These factors could provide a scientific basis for consistency evaluations of the quality and efficacy of insulin biosimilars, study authors wrote. Factors that may affect the bioequivalence of test ...

Eton Pharmaceuticals, Inc. announced positive results from its pivotal bioequivalence study of ET-600, a patented oral solution of desmopressin aimed at treating central diabetes insipidus. The study, ...

TG Therapeutics TGTX has announced positive top-line data from the late-stage ENHANCE study, which evaluated a consolidated single-infusion regimen of its sole marketed drug, Briumvi (ublituximab-xiiy ...

To help the generic pharmaceutical industry identify the most appropriate ways to generate evidence needed to support abbreviated new drug application (ANDA) approval, the US Food and Drug ...

A new study has found that HLX01 (HanliKang), a rituximab biosimilar, had comparable overall survival and progression-free survival rates to the reference product (Rituxan) in patients with diffuse ...

WALTHAM, Mass., Sept. 30, 2021 (GLOBE NEWSWIRE) -- Minerva Neurosciences, Inc. (Nasdaq: NERV), a clinical-stage biopharmaceutical company focused on the development of therapies to treat central ...

The sensitivity and precision of bioequivalence assessments for LT 4 products need to be improved so that the designation of bioequivalence ensures therapeutic equivalence. One solution to this ...

VANCOUVER, British Columbia--(BUSINESS WIRE)--Alpha Cognition Inc. (TSX-V: ACOG) (OTCQB: ACOGF) (“Alpha Cognition,” or the “Company”), a biopharmaceutical company committed to developing novel ...

The US Food and Drug Administration (FDA) on Tuesday gave advice to generic drugmakers on handling disruptions to bioequivalence studies needed to support abbreviated new drug application (ANDA) ...

New Orleans – November 16, 2006 -- Shire plc (LSE: SHP, NASDAQ: SHPGY, TSX: SHQ) announced today that a single once-daily morning dose of the investigational amphetamine compound SPD465, extended ...