Drug Development
An inspection of a facility making Elevar’s rivoceranib uncovered deficiencies, leading the FDA to reject a combination therapy that includes the drug. The rebuff is the third strike for the partners after the agency issued manufacturing-related denials for the other drug in the combo.
FEATURED STORIES
The lineup at the Alzheimer’s Association International Conference will provide critical insight into where the industry is headed with regard to targets being explored to vanquish the elusive neurodegenerative disease.
Psychedelics are gaining momentum in depression, with one treating physician predicting that the drug class could “wipe out the SSRIs” if safety and durability hold up.
Saol Therapeutics is the latest biotech to resubmit for approval of a drug rejected under former FDA Commissioner Marty Makary, following REGENXBIO and Replimune.
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A combination of Exelixis’ cabozantinib and Roche’s Tecentriq missed the primary endpoint of overall survival in a Phase III study.
At ASH 2022, established hematology leaders like AstraZeneca, Janssen and Merck will showcase new data, and new players like Vega Therapeutics will launch new programs.
AstraZeneca posted two mid-stage wins at the 2022 San Antonio Breast Cancer Symposium on Thursday, touting the efficacy of capivasertib and camizestrant against breast cancer.
Compass’ twin clinical updates regarding its lead candidate spotlight the promise of psychedelic medicine.
Novartis reported Thursday that a Phase III trial of iptacopan met its primary endpoint in paroxysmal nocturnal hemoglobinuria (PNH) - the company’s second win in this indication in as many months.
Vertex Pharmaceuticals agreed to a collaboration deal with Entrada Therapeutics. The two companies announced a collaboration to develop an intracellular Endosomal Escape Vehicle.
Relmada’s investigational NDMA receptor channel blocker, REL-1017, failed to meet its primary endpoint in major depressive disorder in the Phase III RELIANCE I trial.
AVROBIO is planning a Phase II/III registrational trial for its Gaucher Disease Type 3 (GD3) gene therapy candidate, AVR-RD-02, in 2023.
Neurocrine’s NBI-827104 failed to meet the primary endpoint in a Phase II study for epileptic encephalopathy with continuous spike-and-wave during sleep, the company announced Tuesday.
Eli Lilly and Boehringer Ingelheim declared another victory Wednesday for Jardiance – this one for children and adolescents with Type 2 Diabetes.