GeneType Multi-Test Panel Expanded: Inclusion of 3 New D iseases
Posted: 28 March 2023 Genetic Technologies Limited – a global leader in genomics-based tests in health, wellness and serious disease – is pleased to announce the initiation of phase 2 of the rollout plan for the geneType Multi-Test.…
Imagion to proceed to file an IND for the MagSense® HER2 Imaging Agent following FDA feedback
Posted: 28 March 2023 Imagion Biosystems Limited, a company dedicated to improving healthcare through the earlier detection of cancer, is pleased to provide an update on development plans for its MagSense® HER2 imaging agent. Based on feedback the…
US FDA clearance of Adherium’s Hailie for Teva inhalers
Posted: 24 March 2023 Adherium Limited, a leader in respiratory eHealth, remote monitoring and data management solutions, is pleased to announce that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance to market application, connecting Teva Pharmaceutical…
Firebrick Pharma’s Phase 3 Trial of Nasodine Resumes
Posted: 23 March 2023 Firebrick Pharma Limited is pleased to announce that its Phase 3 clinical trial of Nasodine Nasal Spray (Nasodine) as a treatment for the common cold has received the necessary ethics approvals to re-open for…
ANDHealth Announces Partnership with Brandon BioCatalyst for $50m BioMedtech Incubator
Posted: 21 March 2023 We are delighted to announce that, ANDHealth, in partnership with Brandon BioCatalyst, has been selected by the Medical Research Future Fund to deliver the $50m BioMedTech Incubator Program (BMTI). This investment substantially increases the combined non-dilutive…
FDA Approves Expanded Indication for Telix’s Illuccix to Include Patient Selection for PSMA-Directed Radioligand Therapy
Posted: 17 March 2023 Telix Pharmaceuticals today announces that the United States Food and Drug Administration (FDA) has approved a supplementary New Drug Application (sNDA) for Illuccix® (kit for the preparation of gallium Ga 68 gozetotide injection) to enable…
Alterity Therapeutics Enrolls First Patient in the U.S. in ATH434 Phase 2 Clinical Trial in Multiple System Atrophy
Posted: 17 March 2023 Alterity Therapeutics, a biotechnology company dedicated to developing disease modifying treatments for neurodegenerative diseases, announced the first participant has been dosed in the U.S. in the Company’s Phase 2 clinical trial of ATH434 in…
Cynata Adds New Sites for DFU Clinical Trial
Posted: 17 March 2023 Cynata Therapeutics Limited, a clinical-stage biotechnology company specialising in cell therapeutics, has announced that three additional clinical sites have opened for recruitment in the ongoing clinical trial of CYP-006TK in patients with diabetic foot…
Smart nanotechnology for more accurate delivery of insulin
Posted: 16 March 2023 More efficient and longer lasting glucose-responsive insulin that eliminates the need for people with type 1 diabetes to measure their glucose levels could be a step closer thanks to a Monash University-led project. Published…
Women-led startup innovations in pregnancy monitoring, clinical trials supported by $750,000 University investment
Posted: 16 March 2023 The University of Melbourne will provide pre-seed investment to support two innovative female-founded healthcare startups, innovative at-home pregnancy monitoring start-up Kali Healthcare, and clinical trial participant recruitment start-up Torch Recruit. Kali Healthcare, co-founded by…
Immutep Announces Initiation of Phase II/III Trial for Eftilagimod Alpha plus Paclitaxel in Metastatic Breast Cancer
Posted: 16 March 2023 Immutep Limited, a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, announced the initiation of AIPAC-003 (Active Immunotherapy, Eftilagimod Alpha, and PAClitaxel), an integrated Phase II/III trial to evaluate eftilagimod alpha (“efti”)…
Pfizer and BioNTech Receive U.S. Emergency Use Authorization of Omicron BA.4/BA.5-Adapted Bivalent COVID-19 Booster in Children Under 5 Years
Posted: 16 March 2023 Pfizer Inc. and BioNTech SE announced today that the U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) to provide a single booster dose of the companies’ Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine…
