BURLINGAME, Calif. — Ten of the world’s leading biopharmaceutical companies announced the formation of a new non-profit corporation, Accumulus Synergy, which is intended to support interactions between industry and health authorities worldwide to enable real-time collaboration and data exchange, as well as data submission. Accumulus Synergy was formed on July 13, 2020, to develop a
NEW YORK— Pfizer and BioNTech SE announced additional data on neutralizing antibody and T cell responses from the Phase 1/2 trial with BNT162b2 conducted in Germany. The study results demonstrate that BNT162b2 elicits a combined adaptive humoral and cellular immune response against SARS-CoV-2 and provide insights into the composite nature of BNT162b2-induced T cell immunity.
WASHINGTON— A committee of top U.S. vaccine scientists recommended Thursday that the Food and Drug Administration authorize the first COVID-19 vaccine for Americans. This endorsement paves the way for a final decision by the FDA and mass vaccinations to begin within days in thousands of front-line heath care workers and nursing homes residents. After an
WASHINGTON — Commissioner Stephen Hahn said ahead of today’s meeting of the Food and Drug Administration’s vaccine advisory panel is “an important day for all of America.” Pfizer’s COVID-19 vaccine faces one last hurdle as it races to become the first shot greenlighted in the U.S. — a panel of experts who will carefully scrutinize
LONDON — According to various published reports, the U.K. has became the first Western nation to grant emergency-use authorization for a COVID-19 vaccine, clearing a shot developed by Pfizer and BioNTech to be distributed in limited numbers wnext week. The two-shot vaccine is also being reviewed by the Food and Drug Administration in the U.S., where a
NEW YORK — Pfizer and BioNTech SE announced they will submit a request Friday to the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA) of their mRNA vaccine candidate, BNT162b2 against SARS-CoV-2, which will potentially enable use of the vaccine in high-risk populations in the U.S. by the middle to end of
NEW YORK — Final results from Pfizer Inc’s COVID-19 vaccine trial showed its shot had a 95% success rate and two months of safety data, paving the way for the drugmaker to apply for an emergency U.S. authorization within days, it said on Wednesday. The vaccine’s efficacy rate, the highest of any candidate in late-stage
NEW YORK — Pfizer announced on Monday that the vaccine the company jointly developed with BioNTech was 90% effective in preventing COVID-19 infections in ongoing Phase 3 trials. Protection in patients was achieved seven days after the second of two doses, and 28 days after the first, according to preliminary findings. “The first set of
Hertfordshire, England – Mylan and Pfizer announced that the U.S. Federal Trade Commission accepted a proposed consent order, which concludes the FTC’s review of the proposed combination of Mylan and Pfizer’s Upjohn Business. The parties have now obtained all required antitrust clearances for the proposed transaction. The combination will be effected through a Reverse Morris
NEW YORK — According to published reports, the U.S. could authorize emergency use of Moderna’s experimental COVID-19 vaccine in December with FDA approval. The company’s CEO Stéphane Bancel said if the company gets positive interim results in November from a large clinical trial. Bancel’s comments suggest Moderna’s timetable isn’t that far off from Pfizer’s, which
NEW YORK — Pfizer and BioNTech SE announced the execution of an agreement with the U.S. Department of Health and Human Services and the Department of Defense to meet the U.S. government’s Operation Warp Speed program goal to begin delivering 300 million doses of a vaccine for COVID-19 in 2021. Under the agreement, the U.S.
NEW YORK — Pfizer and BioNTech SE announced Tuesday that the first participants have been dosed in the U.S. in the Phase 1/2 clinical trial for the BNT162 vaccine program to prevent COVID-19. The trial is part of a global development program, and the dosing of the first cohort in Germany was completed last week.
WARREN, N.J. — GlaxoSmithKline said Thursday that it has closed a previously announced joint venture deal with Pfizer Inc. that will combine their respective consumer healthcare businesses. The move will create the world’s largest supplier of over-the-counter medications. The joint venture company will operate as GSK Consumer Healthcare. Pfizer owns a 32% equity stake in
NEW YORK— Pfizer and Mylan announced Monday a definitive agreement to combine Mylan with Upjohn, Pfizer’s off-patent branded and generic established medicines business, creating a new global pharmaceutical company. Under the terms of the agreement, which is structured as an all-stock, Reverse Morris Trust transaction, each Mylan share would be converted into one share of