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India-Sweden Healthcare Innovation Centre in collaboration with AstraZeneca India launches a Nurses' Upskilling in NCDs (NUN) program – India Education | Latest Education News | Global Educational News indiaeducationdiary.in - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from indiaeducationdiary.in Daily Mail and Mail on Sunday newspapers.
Interim Report Q1, 2021 Share this article Filing of New Drug Application submission to the FDA Following the positive top line readout of our pivotal Phase 3 trial NefIgArd, which met both the primary and key secondary endpoints with results being statistically significant and clinically relevant we commenced the regulatory filing process which ultimately resulted in the timely filing of the submission to the FDA in Q1 as planned. In April, we received the response from the Food and Drug Administration (FDA) who accepted the submission and granted Priority Review for the New Drug Application (NDA) for Nefecon. The FDA have set a Prescription Drug User Fee Act (PDUFA) goal date of September 15, 2021. During Q1, we also submitted a request for accelerated assessment to the EMA, which was granted on April 23rd. These grants reflect the perceived unmet medical need in IgAN by regulators and, in my view, also the strength and overall quality of our dossier. ....
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COVID infections down in Texarkana (Source: WBTV File) By Fred Gamble | April 16, 2021 at 1:20 PM CDT - Updated April 16 at 1:21 PM TEXARKANA, Texas (KSLA) - Over 10,000 shots of the COVID-19 vaccine have been administered at Christus St. Michael Health System in Texarkana since Texas state leaders declared it a hub three months ago. The results are positive for the community and health care providers. “We are finally at a point in Texarkana where we can say that the number of people we have vaccinated has had a positive effect on our community,” said Dr. Loren Robinson, VP Medical Affairs. Christus St. Michael Health Center, like other health care providers, has been affected by COVID-19. While treating patients many front-line workers have been infected with the virus. However, here at this Texarkana hospital employees began receiving a COVID vaccine this past December, and leaders are pleased with the results. ....