Immunology deals with physiological functioning of the immune system in states of both health and disease as well as malfunctions of the immune system in immunological disorders With the new […]readmore
Tags : Merck
Shots: The approval is based on P-III CLEAR /KEYNOTE-581 trial that evaluates Keytruda (200 mg, IV, q3w) + Lenvima (20 mg, PO, qd) or Lenvima (18mg) + everolimus (5mg, PO, […]readmore
Shots: The application is based on ORR data from cohorts D & K of KEYNOTE-158 trial evaluating Keytruda as monothx. (200 mg, q3w) in 90 patients with MSI-H/dMMR advanced EC […]readmore
Shots: The sBLA is based on P-III KEYNOTE-564 trial evaluating Keytruda monothx. (200mg, IV on day 1 of each 3wks. cycle for ~17 cycles) vs PBO in 994 patients with […]readmore
Medtronic to Acquire Intersect ENT for ~$1.1B Published: Aug 6, 2021 | Tags: Medtronic, Intersect ENT, ~$1.1B Kite Signs a License Agreement with Appia to Develop Allogeneic Cell Therapies for […]readmore
Shots: The priority review is based on P-III KEYNOTE-716 trial assessing Keytruda (anti-PD-1 therapy) vs PBO in 954 patients aged ≥12yrs. with stage II resected high-risk melanoma. The anticipated PDUFA […]readmore
Biotech
Regulatory
Merck’s Vaxneuvance (pneumococcal 15-valent conjugate vaccine) Receives the US FDA’s
Shots: The approval is based on seven P-II & III clinical studies involves assessing the safety, tolerability & immunogenicity of Vaxneuvance vs PCV13 in 7,438 adults aged >18yrs. with IPD […]readmore
Lysogene Receives the US FDA’s Fast Track Designation for LYS-GM101 Gene Therapy to Treat GM1 Gangliosidosis Published: July 9, 2021 | Tags: Lysogene, US, FDA, Fast Track Designation, LYS-GM101 Gene […]readmore
Shots: The companies collaborated to evaluate OncoSec’s TAVO + Merck’s Keytruda vs SoC in a P-III KEYNOTE-C87 trial in ~400 patients with metastatic melanoma who are refractory to immune checkpoint […]readmore
Shots: The approval is based on data from the second interim analysis of the P-II KEYNOTE-629 trial assessing Keytruda (200mg, IV, q3w) in 159 patients with recurrent, metastatic, or LA […]readmore