Recon: Moderna Says COVID-19 Vaccine may Reach Health Care Workers by Fall; BMS Puts New Trials on Hold

• US has potential of becoming coronavirus epicenter, says WHO (Reuters)
• Trump and FEMA chief contradict each other on Defense Production Act (CNN)
• Trump will use Defense Production Act to secure thousands of test kits (Politico)
• Mnuchin hopes deal is 'very close' on $2-trillion coronavirus aid package in US Senate (Reuters)
• Pelosi: "Real optimism" for coronavirus stimulus deal "in the next few hours" (Axios)
• $500 billion corporate relief program will include inspector general, oversight board (The Hill)
• Moderna’s Covid-19 Vaccine May Reach Some by as Soon as Fall (Bloomberg)
• Two large US private labs say they could soon process 300,000 coronavirus tests per week (CNBC)
• Germany's Qiagen starts shipping coronavirus diagnostic tests to United States (Reuters)
• When might experimental drugs to treat Covid-19 be ready? A forecast (STAT)
• Bristol Myers puts new clinical trials on hold due to coronavirus (Reuters)
• CytomX pens $1.6B Astellas biobucks pact for T-cell R&D (Fierce) (Endpoints) (Press)
• Man dies after ingesting chloroquine in an attempt to prevent coronavirus (NBC)
• US launches probes as Trump bans hoarding, price gouging to combat coronavirus (Reuters)

• FDA and EMA Collaborate to Facilitate SARS-CoV-2 Vaccine Development (FDA)
• Italy's coronavirus deaths slow, offering glimmer of hope (Reuters)
• Italian coronavirus cases seen "10 times higher" than official tally (Reuters)
• Britain Placed Under a Virtual Lockdown by Boris Johnson (NYTimes) (Reuters)
• China to lift lockdown in most of virus-hit Hubei province (AP)
• China health commission says virus transmission risks remain (Reuters)
• Fresenius says China drug production back to normal (Reuters)
• Ecuador becomes the latest country to eye compulsory licensing for Covid-19 products (STAT)
• Novartis announces positive data from halted Zolgensma trial (Endpoints) (PMLive)

• The Coronavirus Testing Paradox (ProPublica)
• These Drugs Are Helping Our Coronavirus Patients (WSJ)
• Roche says limit tests to people with coronavirus symptoms (Reuters)
• French group Biomerieux gets US approval for coronavirus testing product (Reuters)
• Coronavirus pandemic leads big drugmakers to hit pause on clinical trials (Reuters) (STAT) (BioPharmaDive)
• G20 leaders to speak on Thursday about coronavirus, sources say (Reuters)
• Desperate for Covid-19 answers, US doctors turn to colleagues in China (STAT)
• Experimental Drug Out of Emory University to be Tried Against Coronavirus (WSJ)
• New Mexico governor issues statewide stay-at-home order (Reuters)
• California governor says state needs 50,000 more hospital beds (Reuters)
• US health officials say 147 nursing homes have at least one resident with coronavirus (CNBC)
• Italy's medics at 'end of our strength' as they too fall ill (Reuters)
• Germany: 750 billion euro aid package is just first step in tackling coronavirus (Reuters)
• French prime minister says coronavirus lockdown could last weeks (Reuters)
• South Africa to impose 21-day lockdown as coronavirus cases jump (Reuters)
• German coronavirus cases rise by 4,764 cases to 27,436: Robert Koch Institute (Reuters)
• Russia investigates health official who infected people with coronavirus after Spain trip (Reuters)
• UK awards funding to coronavirus research, including vaccines (Reuters) (GOV.UK)
• Pharma firm Anges and Osaka University to begin testing coronavirus vaccine on animals (Reuters)
• Experts warn Japanese growing complacent of coronavirus risk (Reuters)
• South Korea doubles coronavirus rescue package to $80 billion (Reuters)
• China's Shenzhen says all arrivals must be tested for coronavirus (Reuters)
• Beijing tightens quarantine rules for travelers from overseas: official media (Reuters)
• Amazon teams up with Bill Gates-backed group to deliver coronavirus test kits (Reuters)
• Embattled Cel-Sci to tackle COVID-19 with immunotherapy platform tech LEAPS (Fierce)
• CDC says coronavirus survived in Princess Cruise ship cabins for up to 17 days after passengers left (CNBC)
• Singapore scientists study genes to fast-track coronavirus vaccine (Reuters)
• Ford joins 3M, GE in speeding up ventilator, respirator production (Reuters)
• Tesla CEO says bought ventilators in China for US (Reuters)
• GM Considers Building Ventilators At Indiana Plant (NPR)
• Fiat Chrysler to make face masks for North America (Reuters)
• Petition urges repeal of restrictions on gay donors amid blood shortage (NBC)
• Doctors Are Hoarding Unproven Coronavirus Medicine by Writing Prescriptions for Themselves and Their Families (ProPublica)
• A Message to Patients With Cancer and Health Care Providers About COVID-19 (FDA)
• Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Additional Safety Protections Pertaining to SARS-CoV-2 and COVID-19 (FDA)

