Recon: FDA Approves BMS’ MS Drug, Launch Delayed by COVID-19; Pfizer Halts New Studies

• FDA approves BMS MS drug, Covid-19 to delay launch (Reuters) (STAT) (Endpoints) (Press)
• Pfizer pauses new studies due to coronavirus pandemic (Reuters)
• Pfizer, Mylan say COVID-19 delays will postpone their Viatris merger (Fierce) (Endpoints) (Press)
• U.S. slashed CDC staff inside China prior to coronavirus outbreak (Reuters)
• HHS lists hydroxychloroquine under hoarding prevention after Trump's order (Reuters)
• FDA commissioner warns public against taking 'any form of chloroquine' unless prescribed (The Hill)
• Pharmacies set policies to stop U.S. hoarding of potential coronavirus treatments (Reuters)
• 3.3 Million File For Unemployment Claims, Shattering Records (NPR)
• Spain's Grifols to test plasma therapy for COVID-19 with FDA (Reuters)
• Amid Desperate Need for Ventilators, Calls Grow for Federal Intervention (NYTimes)
• Ventilator Makers Ask U.S. Government To Manage Distribution (NPR)
• Mylan waives exclusive US distribution rights for potential COVID-19 therapy (Reuters)
• New Orleans emerges as next coronavirus epicenter, threatening rest of South (Reuters)
• New York sees glimmer of progress against coronavirus, New Orleans worsens (Reuters)
• Conservative Group Pushes for FDA Approval of Drug to Treat Coronavirus (WSJ)
• Inside the pandemic playbook Trump ignored (Politico)

• Countries must not squander chance to control coronavirus: WHO (Reuters)
• British parliament approves emergency coronavirus legislation (Reuters)
• UK struggling with coronavirus tests amid global shortage (Reuters)
• UK will have antibody tests ready in days, official says (Reuters)
• Coronavirus: harmonised standards for medical devices to respond to urgent needs (EC)
• COVID-19: MEPs call for a more unified EU response (European Parliament)
• EU says Johnson & Johnson's deal for Takeda patch may harm competition (Reuters) (Law360-$)
• A Canadian bill would make it easier to issue compulsory licenses for Covid-19 products (STAT)
• Australia enters 4,000 healthcare workers in trial of tuberculosis vaccine for coronavirus (Reuters)
• Mexico City coronavirus test lab draws lines of people (Reuters)
• As virus explodes, world races to mask up (Reuters)
• Bayer And Novartis Lose Challenge To NHS Eye Drug Policy (Law360-$)

• The global hunt for a coronavirus drug (Financial Times)
• Air freight shortage limits Europe’s access to coronavirus drugs (Financial Times)
• Beware second waves of COVID-19 if lockdowns eased early: study (Reuters)
• Summer heat unlikely to halt coronavirus, EU body says (Reuters)
• COVID-19: Legal Considerations for Bringing a New Vaccine to Market (CRS)
• Coronavirus Preparedness and Response Supplemental Appropriations Act, 2020 (P.L. 116-123): First Coronavirus Supplemental (CRS)
• Novartis works with life sciences companies to fight Covid-19 (Reuters)
• Pharmas on one page with action plan to solve COVID-19 together (BioCentury)
• Coronavirus deaths hit 1,000 in U.S. as global death toll passes 20,000 (NBC)
• Hospital Capacity Crosses Tipping Point in U.S. Coronavirus Hot Spots (WSJ)
• What we’ve learned about the coronavirus — and what we still need to know (STAT)
• Can You Become Immune to the Coronavirus? (NYTimes)
• Smokers likely to be more at risk from coronavirus: EU agency (Reuters)
• COVID-19 hospital charges may exceed $1.4 trillion (Modern Healthcare)
• Hydroxychloroquine for COVID-19: What's the Evidence? (Medscape)
• Minnesota doctor engaged in FDA-approved Hydroxychloroquine trials lacks volunteers (ABC)
• More than 140 nursing homes have reported coronavirus cases. Federal officials won’t say which ones. (Washington Post)
• A ‘negative’ coronavirus test result doesn’t always mean you aren’t infected (Washington Post)
• Coronavirus Is an Enemy America Still Can’t See (Bloomberg)
• Critical Supply Shortages — The Need for Ventilators and Personal Protective Equipment during the Covid-19 Pandemic (NEJM)
• The Ethical Allocation of Scarce Resources in the US During the COVID-19 Pandemic: The Role of Bioethics (Harvard Bill of Health)
• Dyson ventilator order dependent on passing tests: UK PM Johnson's spokesman (Reuters)
• UK has 8,000 ventilators and another 8,000 on the way, junior minister says (Reuters)
• Babcock says to design and build thousands of ventilators for UK (Reuters)
• DuPont expediting production of Tyvek hazmat suits for health care workers (NBC)
• Fresenius: Staff, equipment may not suffice for coronavirus peak: WirtschaftsWoche (Reuters)
• Bosch develops Corona test tool to detect virus in under three hours (Reuters)
• Mass testing explains Germany's relatively low death rate from coronavirus: virologist (Reuters)
• Hungary bans export of coronavirus treatment ingredient (Reuters)
• Italy’s death toll rises above 7,000 — but the number of new cases declines for the 4th day in a row (CNBC)
• Almost half New York City’s coronavirus patients are under 45 (CNBC)
• China's local coronavirus cases die down, imported cases rise (Reuters)
• Japan, spared mass outbreak so far, now sees 'national crisis' after Tokyo surge (Reuters)
• Spain's coronavirus death toll surpasses 4,000 (Reuters)
• Dutch coronavirus cases rise by 1,019 to 7,431: authorities (Reuters)
• Swiss coronavirus cases top 10,000, with 161 deaths (Reuters)
• Jordan Keeps Coronavirus In Check With One Of The World's Strictest Lockdowns (NPR)
• Chile's coronavirus outbreak surpasses 1,000-case mark (Reuters)
• Coronavirus (COVID-19) Update: Daily Roundup, March 25, 2020 (FDA)
• Impact of COVID-19 on Regulatory Enforcement and Approvals – Part 2 (Eye on FDA)
• Q&A for Consumers: Hand Sanitizers and COVID-19 (FDA)
• Genomic Study Points to Natural Origin of COVID-19 (NIH)

