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Regulatory Focus™ > News Articles > 2020 > 4 > Recon: GSK partners with Vir for COVID-19 treatments; Gilead to donate 1.5M doses of remdesivir

Recon: GSK partners with Vir for COVID-19 treatments; Gilead to donate 1.5M doses of remdesivir

Posted 06 April 2020 | By Michael Mezher 

Recon: GSK partners with Vir for COVID-19 treatments; Gilead to donate 1.5M doses of remdesivir

Welcome to Regulatory Reconnaissance, your daily regulatory news and intelligence briefing.
 
In Focus: US
  • US faces 'really bad' week as coronavirus deaths spike (Reuters) (NBC)
  • Inside the epic White House fight over hydroxychloroquine (Axios) (Reuters)
  • Pressed by Trump, US pushed unproven coronavirus treatment guidance (Reuters) (NYTimes) (The Guardian) (WSJ)
  • Trump says thousands of military to be sent to help states battle coronavirus (Reuters)
  • GSK to partner with Vir for potential COVID-19 treatments (Reuters) (STAT) (Endpoints) (Press)
  • Coronavirus patients rush to join studies of Gilead drug (AP)
  • Gilead ramps up production of remdesivir amid criticism over access, will donate 1.5 million doses (STAT) (Endpoints) (Press)
  • Biotech execs warn that the FDA is fumbling their response to the Covid-19 open-door promise, delaying progress (Endpoints)
  • Inovio coronavirus vaccine trial starts in Philadelphia, Kansas City (Business Insider) (Press)
  • FDA Commissioner Says China Not Creating Drug Shortages in US (Bloomberg)
  • Bet Big on Treatments for Coronavirus (WSJ)
  • Immunomedics halts late-stage clinical trial, confirming drug benefit for aggressive type of breast cancer (STAT) (Endpoints)
  • Alnylam and Dicerna, onetime rivals, announce a ceasefire (STAT) (Endpoints)
  • Bristol Myers Squibb, Acceleron rack up second OK for Reblozyl, onto blockbuster status (Endpoints) (FDA) (Press)
In Focus: International
  • Greece suggests EU buy patent rights for vaccines and coronavirus tests: FAZ (Reuters)
  • WHO opens door to broader use of masks to limit spread of coronavirus (Reuters)
  • UK PM Johnson in hospital with persistent COVID-19 symptoms but still working (Reuters)
  • Japan to declare coronavirus emergency, launch stimulus of almost $1T (Reuters) (NPR)
  • Japan to boost Avigan drug stockpile as part of coronavirus stimulus (Reuters)
  • South Korea reports fewer than 50 new infections, earning WHO praise (Reuters)
  • Odd number in India coronavirus testing data sparks questions (Reuters)
  • India Bans All Exports of Virus Drug Often Touted by Trump (Bloomberg)
  • Covid-19 battle: Govt may Lift Hydroxychloroquine export ban (Economic Times) (Financial Times)
  • UK's Izana Bioscience tests rheumatoid arthritis drug in COVID-19 patients (Reuters)
  • Lilly Asia Ventures co-leads $100M+ round for Chinese biotech and its late-stage lupus drug (Endpoints)
  • Servier snaps up antibody biotech Symphogen, looks to become 'recognized oncology player' (Fierce) (PMLive)
Coronavirus Outbreak
  • COVID-19 Vaccines: Ex-FDA Leaders Urge High Bar For Emergency Use Authorization (Pink Sheet-$)
  • 430,000 People Have Traveled From China to US Since Coronavirus Surfaced (NYTimes)
  • Democratic Health Leaders Call For Free Covid-19 Treatment For All Americans (Senate Ways and Means)
  • FDA commissioner Hahn: We have been working on convalescent plasma treatment (Fox)
  • FDA: No evidence COVID-19 can be transmitted by food or packaging on food (Roll Call)
  • US coronavirus supply spree sparks outrage among allies (Reuters)
  • How sewage could reveal true scale of coronavirus outbreak (Nature)
  • Tiger at New York's Bronx Zoo tests positive for coronavirus (Reuters)