• Recent History Shows Variability in Vaccine Development Timeline (Avalere)
• Despite investments and advocacy, pharma’s still making its drugs in batches that can take months — rather than continuously. Why? (STAT)
• Antibiotic resistance: the hidden threat lurking behind Covid-19 (STAT)
• Recipe For Managing Data Disclosure Successfully With Academic Partners: A Public Gene Therapy Company Perspective (LifeSciVC)
• PhRMA, BIO campaign champions members' determination to beat COVID-19 (Fierce)
• The Mom Who Took on Purdue Pharma for Its OxyContin Marketing (Wired)
• Palforzia Peanut Allergy Immunotherapy: Aimmune CEO on REMS, Manufacturing (Xconomy)
• AbbVie CEO Gonzalez secured $21.6M in year marked by megamerger, Humira decline (Fierce)
• Her Incredible Sense Of Smell Is Helping Scientists Find New Ways To Diagnose Disease (NPR)
• Coronavirus Industry Impact: Patients, Pharmacies, and Wholesalers (Part 1) (Drug Channels)
• How to build CAR–M: Carl June protégé and his biotech publish first evidence in Nature (Endpoints)
• FDA Warning Letters Hit Small OTC, Large Pharma Firms With Same Citations In FY 2019 (Pink Sheet-$)
• An Indian drug maker is slammed by FDA for tossing ‘cartloads of trash bags’ filled with documents (STAT)

• Despite protests, Milestone Pharma gets clobbered by a PhIII crash in the clinic (Endpoints)
• Four years after near-death experience, PhIII data bring good news for Novavax (Endpoints)
• Data from Phase 3 TRuE-AD Trials of Ruxolitinib Cream in Atopic Dermatitis to be Presented at the 2020 Revolutionizing Atopic Dermatitis Virtual Conference (Press)
• FDA Approves Supplemental New Drug Application (sNDA) for Expanded Indication of EUCRISA® (Crisaborole) Ointment, 2%, in Children as Young as 3 Months of Age With Mild-to-Moderate Atopic Dermatitis (Press)
• The Lancet Haematology Publishes Results From Oncopeptides' Multicenter, International Phase 1/2 Study (O-12-M1) (Press)
• Samsung Bioepis Announces FDA Approval of 420 mg Multi-dose Vial of ONTRUZANT® (trastuzumab-dttb) (Press)

• Third Party Review Program Guidance Finalized (FDA Law Blog)
• AEGEA Medical Receives FDA Approval for and Performs First Commercial Cases With the Mara™ Water Vapor Ablation System (Press)
• AusDiagnostics Gets CE Mark for Multiplex Coronavirus, Flu, RSV Assay (GenomeWeb)

• Obamacare Turns 10. Here’s a Look at What Works and Doesn’t. (NYTimes)
• Eleven States Now Letting Uninsured Sign Up for Obamacare (NYTimes)
• Full Fed. Circ. Won't Review PTAB Unconstitutionality Case (Law360-$)
• Open Issues After Fed. Circ. PTAB Judge Appointments Ruling (Law360-$)
• Justices, Congress Might Tackle PTAB Constitutionality Next (Law360-$)
• Mitsubishi, Janssen Seek To Block Generic Diabetes Drug (Law360-$)
• High Court Turns Down Allergan Breast Implant Suit (Law360-$)
• Walgreens 'Systemically Overcharged' For Drugs, Insurers Say (Law360-$)
• Drug Cos. Want Slow SF Opioid Case Timeline Amid COVID-19 (Law360-$)
• Mallinckrodt Dodges MS Drug Monopoly Suit (Law360-$)
• Ex-Theranos Execs Holmes, Balwani To Get Separate Trials (Law360-$)
• Too Much Isn’t Enough in California (Drug & Device Law)
• New Patent Litigation Playbook For Products Switching To Biologics (Pink Sheet-$)
• Senator Pat Roberts’ OTC Legislation and Priority Zoonotic Animal Drug Designation Included in Coronavirus Phase III Package (Roberts)

• COVID-19: Beware of falsified medicines from unregistered websites (EMA)
• France To Fast-Track COVID-19 Clinical Trial Applications (Pink Sheet-$)
• CMA launches COVID-19 taskforce to combat drug price hikes (EPR)
• MHRA issues FMD over HMS Wholesale Limited products (EPR)
• Novel Combined Contraceptive Estelle Among Nine New Filings At EMA (Pink Sheet-$)
• Fennec Banks On EMA’s Seldom-Used PUMA For Sodium Thiosulfate (Pink Sheet-$)
• Intercept Eyes EU NASH Market (Pink Sheet-$)
• German Ruling Spells More Trouble For Europe’s New Patent System (Pink Sheet-$)
• Novartis recalls Sandimmune and Neoral over risk of poisoning (EPR)

• TGA issues warning about illegal advertising relating to COVID-19 (TGA)
• New restrictions on prescribing hydroxychloroquine for COVID-19 (TGA)
• Notice of an amendment to the current Poisons Standard under paragraph 52D(2)(a) of the Therapeutic Goods Act 1989 (TGA)