https://www.bioworld.com/rss en-us Island Pharmaceuticals Ltd. has secured government and ethics approvals to deploy its investigational antiviral galidesivir in patients infected during the escalating Bundibugyo Ebola outbreak in Africa, giving the small Australian biotech a rare opportunity to collect prospective human data in an active filovirus emergency. http://www.bioworld.com/articles/732432 Wed, 08 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732432-island-pharma-targets-ebola-species-lacking-approved-treatments Ebola virus Regenerative medicine company Bellaseno GmbH is accelerating development of its absorbable breast scaffold, with a pivotal Australian trial recruiting faster than expected and a newly announced licensing deal with Johnson & Johnson subsidiary Mentor Worldwide LLC positioning the technology for global commercialization. http://www.bioworld.com/articles/732474 Tue, 07 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732474-bellaseno-speeds-breast-scaffold-trial-as-j-and-j-deal-clears-path-to-market Illustration of Bellaseno's scaffold placed in the breast Bellaseno’s regenerative absorbable breast scaffold. Credit: Bellaseno. Regenerative medicine company Bellaseno GmbH is accelerating development of its absorbable breast scaffold, with a pivotal Australian trial recruiting faster than expected and a newly announced licensing deal with Johnson & Johnson subsidiary Mentor Worldwide LLC positioning the technology for global commercialization. http://www.bioworld.com/articles/732275 Thu, 02 Jul 2026 12:00:00 -0400 https://www.bioworld.com/articles/732275-bellaseno-speeds-breast-scaffold-trial-as-j-and-j-deal-clears-path-to-market Illustration of Bellaseno's scaffold placed in the breast Bellaseno’s regenerative absorbable breast scaffold. Credit: Bellaseno. Neither of Cynata Therapeutics Ltd.’s pivotal trials for its Cymerus stem cell platform met the primary endpoints, with no statistically significant differences between active and control groups on primary or key secondary efficacy measures, CEO Kilian Kelly told investors during a June 22 conference call. http://www.bioworld.com/articles/732155 Tue, 23 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732155-cynatas-cymerus-flops-in-osteoarthritis-gvhd Stem cells With increasing competition from China and other countries, the U.S. Department of Health and Human Services is rolling out Operation Trailblazer, a department-wide strategy to once again make the U.S. the go-to destination for early stage drug development. http://www.bioworld.com/articles/732065 Tue, 23 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732065-fda-looks-to-pilot-speedier-early-stage-rx-development FDA headquarters signage Credit: Tada Images - stock.adobe.com Neither of Cynata Therapeutics Ltd.’s pivotal trials for its Cymerus stem cell platform met the primary endpoints, with no statistically significant differences between active and control groups on primary or key secondary efficacy measures, CEO Kilian Kelly told investors during a June 22 conference call. http://www.bioworld.com/articles/732047 Mon, 22 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/732047-cynatas-cymerus-flops-in-osteoarthritis-gvhd Stem cells Dimerix Ltd. has signed an exclusive licensing deal with Everest Medicines Ltd. to commercialize its phase III kidney disease candidate DMX-200 in a transaction worth up to AU$481 million (US$340 million), plus sales royalties. http://www.bioworld.com/articles/731893 Tue, 16 Jun 2026 12:00:00 -0400 https://www.bioworld.com/articles/731893-dimerix-out-licenses-dmx-200-to-everest-in-au481m-deal Kidneys Artificial intelligence, remote monitoring and need-based innovation are beginning to reshape Australia’s medtech sector’s devices, as well as the way health care itself is delivered, according to speakers at the 2026 Ausmedtech conference in Perth May 19-20. http://www.bioworld.com/articles/731471 Tue, 26 May 2026 11:00:00 -0400 https://www.bioworld.com/articles/731471-ai-remote-care-drive-new-models-for-australian-medtech Ausbiotech panel - Tracy-Duffy (far left) The TGA’s Tracy Duffy (far left) explains the agency’s thinking about regulating AI-based devices during the 2026 Ausmedtech conference in Perth. Australian researchers have identified a previously overlooked population of immune cells in the skin that physically restrain melanoma growth by engulfing live melanoma cells, and the discovery could reshape thinking around macrophage-targeted cancer therapies and innate immunity in oncology. http://www.bioworld.com/articles/731270 Tue, 26 May 2026 09:00:00 -0400 https://www.bioworld.com/articles/731270-researchers-identify-innate-immune-barrier-against-melanoma Microscopy of a cross-section of mouse skin containing melanoma tumors Microscopy of a cross-section of mouse skin containing melanoma tumors. CD169+ macrophages are shown in green and yellow, forming a distinct boundary as they attempt to locally contain the cancer. Credit: Phan Lab, Garvan Institute Shanghai Henlius Biotech Inc.’s HLX-3902, a trispecific antibody targeting STEAP1xCD3xCD28, has received approval from the Human Research Ethics Committee (HREC) in Australia and has been filed with the Therapeutic Goods Administration (TGA). The T-cell engager is intended for the treatment of metastatic castration-resistant prostate cancer and other advanced solid tumors. http://www.bioworld.com/articles/731251 Fri, 22 May 2026 09:00:00 -0400 https://www.bioworld.com/articles/731251-henlius-gains-australian-trial-clearance-for-hlx-3902 3D illustration showing presence of tumor inside prostate gland Scribe Therapeutics Inc. has obtained clearance from Australia’s Therapeutic Goods Administration (TGA) to initiate a first-in-human study of STX-1150 for the treatment of hypercholesterolemia, a major driver of atherosclerotic cardiovascular disease (ASCVD). The phase I study will enroll adults with elevated LDL-C at increased cardiovascular risk at sites in Australia and New Zealand. http://www.bioworld.com/articles/731249 Fri, 22 May 2026 09:00:00 -0400 https://www.bioworld.com/articles/731249-scribes-stx-1150-for-hypercholesterolemia-cleared-for-clinic Artificial intelligence, remote monitoring and need-based innovation are beginning to reshape Australia’s medtech sector’s devices, as well as the way health care itself is delivered, according to speakers at the 2026 Ausmedtech conference in Perth May 19-20. http://www.bioworld.com/articles/731375 Thu, 21 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731375-ai-remote-care-drive-new-models-for-australian-medtech Ausbiotech panel - Tracy-Duffy (far left) The TGA’s Tracy Duffy (far left) explains the agency’s thinking about regulating AI-based devices during the 2026 Ausmedtech conference in Perth. Shanghai Henlius Biotech Inc.’s HLX-48 for injection has received approval from the Human Research Ethics Committee (HREC) in Australia and been acknowledged by the Therapeutic Goods Administration (TGA). The first-in-human phase I study in Australia will evaluate HLX-48 in patients with advanced or metastatic solid tumors. http://www.bioworld.com/articles/731092 Thu, 14 May 2026 09:00:00 -0400 https://www.bioworld.com/articles/731092-henlius-hlx-48-for-solid-tumors-cleared-for-clinic-in-australia 3D illustration of tumor Singapore’s Communicable Diseases Agency on May 7 said that it isolated two residents for hantavirus testing after the individuals disembarked from an Atlantic cruise ship on May 2 and May 6, respectively. The measure comes in response to the cluster of cases from the cruise ship, MV Hondius, that has resulted in three deaths so far. MV Hondius, that has resulted in three deaths so far.]]> http://www.bioworld.com/articles/731223 Tue, 12 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/731223-apac-monitors-hantavirus-as-singapore-isolates-2-from-cruise-ship Hantavirus cells Singapore’s Communicable Diseases Agency on May 7 said that it isolated two residents for hantavirus testing after the individuals disembarked from an Atlantic cruise ship on May 2 and May 6, respectively. The measure comes in response to the cluster of cases from the cruise ship, MV Hondius, that has resulted in three deaths so far. MV Hondius, that has resulted in three deaths so far.]]> http://www.bioworld.com/articles/730984 Fri, 08 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/730984-apac-monitors-hantavirus-as-singapore-isolates-2-from-cruise-ship Hantavirus cells For the first time in 13 years, the U.S. Trade Representative (USTR) singled out one of the U.S. trading partners as the worst of the worst when it named Vietnam as a Priority Foreign Country (PFC) in its newly released Special 301 Report. http://www.bioworld.com/articles/730920 Tue, 05 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/730920-ustr-calls-out-trade-partners-for-rx-med-tech-pricing-policies Map of Vietnam For the first time in 13 years, the U.S. Trade Representative (USTR) singled out one of the U.S. trading partners as the worst of the worst when it named Vietnam as a Priority Foreign Country (PFC) in its newly released Special 301 Report. http://www.bioworld.com/articles/730832 Mon, 04 May 2026 12:00:00 -0400 https://www.bioworld.com/articles/730832-ustr-calls-out-trade-partners-for-rx-med-tech-pricing-policies Map of Vietnam Shares in Aussie hearing implant maker Cochlear Ltd. plummeted nearly 39% April 22 after the company slashed fiscal 2026 earnings guidance and warned that weaker-than-expected demand in developed markets was exposing a more cyclical and discretionary side to its business than investors had assumed. http://www.bioworld.com/articles/730783 Tue, 28 Apr 2026 12:00:00 -0400 