Month: December 2022
–Results from this ongoing, non-interventional, rollover study were presented at the 23rd Annual Society of Urologic Oncology (SUO) Meeting in San Diego Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to creating novel solutions that treat urothelial and specialty cancers, today announced new data from the OLYMPUS…
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A Phase 2 clinical trial has started of DS-1211 in individuals with Pseudoxanthoma Elasticum (PXE), a rare multisystem genetic disease that causes calcium deposits in soft tissue resulting in considerable morbidity. DS-1211 is a potential first-in-class small molecule developed through a research collaboration between Daiichi Sankyo and Sanford Burnham Prebys. Excerpt from the Press Release:…
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– Preclinical data support twice-yearly dosing in wet AMD – Excerpt from the Press Release: BERKELEY, Calif., Dec. 01, 2022 (GLOBE NEWSWIRE) — Valitor, a biotechnology company engineering better medicines to conquer drug limitations, today announced that its president and chief scientific officer, Wesley Jackson, Ph.D., will present at the Ophthalmology Innovation Source (OIS) XII…
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Researchers highlight efficacy and safety data across three Phase 3 studies of brexpiprazole for agitation in Alzheimer’s dementia Agitation is a highly prevalent clinical manifestation in Alzheimer’s dementia and one of the most complex and stressful aspects of care in patients affected by the disease. It is associated with greater caregiver burden, earlier nursing home…
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Novel best-in-class MEK-RAF complex inhibitor IK-595 targets RAS pathway; IND in 2023 Novel paralog-selective TEAD inhibitor IK-930 advancing as planned in dose escalation; clinical data in 2023 Company prioritizes advancement of targeted oncology portfolio; cash runway extended into 2025 Excerpt from the Press Release: BOSTON, Nov. 28, 2022 (GLOBE NEWSWIRE) — Ikena Oncology, Inc. (Nasdaq:…
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Primary endpoint in Intention to Treat (ITT) was not met despite large absolute reductions in Systolic Blood Pressure (SBP) 12.6 mmHg placebo-adjusted reduction in SBP with 2 mg baxdrostat in a pre-specified subgroup that represents approximately 81-89% of the U.S. hypertension population (nominal p-value = 0.001) Safety profile and tolerability consistent with BrigHtn Phase 2…
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Excerpt from the Press Release: WOBURN, Mass., Nov. 21, 2022 (GLOBE NEWSWIRE) — Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company specializing in the commercialization of dermatological products, announced today the launch of a randomized, double-blind, vehicle-controlled, multicenter Phase 3 clinical study to evaluate the safety and efficacy of Ameluz® and BF-RhodoLED® XL in the field-directed…
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KING OF PRUSSIA, PA, USA This historic approval provides a new treatment option that reduces the rate of annual bleeds, reduces or eliminates the need for prophylactic therapy and generates elevated and sustained factor IX levels for years after a one-time infusion. Excerpt from the Press Release: This historic approval provides a new treatment option…
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Study finds patients with Fragile X who have a highly methylated FMR1 gene that were treated with Zygel showed a significant reduction in behavioral symptoms compared to those treated with placebo Topline results from follow-on RECONNECT confirmatory pivotal Phase 3 trial of Zygel in patients with a completely methylated FMR1 gene expected in second half…
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– PK Data and Safety Profile Consistent with Previous Studies in Healthy Subjects – – Results Support Potential Utility of Lefamulin in Patients with Cystic Fibrosis – Excerpt from the Press Release: DUBLIN, Ireland and FORT WASHINGTON, Pa., Nov. 28, 2022 (GLOBE NEWSWIRE) — Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the…
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