Monday, November 09, 2020 – 06:45am Vaccine candidate was found to be more than 90% effective in preventing COVID-19 in participants without evidence of prior SARS-CoV-2 infection in the first interim efficacy analysis Analysis evaluated 94 confirmed cases of COVID-19 in trial participants Study enrolled 43,538 participants, with 42% having diverse backgrounds, and no serious safety concerns have been observed; Safety and additional efficacy data continue to be collected Submission for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) planned for soon after the required safety milestone is achieved, which is currently expected to occur in the third week of November Clinical trial to continue through to final analysis at 164 confirmed cases in order to collect further data and characterize the vaccine candidate’s performance against other study endpoints This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201109005539/en/ NEW YORK & MAINZ, GERMANY–(BUSINESS WIRE)– Pfizer Inc. (NYSE: ...
Pfizer objected to the use of its drugs for lethal injection procedures last year by asking states to return the drugs immediately for a refund. But not all of them have halted its utilization. Hence, with an execution planned in Nebraska dated Aug. 14, a state senator is urging Pfizer to prosecute if the drug usage is not halted.
The U.S. healthcare system and the FDA have been affected by manufacturing issues at one of the largest U.S. drugmakers, Pfizer. The company’s Hospira unit is the largest producer of injectable opioid analgesics used in hospitals.
The FDA granted approval to Pfizer for Retacrit (epoetin alfa-epbx), which is used for the treatment of anemia, biosimilar of Amgen, a drug which generated sales closely $ 1.8 billion in the U.S market last year for Amgen and Johnson & Johnson partners. Retacrit also received the go-ahead to be used in RBC transfusions by U.S health regulators.
Pfizer announced today that it is receiving applications for its Pfizer Healthcare Hub: London competitive grant. This is the second time that Pfizer has held the startup-focused program, which representatives from biopharmaceutical company said had a strong inaugural year in 2017.
The EU medicines regulator has started its review of Astellas and Pfizer’s prostate cancer drug Xtandi in what looks likely to become a hotly contested indication - non-metastatic castration-resistant prostate cancer (nmCRPC).
Pfizer Inc. announced a positive outcome from today’s U.S. Food and Drug Administration (FDA) Gastrointestinal Drugs Advisory Committee (GIDAC) meeting. The GIDAC met to discuss Pfizer’s supplemental New Drug Application (sNDA) for XELJANZ® (tofacitinib), which is currently under review by the FDA, for the treatment of adult patients with moderately to severely active ulcerative colitis (UC).
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