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Regulatory Focus™ > News Articles > 2020 > 3 > Recon: FDA Approves BMS’ MS Drug, Launch Delayed by COVID-19; Pfizer Halts New Studies

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

Posted 26 March 2020 | By Michael Mezher 

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

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • 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)
In Focus: International
  • 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-$)
  • A Canadian bill would make it easier to issue compulsory licenses for Covid-19 products (STAT)
  • Australia enters 4,000 healthcare workers in trial of tuberculosis vaccine for coronavirus (Reuters)
  • Mexico City coronavirus test lab draws lines of people (Reuters)
  • As virus explodes, world races to mask up (Reuters)
  • Bayer And Novartis Lose Challenge To NHS Eye Drug Policy (Law360-$)
Coronavirus Outbreak
  • 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)
Pharmaceuticals & Biotechnology
  • 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)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • 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)
Medical Devices
  • 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)
US: Assorted & Government
  • 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)
Europe
  • 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)
Asia
  • First for Japan with the approval of AstraZeneca's Lokelma in hyperkalaemia (Pharmafile)
India
  • Cipla gets USFDA nod for generic acid reflux drug (Economic Times)
  • Pharma companies in panic mode as lockdown hits supply chain (Economic Times)
Australia
  • COVID-19 information for clinicians on ventilators and alternative strategies when in short supply (TGA)
Regulatory Reconnaissance is our daily intelligence briefing for the regulatory affairs space, bringing you the top regulatory, biopharma and medtech news stories from around the globe.
 
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