Industry News
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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TrialStat EDC provides integrated IWRS functionality, allowing for any degree of randomization complexity. Tied into screening (inclusion / exclusion criteria) as well as with pain scores or other qualifying metrics to randomize patients into cohorts. Using TrialStat IWRS will enable sites to trigger randomization codes directly without leaving TrialStat EDC, and without the need or…
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KAN-101 represents the first agent to modulate the IL-2 biomarker associated with symptomatic responses to gluten exposure in celiac patients KAN-101 advancing in a Phase 1b/2 clinical trial in celiac disease and immune tolerance Excerpt from the Press Release: CAMBRIDGE, Mass. & LAUSANNE, Switzerland–(BUSINESS WIRE)–Anokion SA, a clinical-stage biotechnology company focused on treating autoimmune disease…
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Excerpt from the Press Release: EMERYVILLE, Calif., June 07, 2023 (GLOBE NEWSWIRE) — 4D Molecular Therapeutics (Nasdaq: FDMT, 4DMT, or the Company), a clinical-stage biotherapeutics company harnessing the power of directed evolution for targeted genetic medicines, today announced positive interim clinical data from the 4D-710 Phase 1/2 AEROW clinical trial for the treatment of cystic…
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— Potent and durable immunogenicity achieved with low dose self-amplifying mRNA vaccine (samRNA) candidate — — Immunity boosted for at least 6 months in previously vaccinated-older adults (administration post-primary series of Vaxzevria®, Comirnaty® or Spikevax®) — — Data underscore the potential of Gritstone’s samRNA candidates to serve as next-generation vaccines against COVID-19 and other infectious…
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