A summary of daily biopharma industry news regarding the novel coronavirus trending on March 27, 2020, with the FDA now working with 220 test developers.
The U.S. Food and Drug Administration accepted a New Drug Application and two supplemental NDAs for Genentech’s Xofluza (baloxavir marboxil).
Swiss drugmaker Novartis won a key European recommendation for the company’s gene therapy Zolgensma against spinal muscular atrophy (SMA), clearing a hurdle for $2.1 million per patient treatment for approval in Europe within months.
Bristol Myers Squibb’s Zeposia (ozanimod) won approval from the U.S. Food and Drug Administration as a new treatment for a type of multiple sclerosis.
A recap of business developments from life sciences companies around the world, including U.K.-based Vaccitech Limited and the University of Oxford touting positive safety and efficacy trends in a mid-stage prostate cancer study.
A day after the announcement that remdesivir received Orphan Drug designation for the treatment of COVID-19 from the U.S. Food and Drug Administration, Gilead Sciences submitted a request for the regulatory agency to rescind that offer after an outcry was raised over the potential for exclusivity for the experimental pandemic treatment.
While COVID-19 dominates headlines as the virus has spread across the globe and the pharmaceutical industry has marshaled its forces to develop therapies and diagnostics against the disease, BioSpace takes a look at key industry news not related to the coronavirus.
The same day that New York Gov. Andrew Cuomo announced the initiation of a clinical trial using blood plasma from patients who have recovered from COVID-19, the U.S. Food and Drug Administration announced wider support for the practice.
Sales of Bristol-Myers Squibb Co.’s cancer drug Abraxane were suspended in China based on findings at a third-party manufacturing plant in the United States.
The U.S. Food and Drug Administration provided Emergency Use Authorization (EUA) for the PerkinElmer Inc.’s New Coronavirus RT-PCR test.