Tag Archive for: Phase III trial

Data from the Phase III LUNA 3 study on Tuesday showed that Sanofi’s BTK inhibitor rilzabrutinib significantly improved durable platelet response in patients with chronic immune thrombocytopenia.

Cerevel Therapeutics reported positive data from its Phase III TEMPO-3 trial, showing that tavapadon can significantly improve symptom control in patients with Parkinson’s disease.

Roche said Monday that its bispecific T-cell engager Columvi improved survival in a Phase III lymphoma trial, clearing the drugmaker to seek a full, expanded label that could drive sales growth.

Bristol Myers Squibb on Saturday unveiled interim data from the Phase III open-label EMERGENT-4 study, showing that the investigational antipsychotic KarXT (xanomeline and trospium) can elicit significant and sustained symptom improvement in patients with schizophrenia.

Bristol Myers Squibb’s $4.8 billion acquisition of Mirati pays off with strong data from the KRYSTAL-12 study of Krazati, showing that the KRAS inhibitor significantly improves progression-free survival.

While Pfizer has ended one of its two Phase III studies for inclacumab in sickle cell disease, the company is still eyeing an approval for the antibody in the inherited blood disorder by 2026.

Despite meeting its primary endpoint in a late-stage generalized myasthenia gravis trial, Roche and Chugai Pharmaceutical’s Enspryng did not demonstrate clinical benefit as expected, the companies announced Thursday.

Bristol Myers Squibb secured another late-phase immuno-oncology victory Wednesday, showing that the combination of Opdivo and Yervoy improved overall survival in a patient population served by rival checkpoint inhibitors from AstraZeneca and Roche.

If shown to be well-tolerated and effective, M72/AS01E could potentially become the first vaccine to help prevent pulmonary TB in adolescents and adults, the most common form of the disease, and the first new TB vaccine in over a century. The first doses were given in South Africa, where TB takes a heavy toll.

Bayer stated that it would request regulatory approval for its menopause drug after the daily pill was shown to ease hot flashes in a third late-stage trial, providing some relief for its pharmaceuticals unit that is reeling from a recent development setback.