Latest Manufacturing News

Immutep has narrowed eftilagimod alfa’s potential registration pathway to PD-L1-negative head and neck cancer and neoadjuvant soft tissue sarcoma after identifying product differences between manufacturing scales used in earlier studies and TACTI-004. A new 200 L manufacturing run is planned, but replacement trials are not targeted to start until the second half of 2027 and remain subject to regulatory, funding and partnering decisions.

Bubs Australia has secured permanent US FDA authorisation for three infant formula products, removing a regulatory barrier in the company’s largest market. The approval supports possible portfolio expansion and contract manufacturing, but the presentation contains no new earnings guidance or quantified financial benefit.

Cleo Diagnostics has appointed Bio-Techne’s CLIA-certified U.S. laboratory Asuragen to run pivotal clinical validation for its pre-surgical ovarian cancer test. The approximately 1,470-sample program is intended to generate the evidence supporting a planned FDA 510(k) submission in the first half of calendar 2027.

Eagers Automotive has signed a non-binding agreement to acquire a 50% interest in Zagame Automotive Group, gaining exposure to 14 premium and luxury vehicle brands across Melbourne and Adelaide. The company expects the proposed joint venture to be immediately earnings accretive, although completion remains conditional and no transaction value has been disclosed.

Critical Resources has completed 65 cycles across more than a month in a full-format pouch cell using its solvent-free DSD cathode matrix. The cell retained about 75% of its starting capacity, offering a useful engineering baseline but not yet a commercial performance result.

A multimillion-dollar, multiyear NIH grant will fund an expanded access program for Neurizon’s investigational NUZ-001, potentially giving up to 200 US patients access to the therapy for as long as 96 weeks. The program is designed to add long-term safety, survival and biomarker data alongside the pivotal HEALEY ALS trial.

KTEK Aerosystems has secured a US$172,500 turnkey contract to design, tool and manufacture two composite prototypes for Israel-based Vestal Technology. The work adds a new customer, but any production beyond the prototypes remains uncertain.

OncoSil Medical has moved closer to local production after contract manufacturer Cyclotek secured ISO 13485 certification for its quality management system. Production at the Macquarie Park facility remains targeted for the end of 2Q FY27, subject to further regulatory approval.

OncoSil Medical has secured $5.6 million from its three largest institutional investors to fund commercial launches of its OncoSil device in the United States and Australia. The commitments follow FDA and TGA approvals and would lift pro-forma cash to $12.1 million once completed.

Clever Culture Systems secures a follow-up order from Novo Nordisk for two APAS Independence instruments, marking a critical step toward broader global deployment and signalling expected sales growth from FY27.

Adisyn Ltd reshuffles leadership with Kevin Crofton stepping up as Executive Chairman while Arye Kohavi moves to a Non-Executive Director role, signalling a strategic pivot to accelerate commercial execution in semiconductor technology.

EBR Systems has secured ISO 13485 certification for its new Santa Clara manufacturing site, paving the way for a 500% increase in WiSE System production pending FDA approval expected by year-end.