The U.S. FDA issued Cytokinetics Inc. a complete response letter (CRL) for omecamtiv mecarbil, branding the clinical evidence behind it as not “persuasive” enough to establish its effectiveness for reducing the risk of heart failure events and cardiovascular death. The company is developing the drug as an add-on therapy for patients with worsening heart failure who remain at high risk for heart failure events and hospitalization.
Transthera Sciences Inc., a Nanjing, China-based company developing small-molecule therapies in cancer, inflammation and cardiovascular disease, raised ¥260 million (US$38 million) in a series D+ funding round to advance its first drug product.
Transthera Sciences Inc., a Nanjing, China-based company developing small-molecule therapies in cancer, inflammation and cardiovascular disease, raised ¥260 million (US$38 million) in a series D+ funding round to advance its first drug product.
Actelion Pharmaceuticals Ltd. has disclosed platelet-derived growth factor receptor beta (PDGFR-β) inhibitors reported to be useful for the treatment of pulmonary arterial hypertension.
Ra Medical Systems Inc. launched a simple device that holds sutures more securely in place for closure of percutaneous wound sites during cardiac electrophysiology, structural heart and vascular surgical procedures.
Medtronic plc recently received the CE mark for its Aurora extravascular implantable cardioverter-defibrillator (EV-ICD) strengthening its cardiovascular portfolio which saw a 7% year-on-year growth in the third quarter of its fiscal year 2023.
Coronary artery disease (CAD) will likely remain the worldwide leading cause of death for the next couple of decades. Genome-wide association studies (GWAS) have been useful to identify hundreds of genomic loci that contribute CAD risk.
Xeltis BV has completed a €32 million (US$34 million) series D2 round that will propel the clinical development of its electrospun polymer implants across several indications. The fully synthetic implants promise the best of both worlds, with the mechanical strength required to be fully functional from day one, and bioresorbable properties that cause gradual degradation as endogenous tissue regenerates to form a natural replacement.