Recent regulatory reforms to Australia’s medical device framework have shown Australia’s Therapeutic Goods Administration (TGA) a new way of collaborating with industry to make improvements and ensure patient safety, said Tracey Duffy, deputy secretary for the TGA’s Medical Devices and Product Quality Division, during the recent Ausmedtech conference in Adelaide.
Cellusion Inc. raised ¥2.83 billion (US$21 million) in a series C round to progress its lead therapy, CLS-001, an iPS cell-derived therapy to treat bullous keratopathy.
Incannex Healthcare Ltd. had quietly been developing its commercialization plans for psychedelic clinics well before Australia’s Therapeutic Goods Administration announced it would allow psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) to be prescribed by authorized psychiatrists for treatment-resistant depression and post-traumatic stress disorder.
Immutep Ltd. announced an AU$80 million (US$52.1 million) capital raise that consists of a AU$50 million placement and a AU$30 million entitlement offer to eligible shareholders to fund clinical programs for lead candidate eftilagimod (IMP-321, efti), a lymphocyte activation gene-3 (LAG-3) fusion protein and major histocompatibility complex class II agonist that stimulates both innate and adaptive immunity for treating cancer.
Gracell Biotechnologies Inc. is initiating two clinical trials in China in refractory systemic lupus erythematosus for lead candidate GC-012F, a CD19/B-cell maturation antigen dual-targeting CAR T.
Incannex Healthcare Ltd. had quietly been developing its commercialization plans for psychedelic clinics well before Australia’s Therapeutic Goods Administration announced it would allow psilocybin and MDMA (3,4-methylenedioxy-methamphetamine) to be prescribed by authorized psychiatrists for treatment-resistant depression and post-traumatic stress disorder.
Immutep Ltd. announced an AU$80 million (US$52.1 million) capital raise that consists of a AU$50 million placement and a AU$30 million entitlement offer to eligible shareholders to fund clinical programs for lead candidate eftilagimod (IMP-321, efti), a lymphocyte activation gene-3 (LAG-3) fusion protein and major histocompatibility complex class II agonist that stimulates both innate and adaptive immunity for treating cancer.
Medicinal cannabis company Zelira Therapeutics Ltd.’s stock shot up 224% on May 31 on the heels of news that its cannabinoid product, ZLT-L-007, outperformed Lyrica (pregabalin, Pfizer Inc) in a head-to-head trial in diabetic nerve pain.
Immunotherapy-focused biotech company LTZ Therapeutics Inc. raised more than $10 million in a pre-A+ financing that will be used to continue establishing the company’s platform and pipeline that is initially focused on solid and liquid tumors.
Heartseed Inc. raised ¥2 billion (US$14.3 million) in a series D round to continue the phase I/II Lapis trial of its allogeneic induced pluripotent stem cell (iPSC)-derived cardiomyocytes for heart failure. The lead asset, HS-001, is an investigational cell therapy consisting of clusters of purified heart muscle cells (cardiomyocyte spheroids) derived from iPSCs that are designed to restore heart muscle and function in patients with advanced heart failure.
