Bio News
Phase 3 trial in patients with PIK3CA-mutated HR+/HER2- breast cancer achieves statistical significance Plans to expand indication through supplemental application after FDA approval decision on July 17
Celcuity’s breast cancer drug gedatolisib demonstrated efficacy in patients with PIK3CA mutations, sending its shares up more than 18%. The phase 3 data achieved statistical significance in the PIK3CA-mutated population, which accounts for about 40% of patients with HR+/HER2- breast cancer. The company plans to expand the indication through a supplemental application after the U.S. Food and Drug Administration (FDA) approval decision on July 17.
BIOBOOK TEAM
biobookmedia@biobook.co.krMerck’s $1.3 trillion eye disease drug raises safety and efficacy concerns: “Limited competitiveness”
CHA Biotech Holds 24.23% Stake in CMG Pharmaceutical as Share Consolidation Reduces Its Share Count
Rural Development Administration Develops Two Molecular Markers to Identify Leaf Splitting in Squash
MFDS Begins Distribution of Internationally Certified Reference Materials, Including 24 New Items, for a Total of 882
Ministry of Trade, Industry and Energy signs agreement to promote biotech and medical devices in Gangwon; site visit set for the 14th
RDA develops technology to produce anti-inflammatory exosomes for pets and files patent application
Merck’s $1.3 trillion eye disease drug raises safety and efficacy concerns: “Limited competitiveness”
CHA Biotech Holds 24.23% Stake in CMG Pharmaceutical as Share Consolidation Reduces Its Share Count
Rural Development Administration Develops Two Molecular Markers to Identify Leaf Splitting in Squash
