Latest Manufacturing And Distribution News

Rhythm Biosciences marked a pivotal shift from development to commercial diagnostics in Q3 FY26, recording its first ColoSTAT® clinical sale and initiating NHS England evaluation while expanding geneType™ partnerships across Asia and Australia.

Nexsen Limited has cleared a major FDA regulatory hurdle for its StrepSure rapid Group B Streptococcus test, confirmed a clear 510(k) submission pathway, and secured over A$1.7 million in non-dilutive grants to expand clinical validation and market rollout in Asia-Pacific and neonatal diagnostics.

Multistack International is progressing with the sale of its core assets to Willing Y Limited, maintaining operations cautiously while cash reserves decline amid ongoing operating losses.

Clarity Pharmaceuticals has secured a major manufacturing deal with Nucleus RadioPharma to produce its next-generation prostate cancer imaging agent, 64Cu-SAR-bisPSMA, ramping up supply ahead of anticipated US market entry.

Radiopharm Theranostics has secured a clinical supply agreement with Siemens Healthineers to manufacture and distribute RAD101, advancing its Phase 3 trial in the U.S. Interim Phase 2b data showed 90% concordance with MRI in detecting brain metastases.

Nexsen Limited (ASX:NXN) has completed its Stage 1 ISO 13485 audit, confirming its Quality Management System (QMS) supports clinical validation and regulatory submissions for its diagnostic products, including StrepSure®. The company is progressing toward full certification and alignment with MDSAP requirements to facilitate global market access.

Nexsen Limited's subsidiary has won a HK$6 million grant to accelerate clinical validation and manufacturing of its rapid Group B Streptococcus diagnostic in Hong Kong, positioning the city as a key Asia-Pacific hub.

DGL Group Limited has replaced its ANZ-led financing with a new $120 million facility from ScotPac, extending maturity and enhancing working capital flexibility amid ongoing management restructuring.

EVE Health Group has completed R&D on multiple reformulated drug candidates targeting major sexual health and cardiovascular markets, preparing patent filings and licensing strategies to capitalise on a combined $30 billion global opportunity.

Pure Foods Tasmania reports a significant operational turnaround in 1H FY26, driven by strategic cost reductions, expanded distribution deals with major retailers, and the acquisition of premium ice cream brand Elato.

Bioxyne Limited has reported a remarkable half-year performance, with revenues soaring 149% to $31.3 million and net profit more than doubling to $7.3 million, driven by strong demand for medicinal cannabis, MDMA, and psilocybin products and expanding international operations.

Star Combo Pharma reported a 23% decline in revenue to $11.9 million for the half year ended December 2025, driven by the loss of a major OEM contract and closure of its AustoYou retail business. Despite this, operating profit after tax rose 49% to $413,243, reflecting effective cost management.