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Sputnik-V (Gam-COVID-Vac Lyo) / Gamaleya Research InstituteIndia trials for Russia's 'Sputnik-V' vaccine could start in next few weeks: exec (Reuters) - Sep 22, 2020 - "Dr Reddy’s Laboratories Ltd could begin late-stage Indian clinical trials of Russia’s potential coronavirus vaccine in the next few weeks....Indian trials of the Sputnik-V vaccine candidate...will enroll 1,000-2,000 participants and be conducted at multiple government and private hospitals across the country....Indian firm will conduct Phase III studies in India, pursue local regulatory approvals and, subject to approval, distribute the finished vaccine product in India....The RDIF has also reached agreements with Indian manufacturers to produce 300 million doses of the shot in India."remdesivir / Generic mfg.Veklury: “The Committee adopted a positive opinion recommending the granting of a conditional marketing authorization by consensus together with the CHMP assessment report and translation timetable [Coronavirus disease]” (European Medicines Agency) - Sep 25, 2020 - CHMP Final Minutes of the meeting on 22-25 June 2020aviptadil intravenous (RLF-100 IV) / Relief Therap, NeuroRxRelief partner NeuroRx submits request for Emergency Use Authorization for RLF-100 (aviptadil) in the treatment of patients with Critical COVID-19 and Respiratory Failure who have exhausted approved therapy (PharmiWeb) - Sep 23, 2020 - P=NA, N=51; SAMICARE (NCT04453839); Sponsor: NeuroRx, Inc.; "...NeuroRx, Inc. has submitted a request for an Emergency Use Authorization (EUA) with the US FDA for the use of RLF-100(TM) aviptadil in patients who are receiving intensive care and who have exhausted all approved treatments....The submission is based on a case-control study that compared patients who were treated with RLF-100(TM) (n=21) to those receiving maximal standard of care treatment (n=30) in the same ICU by the same medical staff. Patients treated with RLF-100(TM) demonstrated a 3-fold advantage in survival, recovery from respiratory failure, and other parameters indicative of meaningful clinical improvement."favipiravir / Generic mfg.Japanese approval sought for Avigan to treat COVID-19 (Nikkei) - Sep 21, 2020 - "Fujifilm Holdings will soon apply to produce and sell its Avigan antiviral drug as a treatment for the new coronavirus in Japan....The health ministry could give the go-ahead this year, making Avigan the third drug overall and the first domestically developed drug to receive such approval....The health ministry has said it plans to fast-track approval for the drug. 'If the data from the clinical trials looks good, we could approve it in a month from when Fujifilm submits an application,' a ministry source said."remdesivir / Generic mfg.Cabinet may reduce remdesivir injection price (Dawn) - Sep 22, 2020 - "According to sources in the Ministry of National Health Services (NHS), the cabinet will consider reducing the price of remdesivir 100mg injection which is given to Covid-19 patients. 'At present, each injection is being sold for Rs10,873 but it has been decided to reduce the price to ensure that it would become affordable for all patients,' an official of the health ministry said requesting not to be quoted....The official said the cabinet will also consider the grant of exemption from section 23(1)(a)(VII) of the Drugs Act 1976."favipiravir / Generic mfg.Hetero launches pack of generic COVID-19 drug favipiravir at Rs 2,640 (The Economic Times) - Sep 26, 2020 - "Drug firm Hetero...said it has launched a pack of its generic oral antiviral drug-- Favivir 800/200-- for the treatment of mild-to-moderate symptomatic COVID-19 patients in India. Favivir 800/200 will be available in a pack containing 16 tablets of favipiravir 800 mg and 2 tablets of favipiravir 200 mg priced at Rs 2,640 per pack....The higher strength of Favipiravir 800 mg by the company has been approved by the Drug Controller General of India (DCGI). The product will be marketed and distributed by Hetero Healthcare Ltd, it added."Early Covid-19 treatments could be ‘bridge’ to vaccine, says Anthony Fauci (Hindustan Times) - Sep 27, 2020 - "Anthony Fauci said 100 million doses of vaccine may be produced by December, with all six companies supplying the US slated to have made 700 million doses by next April."Coronavirus vaccines: US, China and Russia absent from WHO's equal access COVAX coalition - Sep 22, 2020 - "However, numerous countries that have signed their own bilateral deals with vaccine makers have declined to participate or to use the facility to secure their own vaccines, including China, Russia, and the United States....Tedros Adhanom Ghebreyesus said the Covax facility, which WHO is heading up alongside with vaccines alliance GAVI and the Coalition for Epidemic Preparedness and Innovations (CEPI), will help bring the COVID-19 pandemic under control. Dr Richard Hatchett...said that 'COVID-19 cannot be beaten one country at a time. We must be able to share lifesaving vaccines globally at the same time.'"CDC’s Messonnier Says She Trusts COVID Vaccine Process (WebMD) - Sep 21, 2020 - "Nancy Messonnier, MD...We are working in partnership with Operation Warp Speed and my colleagues say that there will be vaccine available this fall but that they expect the quantities of vaccine to be limited. By next year, we should have much larger quantities of vaccine available. So, on the delivery side, we’re working to ready the country for the first implementation of vaccine this fall, but then also getting ready for a much larger availability of vaccine next year."
