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Actemra IV (tocilizumab) / Roche, JW PharmaRoche’s phase III EMPACTA study showed Actemra/RoActemra reduced the likelihood of needing mechanical ventilation in hospitalised patients with COVID-19 associated pneumonia (GlobeNewswire) - Sep 18, 2020 - P3, N=379; EMPACTA (NCT04372186); Sponsor: Genentech, Inc.; "Roche plans to share these results with health authorities, including the US FDA; Roche...today announced that the phase III EMPACTA study met its primary endpoint...patients with COVID-19 associated pneumonia who received Actemra®/RoActemra®...plus standard of care were 44% less likely to progress to mechanical ventilation or death compared to patients who received placebo plus standard of care....The cumulative proportion of patients who progressed to mechanical ventilation or death by day 28 was 12.2% in the Actemra/RoActemra arm versus 19.3% in the placebo arm. The EMPACTA study did not identify any new safety signals for Actemra/RoActemra....The majority of patients were Hispanic, with significant representation of Native American and Black populations."dexamethasone / Generic mfg.EU regulator backs dexamethasone as COVID-19 treatment (Reuters) - Sep 18, 2020 - "Europe’s healthcare regulator has endorsed using dexamethasone to treat COVID-19 patients with breathing difficulties....The European Medicines Agency (EMA) said...drug could be an option to treat adults and adolescents needing oxygen therapy or mechanical ventilation....It said the recommended dose in adults and adolescents, from the age of 12 years and weighing at least 40 kilograms, was 6 milligrams once a day for up to 10 days."BBIBP-CorV / Wuhan Institute of Virology, SinopharmUAE announces emergency approval for use of COVID-19 vaccine (Reuters) - Sep 14, 2020 - "The United Arab Emirates on Monday granted emergency approval for use of a coronavirus vaccine, six weeks after human trials in the Gulf Arab state started....Emergency use of the vaccine, which is still being tested, was granted after a set criteria and after it had been tested on 31,000 volunteers, it said."CoronaVac / Sinovac, Bio Farma Indonesia; Recombinant Novel Coronavirus Vaccine (Adenovirus Type 5 Vector) / CanSinoChina coronavirus vaccine may be ready for public in November: official (Reuters) - Sep 15, 2020 - "Coronavirus vaccines being developed in China may be ready for use by the general public as early as November....China has four COVID-19 vaccines in the final stage of clinical trials. At least three of those have already been offered to essential workers....Phase 3 clinical trials were proceeding smoothly and the vaccines could be ready for the general public in November or December, CDC chief biosafety expert Guizhen Wu said in an interview with state TV late on Monday."Sputnik-V (Gam-COVID-Vac Lyo) / Gamaleya Research InstituteRussia completes volunteer recruitment for COVID-19 vaccine trial: fund (Reuters) - Sep 14, 2020 - "Russia has recruited sufficient participants for its large-scale COVID-19 vaccine trial, known as a Phase III trial, the head of Russia’s sovereign wealth fund, which is backing the vaccine, said on Monday....Initial results are expected in October or November this year, officials have said."Coronavirus Vaccine / Sanofi, GSKEU pays $384 million for Sanofi-GSK COVID vaccine as WHO scheme deadline looms (Reuters) - Sep 18, 2020 - "The European Union has agreed to buy a potential COVID-19 vaccine from Sanofi and GSK in its second such deal to secure supplies....The deal will see the French and British drugmakers...provide the EU with up to 300 million doses in exchange for a down payment of 324 million euros ($384 million)....Sanofi and GSK started clinical trials of their vaccine this month and aim to reach the final testing stage by December."Dr. Fauci Says ‘There Will Be an End’ to Covid-19 - Sep 20, 2020 - "Covid-19 can be removed as a public-health threat with good, widely administered vaccines and strong public-health measures, and a degree of normality might return by the end of 2021, Dr. Anthony Fauci said Wednesday."Actemra SC (tocilizumab SC) / Roche, Halozyme, Frederiksberg University HospitalRoche rises on word of COVID trial win, new test and European cancer drug nod (Reuters) - Sep 18, 2020 - "'The EMPACTA trial demonstrated that Actemra/RoActemra can reduce the need for mechanical ventilation in patients with COVID-19 associated pneumonia,' said Levi...Empacta is the first global phase III COVID-19 clinical trial using minority patients, Roche said, adding this group, including Hispanic, Black and Native American patients, is often underrepresented in studies and has been hit harder by the pandemic than other groups."Coronavirus vaccine: EU seals second coronavirus vaccine deal (The Financial Express) - Sep 18, 2020 - "The EU Commission has finalised a deal with Sanofi and GSK allowing its 27 member states to buy up to 300 million doses of a potential COVID-19 vaccine. It's the second contract signed by the bloc's executive arm after a first agreement was reached last month with AstraZeneca for up to 400 million doses. 'With several countries in Europe experiencing new outbreaks after the summer period, a safe and effective vaccine is more instrumental than ever to overcome this pandemic and its devastating effects on our economies and societies,' said Stella Kyriakides..."
