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bucillamine / Revive TherapRevive Therapeutics Announces U.S. FDA Approval of Confirmatory Phase 3 Clinical Trial for Bucillamine in COVID-19 (GlobeNewswire) - Jul 31, 2020 - "Revive Therapeutics Ltd...is pleased to announce that the U.S. Food & Drug Administration ('U.S. FDA') has approved the Company to proceed with a randomized, double-blind, placebo-controlled confirmatory Phase 3 clinical trial protocol to evaluate the safety and efficacy of Bucillamine in patients with mild-moderate COVID-19....'We are now focused on executing on our plans for initiating the clinical trial in an expeditious manner'....The Phase 3 confirmatory clinical study...will enroll up to 1,000 patients..."remdesivir / Generic mfg.Health Canada Grants Marketing Authorization with Conditions (NOC/c) for Gilead's Veklury (Remdesivir) for the Treatment of Coronavirus Disease 2019 (COVID-19) (Canada Newswire) - Jul 28, 2020 - "Gilead Sciences Canada, Inc. today announced that Health Canada has issued a marketing authorization with conditions (Notice of Compliance with Conditions, or NOC/c) for Veklury® (remdesivir). Under this conditional authorization, Veklury is indicated for the treatment of COVID-19 in adults and adolescents aged 12 years and older and weighing at least 40 kg, with pneumonia requiring supplemental oxygen....Gilead is working with the Public Health Agency of Canada (PHAC) and Health Canada to provide Veklury for Canadians over the coming weeks."Actemra IV (tocilizumab) / Roche, JW PharmaRoche provides an update on the phase III COVACTA trial of Actemra/RoActemra in hospitalised patients with severe COVID-19 associated pneumonia (GlobeNewswire) - Jul 29, 2020 - P3, N=450; COVACTA (NCT04320615); Sponsor: Hoffmann-La Roche; "...COVACTA study of Actemra®/RoActemra® (tocilizumab) did not meet its primary endpoint of improved clinical status in hospitalised adult patients with severe COVID-19 associated pneumonia. In addition, the key secondary endpoints...were not met; however, there was a positive trend in time to hospital discharge in patients treated with Actemra/RoActemra....There was no difference between Actemra/RoActemra and placebo in the percentage of patients that died by week four..."interferon beta inhalation (SNG001) / SynairgenUndercutting severe COVID-19 with inhaled interferon beta (Ophthalmology Times) - Jul 31, 2020 - "SNG001, the inhaled formulation of interferon beta, significantly decreased the chances of hospitalized patients developing severe COVID-19 compared to placebo....Synairgen is now working with regulators and other key groups to obtain approval of this potential COVID-19 treatment."BNT162b2 / Pfizer, Fosun Pharma, BioNTechPfizer and BioNTech to Supply Japan with 120 Million Doses of their BNT162 mRNA-based Vaccine Candidate (Businesswire) - Jul 31, 2020 - "Pfizer Inc. (NYSE: PFE) and BioNTech SE (Nasdaq: BNTX) today announced an agreement with the Ministry of Health, Labour and Welfare (MHLW) in Japan to supply 120 million doses of BNT162 mRNA-based vaccine candidate against SARS-CoV2, subject to clinical success and regulatory approval....As requested by the Government of Japan, deliveries of the vaccine candidate are planned for the first half of 2021....Assuming clinical success, Pfizer and BioNTech are on track to seek regulatory review for BNT162b2 as early as October 2020..."BNT162b2 / Pfizer, Fosun Pharma, BioNTechPfizer and BioNTech Choose Lead mRNA Vaccine Candidate Against COVID-19 and Commence Pivotal Phase 2/3 Global Study (Businesswire) - Jul 27, 2020 - "Pfizer...announced the start of a global (except for China) Phase 2/3 safety and efficacy clinical study to evaluate a single nucleoside-modified messenger RNA (modRNA) candidate from their BNT162 mRNA-based vaccine program against SARS-CoV-2....Pfizer and BioNTech have chosen to advance their BNT162b2 vaccine candidate into the Phase 2/3 study, at a 30 µg dose level in a 2 dose regimen....If the Phase 2/3 trial is successful, Pfizer and BioNTech expect to be ready to seek Emergency Use Authorization or some form of regulatory approval as early as October 2020."dexamethasone / Generic mfg.EMA initiates review of dexamethasone for treating COVID-19 (European Pharmaceutical Review) - Jul 28, 2020 - P2/3, N=15,000; RECOVERY (NCT04381936); "The European Medicines Agency (EMA) has announced it is reviewing results from the RECOVERY study arm that involved the use of dexamethasone....This part of the study looked into the effects of adding dexamethasone to usual care in adults receiving invasive ventilation....Compared with usual care, dexamethasone: reduced mortality by about 35 percent in patients on invasive mechanical ventilation; reduced mortality by about 20 percent in patients receiving oxygen without invasive ventilation; did not reduce death in patients who were not receiving oxygen therapy."Ii-Key Peptide-based Covid-19 vaccine / Shandong Academy of Sciences, GenerexGenerex Biotechnology Announces That FDA has Accepted the Pre-IND Briefing Package for the Company’s Ii-Key-SARS-CoV-2 Vaccine and Will Provide a Written Response by August 24, 2020 (GlobeNewswire) - Jul 27, 2020 - "Generex Biotechnology Corporation...today announced that the FDA has accepted their pre-IND briefing package for the Ii-Key-SARS-CoV-2 coronavirus prophylactic vaccine, and will provide a written response by August 24, 2020....With their response, the FDA will comment on the Phase I/II clinical trial plan and will provide guidance on the overall development program for the Ii-Key-SARS-CoV-2 vaccine."remdesivir / Generic mfg.Colombia started studies with Remdesivir and Interferon Beta in patients with Covid-19 (Valora Analitik) - Jul 27, 2020 - "...in Colombia, the Ministry of Health decided to do the studies with two drugs: Remdesivir and Interferon Beta....The inclusion of the first patient in the study began at the Colombia University Clinic in Bogotá. Participation in this procedure was completely voluntary. In the coming weeks, other patients...are expected to agree to be treated with one of these two drugs....The National Institute of Surveillance and Medicines (Invima) approved the 'Solidarity' study...and, currently, there are about 20 more medical institutions in administrative processes typical of clinical research to start the research."mRNA-1273 / ModernaModerna Announces Expansion of BARDA Agreement to Support Larger Phase 3 Program for Vaccine (mRNA-1273) Against COVID-19 (Businesswire) - Jul 26, 2020 - "Moderna, Inc....today announced a modification to its contract with the Biomedical Advanced Research and Development Authority (BARDA) for an additional commitment of up to $472 million....Company has decided to conduct a significantly larger Phase 3 clinical trial, leaving a gap in BARDA funding....Under the terms of the revised contract, BARDA is expanding their support of the Company’s late stage clinical development....The total value of the award is now approximately $955 million....The Phase 3 COVE study...is expected to begin tomorrow, July 27."Ryoncil (remestemcel-L) / Mallinckrodt, Mesoblast, JCR PharmaMesoblast Provides Remestemcel-L Update and Quarterly Activity Report (GlobeNewswire) - Jul 30, 2020 - "The independent Data Safety Monitoring Board (DSMB) has set a date for early September to complete the first interim analysis of the Phase 3 trial of remestemcel-L in ventilator-dependent COVID-19 patients....The clinical protocol evaluating remestemcel-L in patients in the Phase 3 trial was based on results from a pilot study...Up to 30 leading medical centers across the United States are expected to participate in the trial, which is expected to complete recruitment in September 2020."
