Tag Archive for: Clinical studies

Nearly three years after European approval, the U.S. regulator has accepted Orchard Therapeutics’ BLA for its gene therapy OTL-200, being proposed for metachromatic leukodystrophy.

The Omicron-adapted COVID-19 vaccine booster developed by Pfizer Inc. and BioNTech SE sharply reduced hospitalizations among older patients, Israeli researchers said on Monday, in some of the first evidence of the jab’s real-world effectiveness.

Vaccine maker Novavax Inc said on Tuesday its COVID-19 shot retooled against the Omicron BA.1 variant showed a strong immune response as the fourth dose and met the main goal of strain change in a late-stage study.

Germany’s Bayer said on Sunday it was starting a Phase III study program to investigate the efficacy and safety of asundexian, an oral Factor XIa (FXIa) inhibitor.

The top performers among drugs launched in 2020 were each the first of their kind.

Compared with the earlier Omicron BA.2 subvariant, currently dominant Omicron BA.5 is linked with higher odds of causing a second SARS-COV-2 infection regardless of vaccination status, a study from Portugal suggests.

Sage Therapeutics and partner Biogen shared news that their Phase III Skylark study has yielded promising results for women suffering from severe postpartum depression (PPD).

On Thursday, Pfizer announced the U.S. Food and Drug Administration granted the company’s combinatorial therapeutic ervogastat/clesacostat Fast Track Designation. The therapeutic combo is intended for the treatment of non-alcoholic steatohepatitis (NASH) with liver fibrosis.