Other Posts
remdesivir / Generic mfg.
U.S. Food and Drug Administration Approves Gilead’s Antiviral Veklury (remdesivir)for Treatment of COVID-19 (Gilead PressRelease) - Oct 22, 2020 - "Gilead Sciences...announced that the U.S. Food and Drug Administration (FDA) has approved the antiviral drug Veklury®(remdesivir)....The drug is now widely available in hospitals across the country....In the United States, Veklury is indicated for adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization....FDA also issued a new Emergency Use Authorization (EUA) for the use of Veklury to treat hospitalized pediatric patients under 12 years of age weighing at least 3.5 kg or hospitalized pediatric patients weighing 3.5 kg to less than 40 kg with suspected or laboratory confirmed COVID-19 for whom use of an intravenous (IV)agent is clinically appropriate."
Alzumab (itolizumab) /Biocon, Equillium
Bioconinitiates global phase-3 trials for Itolizumab, holds meeting with USFDA(The Hindu Business Line) - Oct 23, 2020 -"The phase-4 clinical study in India is being conducted to generate a larger body of scientific evidence....'Equilium...is advancing along a regulatory pathway in preparation in initiating global phase-3 clinical trials in Q4 of Calendar 2020'....'We have commenced enrolment for a 300-patient,phase-4 clinical study across 15 centres,' she added."
Sputnik-V (Gam-COVID-VacLyo) / Gamaleya Research Institute
Second Brazilian company to produce Russia’s Sputnik V COVID-19 vaccine (Reuters) - Oct 24, 2020 - "A Brazilian pharmaceutical company...has signed an agreement with the Russian Direct Investment Fund (RDIF) to produce Russia’s Sputnik V vaccine against COVID-19starting in the second half of November....The Brazilian state of Bahia has also signed an agreement to conduct Phase III clinical trials of the Sputnik V vaccine and plans to buy 50 million doses to market in northeastern Brazil....'We have to conduct a Phase III clinical trial, which should start in November and take until January or February'....'Only after that study will Anvisa decide on registering the Russian vaccine.'"
AZD1222 / OxfordBiomedica, Emergent Biosolutions, Jenner Institute, Vaccitech, AstraZeneca,University of Oxford
FDA authorises restart of the COVID-19 AZD1222 vaccine US Phase III trial(AstraZeneca Press Release) - Oct 23, 2020 -"AZD1222 clinical trials now resumed globally; The Food and Drug Administration (FDA) today authorised the restart in the US, following theresumption of trials in other countries in recent weeks. The FDA reviewed all safety data from trials globally and concluded it was safe to resume thetrial....Results from the late-stage trials are anticipated later this year,depending on the rate of infection within the communities where the clinical trials are being conducted."
mRNA-1273 / Moderna
Moderna’schief exec expects to have COVID-19 vaccine data in November (PMLive) - Oct 20, 2020 - "Moderna’s chief executive officer Stéphane Bancel...expects interim results from the company’sCOVID-19 vaccine trial in November....Vaccine candidate could be granted an emergency use authorisation (EUA) by the US Food and Drug Administration(FDA) in December, assuming that the data from its phase 3 trial is positive....'Depending on if there are sufficient interim results demonstrating efficacy from the study, Moderna may have to push back its regulatory submission to next year'....For Moderna to apply for an EUA, 53 subjects in its phase 3 study need to be infected with the novel coronavirus, and the cases in the placebo arm need to be significantly higher than those in the vaccinated arm. If the trial does not show sufficient efficacy at this point, Moderna will aim to evaluate the success of the vaccine when 106 trial participants contract symptomatic COVID-19."
remdesivir / Generic mfg.
WHO says it will have advice on remdesivir in 3-4 weeks (Reuters) - Oct 23, 2020 - "The World Health Organization (WHO) said on Friday it is preparing guidelines on use of the drug remdesivir for COVID-19 and should be able to release them in three to four weeks....A large WHO study earlier this year on COVID-19 patients in hospital found that the drug probably had no effect on their survival rate....A WHO panel will convene next week to look at all evidence of the effectiveness of the drug....U.S. FDA drug regulator does not appear to have taken the results of the global health body’s study into account in giving approval."
