’ Metric (Bloomberg)
• Why the US doesn't have more hospital beds (Axios)
• WHO Reviews 'Current' Evidence On Coronavirus Transmission Through Air (NPR) (WHO)
• CDC warns residents of New York, New Jersey, Connecticut against non-essential travel (Reuters)
• FDA fast tracking makes Houston Methodist first hospital to treat COVID-19 with recovered patient’s blood (Houston Chronicle)
• ‘A Heart-Wrenching Thing’: Hospital Bans on Visits Devastate Families (NYTimes)
• 'No farewells, no ceremonies': China's Hubei cremates coronavirus dead (Reuters)
• New Orleans doctors scramble as coronavirus deaths, cases soar (Reuters)
• It’s past time to fully deploy the US Public Health Service Commissioned Corps to fight Covid-19 (STAT)
• Healthcare group Novacyt steps up progress on coronavirus test product (Reuters)
• UK trials new breathing aid developed by Mercedes Formula One (Reuters)
• Britain orders 10,000 ventilators from F1, aerospace consortium (Reuters)
• Biotech VC Bob Nelsen called it right on the coronavirus. Now he has thoughts on therapeutics — and masks (STAT)
• CRISPR pioneer Doudna opens lab to run Covid-19 tests (STAT)
• India says no plan to extend coronavirus lockdown as poor struggle (Reuters)
• Japan to ban U.S., China, Europe travelers as coronavirus spread stokes Tokyo lockdown fears (Reuters)
• Italy coronavirus deaths rise by 756, lifting total death toll to 10,779 (Reuters)
• Russia weighs nationwide coronavirus lockdown after Moscow acts (Reuters)
• Iran plans tougher restrictions as coronavirus toll rises (Reuters)
• Coronavirus deaths fall again in Italy but lockdown extension looms (Reuters)
• China defends against incoming second wave of coronavirus (Reuters)
• Mexico asks residents to stay home for a month to slow coronavirus as cases rise (Reuters)
• Mexico's confirms 145 new coronavirus cases, four new deaths (Reuters)
• Number of coronavirus cases in Germany rises to 57,298: RKI (Reuters)
• Face mask rule could help when unwinding lockdown: German health ministry (Reuters)
• Special Report: Five days of worship that set a virus time bomb in France (Reuters)
• Spain's coronavirus cases rise to 85,195, surpass China's (Reuters)
• Nearly 12,300 Spanish health workers have coronavirus (Reuters)
• Airbus plane delivers face masks from China to coronavirus-hit Spain (Reuters)
• South Korea to impose mandatory coronavirus quarantine on all arrivals (Reuters)
• Vietnam PM asks major cities to prepare for lockdown to stop virus (Reuters)
• Vietnam asks mask firms to increase production to five million a day (Reuters)
• Shielding the Fetus From the Coronavirus (NYTimes)

• FDA on Signing of the COVID-19 Emergency Relief Bill, Including Landmark Over-the-Counter Drug Reform and User Fee Legislation (FDA)
• 5 FDA approval decisions to watch in the 2nd quarter (BioPharmaDive)
• Pharma’s Future Blockbusters Laid Up With Coronavirus (WSJ)
• Daily Aspirin Does Not Lower Alzheimer’s Risk (NYTimes)
• New dashboard tracks top COVID-19 content among life sciences companies, influencers and media (Fierce)
• Janssen's experience illustrates the COVID-19 logistics maze drugmakers must solve: report (Fierce)
• Fujifilm ramps up production of flu drug Avigan as possible COVID-19 treatment (Fierce)
• US FDA Commissioner Hahn’s Star Turn: Baptism By Fire Turns Perilous (Pink Sheet-$)
• US FDA Not Changing Assessment Goals Because of Coronavirus-Mandated Telework (Pink Sheet-$)
• Macrophages get a CAR (Nature)
• AC Immune bets that its Alzheimer’s trial design could provide a cleaner test of the amyloid hypothesis (STAT)
• ACC: New owner Novartis presents pooled inclisiran data cutting LDL cholesterol by half (Fierce)
• COVID-19 causes Moderna to pause a clutch of clinical trials (Fierce)
• The Balancing Act: Taking A Systematic Approach To Hard Decisions In Times Of Rapid Change (LifeSciVC)
• Biotech in the time of the coronavirus: With China returning to work, preclinical companies ramping back up (STAT)
• Newly-public Immunovant announces first proof-of-concept success (Endpoints)
• Aveo gives up on ficlatuzumab in acute myeloid leukemia, citing COVID-19 (Fierce) (Press)
• AstraZeneca expands deal with ImaginAb; Ovid posts promising data on Takeda-partnered seizure drug (Endpoints)
• David Hallal bags another whopper round, looking to recruit more cell and gene therapy upstarts to ElevateBio BaseCamp (Endpoints)
• NIH-funded studies show stents and surgery no better than medication, lifestyle changes at reducing cardiac events (NIH)