• Strategic Planning In Biotech During A Pandemic Crisis (LifeSciVC)
• Gene therapy regulation: could in-body editing fall through the net? (Nature)
• What it’s like to go into the lab at a biopharma company during the coronavirus pandemic (STAT)
• Covid-19 roundup: Intercept, bluebird and a growing list of biotechs feel the pain as pandemic mangles FDA, R&D schedules (Endpoints)
• bluebird bio Provides Assessment of Impact of COVID-19, Update on Business Operations and Clinical Program Development (Press)
• Galapagos CEO talks next steps as coronavirus stalls the biotech's top drug (BioPharmaDive)
• SutroVax lands another $100M+ in upstart quest against Pfizer’s blockbuster Prevnar 13 (Endpoints)
• Coupling mRNA with tRNA and new delivery tech, MPM and OrbiMed help birth new $80M biotech into a slowed down world (Endpoints)
• Ipsen scraps pivotal trial as partial clinical hold drags on (Fierce) (Endpoints)
• Takeda antes up $44M for rare disease pact, turning to Oxford spinout's exosome tech (Endpoints)
• Cancer biotech Viracta nabs Nordic Nanovector exec as CMO (Fierce)
• A tale of 2 meetings: Amid pandemic, ASCO moves online while ADA plows ahead (Fierce)
• Xellia Pharmaceuticals Obtains FDA Approval of Injectable Manufacturing Site in Cleveland, Ohio (Press)

• New England Journal of Medicine Publishes Results from Pivotal Phase 3 BELIEVE Trial of Reblozyl (luspatercept-aamt) in Adult Patients With Beta Thalassemia (Press)
• Orphan Technologies Receives Rare Pediatric Disease Designation from FDA for OT-58 to Treat Cystathionine B-synthase Deficiency Homocystinuria (Press)
• Inzomelid completes Phase I studies and shows positive results in the treatment of Cryopyrin-Associated Periodic Syndrome (CAPS) (Press)
• Qurient Announces Publication in New England Journal of Medicine of Phase 2 Data for Telacebec, a First-in-Class Antibiotic for the Treatment of Tuberculosis (Press)
• European Medicines Agency Grants Orphan Drug Designation to AlloVir’s Viralym-M, an Allogeneic, Off-the-Shelf, Multi-Virus Specific T-Cell Therapy (Press)

• FDA still trying to fine-tune Pre-Cert as pilot enters 2020 (MedtechDive)
• Pear’s digital therapy for chronic insomnia gains FDA signoff (STAT) (Press)
• Butterfly rescinds features from handheld ultrasound device, working with FDA to re-enable (mobihealthnews)
• Aegea Medical device to treat heavy menstrual bleeding wins FDA approval (MassDevice)
• FDA approves BioStage’s esophageal device investigational new drug application (MassDevice)
• AgNovos Healthcare Receives Breakthrough Designation for Spine Device (Press)
• Class 1 Device Recall Imager II 5F Angiographic Catheter (FDA)
• COVID-19 Response: What manufacturers should know about US FDA Emergency Use Authorizations (EUA) for medical devices and IVDs (Emergo)

• Teva Sues FDA For Excluding Copaxone From BLA Transition; Wants To Use Biosimilar Litigation Process (Pink Sheet-$)
• Small-time actor peddled fake coronavirus cure to millions online, feds charge in first covid-19 prosecution (Washington Post)
• Genentech v. Amgen Jury Trial Postponed (Big Molecule Watch)
• Regulating Vaping — Policies, Possibilities, and Perils (NEJM)
• Novartis Wants Lupin's Generic Heart Failure Drug Blocked (Law360-$)
• Kaken Pharmaceutical Co. v. Iancu (Fed. Cir. 2020) (Patent Docs)
• Open for Business: DEA’s Proposed Rule Would Make the Agency an Active Buyer and Seller of Marijuana (FDA Law Blog)

• France's Macron pledges massive investment in health system after virus crisis (Reuters)
• Regulatory status of equipment being used to help prevent coronavirus (COVID-19) (MHRA)
• Chloroquine and Hydroxychloroquine not licensed for coronavirus (COVID-19) treatment (MHRA)
• Exemptions from Devices regulations during the coronavirus (COVID-19) outbreak (MHRA)
• Reporting suspected side effects during the Coronavirus (COVID-19) outbreak (MHRA)
• Botox gets license update in UK (PharmaTimes)
• The European MDR and human factors engineering: Intended purpose (Emergo)
• Coronavirus: Belgian guideline for the management of clinical trials during the coronavirus pandemic (FAMHP)

• First for Japan with the approval of AstraZeneca's Lokelma in hyperkalaemia (Pharmafile)

• Cipla gets USFDA nod for generic acid reflux drug (Economic Times)
• Pharma companies in panic mode as lockdown hits supply chain (Economic Times)

• COVID-19 information for clinicians on ventilators and alternative strategies when in short supply (TGA)