Industry News
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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-Company on track to begin enrolling healthy volunteers in the second half of 2023- Excerpt from the Press Release: DIEGO–(BUSINESS WIRE)–Pipeline Therapeutics, a clinical-stage biopharmaceutical company pioneering precision neuroregeneration, today announced that the U.S. Food and Drug Administration (FDA) cleared the company to initiate its Phase 1 clinical trial of PIPE-791 in healthy volunteers. The…
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TrialStat’s ePRO module is a fully integrated extension of our EDC platform. ePRO questionnaires are configured within our web-based study designer and have all of the features and capabilities available to traditional eCRFs. 100% web-based, online ePRO functionality. Avoid the hassle of offline ePRO providers – no need to provision, validate and ship devices, and…
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Findings from the ongoing Phase 1 MYTHIC study demonstrated a favorable and distinctive tolerability profile for monotherapy lunresertib Monotherapy antitumor activity observed, including confirmed partial response and several patients with long stable disease Identified both intermittent and continuous schedules to enable combination studies Encouraging early responses across gemcitabine, camonsertib and FOLFIRI clinical combinations Repare to…
Read More Secondary Efficacy Analyses, Including of Neuromuscular Blockade and Spontaneous Reversal, Support Earlier Reported Clinical Results with BX1000 Excerpt from the Press Release: MALVERN, Pa., June 07, 2023 (GLOBE NEWSWIRE) — Baudax Bio, Inc. (Nasdaq:BXRX) (the “Company”), a pharmaceutical company focused on innovative products for acute care and related settings, today announced additional results from its…
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