The promise of mesenchymal stem cells (MSCs) to heal heart disease could be around the corner thanks to a new delivery method tested by regenerative medicine company Cynata Therapeutics Ltd.
Dimerix Ltd. sealed an exclusive license agreement with Amicus Therapeutics Inc. for commercialization of its phase III kidney disease candidate, DMX-200, in a deal valued at AU$940 million (US$601.22 million).
Immutep Ltd. announced strong median overall survival of 17.6 months in cohort B of the TACTI-003 (Keynote-PNC-34) phase IIb trial that evaluated eftilagimod alfa in combination with Merck & Co.’s Keytruda (pembrolizumab) as first-line therapy in recurrent/metastatic head and neck squamous cell carcinoma in patients with PD-L1 expression below 1.
Australian biopharma stakeholders welcomed the reelection of Prime Minister Anthony Albanese, who promised to expand Medicare and to invest more in Australian research.
Echoing President Donald Trump’s justification for reciprocal tariffs, the U.S. Trade Representative’s annual Special 301 Report is a bit more aggressive in tone this year as it calls out trading partners that don't adequately enforce intellectual property rights or that otherwise discriminate against products from foreign companies.
The U.S. FDA issued a complete response letter (CRL) to Telix Pharmaceuticals Ltd. for its NDA for glioma imaging agent, TLX-101-CDx (floretyrosine F18 or 18F-FET, Pixclara), citing the need for additional confirmatory clinical evidence.
Telix Pharmaceuticals Ltd.’s glioblastoma theranostic, TLX-101, is showing promising overall survival in a phase II trial in recurrent high-grade glioma. The targeted radiation therapy, combined with external beam radiation therapy, demonstrated a median overall survival of 12.4 months from treatment initiation and 32.2 months from initial diagnosis. The results significantly outperform the 9.9-month median survival typically observed with radiation therapy alone in recurrent glioblastoma patients.
Tryptamine Therapeutics Ltd. is gearing up to enter the clinic with lead compound TRP-8803, an intravenous-infused psilocybin therapy, in patients with binge eating disorder in conjunction with psychotherapy.
Following news of U.S. President Donald Trump’s 10% across-the-board tariffs on Australian exports to the U.S., Australia’s Securities Exchange shed nearly AU$55 billion in losses Thursday morning. Even so, pharmaceuticals have escaped the tariffs for now. In China, Trump’s tariffs are not a big concern for China’s health care because drugs and active pharmaceutical ingredients are exempted from the tariffs. Even if tariffs are imposed in the future, Chinese pharmaceutical companies have already significantly de-risked themselves in recent months by increasing out-licensing models with U.S. partners.
Opthea Ltd. is considering its options after lead candidate sozinibercept (OPT-302) failed the phase III Coast trial in wet age-related macular degeneration (AMD). The global Coast phase III trial evaluated the efficacy and safety of intravitreally administered 2-mg sozinibercept every four or eight weeks in combination with 2-mg aflibercept every eight weeks after a loading phase for the treatment of wet AMD. The trial did not meet its primary endpoint of mean change in best corrected visual acuity from baseline to week 52.
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