• Axsome reports late-stage depression trial defeat, shares wilt (Endpoints)
• Intensity Therapeutics Reports Safety Results from First Cohort of the KEYNOTE A10 Combination Clinical Trial of INT230-6 and Keytruda® (Press)
• BRILINTA reduced bleeding vs dual therapy in high-risk coronary patients in sub-analyses from Phase IV TWILIGHT trial (Press)
• ACC: Amgen's Repatha cuts cholesterol in rarely studied HIV patients (Fierce) (Press)
• ACC: Esperion's Nexletol busts cholesterol levels regardless of statin, ezitimibe therapy (Fierce) (Press)
• Landmark Phase 3 VOYAGER PAD Study of XARELTO® (rivaroxaban) Plus Aspirin Shows Significant Benefit in Patients with Symptomatic Peripheral Artery Disease (PAD) after Lower-Extremity Revascularization (Press)
• Seres Therapeutics Announces Completion of Enrollment in SER-109 Phase 3 ECOSPOR III Study for Recurrent Clostridium difficile Infection and Provides Clinical Pipeline Updates (Press)
• Can-Fite Implements Interim Analysis for its Phase III Psoriasis Trial with Data Expected Q4 2020 (Press)
• Ryvu Therapeutics Receives Orphan Drug Designation From FDA for SEL120 to Treat Acute Myeloid Leukemia (Press)

• Digital health advice from FDA amid coronavirus leaves more questions than answers (MedtechDive)
• Medical Device Entrepreneur Designs Emergency Ventilator, At $10,000 Price Point, To Battle Coronavirus (Forbes)
• Virtual Town Hall Series - Immediately in Effect Guidance on Coronavirus (COVID-19) Diagnostic Tests – 1 April 2020 (FDA)
• South Korean coronavirus test kit makers win U.S. FDA pre-approval (Reuters)
• FDA Approves Next-Generation ZOLL® TherOx System for Widowmaker Heart Attack Patients (Press)

• Federal Circuit Issues Two Rulings in Biosimilar-Related IPR Appeals (Big Molecule Watch)
• Insurers Tell Justices Fed. Circ. Rule Will Keep Drug Prices Up (Law360-$)
• Intercept Beats Investor Suit Over Liver Disease Drug Deaths (Law360-$)
• Pfizer Wins Delay For Expert Busy On Coronavirus Task Force (Law360-$)
• State Regulators Issue Pharmacy Law Waivers in COVID-19 Response (FDA Law Blog)
• Straightforward Statutory Abrogation Of Certain Pelvic Mesh Claims (Drug & Device Law)
• Galderma Laboratories, L.P. v. Amneal Pharmaceuticals LLC (Fed. Cir. 2020) (Patent Docs)
• Impact of COVID-19 Pandemic on Patent Offices and Federal Courts -- March 29 UPDATE (Patent Docs)

• England's NICE To Focus On COVID-19 And Other Critical Therapies (Pink Sheet-$)
• A Look At The New Leadership Team At NICE (Pink Sheet-$)
• EMA accepts Arvelle’s cenobamate MAA (PharmaTimes)
• Coronavirus (COVID-19) and high blood pressure medication (MHRA)
• Specification for Rapidly Manufactured CPAP System to be used during the coronavirus (COVID-19) outbreak (MHRA)

• NPPA fixes retail prices of 869 formulations & coronary stents under DPCO 2013 based on price revision as per annual WPI (Pharmabiz)
• USP collaborates with Gujarat FDCA to adopt best practices on regulatory compliances and drug standards (Pharmabiz)
• Sun: Update on Halol facility (Press)

• Summary: Guidance Document - Drug Identification Numbers for Schedule C Drugs (Radiopharmaceuticals and Kits) (Health Canada)