Tags : Positive

Regulatory

Incyte Receive Positive CHMP’s Opinion for Pemigatinib

Shots: The EMA’s CHMP has adopted a positive opinion of pemigatinib for the treatment of adults with unresectable locally advanced or metastatic cholangiocarcinoma with documented FGF/FGFR status, after at least one line of ST The CHMP opinion is based on P-II FIGHT-202 and patients enrolled into one of three cohorts – cohort a (FGFR2 fusions […]Read More

Regulatory

Daiichi Sankyo and AZ’s Trastuzumab Deruxtecan Receives CHMP’s Recommendation for

Shots: The recommendation is based on a P-II DESTINY-Breast01 study assessing trastuzumab deruxtecan in patients with HER2 positive unresectable/ m-BC prior treated with trastuzumab emtansine The trial demonstrated a meaningful & durable activity in patients who had received two or more prior anti-HER2 therapies. The safety & tolerability profile of the therapy was consistent with […]Read More

Clinical Trials

BMS’ Deucravacitinib (BMS-986165) Demonstrate Superiority Over Amgen’ Otezla (apremilast) in

Shots: The P-III POETYK PSO-1 study involves assessing deucravacitinib (6mg, qd) vs PBO & Otezla (apremilast) in 666 patients with moderate to severe plaque psoriasis The trial met its co-1EPs & 2EPs demonstrating deucravacitinib was superior to Otezla (apremilast) in the patients reaching a PASI 75 and sPGA 0/1 @16wks. The overall safety profile of […]Read More

Biotech

GSK Presents Results of Maternal & Older Adults RSV Vaccines

Shots: GSK reported that its RSV vaccines for maternal immunization (GSK3888550A) and older adults (GSK3844766A) were well-tolerated and highly immunogenic in P-I/II clinical studies. Both the candidate vaccines contain a recombinant RSVPreF3, that triggers the required immune response The GSK3844766A was first tested in 48 healthy adults (18-40yrs.) & then in 1005 healthy older adults […]Read More