NDA
Company to Move Forward with Key U.S. Regulatory Applications – Investigational New Drug and Orphan Drug Designation BOSTON, July 26, 2022 (GLOBE NEWSWIRE) — Aisa Pharma, Inc. a privately-funded, clinical-stage biopharmaceutical company, today announced that the Data Safety Monitoring Board (DSMB) for the RECONNOITER Phase 2 study of Aisa’s Profervia® once-daily novel, oral calcium-channel antagonist…
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Phase 2a trial initiation planned for the first half of 2023 subject to IND clearance and available capital Excerpt from the Press Release: NEWTON, Mass. and GENEVA, Switzerland, July 28, 2022 (GLOBE NEWSWIRE) — Acer Therapeutics Inc. (Nasdaq: ACER) (Acer) and its collaboration partner, RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief), today…
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Investigational New Drug Application Submitted by Omega Represents the First Epigenomic Controller in a New Class of Programmable mRNA Therapeutics Excerpt from the Press Release: CAMBRIDGE, Mass., June 15, 2022 /PRNewswire/ — Omega Therapeutics, Inc. (Nasdaq: OMGA) (“Omega”) today announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug…
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Automated and Easily Scalable Swab-Based Workflow Supports Increased Sample Throughput and Processing Consistency Excerpt from the Press Release: WALTHAM, Mass. & WATERTOWN, Mass.–(BUSINESS WIRE)–Rhinostics Inc. and Nexus Medical Labs recently received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for a molecular SARS-CoV-2 test enabling unsupervised self-collection. The test, based on…
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Company to initiate Phase 1 dose escalation and expansion trial for the treatment of Wilms’ Tumor 1 (WT1) positive recurrent/metastatic cancers Starting dose of 1 mg/kg expected to reduce time and cost of dose escalation phase of trial, supporting development efficiency of CUE-100 series platform BOSTON, May 11, 2022 (GLOBE NEWSWIRE) — Cue Biopharma, Inc. (Nasdaq: CUE),…
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Poster selected for inclusion in conference’s Elevator Pitch Session: GDA-301 produces enhanced potency and persistence with combined genetic manipulation of CISH gene editing and the engineered expression of membrane-bound IL-15 for targeting hematologic malignancies and solid tumors GDA-601 generates promising immunotherapeutic potential to target multiple myeloma cells Company plans to select a genetically modified NK…
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Excerpt from the Press Release: NEWTOWN, Pa., May 5, 2022 /PRNewswire/ — Sen-Jam Pharmaceuticals and KVK Tech are collaborating to develop a Covid-19 oral therapy. The companies will operate in parallel while they complete the Phase II clinical trials in Nepal. KVK Tech will offer formulation and chemistry, manufacturing and controls (CMC) for the oral therapy. Furthermore, KVK…
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Excerpt from the Press Release: CAMBRIDGE, Mass., April 06, 2022 (GLOBE NEWSWIRE) — Spero Therapeutics, Inc. (Nasdaq: SPRO) today announced publication in The New England Journal of Medicine (NEJM) of the results from the Phase 3 ADAPT-PO clinical trial for its investigational oral carbapenem antibiotic, tebipenem pivoxil hydrobromide (tebipenem HBr). The paper, titled “Oral Tebipenem Pivoxil Hydrobromide in…
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Transfer of Trial Sponsorship Final Major Milestone before Initiation of Lung Failure Pivotal Clinical Trial Excerpt from the Press Release: CEANSIDE, Calif.–(BUSINESS WIRE)–Therapeutic Solutions International announced today the execution of a purchase agreement covering sponsorship and leadership of the FDA cleared Phase III pivotal trial assessing JadiCell adult stem cells for treatment of COVID-19 associated…
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Clinical Study Expected to Begin in 2022 to Investigate the Safety and Efficacy of IOV-4001 to Deliver TIL and PD-1 Inhibition within a Single Cancer Therapy First Genetically Modified Iovance TIL Therapy Leverages TALEN® technology Licensed from Cellectis to Inactivate PD-1 Expression Excerpt from the Press Release: SAN CARLOS, Calif., March 15, 2022 (GLOBE NEWSWIRE) — Iovance…
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