Telix Pharmaceuticals Ltd. will acquire Lightpoint Medical Ltd. in a $35 million deal that will expand its urology pipeline and bring in house a new surgery-focused unit. Under the terms of the deal, Telix of Melbourne, Australia, will pay Lightpoint $20 million up front and a further $15 million on achievement of certain development milestones. The up-front payment will be paid in equity, and the additional milestones will be payable in cash or equity, at Telix’s election.
The EU’s In Vitro Diagnostic Regulation (IVDR) has not yet been fully implemented, but Australia’s Therapeutic Goods Authority (TGA) is wasting no time attempting to harmonize with the IVDR.
In its second approval this month from the U.S. FDA, Avita Medical Inc.’s Recell system received premarket approval for the repigmentation of stable depigmented vitiligo lesions. The approval marks the first therapeutic device offering a one-time treatment for vitiligo at the point of care. Using the device, a clinician prepares and delivers autologous skin cells from pigmented skin to stable depigmented areas.
After raising AU$4 million (US$2.6 million), Argenica Therapeutics Pty. Ltd. is gearing up to begin phase II trials in ischemic stroke for ARG-007, a glutamate receptor modulator that is believed to reduce brain tissue death after stroke.
After raising AU$4 million (US$2.6 million), Argenica Therapeutics Pty. Ltd. is gearing up to begin phase II trials in ischemic stroke for ARG-007, a glutamate receptor modulator that is believed to reduce brain tissue death after stroke.
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.
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.
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.