Vyrologix (leronlimab) /CytoDyn, Vyera Pharma
CytoDynReceives Positive DSMC Recommendation after Interim Analysis for Leronlimab Phase 2b/3 COVID-19 Registrational Trial (GlobeNewswire)- Oct 20, 2020 - "The interim analysis was performed on data from the first 195 (50%) of 390 planned patients....The DSMC recommends the trial continue without modification to achieve the primary endpoint and requests another interim analysis when enrollment reaches 75% level....Trial enrollment is currently at 230 patients. The Company is working diligently to accelerate patient enrollment in the U.S. and U.K....with the goal of full enrollment(390) before year end. Clinical trial sites in the U.K. are expected to initiate enrollment in the coming days....'We are seeking ongoing guidance...for a swift regulatory approval pathway for leronlimab to treat COVID-19. During today’s webcast, we will discuss in depth all of our priorities dedicated to advancing leronlimab as a therapeutic forCOVID-19...'"
Ad26.COV2-S / J&J,BARDA
Johnson& Johnson Prepares to Resume Phase 3 ENSEMBLE Trial of its Janssen COVID-19Vaccine Candidate in the U.S. (J&J Press Release) - Oct 23, 2020 - "Johnson & Johnson announced today that it is preparing to resume recruitment in the pivotal Phase 3ENSEMBLE trial...after a temporary pause. The independent Data Safety and Monitoring Board (DSMB) overseeing the ENSEMBLE study has recommended resuming trial recruitment....Preparations to resume the trial in the United States, including submissions for approval by the Institutional Review Boards, are now underway. Discussions with other regulators around the world to resume the clinical trial program are progressing."
Sputnik-V (Gam-COVID-VacLyo) / Gamaleya Research Institute
First results of Russian COVID vaccine trial to include data from 5,000-10,000 people- developers (Reuters) - Oct 19,2020 - "Interim results from Russia’s late-stage human trial of a COVID-19vaccine could include data from 5,000-10,000 participants, Denis Logunov, a director at the Gamaleya Institute that developed the vaccine, said on Monday. The trial of the Sputnik V vaccine, involving 40,000 volunteers, has been underway in Moscow since the beginning of September. Interim results are expected to be published in November."
Kineret (anakinra) /SOBI, Affibody; dexamethasone / Generic mfg.; Actemra IV (tocilizumab)/ Roche, JW Pharma
Feinstein Institutes researchers find effective COVID-19 ‘cytokine storm’ treatment (Businesswire) - Oct 20, 2020 - "In a retrospective study of nearly 6,000 patients, researchers from...have identified the most effective immunomodulatory therapies to treat patients with evidence of this cytokine storm and improve patient survival....Patients were divided into one of six groups....The results show that the most effective treatment was the combination of corticosteroids – such as dexamethasone – with tocilizumab when compared to standard of care...There was an improvement if corticosteroids were used alone, or in combination with tocilizumab or anakinra when compared with standard of care."
U.S. FDA panel to discuss COVID-19 vaccine trials after emergency authorization(Reuters) - Oct 21, 2020 - "A panel of independent experts to the U.S. health regulator will decide on the nature of clinical trials that coronavirus vaccines should go through after receiving U.S. emergency use authorization. The panel will also deliberate whether during such trials, volunteers should continue to receive placebo....The U.S. Food and Drug Administration’s (FDA) experts will also discuss on Thursday the criteria for allowing emergency use of a COVID-19 vaccine and plans to monitor its safety after a regulatory go-ahead."
Comparative Analysis of COVID-19 Reveals a Cytokine Shower, Not a Storm (Businesswire) - Oct 19, 2020 - "The study, which analyzed data from 25 research studies between November 1, 2019 and April14, 2020, revealed that cytokine levels in both severely and critically illCOVID-19 patients were profoundly lower than what was observed in other inflammatory syndromes....The results show the cytokine response in ARDS was12-fold higher than what was seen in those with COVID-19, compared to 25 times higher with sepsis and 85 times higher with CRS. The findings suggest clinicians should exercise restraint in administering anti-cytokine therapies for COVID-19 until randomized evidence is available."
U.S. disease expert Fauci says vaccine verdict due by early December (Reuters) - Oct 25, 2020 - "U.S. infectious disease expert Anthony Fauci said on Sunday it would be clear whether aCOVID-19 vaccine was safe and effective by early December, but that more widespread vaccination would not be likely until later in 2021. 'We will know whether a vaccine is safe and effective by the end of November, the beginning of December,' Fauci told the BBC. 'When you talk about vaccinating a substantial proportion of the population, so that you can have a significant impact on the dynamics of the outbreak, that very likely will not be until the second or third quarter of the year.'"
