Clinical Trials (Phase I)
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Veru Inc. has announced the publication of positive Phase III results from its COVID-19 antiviral therapeutics that could lead to potential Emergency Use Authorization.
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Boehringer, Evotec and bioMérieux found Aurobac to combat antimicrobial resistance, Turnstone and Moffitt Expand TIL Collab, Skyhawk to gain potential $2B from Sanofi RNA splicing deal.
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Cend Therapeutics Announces Publication of Pancreatic Cancer Trial Data in the Lancet Gastroenterology and Hepatology
7/6/2022
Cend Therapeutics, Inc. today announced that The Lancet Gastroenterology and Hepatology published data from the Phase 1b study of CEND-1.
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Immunome’s COVID-19 Cocktail Retains Neutralizing Activity Against the Most Prevalent Omicron Subvariants* in the US, BA.4/5 and BA.2.12.1
7/6/2022
Immunome, Inc. today announced that their cocktail (IMM-BCP-01) retained activity against the BA.4/5 and BA.2.12.1 subvariants in pseudovirus testing.
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Caladrius Biosciences and Cend Therapeutics Announce Publication of Pancreatic Cancer Trial Data in The Lancet Gastroenterology and Hepatology
7/6/2022
Caladrius Biosciences, Inc. (Nasdaq: CLBS) (“Caladrius” or the “Company”), and Cend Therapeutics, Inc. (“Cend”), today announced that The Lancet Gastroenterology and Hepatology has published data from the Phase 1b study of CEND-1.
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Sheba Medical Center and Enlivex Announce Dosing of the First Patient in Phase I/II Trial Evaluating Allocetra Combined with Chemotherapy in Patients with Peritoneal Metastases Arising from Solid Cancers
7/6/2022
Enlivex Therapeutics Ltd. (Nasdaq: ENLV, the “Company”), today announced that the first patient has been dosed in a Phase I/II clinical trial evaluating Allocetra™ combined with chemotherapy in patients with peritoneal metastases arising from solid cancer.
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Inmagene and HUTCHMED Announce First Participants in Global Phase I Trial of IMG-007
7/6/2022
Inmagene Biopharmaceuticals (" Inmagene ") and HUTCHMED (China) Limited (“ HUTCHMED ”) (Nasdaq/AIM:HCM; HKEX:13) announce today that the first participant, based in Australia, was dosed in a global Phase I trial of IMG-007, an investigational OX40 antagonistic monoclonal antibody.
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Inmagene and HUTCHMED Announce First Participants in Global Phase I Trial of IMG-007
7/6/2022
Inmagene Biopharmaceuticals and HUTCHMED Limited announces that the first participant, based in Australia, was dosed in a global Phase I trial of IMG-007, an investigational OX40 antagonistic monoclonal antibody.
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The FDA lifted its clinical hold on Vertex Pharmaceuticals' Phase I/II clinical trial of VX-880, a pancreatic islet cell replacement therapy for people with Type I Diabetes (TID).
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The FDA lifted the clinical hold on Dyne Therapeutics’ clinical study of DYNE-251 in Duchenne muscular dystrophy (DMD) patients amenable to skipping exon 51. A Phase I/II trial is expected by mid-year.
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Quris has developed an alternative to testing on animal models, and each one is smaller than the head of a pin. It holds the potential to increase the currently terrible odds in drug development.
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Otsuka and Lunbeck report positive Phase III results in agitation in Alzheimer's, Acer's vEDS program hits Phase III and BridgeBio's primary hyperoxaluria type 1 program progresses.
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Many of Innate Pharma’s cancer-fighting products are making clinical progress. BioSpace spoke with the company's head of product portfolio strategy and business development, Yannis Morel, Ph.D.
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OBI Pharma Announces Discontinuation of the Phase 1/2 Study of its Antibody- OBI 888 to focus on other priority Cancer programs
7/5/2022
OBI Pharma, a Taiwan biopharma company (TPEx: 4174), today announced discontinuation of the Phase 1/2 Study* for OBI 888, a Globo H antibody, upon completion of enrollment in our investigative sites.
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Titan Pharmaceuticals Announces FDA Clearance of IND Application for Nalmefene Implant
7/5/2022
Titan Pharmaceuticals, Inc. (NASDAQ: TTNP) ("Titan" or the "Company") today announced that the U.S. Food and Drug Administration ("FDA") has cleared its Investigational New Drug ("IND") application for a Phase 1 study of its six-month or longer subdermal formulation of nalmefene.
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Vertex Announces FDA Has Lifted the Clinical Hold on VX-880 Phase 1/2 Clinical Trial for the Treatment of Type 1 Diabetes
7/5/2022
Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold placed on the Phase 1/2 clinical trial of VX-880, an investigational stem cell-derived, fully differentiated pancreatic islet cell replacement therapy for people with type 1 diabetes (T1D) with impaired hypoglycemic awareness and severe hypoglycemia.
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Arrowhead Pharmaceuticals Initiates Phase 1/2a Studies for Two Pulmonary Candidates ARO-MUC5AC and ARO-RAGE
7/5/2022
Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced that it has dosed the first subjects in two Phase 1/2a clinical trials of ARO-MUC5AC and ARO-RAGE, the company’s investigational RNA interference (RNAi) therapeutics designed to reduce production the of mucin 5AC (MUC5AC).
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Abbisko Therapeutics Completed Dosing of First Patient for Its First-in-Class Highly Selective FGFR2/3 Inhibitor ABSK061
7/4/2022
Abbisko Therapeutics Co., Ltd. announced completion of dosing of the first patient in the Phase 1 clinical trial in advanced solid tumors for ABSK061, which becomes the first highly selective FGFR2/3 inhibitor advanced into clinical stage globally.
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OliX Pharmaceuticals Announces IND Submission to U.S. FDA to Evaluate Safety and Tolerability of OLX10212 in Phase 1 Clinical Trial
7/1/2022
OliX Pharmaceuticals, Inc. (KOSDAQ: 226950), a leading developer of RNAi therapeutics, today announced the submission of an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) to evaluate the safety and tolerability of OLX10212 for the treatment of advanced age-related macular degeneration (AMD).
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Italfarmaco is making headway against DMD as it announced positive results from a Phase III study, Clover's homologous booster against Omicron increases antibodies, and much more.