https://www.bioworld.com/articles/730783-cochlears-39-stock-plunge-resets-defensive-growth-narrative Cochlear Nucleus system Nucleus Nexa cochlear implant system. Credit: Cochlear Ltd. Shares in Aussie hearing implant maker Cochlear Ltd. plummeted nearly 39% April 22 after the company slashed fiscal 2026 earnings guidance and warned that weaker-than-expected demand in developed markets was exposing a more cyclical and discretionary side to its business than investors had assumed. http://www.bioworld.com/articles/730605 Thu, 23 Apr 2026 12:00:00 -0400 https://www.bioworld.com/articles/730605-cochlears-39-stock-plunge-resets-defensive-growth-narrative Cochlear Nucleus system Nucleus Nexa cochlear implant system. Credit: Cochlear Ltd. A pricing standoff between Pfizer Inc. and the Australian government has left women with advanced breast cancer facing tens of thousands of dollars in out-of-pocket costs, underscoring a growing global trend in which access to life-extending drugs is increasingly being shaped by pricing negotiations rather than clinical merit. http://www.bioworld.com/articles/730577 Tue, 21 Apr 2026 12:00:00 -0400 https://www.bioworld.com/articles/730577-pricing-standoff-leaves-australian-patients-in-limbo White tablet imprinted with dollar sign A new metasurface design strategy that replaces rigid order with “engineered disorder” could significantly increase how many optical functions can be integrated into a single ultra-thin device without increasing size or complexity, according to a study published in Nature Communications. The study challenges a longstanding assumption in optical engineering that highly ordered, periodic structures are required to precisely control light. Nature Communications. The study challenges a longstanding assumption in optical engineering that highly ordered, periodic structures are required to precisely control light.]]> http://www.bioworld.com/articles/730575 Tue, 21 Apr 2026 09:00:00 -0400 https://www.bioworld.com/articles/730575-kaleidoscope-like-engineered-disorder-expands-imaging-potential Photo of kaleidoscope pattern A pricing standoff between Pfizer Inc. and the Australian government has left women with advanced breast cancer facing tens of thousands of dollars in out-of-pocket costs, underscoring a growing global trend in which access to life-extending drugs is increasingly being shaped by pricing negotiations rather than clinical merit. http://www.bioworld.com/articles/730311 Wed, 15 Apr 2026 12:00:00 -0400 https://www.bioworld.com/articles/730311-pricing-standoff-leaves-australian-patients-in-limbo White tablet imprinted with dollar sign Regeneron Pharmaceuticals Inc. is entering the radiopharmaceutical space via a collaboration with Telix Pharmaceuticals Ltd. to jointly develop and commercialize next-generation radiopharmaceutical therapies. http://www.bioworld.com/articles/730422 Tue, 14 Apr 2026 12:00:00 -0400 https://www.bioworld.com/articles/730422-regeneron-enters-radiopharma-space-via-telix-deal Open blue capsule with yellow radioactive symbol Regeneron Pharmaceuticals Inc. is entering the radiopharmaceutical space via a collaboration with Telix Pharmaceuticals Ltd. to jointly develop and commercialize next-generation radiopharmaceutical therapies. http://www.bioworld.com/articles/730282 Mon, 13 Apr 2026 12:00:00 -0400 https://www.bioworld.com/articles/730282-regeneron-enters-radiopharma-space-via-telix-deal Open blue capsule with yellow radioactive symbol The U.S. FDA has accepted for review Telix Pharmaceuticals Ltd’s resubmitted NDA for TLX101-Px (Pixclara, 18F-floretyrosine, 18F-FET), its radiolabeled glioma imaging product for characterizing progressive or recurrent glioma in adult and pediatric patients. The FDA assigned a Sept. 11, 2026, PDUFA date. http://www.bioworld.com/articles/730421 Fri, 10 Apr 2026 12:00:00 -0400 https://www.bioworld.com/articles/730421-fda-accepts-telixs-resubmitted-nda-for-brain-imaging-agent Brain scans The U.S. FDA has accepted for review Telix Pharmaceuticals Ltd’s resubmitted NDA for TLX101-Px (Pixclara, 18F-floretyrosine, 18F-FET), its radiolabeled glioma imaging product for characterizing progressive or recurrent glioma in adult and pediatric patients. The FDA assigned a Sept. 11, 2026, PDUFA date. http://www.bioworld.com/articles/730225 Fri, 10 Apr 2026 12:00:00 -0400 https://www.bioworld.com/articles/730225-fda-accepts-telixs-resubmitted-nda-for-brain-imaging-agent Brain scans Ibio Inc. has received clinical trial notification (CTN) acknowledgement from Australia’s Therapeutic Goods Administration (TGA), as well as Human Research Ethics Committee approval, for IBIO-600, enabling the initiation of a first-in-human trial in Australia. http://www.bioworld.com/articles/730241 Thu, 09 Apr 2026 09:00:00 -0400 https://www.bioworld.com/articles/730241-ibios-ibio-600-cleared-to-enter-clinic-in-australia-for-obesity Tape measure, apple on scale