Published: Feb 22, 2021
AUSTIN, Texas, Feb. 22, 2021 (GLOBE NEWSWIRE) Cassava Sciences Inc., (Nasdaq: SAVA), a biotechnology company developing product candidates for Alzheimer’s disease, today announced the successful completion of an End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) for simufilam, its lead drug candidate for the treatment of Alzheimer’s disease. Official EOP2 meeting minutes indicate FDA and Cassava Sciences agree on key elements of a pivotal Phase 3 clinical program in support of a New Drug Application (NDA) filing for simufilam in Alzheimer’s disease. Agreements reached during the EOP2 meeting show a clear path forward for advancing simufilam into Phase 3 studies in the second half of 2021.
Some Safety Concerns about Vaccines
A report raised alarm about at least 36 people who developed a rare, lethal blood disorder, called thrombocytopenia, after receiving either of the two approved COVID-19 vaccines in the US. A Miami obstetrician, Gregory Michael, just 56, died of a brain hemorrhage just 16 days after receiving a Pfizer vaccination. His thrombocytopenia had caused his platelets to drop to virtually zero.
A Johns Hopkins University expert on blood disorders, Jerry L. Spivak, who was uninvolved in Michael’s care, said that based on Michael’s wife’s description: “I think it is a medical certainty that the vaccine was related [to Michael’s death].”
William Beaver, groundbreaking painkiller researcher who drafted the initial rules for FDA clinical drug trials, dies of covid complications Spencer Hsu William T. Beaver, a medical educator and researcher who helped establish a scientific basis for the use of painkilling drugs from aspirin to morphine and later chaired a federal panel on the medical use of marijuana, died of complications from covid-19 on Nov. 12 at a care facility near his longtime home in Waterford, Va., his family said. He was 87. Beaver was the clinical pharmacologist at Georgetown University who is credited with drafting the initial federal regulations defining “adequate and controlled” clinical studies, according to a 2008 history of clinical trials and the U.S. Food and Drug Administration.
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