  • The ‘certified recovered’ from Covid-19 could lead the economic recovery (STAT)
  • CVS ramps up drive-through coronavirus testing sites with faster kits (Reuters)
  • Could TB vaccine protect medics from COVID-19? (France24)
  • Mysterious Heart Damage, Not Just Lung Troubles, Befalling COVID-19 Patients (KHN)
  • ‘You Pray That You Got The Drug.’ Ailing Couple Gambles On Trial For COVID-19 Cure (KHN)
  • Early Data Shows African Americans Have Contracted and Died of Coronavirus at an Alarming Rate (ProPublica)
  • Does Covid-19 Hit Women and Men Differently? U.S. Isn’t Keeping Track (NYTimes)
  • Along the Border, the Population Is High Risk for Coronavirus, but Testing Is In Short Supply (ProPublica)
  • This tiny federal agency was built to respond to a crisis like coronavirus. Now that it’s here, is BARDA ready? (STAT)
  • New York governor sees 'return to normalcy' with rapid coronavirus testing (Reuters)
  • Getinge to ramp up ventilator production capacity by 160% due to coronavirus (Reuters)
  • Tesla engineers show ventilator prototype on YouTube (Reuters)
  • Key Issues As Automakers Shift To Medical Device Production (Law360)
  • CDC launches studies to get more precise count of undetected Covid-19 cases (STAT)
  • An interview with the CDC director on coronavirus, masks, and an agency gone quiet (STAT)
  • Inside a major coronavirus vaccine effort that hopes to start early production to meet demand (NBC)
  • Amazon in contact with coronavirus test makers for potential screenings on employees (Reuters)
  • China Pushes for Quiet Burials as Coronavirus Death Toll Is Questioned (NYTimes)
  • China sees rise in asymptomatic coronavirus cases, to tighten controls at land borders (Reuters)
  • Japan animal ventilator maker looks to boost output for human coronavirus patients (Reuters)
  • Queen Elizabeth II Addresses U.K. In Rare Televised Speech About The Coronavirus (NPR)
  • UK ramps up coronavirus trials but results 'a few months away' (Reuters)
  • Miracle cures? UK investigators go after fake coronavirus medicines (Reuters) (MHRA)
  • Britain secures 300 new ventilators from China (Reuters)
  • NICE publishes new COVID-19 management guidelines (PMLive)
  • Novacyt wins French approval for COVID testing kit (Reuters)
  • Italy starts to look ahead to 'phase two' as COVID-19 death toll slows (Reuters)
  • Italy experts say reliable coronavirus antibody test may be ready soon (Reuters)
  • Germany ‘is still at the beginning of the epidemic’ despite low death rate, health body warns (CNBC)
  • Swiss face shortage of ethanol for disinfectant after abandoning stockpile (Reuters)
  • Finland, ‘Prepper Nation of the Nordics,’ Isn’t Worried About Masks (NYTimes)
  • Ontario lab design left province short of coronavirus testing supplies (Reuters)
  • Canada's Ontario warns coronavirus cases will soar without further distancing measures (Reuters)
  • Russia's coronavirus cases jump by almost 1,000 in 24 hours (Reuters)
  • "They just sedate them"; coronavirus overwhelms Spain's care homes (Reuters)
  • Wockhardt Hospital in Mumbai unwittingly becomes a Covid hot zone after many staffers test positive (Economic Times)
  • 23andMe Engages Its Millions of Research Participants to Study COVID-19 (Press)
  • Hope Biosciences Receives FDA Approval to Commence First Stem Cell Clinical Trial for Protection Against COVID-19 (Press)
  • OncoSec Collaborates with Providence Cancer Institute to Conduct First-in-Human Trial of OncoSec's CORVax12, an Investigational Vaccine to Prevent COVID-19, Combining an Enhanced "Spike" DNA Sequence and TAVO (Press)
Pharmaceuticals & Biotechnology
