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Kevzara (sarilumab) / Asahi Kasei, Regeneron, SanofiSanofi provides update on Kevzara (sarilumab) Phase 3 trial in severe and critically ill COVID-19 patients outside the U.S. (GlobeNewswire) - Sep 1, 2020 - P3, N=409; NCT04327388; Sponsor: Sanofi; "Sanofi today announced that the global Phase 3 trial investigating intravenously administered Kevzara...did not meet its primary endpoint and key secondary endpoint....Although not statistically significant, numerical trends were observed toward a decrease in duration of hospital stay as well as an acceleration in time to improve clinical outcomes....A trend was observed towards reduced mortality in the critical patient group which was not seen in the severe patient group....At this time, Sanofi and Regeneron do not anticipate conducting further clinical studies for Kevzara in COVID-19."Coronavirus Vaccine / Sanofi, GSKSanofi and GSK initiate Phase 1/2 clinical trial of COVID-19 adjuvanted recombinant protein-based vaccine candidate (GlobeNewswire) - Sep 3, 2020 - "Sanofi and GSK today started the Phase 1/2 clinical trial for their adjuvanted COVID-19 vaccine. The companies anticipate first results early December 2020 which will support the initiation of a Phase 3 trial in December 2020. If data are sufficient for licensure application, the plan is to request regulatory approval in the first half of 2021....Preclinical data showed an acceptable reactogenicity profile....The partners plan to supply a significant portion of total worldwide available supply in 2021/2022 to COVAX..."BNT162b1 / Fosun Pharma, BioNTech, Pfizer; BNT162b2 / Pfizer, Fosun Pharma, BioNTechCOVID-19 Vaccine Could Come In Late October; White House Says No Pressure On Timing (News18 India) - Sep 3, 2020 - "U.S. public health officials and Pfizer Inc said a COVID-19 vaccine could be ready for distribution as soon as late October....Pfizer on Thursday said it should know by the end of October whether a COVID-19 vaccine it is developing with German partner BioNTech SE is safe and effective. The U.S. drugmaker said it will seek approval immediately if trial results are positive. It has already manufactured hundreds of thousands of doses."remdesivir / Generic mfg.Remdesivir prices may rise after Gilead gets full authorisation from USFDA (Business Standard) - Sep 5, 2020 - "Prices of a key drug used to treat hospitalised Covid-19 patients, remdesivir, may rise once the innovator, Gilead, gets a full approval from the US drug regulator....Currently, generic manufacturers make and sell remdesivir in India under a voluntary licensing agreement and are not required to pay any royalty to the innovator....Company had met all requirements for a full authorisation for remdesivir, and expected the approval to come soon."AZD1222 / Oxford Biomedica, Emergent Biosolutions, Jenner Institute, Vaccitech, AstraZeneca, University of OxfordOxford Biomedica Signs Supply Agreement with AstraZeneca to Expand Manufacturing Support of COVID-19 Vaccine Candidate, AZD1222 (GlobeNewswire) - Sep 1, 2020 - "Oxford Biomedica plc...announced today that it has signed an 18 month supply agreement under a three year Master Supply and Development Agreement ('the Agreement') with AstraZeneca UK Ltd ('AstraZeneca') for large-scale commercial manufacture of the adenovirus vector-based COVID-19 vaccine candidate, AZD1222. The Parties may extend the supply period for AZD1222 by a further 18 months into 2022 and 2023 by mutual agreement. Under the terms of the Agreement, AstraZeneca will pay Oxford Biomedica £15million upfront as a capacity reservation fee."Coronavirus: What Is Herd Immunity And Is It A Possibility For The UK? (The Independent) - Sep 2, 2020 - "Professor Paul Hunter...added that herd immunity is 'an indication of the proportion of people who are immune in a population'. 'The relationship of the proportion of people that are immune that you need to prevent an epidemic varies from infection to infection,' he outlined....In Professor Hunter's opinion, herd immunity is unlikely to happen until next year 'when we hopefully will have a vaccine'. 'I am just making effectively educated guesses at this point, but I suspect we won't see the last of it this year,' he stated."Despite CDC’s Changed Advice, WHO Confirms Anyone Exposed to COVID-19 Should Be Tested - Aug 31, 2020 - "When asked about the shift...Maria Van Kerkhove did not mention the US situation specifically but told reporters the UN health agency recommends that contacts, if feasible, should be tested, regardless of the development of symptoms....While the main focus of testing is on those who develop symptoms, Van Kerkhove said that especially when investigating clusters of cases, 'testing may need to be expanded to look for individuals who are on the more mild end of the spectrum or who may indeed be asymptomatic.'"
