BioSpace News Archive

Studying Immune Cell Aging in Space May Lead to New Therapies for Patients on Earth

A healthy immune system is what defends the body from invaders like bacteria and viruses.

October 3, 2023
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2 min read
Drug Development

Vertex Presents Positive, Updated VX-880 Results From Ongoing Phase 1/2 Study in Type 1 Diabetes at the European Association for the Study of Diabetes 59th Annual Meeting

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today presented longer-term data on patients dosed in Parts A and B of its Phase 1/2 clinical trial of VX-880, an investigational stem cell-derived, fully differentiated islet cell therapy in people with type 1 diabetes (T1D) with impaired hypoglycemic awareness and severe hypoglycemic events (SHEs).

October 3, 2023
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8 min read
Drug Development

FDA Grants Transcenta Clearance to Proceed with Global Phase III Trial of Osemitamab (TST001) as First-Line Treatment for Gastric/Gastroesophageal Cancer Patients

Transcenta Holding Limited (“Transcenta”) (HKEX: 06628) announces that FDA has granted it clearance to proceed with TranStar 301 global Phase III pivotal trial of Osemitamab (TST001) in combination with Nivolumab and chemotherapy as first-line treatment in patients with HER2-negative, CLDN18.2 expressing locally advanced or metastatic gastric or gastroesophageal (G/GEJ) adenocarcinoma.

October 3, 2023
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7 min read
FDA

EntroGen Receives FDA Approval for CRCdx® RAS Mutation Detection Kit as Companion Diagnostic for Vectibix®

The U.S. Food and Drug Administration has granted approval for EntroGen’s CRCdx® RAS Mutation Detection Kit as a companion diagnostic for Vectibix®, a targeted therapy used in the treatment of colorectal cancer.

October 3, 2023
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2 min read