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Janet Woodcock, the longtime director of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration, is set to take over the top spot of the regulatory agency on an interim basis following the presidential inauguration of Joe Biden.
Johnson & Johnson published interim Phase I/IIa data in the New England Journal of Medicine showing the company’s single-dose Covid-19 vaccine candidate created an immune response that lasted at least 71 days.
People who have had Covid-19 are highly likely to have immunity to it for at least five months, but there is evidence that those with antibodies may still be able to carry and spread the virus, a study of British healthcare workers found.
The U.S. Food and Drug Administration granted Novartis’ ligelizumab (QGE031) Breakthrough Therapy designation for the treatment of chronic spontaneous urticaria (CSU), also known as chronic idiopathic urticaria (CIU), in patients who have an inadequate response to H1-antihistamine treatment.
Precision Medicine Group acquired Project Farma, a patient-focused bioengineering services firm that supports life science innovators in the manufacturing and scale-up of advanced therapies.
More than 10 million Americans had received their first dose of a Covid-19 vaccine as of Jan. 13, according to the U.S. Centers for Disease Control and Prevention, as the year-old pandemic roared on unchecked.
Alexion Pharmaceuticals Inc. paused enrollment in a late-stage study testing the company’s rare blood-disorder drug in adults with severe Covid-19 requiring mechanical ventilation.
BioSpace looks at some of the top stories from Day 2 of the virtual JP Morgan Annual Healthcare Conference.
The microscopic organisms living in our intestines may influence the severity of Covid-19 and the body’s immune response to it, and could account for lingering symptoms, researchers reported.
Johnson & Johnson is on track to roll out a single-shot coronavirus vaccine in March, and plans to have clear data on how effective it is by the end of January or early February, the U.S. healthcare company’s chief science officer said.