LianBio to receive total upfront consideration of $350 millionLianBio Board of Directors to conduct strategic review of business SHANGHAI and PRINCETON, N.J., Oct. 24, 2023 (GLOBE NEWSWIRE) --...
EXPLORER-CN data presented in oral late-breaking science session at ESC 2023Data from the trial published simultaneously in JAMA CardiologyMavacamten demonstrated improvement in Valsalva LVOT peak...
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol Myers Squibb (NYSE: BMY) today announced new long-term follow-up results from two Phase 3 studies evaluating CAMZYOS® (mavacamten), a first-in-class cardiac myosin inhibitor, in adult patients with symptomatic obstructive hypertrophic cardiomyopathy (HCM). Results from the 56-week analysis of the VALOR-HCM long-term extension (LTE) study were presented as a late-breaking oral presentation, with simultaneous publication in JAMA Cardiology, and results from the cumulative 120-week analysis of the EXPLORER cohort of the MAVA-LTE study were presented as an oral presentation at the European Society of Cardiology (ESC) Congress 2023.
BMS` Camzyos (mavacamten) Receives Approval in Europe
Bristol Myers Squibb`s Camzyos (mavacamten) Receives Approval in Europe
PRINCETON, N.J., June 26, 2023--(BUSINESS WIRE)--Bristol Myers Squibb (NYSE: BMY) today announced that the European Commission (EC) has approved CAMZYOS® (mavacamten, 2.5 mg, 5 mg, 10 mg, 15 mg capsules) for the treatment of symptomatic (New York Heart Association, NYHA, class II-III) obstructive hypertrophic cardiomyopathy (HCM) in adult patients. CAMZYOS is the first and only allosteric and reversible inhibitor selective for cardiac myosin approved in all European Union (EU) member states* and is the first cardiac myosin inhibitor that targets the underlying pathophysiology of HCM. The EC approval of CAMZYOS is based upon positive efficacy and safety results from two Phase 3 trials, EXPLORER-HCM and VALOR-HCM.
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Adistration (FDA) approved the supplemental New Drug Application (sNDA) to add positive data from the Phase 3 VALOR-HCM study to the U.S. Prescribing Information for CAMZYOS® (mavacamten, 2.5 mg, 5 mg, 10 mg, 15 mg capsules). Data added to the label showed that treatment with CAMZYOS significantly reduced the composite endpoint of guideline-based eligibility for septal reduction therapy (SRT) at Week 16 or the decision to proceed with SRT prior to or at Week 16. This approval follows last year’s FDA approval of CAMZYOS, based on results from the Phase 3 EXPLORER-HCM trial, for the treatment of adults with symptomatic New York Heart Association (NYHA) class II-III obstructive HCM to improve functional capacity and symptoms.
As Bristol Myers Squibb braces for increasing generic competition this decade, the company is counting on its newer medicines to drive growth. Now, one of those new launches has picked up a key early endorsement in England.
SHANGHAI, China and PRINCETON, N.J., May 11, 2023 (GLOBE NEWSWIRE) -- LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing innovative medicines to patients in China and other major...
PRINCETON, N.J.--(BUSINESS WIRE)--Bristol Myers Squibb (NYSE: BMY) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of CAMZYOS® (mavacamten) for the treatment of symptomatic (New York Heart Association, NYHA, class II-III) obstructive hypertrophic cardiomyopathy (HCM) in adult patients. The European Commission (EC), which has the authority to approve medicines for the European Union (EU), will now review the CHMP opinion.