Bayer Submits Supplemental New Drug Application to U.S. FDA Seeking New Indication for KERENDIA® (finerenone) in Patients with Heart Failure with Left Ventricular Ejection Fraction of ≥40%

WHIPPANY, N.J.–(BUSINESS WIRE)–Bayer today announced the submission of a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) for KERENDIA® (finerenone) for the treatment of patients with heart failure (HF) with a left ventricular ejection fraction (LVEF) of ≥40%. The submission is based on positive results from the Phase III FINEARTS-HF trial that showed finerenone achieved a statistically significant reduction of the composite of cardiovascular death and t
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Atropos Health Collaborates with Merck for Rapid Evidence Generation to Accelerate Innovation for Life-Saving Treatments

PALO ALTO, Calif.–(BUSINESS WIRE)–Atropos Health, a pioneer in translating real-world clinical data into real-world evidence (RWE) for decision-making, today announced it will collaborate with Merck as a premier platform to generate RWE, replicate studies and produce rapid insights and analytics on real-world data (RWD). Through this collaboration, Atropos Health will enable rapid cohort creation, advanced analytics and publication-grade studies in less than 48 hours. As part of the agreement
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Otsuka Announces FDA Plans to Host an Advisory Committee Meeting to Discuss the sNDA for Brexpiprazole in Combination with Sertraline for the Treatment of Adults with Post-Traumatic Stress Disorder (PTSD)

PRINCETON, N.J. & TOKYO–(BUSINESS WIRE)–Otsuka America Pharmaceutical, Inc., (OAPI) and Otsuka Pharmaceutical, Co., Ltd. (Otsuka) announce that the U.S. Food and Drug Administration (FDA) plans to host a Psychopharmacologic Drugs Advisory Committee (PDAC) meeting to seek input on issues related to the Supplemental New Drug Application (sNDA) for brexpiprazole in combination with sertraline for the treatment of adults with post-traumatic stress disorder (PTSD). The FDA’s decision to host a PDA
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Virta Health Announces Record and Accelerating Growth at a Scale of More Than $100M in Annualized Revenue, Driven by Sustainable Weight Loss and GLP-1 Solutions

DENVER–(BUSINESS WIRE)–Virta Health, the leader in diabetes reversal and sustainable weight loss with a nutrition-first approach, announced record and accelerating growth of more than 60% year-over-year, at a scale of more than $100 million in annualized revenue. Driven by demand for its Sustainable Weight Loss (SWL) solution—now expanded to include ‘Responsible Prescribing’ capabilities—and continued growth of its diabetes reversal offering, Virta works with more than 550 organizations and c
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Andreessen Horowitz Partners with Lilly to Launch First-of-Its-Kind Biotech Ecosystem Venture Fund

MENLO PARK, Calif.–(BUSINESS WIRE)–Andreessen Horowitz (a16z) Bio + Health today announced a newly formed, first-of-its-kind venture capital fund to fuel broader innovation in human health, in partnership with Eli Lilly and Company (“Lilly”). The Biotech Ecosystem Venture Fund (“Fund”) seeks to drive transformative progress in healthcare by investing in therapeutic platforms and cutting-edge technology companies that can bring new medicines and disease treatments to improve patients’ lives. M
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