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PiCoVacc / SinovacChinese COVID-19 vaccine approved to enter Phase III clinical trial in Brazil (Globaltimes) - Jul 7, 2020 - "The Brazilian National Regulatory Agency, Anvisa, granted approval to a phase III clinical trial sponsored by Instituto Butantan... to test the efficacy and safety of the inactivated COVID-19 vaccine developed by Sinovac Life Sciences Co in Brazil. This trial aims to be a pivotal study to support the licensing of the product....The trial will recruit nearly 9,000 healthcare professionals to work in COVID-19 specialized facilities in 12 clinical sites in several states in Brazil. The recruitment is scheduled to start this month after ethical approval is obtained from each clinical site."desidustat (ZYAN 1) / Zydus CadilaZydus receives approval from COFERIS, Mexico to study Desidustat in the management of COVID-19 (Equitybulls) - Jul 5, 2020 - "Zydus...today announced that it has received approval from the regulatory authority of Mexico...Desidustat to be tested in the management of COVID-19....The company will be conducting a Phase 2b, Multicenter, Open-label, Randomized, Comparator- Controlled Study....Zydus had initiated two Phase III trials of Desidustat. The DREAM-ND Phase III trial is being conducted in 588 CKD patients not-on-dialysis. The DREAM-D Phase III trial is being conducted in 392 CKD patients on Dialysis'."remdesivir / Generic mfg.Australia approves Gilead's remdesivir for COVID-19 treatment (Yahoo News) - Jul 10, 2020 - "Australia has granted provisional approval to Gilead Sciences Inc's remdesivir as the first treatment option for COVID-19 in the country....The approval is for adults and adolescent patients with severe COVID-19 symptoms and have been hospitalised..."Alzumab (itolizumab) / Biocon, EquilliumBiocon Biologics’ itolizumab gets DCGI nod for emergency use to treat covid-19 (Livemint) - Jul 11, 2020 - "Biocon Biologics has received an emergency use authorisation (EUA) for its monoclonal antibody Itoliuzumab from the Drug Controller General of India (DCGI) to treat cytokine storms....As per the DCGI, the novel drug can be used only in a hospital set-up, and requires informed consent of patients and a risk management plan."Ryoncil (remestemcel-L) / Mallinckrodt, Mesoblast, JCR PharmaExpanded Access Protocol Initiated for Compassionate Use of Remestemcel-L in Children With Multisystem Inflammatory Syndrome Associated With COVID-19 (GlobeNewswire) - Jul 6, 2020 - "Mesoblast Limited...today announced that an expanded access protocol (EAP) has been initiated in the United States for compassionate use of its allogeneic mesenchymal stem cell (MSC) product candidate remestemcel-L in the treatment of COVID-19 infected children with cardiovascular and other complications of multisystem inflammatory syndrome (MIS-C). Patients aged between two months and 17 years may receive one or two doses of remestemcel-L within five days of referral under the EAP....The protocol was filed with the United States Food and Drug Administration (FDA)..."Constant Therapeutics' TXA127 to be tested in Multiple Clinical Trials for COVID-19 Patients (PRNewswire) - Jul 8, 2020 - "Constant Therapeutics today announced that its peptide drug TXA127 will be tested in a series of Phase 2 clinical trials in hospitalized COVID-19 patients who are not in the Intensive Care Unit (ICU). The trials will be conducted at medical centers in the United States, including the Brigham and Women's Hospital in Boston, Massachusetts; Policlinico S. Orsola-Malpighi Hospital in Bologna, Italy; and at sites in Israel affiliated with Bar-Ilan University and Technion Israel Institute of Technology. Over 400 patients are expected to be recruited."cryopreserved cord blood derived T-regulatory cells (CK0802) / CellenkosJohns Hopkins Reports Promising Clinical Data in COVID-19 ARDS Treated with Cellenkos' Cord Blood T-Regulatory Cells (PRNewswire) - Jul 7, 2020 - P=NA, N=2; "Physician-investigators at Johns Hopkins University Hospital report on the promising data of treatment of COVID-19 induced acute respiratory distress syndrome with allogeneic, cord blood derived T-regulatory (Treg) cell therapy....Patients received cell therapy under FDA Emergency Use IND for up to 3 doses. Clinical improvement was evident within 48 hours of first infusion and correlated with concurrent dampening of the cytokine storm....The multicenter clinical trial is set to launch in Q3 2020..."REGN10933/REGN10987 / RegeneronRegeneron Announces Manufacturing and Supply Agreement for BARDA and U.S. Department of Defense for REGN-COV2 Anti-Viral Antibody Cocktail (PRNewswire) - Jul 7, 2020 - "Regeneron Pharmaceuticals, Inc....today announced that, as part of Operation Warp Speed... Executive Office for Chemical, Biological, Radiological and Nuclear Defense have awarded Regeneron a $450 million contract to manufacture and supply REGN-COV2. REGN-COV2 is Regeneron's investigational double antibody cocktail that is currently in two Phase 2/3 clinical trials for the treatment of COVID-19 and in a Phase 3 trial....Regeneron continues to work to maximize manufacturing capacity of REGN-COV2 within Regeneron and with potential partners."beraprost isomer (GP1681) / CytoAgentsCytoAgents Receives Funding to Accelerate COVID-19 Clinical Trials for Cytokine Storm Treatment From Richard King Mellon Foundation (Businesswire) - Jul 7, 2020 - "CytoAgents...announced today that it has received an investment to accelerate the development of its lead drug candidate, GP1681, an investigational new drug to treat 'cytokine storm' induced by COVID-19, from the Richard King Mellon Foundation. The Program Related Investment is part of the foundation’s $25 million Pandemic Solutions Package to jump-start COVID-19 response strategies....The $250,000 investment will accelerate the development of GP1681, which will be going into Phase 1 and Phase 2 human clinical trials in 2020."COVID-19: Moderna's vaccine has shown "very promising results", says Dr. Anthony Fauci (The Economic Times) - Jul 9, 2020 - "Dr. Anthony Fauci...says he is cautiously optimistic a vaccine 'with some degree' of effectiveness will be successfully developed by the beginning of 2021. He said Moderna's vaccine has shown 'very promising' results' which makes me cautiously optimistic, although you could never, ever predict with any certainty whether a vaccine is going to be safe and effective."