  • Another day, another boatload for biotech. Deerfield adds $840M to rush of venture dollars (Endpoints)
  • Small molecules, biologics and now gene therapies: Germany's Evotec adds another feather to its R&D cap (Endpoints)
  • Gilead to lean on Second Genome's microbiome work in $38M research pact (BioPharmaDive)
  • Next-generation stem cells — ushering in a new era of cell-based therapies (Nature)
  • The 20 under 40: Inside the next generation of biopharma leaders (Endpoints)
  • Fate Inks $100M Deal With Janssen for Stem Cell-Derived Cancer Therapies (Xconomy)
  • Individualized Therapeutics Could Get Boost From NIH Platform Gene Therapy Pilot (Pink Sheet-$)
  • Pfizer signs up for longer pact with Icon, pens extra 2-year clause (Fierce)
  • Alkermes clinical lead jumps ship to slimmed-down, refocused Seres (Fierce)
  • Fees for Human Drug Compounding Outsourcing Facilities Under Sections 503B and 744K of the FD&C Act (FDA)
Pharmaceutical & Biotechnology: Study Results, Filings & Designations
  • A pair of PhIII failures spells last rites for Menlo’s once-promising Merck drug (Endpoints)
  • Axsome celebrates migraine PhIII win, shifting eyes toward a pair of Q4 submissions (Endpoints)
  • LFB Announces FDA Approval of SEVENFACT®, a New Recombinant Coagulation Factor VIIa, for the Treatment of Adults and Adolescents with Hemophilia A or B with Inhibitors (Press)
  • The Lancet Simultaneously Publishes Two Phase 3 Studies Detailing Comprehensive Efficacy and Safety of TREMFYA®▼ (guselkumab), a First-in-Class IL-23 p19 Subunit Inhibitor, in Psoriatic Arthritis (Press)
  • Incyte Announces First Presentation of Phase 3 Data from the TRuE-AD Program of Ruxolitinib Cream at the Revolutionizing Atopic Dermatitis Virtual Symposium (Press)
  • OxThera Announces Completion of Recruitment in Phase 3 ePHex Study With Oxabact® in Patients With Primary Hyperoxaluria (Press)
  • Millendo Therapeutics Announces Topline Results for Pivotal Phase 2b Study of Livoletide in Patients with Prader-Willi Syndrome (PWS) (Press)
Medical Devices
  • Updated Letter to Industry on COVID-19 (FDA)
  • Axonics® Submits PMA Supplement to U.S. Food & Drug Administration to Expand Full-Body MRI Labeling for 3T Scans (Press)
  • Aptar Requests US FDA Emergency Use Authorization for N95 Filtering Facepiece Respirator Decontamination with ActivShieldTM (Press)
US: Assorted & Government
  • Obamacare's health care protections face first true test in coronavirus crisis (NBC)
  • Supreme Court Postpones April Argument Session (Law360)
  • More Bad Comment k Law from the Eastern District of Pennsylvania (Drug & Device Law)
  • Boehringer Ingelheim Pharmaceuticals Inc. v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2020) (Patent Docs)
  • FSIS Admits Its Policy for Product of USA Labeling is Misleading; Will Undertake Rulemaking (FDA Law Blog)
Europe
  • The MDR amendment proposal: more than meets the eye (MedicalDevicesLegal)
  • EMA Set To Discuss Safety Of Ranitidine Drugs Soon (Pink Sheet-$)
  • Medicines: get scientific advice from MHRA (MHRA)
India
  • China restarts drug despatches, India's curbs hold them in transit (Economic Times)
  • Indian pharma companies secure 336 ANDA approvals from US FDA during 2019 (Pharmabiz)
  • Lupin launches generic drug used for prevention of organ rejection in kidney transplant in US (Economic Times)
  • India’s regulator looks to relax clinical trial protocols in face of COVID-19 challenge (Pharmaletter-$)
Australia
  • Amendments to the new restrictions on prescribing hydroxychloroquine for COVID-19 (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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