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CRISPR Therapeutics has reported positive results for a phase 1 study evaluating CTX110, its chimeric antigen receptor (CAR) T-cell therapy for the treatment of relapsed or refractory nonHodgkin’s lymphoma in patients who have received at least two prior lines of therapy. Read More
Adicet has won Investigational New Drug clearance from the FDA for ADI-001, a chimeric antigen receptor (CAR) gamma delta T-cell therapy for nonHodgkin’s lymphoma. Read More
Roche and Atea Pharmaceuticals have struck a deal to develop a COVID-19 antiviral pill, AT-527, currently being evaluated in a phase 2 study. Read More
Dr. Reddy’s Laboratories, one of India’s largest pharmaceutical companies, announced Thursday that it has temporarily shut down all of its data center services in response to a cyberattack. Read More
AstraZeneca’s COVID-19 vaccine candidate, AZD1222, currently being evaluated in phase 3 global trials, delivers a strong immune response, according to a new UK study. Read More
The COVID-19 pandemic is worsening a pre-existing problem of drug shortages in the U.S., University of Minnesota researchers report in a new analysis. Read More
The FDA’s Vaccines and Related Biological Products Advisory Committee took no action Thursday after a lengthy discussion of the agency’s COVID-19 vaccine requirements, considerations for continuing blinded phase 3 trials after an Emergency Use Authorization (EUA) is issued and postmarket studies. Read More
HHS Secretary Alex Azar denies a report that he and colleagues are plotting the ouster of FDA Commissioner Stephen Hahn over Hahn’s holding fast to stricter, more time-consuming rules for makers of novel COVID-19 vaccines than what the White House wants. Read More
The FDA on Thursday granted full approval to Gilead Sciences’ Veklury (remdesivir) to treat hospitalized COVID-19 patients, making it the first approved COVID-19 treatment in the U.S. Read More