Recon: Trump Signs $8.3B Coronavirus Response Package; AstraZeneca Imfinzi Combo Misses Main Goal in Bladder Cancer Trial

• Trump signs $8.3 billion spending bill to boost coronavirus response (Reuters) (Axios)
• How the drug industry got its way on the coronavirus (Politico)
• Coronavirus epidemic forces cancellation of HIMSS health tech conference (STAT)
• LabCorp makes coronavirus test available for ordering in US (Reuters)
• Pfizer weighs working with BioNTech on potential coronavirus vaccine: R&D head (Reuters)
• Celltrion Prevails Over Janssen in Infliximab Biosimilar Appeal (Big Molecule Watch)
• Feds Say Spine Device Firm Ran $8M Kickback Scam (Law360-$) (DoJ)
• Five years on, biosimilars need support from all health care players (STAT) (BioWorld)
• Demand for Face Masks Is Booming, But Makers Have a Nagging Concern: Legal Liability (WSJ)

• Coronavirus infections rise above 100,000 worldwide as outbreak wreaks financial havoc (Reuters)
• The Search for New Drugs for Coronavirus Faces Long Odds (Bloomberg)
• EU fails to persuade France, Germany to lift coronavirus health gear controls (Reuters)
• EU looks to produce more drugs, protective gear as coronavirus strains supplies (Reuters)
• EU eyes moves on state subsidy rules to support virus-hit economy (Reuters)
• Stark COVID-19 Drug Shortages Warning From Senior EU Regulator (Pink Sheet-$)
• AstraZeneca's combo cancer treatment fails to meet late-stage study goal (Reuters) (Endpoints)
• Roche Trial of Ionis Huntington’s Disease Drug Halted After Side Effects (Xconomy) (Endpoints)
• Across Asia, countries race to boost face mask supplies (Reuters)
• NICE pushes Doptelet for pre-surgery liver disease treatment (PharmaTimes)
• Shionogi boosts Tetra Alzheimer's deal, nabs buyout option (Fierce) (Endpoints) (Press)

• US labs await virus-testing kits promised by administration (AP)
• Exclusive: The Strongest Evidence Yet That America Is Botching Coronavirus Testing (The Atlantic)
• Trump defends HHS Secretary Alex Azar amid criticism over his response to coronavirus outbreak (CNBC)
• Susan Desmond-Hellmann: The coronavirus is alarming. Here’s why you should not panic (STAT)
• Covid-19 Small Molecule Therapies Reviewed (In The Pipeline)
• With Coronavirus Lurking, Conferences Wrestle With Whether To Cancel (KHN)
• China's Hubei reports no new coronavirus cases outside city of Wuhan (Reuters)
• Harris County, Texas, confirms first two cases of coronavirus (Reuters)
• Three coronavirus cases confirmed in Maryland: governor (Reuters) (Politico)
• Brazil confirms eighth coronavirus case as it spreads across country (Reuters)
• Germany reports 134 new coronavirus cases - Robert Koch Institute (Reuters)
• Dutch coronavirus toll rises to 128 cases, one fatality - health authorities (Reuters)
• Iran says virus death toll jumps by 17 with 1,000-plus new infections (Reuters)
• Total UK coronavirus cases reach 163 (Reuters)
• France reports two more coronavirus deaths, taking total to nine (Reuters)
• South Korea suspends visas for Japanese in tit-for-tat coronavirus curbs (Reuters)
• Coronavirus cases rise to 45 in Greece after group trip to Israel, Egypt (Reuters)
• Bhutan bars tourists after first coronavirus case, India total hits 31 (Reuters)
• Indonesia confirms two more coronavirus cases, total four (Reuters)
• Russia reports six new cases of coronavirus – Ifax (Reuters)
• Malaysia's health ministry confirms 28 new coronavirus infections (Reuters)
• Slovakia reports first case of coronavirus - prime minister (Reuters)
• Vatican reports first case of coronavirus inside its walls (Reuters)
• Peru records first confirmed case of coronavirus, President Vizcarra says (Reuters)
• Togo confirms first case of coronavirus (Reuters)
• Singapore reports 13 new coronavirus cases including Singapore Airlines crew (Reuters)
• Twelve coronavirus cases on Egypt cruise ship are all asymptomatic: WHO, health ministry (Reuters)
• Cruise ship passengers 'in limbo' off San Francisco awaiting coronavirus tests (Reuters)
• With $115 million, more than 80 Boston researchers will collaborate to tackle COVID-19 (Science Mag)
• Big Pharma grounds employees: GSK, Bristol, Roche, Sanofi and more limit travel due to coronavirus (Fierce)
• Biogen cracks down on travel after 3 execs test positive for coronavirus (Fierce)

