PALO ALTO, Calif. & LUGANO, Switzerland – BridgeBio Pharma, Inc. (Nasdaq: BBIO), through its affiliate QED Therapeutics, Inc., and Helsinn Group today announced that the US Food and Drug Administration (FDA) has approved TRUSELTIQ™ (infigratinib) under the accelerated approval program for the treatment of patients with previously-treated locally advanced or...
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PALO ALTO, Calif. — BridgeBio Pharma, Inc. (Nasdaq: BBIO) (“BridgeBio” or the “Company”), a new type of biopharmaceutical company focused on genetic diseases, today announced positive topline results from CALIBRATE, its global Phase 3 study of encaleret in autosomal dominant hypocalcemia type 1 (ADH1). CALIBRATE was designed to study the...
New York, NY – Bristol Myers Squibb (NYSE: BMY) today announced that the pivotal Phase 3 KRYSTAL-12 study, evaluating KRAZATI® (adagrasib) as a monotherapy in patients with pretreated locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring a KRASG12C mutation, met the primary endpoint of progression-free survival (PFS) and...
New York, NY – It isn’t often that a single company has an advisory committee meeting for one product and an FDA decision for another in the same week. Even more unusual is when the two drugs are of the same therapeutic class. That’s what’s happening this week for Bristol...
PRINCETON, N.J. –– Bristol Myers Squibb (NYSE: BMY) reinforces its hematology leadership through new research across multiple therapies for patients with lymphoma at the 67th American Society of Hematology (ASH) Annual Meeting. Highlights include updates from the company’s targeted protein degradation pipeline, including data on first-in-class investigational lymphoma CELMoD™ agent golcadomide and first-in-class...
PRINCETON, N.J. – Bristol Myers Squibb (NYSE: BMY) announced positive topline results from the Phase 3 CheckMate -648 trial evaluating treatment with Opdivo (nivolumab) plus chemotherapy or Opdivo plus Yervoy (ipilimumab) in patients with unresectable advanced or metastatic esophageal squamous cell carcinoma (ESCC). In the study, Opdivo plus chemotherapy demonstrated a statistically...
PRINCETON, N.J. – Bristol Myers Squibb on Saturday released results from the Phase III CheckMate -8HW study showing that the combination of its PD-1 inhibitor Opdivo (nivolumab) and its CTLA-4 blocker Yervoy (ipilimumab) improved progression-free survival in certain metastatic colorectal cancer patients when used in the first-line setting. Patients treated...
PRINCETON, N.J. – Bristol Myers Squibb is pulling the plug on a trial investigating what it calls the Opdulag combination, a pairing of Opdivo (nivolumab) and relatlimab, in patients with microsatellite stable metastatic colorectal cancer. In an announcement on Friday, BMS said that data from the Phase III trial of...
Hamburg, Germany – Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) today announced that Bristol Myers Squibb has decided to exercise their option to extend its partnership with Evotec in the field of targeted protein degradation. Evotec and Bristol Myers Squibb (the successor in interest to Celgene) initiated this...
PRINCETON, N.J. – Bristol Myers Squibb (NYSE: BMY) today announced results from the Phase 3 CheckMate -648 trial, in which two Opdivo-based treatment combinations — Opdivo (nivolumab) plus chemotherapy and Opdivo plus Yervoy (ipilimumab) — demonstrated a statistically significant and clinically meaningful overall survival (OS) benefit compared to chemotherapy at...