Industry News
Company confirms FDA agreement on key elements of the Phase 3 segment of ongoing RINGSIDE study, including dosing regimen of 1.2mg once daily Enrollment in Phase 3 continuing as planned Excerpt from the Press Release: REHOVOT, Israel & MONMOUTH JUNCTION, N.J., July 05, 2023 (GLOBE NEWSWIRE) — Ayala Pharmaceuticals, Inc. (OTCQX: ADXS), a clinical-stage oncology…
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Median Overall Survival of 20.9 Months for Patients Without Active Liver Metastases Surpasses the Recently Reported 12.9-Month Benchmark with Standard of Care in this Population Excerpt from the Press Release: LEXINGTON, Mass.–(BUSINESS WIRE)–Immuno-oncology leader, Agenus (Nasdaq: AGEN), shared promising data today from its Phase 1b trial on the botensilimab and balstilimab combination at a late-breaking…
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Excerpt from the Press Release: WATERTOWN, Mass., July 05, 2023 (GLOBE NEWSWIRE) — C4 Therapeutics, Inc. (C4T) (Nasdaq: CCCC), a clinical-stage biopharmaceutical company dedicated to advancing targeted protein degradation (TPD) science to develop a new generation of small-molecule medicines and transform how disease is treated, today announced that the U.S. Food and Drug Administration (FDA)…
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Oxford BioTherapeutics expanded its US-based trial investigating OBT-076 as monotherapy and combination treatment to European sites. Excerpt from the Press Release: UK-based oncology company Oxford BioTherapeutics has initiated a Phase Ib trial evaluating OBT-076 in patients with solid tumours at a European site. The company dosed the first patient with its CD205 targeting antibody-drug conjugate…
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Excerpt from the Press Release: The Food and Drug Administration has fully approved the first drug shown to slow down Alzheimer’s disease. The action means that Leqembi, whose generic name is lecanemab, should be widely covered by the federal Medicare health insurance program, which primarily serves adults age 65 and older. So more people who…
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Excerpt from the Press Release: ATHENS, Ga. and LOS GATOS, Calif., June 29, 2023 /PRNewswire/ — Blue Lake Biotechnology, Inc., a clinical stage intranasal vaccine company harnessing the full breadth of the immune system to protect against serious infectious disease, announced that the first child has been dosed in its Phase 1/2a trial (NCT05655182) of…
Read MoreExcerpt from the Press Release: UTRECHT, The Netherlands and CAMBRIDGE, Mass., June 29, 2023 (GLOBE NEWSWIRE) — Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics® and Triclonics®) for cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for zenocutuzumab (Zeno) for the treatment…
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Phase 2 Data at EULAR Suggested Profervia® Treatment Might Influence Systemic Sclerosis (SSc) Disease Severity Excerpt from the Press Release: BOSTON, June 21, 2023 /PRNewswire/ — Aisa Pharma, Inc. a private, clinical-stage biopharmaceutical company today announced initiation of Part 2 of the RECONNOITER Phase 2 study, evaluating Profervia®, a once-daily novel, oral calcium-channel antagonist (CCB) in patients with SSc…
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Adaptive clinical trial designed to accelerate registration pathways for pancreatic cancer therapies and expected to reduce cost of a Phase 3 study for pelareorep by ~50% compared to a traditional trial If successful, new clinical study expected to support approval of pelareorep in combination with a checkpoint inhibitor, gemcitabine, and nab-paclitaxel in first-line metastatic pancreatic…
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Excerpt from the Press Release: LEXINGTON, Mass., June 15, 2023 /PRNewswire/ — Pulmatrix, Inc. (NASDAQ: PULM), a clinical-stage biopharmaceutical company developing innovative inhaled therapies to address serious pulmonary and central nervous system disease using its patented iSPERSE™ technology, today announced it will present data at the American Headache Society 65th Annual Meeting, being held from June…
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