The U.S. Food and Drug Administration extended the review period for expanded use of Abbvie Inc.’s rheumatoid arthritis drug Rinvoq by three months, citing the need for more time to assess the drug’s benefit-risk profile.
Shares of bluebird bio climbed in trading after the company announced on March 10 that analyses demonstrate the lentiviral vector BB305 was unlikely to be the cause of acute myeloid leukemia (AML) reported in an early-stage clinical study of LentiGlobin for sickle cell disease.
Vir Biotechnology and Britain’s GlaxoSmithKline said on March 3 they would pause enrollment into a study testing their experimental Covid-19 antibody therapy, which is a part of a large U.S. trial.
U.S. vaccine developer Inovio Pharmaceuticals completed Phase II enrollment for a mid-to-late stage U.S. trial of the company’s Covid-19 vaccine candidate and expects to report data early in the second quarter.
Johnson & Johnson’s newly authorized Covid-19 vaccine started shipping and the company’s top executive said on March 1 that Americans should be able to receive the single-dose shot within 24 to 48 hours, adding a third vaccine in the United States.
Shares of Pandion Therapeutics soared more than 131 percent in trading after pharma giant Merck announced the acquisition of the autoimmune-focused company for up to $1.85 billion.
Otonomy shares plunged 50.1 percent at news that the company’s drug to treat Meniere’s disease failed to hit the primary endpoint in a Phase III trial.
Texas-based Molecular Templates (MTEM) and Bristol Myers Squibb forged a strategic research collaboration worth a potential $1.3 billion to discover and develop multiple oncology therapies using a next-generation engineered toxin body platform.
Shares of Avrobio were up in trading after the company posted positive clinical data from gene therapy trials in three different rare lysosomal diseases: Fabry, Gaucher type 1 and cystinosis.
U.S. biotech Amgen Inc. provided a 2021 earnings forecast below Wall Street estimates and said the company paused or halted enrollment for clinical trials of three cancer drugs.
