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remdesivir (GS-5734) / GileadUS FDA approves emergency use of remdesivir for Covid-19 patients (Outlookindia.com) - May 2, 2020 - "The US Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for the experimental anti-viral drug remdesivir to treat COVID-19. In an FDA fact sheet for patients and their families and caregivers, the agency...noted that remdesivir has not undergone the same type of review as an FDA-approved or cleared product....Remdesivir is an investigational antiviral medicine to treat certain people in the hospital with COVID-19, said the FDA, adding the drug was still being studied."Ryoncil (remestemcel-L) / Mallinckrodt, Mesoblast, JCR PharmaPhase 2/3 Randomized Controlled Trial of Remestemcel-L in 300 Patients With COVID-19 Acute Respiratory Distress Syndrome Begins Enrollment (GlobeNewswire, Mesoblast Limited) - Apr 30, 2020 - "Mesoblast Limited...today announced a Phase 2/3 randomized, placebo-controlled trial to rigorously confirm whether its allogeneic mesenchymal stem cell therapy remestemcel-L provides a survival benefit in moderate/severe acute respiratory distress syndrome (ARDS) due to COVID-19 has commenced enrollment. More than 20 medical centers across the United States will participate in the trial which is expected to complete enrollment within three to four months, with interim analyses planned....The specific clinical protocol for use of remestemcel-L in patients in this trial...previously reported positive results from the emergency compassionate use protocol patients with COVID-19 ARDS....The trial will be conducted in collaboration with the Cardiothoracic Surgical Trials Network, which was established...for conducting collaborative trials."remdesivir (GS-5734) / GileadEvergreenHealth prepares for second arm of clinical trial after initial findings show promising results for remdesivir as potential treatment for Covid-19 (Businesswire) - Apr 30, 2020 - P=3, N=800; ACTT (NCT04280705); Sponsor : National Institute of Allergy and Infectious Diseases (NIAID); "EvergreenHealth is preparing to move forward with the next phase of clinical research studying the anti-viral Remdesivir as a potential treatment for COVID-19. The second phase of the trial, ACTT II, will eliminate the placebo group, and instead provide all study participants with Remdesivir....Results from the trial’s primary ACTT phase....showed that hospitalized patients with advanced symptoms of COVID-19 who received Remdesivir recovered 31% more quickly than those who received the placebo....ACTT II will be introducing an immunomodulator, a sister drug used to help regulate the immune system, to study its potential as another treatment for COVID-19....The ACTT II is expected to run for three years..."MultiStem (PF-05285401) / Athersys, HealiosAthersys and University Hospitals Cleveland Medical Center announce activation of the first clinical site for the MACOVIA study, a pivotal phase 2/3 study evaluating MultiStem cell therapy for Covid-19 Induced ARDS (Businesswire) - May 1, 2020 - "Athersys, Inc....and University Hospitals Cleveland Medical Center (UH Cleveland) announced today that UH Cleveland is now open as the first clinical site for the MACOVIA (MultiStem® Administration for COVID-19 Induced Acute Respiratory Distress Syndrome) trial....The Company is in discussions with the Biomedical Advanced Research and Development Authority (BARDA) to advance the development of MultiStem to treat patients with ARDS resulting from the COVID-19 epidemic and other potential pandemic outbreaks."Inomax (nitric oxide) / MallinckrodtMallinckrodt supports investigator-initiated study at Massachusetts General Hospital to assess effectiveness of inhaled nitric oxide in patients with severe acute respiratory distress syndrome due to Covid-19 (PRNewswire) - Apr 30, 2020 - "Mallinckrodt plc...announced today that it is supporting an investigator-initiated clinical study at Massachusetts General Hospital....Mallinckrodt's support to Massachusetts General Hospital includes providing funding as well as INOmax® (nitric oxide) gas, for inhalation, to facilitate the study. The study is titled 'Inhaled Nitric Oxide Gas Therapy in Mechanically Ventilated Patients with Severe Acute Respiratory Syndrome in COVID-19'....The trial initiation follows Mallinckrodt's earlier announcement of a research project in Canada....Mallinckrodt and Novoteris LLC....announced that the companies received approval from Health Canada to begin a pilot trial....Enrollment is expected to begin in the coming days." "Roche’s COVID-19 antibody test receives FDA Emergency Use Authorization and is available in markets accepting the CE mark (GlobeNewswire, F. Hoffmann-La Roche Ltd) - May 2, 2020 - "Roche...today announced that the U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for its new Elecsys® Anti-SARS-CoV-2 antibody test. The test is designed to help determine if a patient has been exposed to the SARS-CoV-2 virus and if the patient has developed antibodies against SARS-CoV-2. Roche has already started shipping the new antibody test to leading laboratories globally....Roche’s SARS-CoV2 antibody test, which has a specificity greater than 99.8% and 100% sensitivity...can help assess patients’ immune response to the virus."Rheonix Inc. receives FDA emergency use authorization for rapid, fully automated molecular Covid-19 test (Businesswire) - Apr 30, 2020 - "Rheonix Inc. announced today that it has received Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA) for the Rheonix COVID-19™ MDx Assay. The fully automated test enables detection of SARS-CoV-2, the virus that causes COVID-19, directly from respiratory samples. The test is designed to operate on the Rheonix Encompass MDx® workstation, and will facilitate same-day test results for small and medium-throughput laboratories."mRNA-1273 / Moderna TherapeuticsModerna and Lonza announce worldwide strategic collaboration to manufacture Moderna’s vaccine (mRNA-1273) against novel coronavirus (Businesswire) - May 1, 2020 - "Moderna, Inc....and Lonza Ltd....today announced a 10-year strategic collaboration agreement to enable larger scale manufacture of Moderna’s mRNA vaccine (mRNA-1273)....Technology transfer is expected to begin in June 2020, and the companies intend to manufacture the first batches of mRNA-1273 at Lonza U.S. in July 2020...A portion of the funding for the establishment of manufacturing operations at Lonza U.S. is covered by Moderna’s contract with Biomedical Advanced Research and Development Authority (BARDA)....BARDA will support late-stage clinical development programs of mRNA-1273."remdesivir (GS-5734) / GileadCOVID-19 daily: Remdesivir results, resident abuse (Medscape) - Apr 29, 2020 - P=NA, N=1,063; "The medical community learned Wednesday about the results of three different trials testing Gilead Sciences' experimental drug remdesivir as a COVID-19 treatment. Based on the results from one of those trials from the National Institute of Allergy and Infectious Diseases (NIAID), Anthony Fauci...called the drug the new 'standard of care.' The randomized, placebo-controlled trial of remdesivir conducted by NIAID, of 1063 hospitalized patients with advanced COVID-19, indicate that patients who received the drug recovered more quickly than patients who received a placebo, the institute announced. The median time to recovery for patients who received remdesivir was 11 days compared with 15 for patients who received placebo."Dr. Anthony Fauci talks about COVID-19 with Local 12 (Local 12 WKRC-TV) - Apr 30, 2020 - "Dr. Fauci said he has 'cautious optimism' that a vaccine for COVID-19 can be developed, but he said there are no guarantees. 'Vaccines are tricky. Sometimes you're successful and sometimes you're not. It really depends on the nature of the virus that you're dealing with,' Dr. Fauci said....'Once we get into that and get to Phase 2, 3, right away, it is conceivable that we'll be able to shave some months off of that and perhaps have a vaccine that would hopefully be at least available in moderate numbers to people as we get into the winter of 2021,' Dr. Fauci said."
