PARIS–(BUSINESS WIRE)–Regulatory News: CARMAT (Paris:ALCAR): Videoconference in English with Stéphane Piat at 8 pm CET today. To participate, please register by clicking on this link CARMAT (FR0010907956, ALCAR), the designer and developer of the world’s most advanced total artificial heart, aiming to fulfill an unmet medical need by providing a therapeutic […]
Coronary/Structural Heart
Pfizer and Ionis announce discontinuation of vupanorsen clinical development program
NEW YORK and CARLSBAD, Calif., Jan. 31, 2022 /PRNewswire/ — Pfizer Inc. (NYSE: PFE) and Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) today announced the discontinuation of the Pfizer-led clinical development program for vupanorsen (PF-07285557), an investigational antisense therapy that was being evaluated for potential indications in cardiovascular (CV) risk reduction and severe hypertriglyceridemia (SHTG). Pfizer made this decision after a thorough […]
Much Awaited, Much Needed: TRANSFORM II Randomized Controlled Trial, by Fondazione RIC, gets rolling
MILANO, Italy, Jan. 28, 2022 /PRNewswire/ — FONDAZIONE Ricerca e Innovazione Cardiovascolare, Milano, focused on cardiovascular research, reports the first patient enrolment of the TRANSFORM II Randomized Controlled Trial (Sirolimus-coated Balloon Versus Drug-eluting Stent in Native Coronary Vessels) setting in motion a crucial trial in the Native Coronary Vessel Treatment domain. TRANSFORM II RCT, determined to […]
CHMP issues positive opinion to expand Jardiance (empagliflozin) indication based on unprecedented benefit in adult heart failure patients with preserved ejection fraction
– The positive opinion is based on the landmark EMPEROR-Preserved Phase III trial, which showed significant outcomes in patients with heart failure with left ventricular ejection fraction over 40%1 – If approved, Jardiance would be the first and only clinically proven treatment approved for all adults with symptomatic chronic heart failure including […]
The Heart Failure Society of America Releases Review Examining the Growing Economic Burden of Heart Failure in the United States
ROCKVILLE, Md., Jan. 24, 2022 /PRNewswire/ — Today, the Heart Failure Society of America (HFSA) released a review, Economic Issues in Heart Failure in the United States, in the Journal of Cardiac Failure (JCF). The review examines the growing economic burden of heart failure for patients and the health care system in the United States, providing a summary of […]
Imara Announces FDA Clearance of Investigational New Drug Application (IND) for Tovinontrine (IMR-687) for Heart Failure with Preserved Ejection Fraction (HFpEF)
Expanding patient base and potential of Imara’s small molecule oral inhibitor of phosphodiesterase-9 (PDE9) alongside hemoglobin disorders Phase 2 trial aims to select HFpEF patients with enriched PDE9 expression for targeted approach to a heterogeneous disease Study initiation planned for second quarter of 2022 BOSTON, Jan. 25, 2022 (GLOBE NEWSWIRE) […]
Chiesi USA Announces New Publication of Post Hoc Analysis on Timing of Ischemic Events in Cardiac Patients and Role of KENGREAL® (cangrelor) in Reducing Risk
Post hoc analysis of the CHAMPION PHOENIX clinical trial demonstrates that the majority of ischemic events occurred early in percutaneous coronary intervention (PCI), and KENGREAL® (cangrelor) treatment significantly reduced these events in the first two hours post-randomization compared to clopidogrel (4.1% vs 5.4%, p=0.002) CARY, N.C., Jan. 25, 2022 (GLOBE […]
Matinas BioPharma Provides Business Update and 2022 Strategic Outlook
– End of Phase 2 Meeting with FDA Provides Pathway to NDA Submission for MAT2203 Following Confirmatory Data to be Generated in an Additional Cohort; Cohort 5 in Ongoing EnACT Trial – – Cohort 4 of EnACT (all oral induction regimen) Underway With Six Patients Enrolled and Topline Interim Data […]
Eplontersen granted Orphan Drug Designation in the US for transthyretin amyloidosis
WILMINGTON, Del., January 24, 2022 – Eplontersen has been granted Orphan Drug Designation (ODD) in the US by the Food and Drug Administration (FDA) for the treatment of transthyretin-mediated amyloidosis, a systemic, progressive and fatal condition. Eplontersen, formerly known as IONIS-TTR-LRx, is a ligand-conjugated antisense (LICA) investigational medicine currently in […]
Alnylam Presents Positive 18-Month Results from HELIOS-A Phase 3 Study of Investigational Vutrisiran in Patients with hATTR Amyloidosis with Polyneuropathy
– Vutrisiran Met All 18 Month Secondary Endpoints, Including Statistically Significant Improvements in Neuropathy Impairment, Quality of Life (QoL), Gait Speed, Nutritional Status and Overall Disability, Relative to External Placebo – – Vutrisiran Continued to Demonstrate Halting or Reversal of Polyneuropathy, with Improvements in Neuropathy Impairment and QoL Relative to […]



