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Takeda Reports Results of Entyvio (vedolizumab) in Interim Analysis from

Shots: The ongoing P-IIIb VISIBLE OLE study involves assessing of Entyvio (SC) in adult patients with UC or CD, following enrolment and participation in the VISIBLE 1 (UC) or VISIBLE 2 (CD) studies. Patients who completed the maintenance period up to 52wks. (randomized completers) or who achieved clinical response @14wks. (non-randomized 14wks. responders) after a […]Read More

Roche Report Mixed Results of Etrolizumab in P-III Studies for

Shots: In the HIBISCUS I induction study, in patients without prior anti-TNF treatment, etrolizumab met its 1EPs while in HIBISCUS II study in the same kind of people, it did not meet its 1EPs. In the HICKORY study, in patients with prior anti-TNF treatment, therapy met its 1EPs at induction but not at maintenance In […]Read More

Seattle Genetics Report Updated Results of Tukysa (tucatinib) in HER2CLIMB

Shots: HER2CLIMB study involves assessing of Tukysa (tucatinib) + trastuzumab + capecitabine vs trastuzumab + capecitabine alone in 612 patients in a ratio (2:1) with LA unresectable/m-HER2+ BC prior treated with trastuzumab, pertuzumab, and T-DM1 Updated results: 42% reduction in the risk of death, 68% reduction in the risk of CNS disease; intracranial response rate […]Read More

Gilead and Galapagos Report Results of Filgotinib in P-IIb/III SELECTION

Shots: The P-IIb/III SELECTION study involves assessing of filgotinib (200/ 100mg) vs PBO in 1,348 biologic-naïve & biologic-experienced patients in a ratio (2:2:1) with mod. to sev. UC. The SELECTION study consists of 2 induction trials and a maintenance trial Filgotinib (200mg) achieved all its 1EPs inducing clinical remission @10wks. in biologic-naïve & experienced patients […]Read More

Takeda Reports Submission of NDA to MHLW for Vedolizumab SC

Shots: The NDA filing is based on P-III VISIBLE 1 study results assessing Vedolizumab (SC, 108mg, q2w) as maintenance therapy vs PBO in 216 patients with mod. to sev. active UC following two doses of IV administration of vedolizumab (300 mg) as an induction therapy at 0 to 2 wks. P-III VISIBLE 1 study results: […]Read More