Latest Biopharmaceutical Industry News

Race Oncology has uncovered that its anticancer drug bisantrene exists as three light-sensitive isomers, with only one showing potent activity. The company has filed patents to protect this active form, potentially extending its intellectual property rights until 2045.

Telix Pharmaceuticals has secured FDA agreement on a resubmission plan for its glioma imaging agent TLX101-CDx, aiming for a Q4 2025 filing that includes additional efficacy data. The FDA signals likely expedited review, underscoring the unmet medical need.

Clinuvel Pharmaceuticals has reported a robust financial year ending June 2025, marked by solid revenue growth and sustained profitability, while advancing its clinical pipeline and maintaining a strong balance sheet.

Telix Pharmaceuticals has received a Complete Response Letter from the FDA for its TLX250-CDx diagnostic agent, citing manufacturing concerns. The company plans immediate remediation and maintains its 2025 revenue guidance.

CSL Limited posted a 14% rise in net profit for FY2025, underpinned by strong immunoglobulin sales and new product launches, while announcing plans to demerge its vaccines business, CSL Seqirus, to sharpen strategic focus.

Radiopharm Theranostics has secured key ethics approvals to expand its clinical trial portfolio, completed significant preclinical milestones, and raised A$8 million through a strategic placement, while maintaining its cash runway to mid-2026.