Provention Bio will have to wait a little bit longer to see if the U.S. Food and Drug Administration will approve its diabetes prevention drug, teplizumab. On Thursday, the company announced the regulatory agency extended its review period by three months for the Biologics License Application (BLA) to Nov. 17.
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The U.S. government has ordered 2.5 million more doses of Bavarian Nordic’s vaccine for use against monkeypox outbreaks, the Department of Health and Human Services said on Friday.
Cambridge, Massachusetts’ Kendall Square just got a little more crowded. Following announcements of new facilities made by Takeda, Sanofi and life sciences giant Bayer which opened its new research and innovation center in the busy biotech hotspot known as Genetown.
The U.S. Food and Drug Administration has reportedly given the green light to begin clinical trials of pig heart transplantation in humans.
Coronavirus vaccines tweaked to include the Omicron variant strain can improve protection when used as a booster, the European Medicines Agency and other global health regulators said on Friday.
The COVAX facility, backed by the World Health Organization and the Global Alliance for Vaccines and Immunization, has delivered 1.55 billion COVID-19 vaccine doses to 146 countries. In December, COVAX set a target of achieving 70% COVID-19 immunization coverage by mid-2022.
Just days after the U.S. Supreme Court abolished women’s constitutional right to abortion, Alabama has cited that ruling in a bid to outlaw parents from obtaining puberty blockers and certain other medical treatment for their transgender children.
Under the expanded deal, AstraZeneca’s will have access to Oxford Biomedica’s Oxbox manufacturing facility to produce its shot on an as-needed basis beyond 2022.
North Korea claimed on Friday that the country’s first COVID-19 outbreak began with patients touching “alien things” near the border with South Korea, apparently shifting blame to the neighbour for the wave of infections in the isolated country.
Novartis prefers a spinoff of its generic drug unit over a potential sale to private equity firms, Bloomberg News reported on Thursday, citing people familiar with the matter.