BURNABY, British Columbia--(BUSINESS WIRE)--ARTMS Inc. (ARTMS), the global leader in developing and commercializing novel products enabling cyclotron production of the world’s most needed medical radioisotopes, is pleased to announce the submission of a Type 1 Master File with the Health Products & Food Branch, Health Canada (HC) for the production of gallium-68 (Ga-68). Gallium-68 is a critical medical isotope of significant clinical importance in nuclear medicine diagnostic procedures utilizing Positron Emission Tomography (PET) imaging. ARTMS’ Health Canada filing will help alleviate the current supply constraints and provide innovators the ability to advance new radiopharmaceutical drugs into development.
MELBOURNE, Australia and KYOTO, Japan, Sept. 08, 2021 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the last patient has been imaged in a Phase I clinical study of Telix’s investigational prostate cancer imaging product TLX591-CDx (Illuccix®, Kit for the preparation of 68Ga-PSMA-11 injection) in collaboration with Kanazawa University.
MELBOURNE, Australia, Oct. 14, 2019 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX:TLX, “Telix”, the “Company”) a clinical-stage biopharmaceutical company focused on the development of diagnostic and therapeutic products based on “molecularly-targeted radiation” (MTR), today announced the completion of the integration of GE Healthcare’s cyclotron-based 68Ga (gallium) production data with Telix’s regulatory package for TLX591-CDx for the imaging of prostate cancer with Positron Emission Tomography (PET)1.
Roche announced data from the positive, pivotal phase III GALLIUM study that compared Gazyva/Gazyvaro (obinutuzumab) plus chemotherapy followed by Gazyva/Gazyvaro alone head-to-head against MabThera/Rituxan (rituximab) plus chemotherapy followed by MabThera/Rituxan alone for people with previously untreated follicular lymphoma. At a pre-planned interim analysis in May 2016, an independent data monitoring committee determined that the study met its primary endpoint early. The results showed Gazyva/Gazyvaro-based treatment reduced the risk of disease worsening or death (progression-free survival; PFS, as assessed by investigator) by 34 percent compared to MabThera/Rituxan-based treatment (HR=0.66; 95% CI 0.51-0.85, p=0.0012). Median PFS was not yet reached. Adverse events with either Gazyva/Gazyvaro or MabThera/Rituxan were consistent with those seen in previous studies.