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Vyrologix (leronlimab) / CytoDyn, Vyera PharmaCytoDyn Requests “Fast Track Approval” for COVID-19 Patients from U.K.’s Regulatory Agency MHRA based on its Top-line Report Showing Statistically Significant Endpoint, NEWS2 (p < 0.023) and Notable Safety Results (GlobeNewswire) - Aug 19, 2020 - "CytoDyn Inc....announced today the Company provided its Top-line Report from its recently completed Phase 2 clinical trial...to Medicines and Healthcare Products Regulatory Agency....Company requested the regulatory pathway for Fast Track approval noting the efficacy and safety results from the Phase 2 trial....'We are eager to see the capabilities of leronlimab in our Phase 3 clinical trial for the severe-to-critical patient population. Our enrollment is now at 182 and we are very optimistic we will reach 195 by the end of August.'"favipiravir / Generic mfg.Dr Reddy’s launches antiviral drug Avigan in India, to launch remdesivir in September (The Economic Times) - Aug 19, 2020 - "Generic drugmaker Dr Reddy’s Laboratories launched antiviral drug Avigan (favipiravir) tablets....Company’s US arm is currently taking up a multi-centre, randamised, double blind, placebo controlled clinical trials to further evaluate the efficacy and safety of favipiravir....The study in collaboration with GRA obtained approval for the protocol to be initiated this month, beginning the study on the first patient on Wednesday. The generic drugmaker hopes to complete the multi-ethnic trials on over 700 patients during the 10-12 weeks....Pricing Avigan in 200mg dosages at Rs 99 a tablet in a complete therapy pack of 122 tablets with a two-year shelf life....Dr Reddy’s will initiate phase-IV study for Avigan in India to further establish its efficacy....The company is also looking at coming up with Avigan in 400mg dosages for the benefit of patients."Vyrologix (leronlimab) / CytoDyn, Vyera PharmaCytoDyn Submits its Top-line Report from its Phase 2 COVID-19 Trial to the U.S. FDA and Requests Emergency Use Approval (GlobeNewswire) - Aug 17, 2020 - "CytoDyn Inc....has provided its Top-line Report from its recently completed, randomized, double-blind, Phase 2 trial for COVID-19 patients...to the U.S. Food and Drug Administration (FDA), and requested emergency use approval. In addition, CytoDyn has sent...to the regulatory authorities in Mexico and hopes to obtain emergency use approval from the MHRA in the U.K., EMA in the European Union, as well as the regulatory authorities in the Philippines....The Company is preparing a Phase 3 protocol and will file it as soon as possible."FDA's emergency approval of blood plasma as COVID-19 treatment on hold - NYT (Reuters) - Aug 19, 2020 - "The emergency approval of blood plasma as a potential COVID-19 treatment by the U.S. Food and Drug Administration has now been put on hold....A group of top federal health officials including Anthony Fauci have argued that the emerging data on the treatment was too weak the report said, adding that an emergency approval could still be granted in the near future. The authorization is on hold for now..."ArtemiC / MGC PharmaMGC Pharmaceuticals interim results of ArtemiC in Phase II trial on COVID-19 infected patients meet all primary objectives (Proactiveinvestors) - Aug 19, 2020 - P2, N=50; NCT04382040; Sponsor: MGC Pharmaceuticals d.o.o; "The Phase II double-blind, placebo-controlled clinical trial has met all the primary objectives, with all 10 patients showing significant improvement. Shares jumped 43% on release of the news to A$0.037 and are up from A$0.021 at the market close on July 31....The statistically proven results show two important clinical outcomes: A significant improvement in the clinical parameters of patients in the treatment group; and; No adverse events occurred, demonstrating the safety of the treatment."azithromycin / Generic mfg.COVID-19 pandemic ‘could be quite damaging’ to efforts to end other diseases (Healio) - Aug 21, 2020 - "According to Peter J. Hotez, MD, PhD...Because of the COVID-19 pandemic, however, Hotez worries these efforts may be slowed, interrupted or halted. 'The Mass Drug Administration's program is huge in continuing eradication efforts toward lymphatic filariasis, river blindness and trachoma. It's really important,' Hotez said. 'Now we're finding it extends to yaws, scabies and some of the others. So, continuing those programs of preventive treatment for the Mass Drug Administration is a top priority'....Hotez named azithromycin, a common antibiotic for strep throat and sinusitis that can also be used for trachoma, as an example. However, efforts to use this drug may be slowed because of the pandemic, he said."Dr. Fauci: Long-term effects of COVID-19 'really troublesome' (The Denver Channel) - Aug 18, 2020 - "Dr. Anthony Fauci has a warning for young adults who think they will bounce back from COVID-19....'We'd better be careful when we say 'Young people who don't wind up in the hospital are fine, let them get infected, it's OK.' No, it's not OK,' Dr. Fauci said during the briefing....He called these findings 'really troublesome' because they are constantly evolving as the world learns more about COVID-19 and the long-term impacts on the human body."Coronavirus: Vaccine will not be mandatory in US, says health expert Anthony Fauci - Aug 20, 2020 - "United States' top infectious disease expert Dr Anthony Fauci on Wednesday said any future coronavirus vaccine would not be mandatory for the general public in the America, AFP reported. He, however, said that states can make it obligatory for some groups. 'You can mandate [the vaccine] for certain groups of people like health workers, but for the general population you can’t,' he said. Fauci, who was speaking at a video conference organised by the George Washington University, added that at the National Institutes of Health, health workers need to have a flu shot before they can treat patients."WHO hopes COVID-19 pandemic ends within 2 years, says chief Tedros Adhanom Ghebreyesus - Aug 22, 2020 - "Tedros Adhanom Ghebreyesus described COVID-19 as a once-in-a-century health crisis and said that while globalisation had allowed the virus to spread quicker than the flu did in 1918, there was also now the technology to stop it that hadn't been available a century ago....'We hope to finish this pandemic (in) less than two years, especially if we can pool our efforts,' he said during a press briefing on Friday."COVID-19: Herd immunity requires effective vaccine, says WHO (The Tribune) - Aug 18, 2020 - "WHO's emergencies chief Dr Michael Ryan largely dismissed that theory at a press briefing on Tuesday, saying we should not live 'in hope' of achieving herd immunity. 'As a global population, we are nowhere close to the levels of immunity required to stop this disease transmitting,' he said. 'This is not a solution and not a solution we should be looking to.' Most studies conducted to date have suggested only about 10 per cent to 20 per cent of people have antibodies."
