Pfizer’s JAK inhibitor Xeljanz reduced the risk of severe outcomes in hospitalised adult patients with COVID-19 pneumonia who were not on ventilation, according to new study data. The STOP-COVID trial was conduction by Pfizer and the ARO from the Hospital Israelita Albert Einstein in Sao Paolo, Brazil, which was also the trial coordinating centre. Patients were randomised to receive either Xeljanz (tofacitinib) 10mg twice daily plus standard of care (SoC) or placebo twice daily plus SoC for up to 14 days or until hospital discharge. The trial demonstrated a reduced cumulative incidence of death or respiratory failure through day 28 with Xeljanz (18.1%) compared to placebo (29.9%). In addition, death from any cause occurred in 2.8% of Xeljanz-treated patients compared to 5.5% in the placebo group. In the study, serious adverse groups occurred in 14.1% of patients in the Xeljanz group and 12% in the placebo group. Protocol-specified adverse events ...
Pfizer and BioNTech have revealed positive top-line data for their COVID-19 vaccine – BNT162b2 – in adolescents aged 12 to 15 years old. The vaccine demonstrated 100% efficacy in a Phase III trial in adolescents aged 12 to 15 years old, with or without prior evidence of SARS-CoV-2 infection. BNT162b2 also produced ‘robust’ antibody responses in the younger population, exceeding those reported in an earlier trial in participants aged 15 to 25 years old. The jab was also found to be well tolerated in the 12 to 15 age group. The companies are now planning to submit the data to the Food and Drug Administration (FDA) in the US and the European Medicines Agency (EMA) to extend the use of the vaccine for this age group ‘as quickly as possible’. Pfizer and BioNTech will also continue to monitor the participants for long-term protection and safety for an additional two years after their ...
The companies announced the conclusion of the vaccine’s Phase 3 trial earlier this week: reporting 95% efficacy. They also announced that they had gathered the two months of safety data required by the US’ Food and Drug Administration (FDA) for a Emergency Use Authorization (EUA) submission. Dr. Albert Bourla, Pfizer Chairman and CEO, said: “Filing in the US represents a critical milestone in our journey to deliver a COVID-19 vaccine to the world and we now have a more complete picture of both the efficacy and safety profile of our vaccine, giving us confidence in its potential. “We look forward to the upcoming Vaccines and Related Biological Products Advisory Committee discussion and continue to work closely with the FDA and regulatory authorities worldwide to secure authorization of our vaccine candidate as quickly as possible.” Other regulatory submissions will follow ‘immediately’ Pfizer and BioNTech have already started rolling reviews of the ...
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: ...
Risk of mortality in a rare cardiac condition, transthyretin amyloid cardiomyopathy, plunged by 30% on administration of Pfizer’s tafamidis in a 30-month long study on 440 patients.
A new report by nonprofit group Initiative for Medicines, Access & Knowledge (I-MAK) exposes the prime offenders of the U.S. patent system, the pharma giants who are taking advantage of its loopholes to amass huge profits.
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.
Pfizer has initiated its new work on a phase 3 study of an investigational gene therapy designed to treat hemophilia B.
It is broadly estimated that JAKs are likely to dominate around 24% of the market which is not a good news for products like Enbrel manufactured by Amgen. It is likely that the drug is to cascade into fast decline as physicians increasingly prefer JAK as a second drug after Humira of AbbVie.
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.
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