Regulatory
The fate of three cancer immunotherapies that had been authorized under the U.S. Food and Drug Administration’s Accelerated Approval pathway will be determined next week following failures in confirmatory trials.
Molecular Partners announced yesterday it has filed for a $100 million initial public offering with the Securities and Exchange Commission in the U.S., funding which will go toward supporting the company’s work in the development of protein-based treatments for COVID-19 and various cancers.
The long and strange journey of Biogen’s Alzheimer’s drug aducanumab is coming to an end. Whether it will be a complete ending—with the U.S. FDA rejecting it—or a new chapter, with an approval, remains to be seen.
The U.S. FDA has requested that Emergent BioSolutions temporarily pause production of ingredients for the Johnson & Johnson COVID-19 vaccine at their facility in Baltimore.
Amgen announced the U.S. FDA awarded Breakthrough Therapy Designation to the bemarituzumab as a first-line treatment for certain types of gastric cancer.
The agency is requesting additional information and analysis of preclinical studies regarding KVD824 before giving the go-ahead to the Phase II trial.
Please check out the biopharma industry’s COVID-19 stories that are trending for April 20, 2021.
The government agency is asking for more information before approving a clinical study on the company’s Chimeric Antigen Receptor-T cell therapy (CAR-T).
Acting FDA Commissioner Janet Woodcock shared her thoughts on pandemic issues and outlined FDA modernization plans in a recent Q&A session with the Alliance for a Stronger FDA (Alliance).
The reason for the request was the monotherapy antibody therapy is less effective against the COVID-19 variants, such as have risen from the U.K., South Africa and Brazil, as well as the growing B.1.427/B.1.429 California variant.
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