• Gene and cell therapies continue growth in patients, financing, and costs (STAT)
• Orphan drugs face “uphill battle” in 2020 (PharmaTimes)
• FDA approves Allergan’s biodegradable glaucoma implant drug (PMLive) (Press)
• New drugs aim to disarm the immune system’s ‘atomic bomb’ cells (Science Mag)
• Real-World Empagliflozin Data Support Key Trial Findings (NEJM)
• FDA Readies ICH Q12 Implementation Guidance, Learns Lessons From Pilot (Pink Sheet-$)
• Merck KGaA's Mavenclad stakes its claim in massively competitive MS market (Fierce)
• Abraxane developer Iglesias joins Senti Biosciences; AB2Bio recruits CEO (Endpoints)
• Biosimilar Developers Comment on Regulatory Delays (Big Molecule Watch)
• Revance, Mylan Provide Updates on BOTOX Biosimilar Collaboration (Big Molecule Watch)
• Insights into Prescription Decision Support Through the Patient Journey (Drug Channels)
• Taro Pharmaceuticals U.S.A. Issues Voluntary Nationwide Recall of Phenytoin Oral Suspension Usp, 125 Mg/5 Ml due to Possible Underdosing or Overdosing (FDA)
• Hikma Pharmaceuticals USA Inc. Extends Voluntary Nationwide Recall of Ketorolac Tromethamine Injection, USP 30mg/mL, 1mL Fill/2mL Vials Due to the Potential Presence of Small Particulates (FDA)

• FDA sets Dec. PDUFA date for Urovant rival to Astellas drug (Fierce) (Press)
• Trevena gets second go at FDA approval for pain drug (PMLive) (Endpoints)
• Long-Acting Cabotegravir and Rilpivirine for Maintenance of HIV-1 Suppression (NEJM)
• Terns Pharmaceuticals to Present Data from an Ongoing Phase 1 Clinical Trial of TERN-201, a SSAO Inhibitor in Development for NASH (Press)

• Becton Dickinson (BD) CareFusion 303 Inc. Recalls Alaris System Infusion Pumps Due to Software and System Errors (FDA)
• FDA Defends Actions Against PGx Testing Labs As Necessary to Protect Public Health (GenomeWeb)
• Cardiologist groups back Abbott push to change heart device coverage (MedtechDive)
• Aerin Medical wins FDA clearance for nonsurgical chronic rhinitis procedure (MassDevice)
• V-Wave lands CE Mark for heart-failure device (MassDevice)
• CryoLife wins CE mark for E-vite Open NEO stent graft system (MassDevice)
• Abbott wins CE Mark for FlexNav delivery system (MassDevice)
• Alphatec posts wider-than-forecast losses in Q4 results (MassDevice)
• Reflow Medical Announces 510(k) Clearance for an Expanded Indication for the Wingman Catheter to Cross Chronic Total Occlusions (CTOs) in Peripheral Artery Disease (Press)

• Congress asked the FDA to explain its rules on CBD — but its new report offers little clarity (STAT) (FDA)
• Amgen likely to win Enbrel patent appeal, but Novartis scored some points: analyst (Fierce)
• Purdue Wants Ch. 11 To Hold Opioid Cases At Bay Longer (Law360-$)
• Insys Execs Can't Delay Prison In Opioid Kickback Case (Law360-$)
• Utah Decision On SOL in Med Mal Cases Touches On Recurring Issues (Drug & Device Law)

• FDA Advisory Committee Calendar
• United States Food and Drug Administration and Health Canada Joint Regional Consultation on the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use – 23-27 May 2020
• Multi-stakeholder workshop to support implementation of the Medical Devices Regulation on drug-device combinations – 31 March 2020

• Regulatory information – adjusted fees for applications to EMA from 1 April 2020 (EMA)
• Postponed: Joint European Medicines Agency (EMA) / European Organisation for Research and Treatment of Cancer (EORTC) workshop on novel patient-reported outcomes (PRO) and quality of life (QoL) approaches in cancer clinical research (EMA)
• EU Approval Decision Delay For BMS’s Ozanimod (Pink Sheet-$)
• European regulators expand use of AbbVie's two-month hep C regimen (Endpoints)

• Coronavirus kits to be sold only on doctors' prescription: Maharashtra FDA (Economic Times)

• PAHO/WHO and Mexico strengthen laboratory capacity to detect yellow fever in the Americas (PAHO)
• Industry Slams Brazilian Plans To Change Importation Rules (Pink Sheet-$)

• Moderate Drinking Tied to Lower Levels of Alzheimer’s Brain Protein (NYTimes)