Australian cell therapy company Cartherics has announced that the Japanese Patent Office has issued a new patent for its off-the-shelf immune cell therapies.

CEO and Managing Director Dr David Foster said, “The expansion of our CRADA with USAMRIID and Geneva represents a major strategic milestone for Island and positions the Company to undertake the efficacy study prior to the pivotal study for Galidesivir.”

“We want to work with the Government to get these policy settings right and at speed so we can give Australia’s biotech, medtech and health tech companies the policy certainty they need to continue to thrive. We just need Government to meet us at the table,” said AusBiotech CEO Rebekah Cassidy.

Alterity Therapeutics has announced that the US Food and Drug Administration has agreed on the key design elements for a pivotal Phase 3 trial of ATH434 in Multiple System Atrophy following a successful End of Phase 2 meeting.

The company said the FDA correspondence represents a significant regulatory milestone because it completes the substantive review and moves the filing to the last administrative step before a decision.

LTR Pharma has taken a decisive step toward bringing its rapid-acting intranasal erectile dysfunction treatment ROXUS to the United States by signing a binding term sheet with Shed Holdings, a US direct-to-consumer telehealth platform.

Researchers at the Snow Centre for Immune Health have uncovered subtle but consistent differences in immune cell behaviour in people with coeliac disease, suggesting risk may arise from how the immune system functions long before symptoms appear.

The forum, running since 2018, gives early-stage innovators the chance to pitch to a panel of industry experts and receive feedback that helps move projects and technologies toward commercialisation, one of AusBiotech’s key efforts to support start-ups and SMEs on their commercial journeys.

Opthea has announced its reinstatement to the ASX and unveiled a sharply refocused strategy centred on advancing OPT-302 for lymphangioleiomyomatosis, or LAM, a rare pulmonary disease with significant unmet need.

Nyrada has completed a pilot preclinical study testing repeated subcutaneous dosing of its lead candidate Xolatryp in combination with the chemotherapy drug doxorubicin.

Island Pharmaceuticals has announced it is advancing GMP manufacturing of its antiviral, Galidesivir, to support a pivotal Marburg study under the US FDA Animal Rule pathway.

Executive Chair Dr Pete Smith said, “The support from our shareholders is deeply appreciated. Achieving a 97 per cent conversion rate is a remarkable outcome and an endorsement of our clinical development program for RC220."

Tetratherix has raised $15 million through a placement to institutional investors and announced a share purchase plan to raise up to a further $2 million from eligible shareholders.

Percheron Therapeutics and researchers at QIMR Berghofer unveiled new preclinical findings at the American Society for Clinical Oncology annual meeting suggesting that the immune checkpoint VISTA is a potential driver of treatment resistance in triple-negative breast cancer.

The three-year project will seek new ways to repair the heart and improve outcomes for people recovering from heart attacks or living with heart disease.

Chimeric Therapeutics has reported encouraging early results from its CHM CDH17 program, which were presented at the American Society of Clinical Oncology.

Cynata Therapeutics has been notified by the World Health Organization that the name Pixenstrocel has been selected as the proposed International Nonproprietary Name (INN) for its Cymerus iPSC-derived mesenchymal stem cells.