Australia

Cochlear’s 39% stock plunge resets ‘defensive growth’ narrative

Thu, 23 Apr 2026 12:00:00 -0400

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.

Pricing standoff leaves Australian patients in limbo

Tue, 21 Apr 2026 12:00:00 -0400

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.

Kaleidoscope-like ‘engineered disorder’ expands imaging potential

Tue, 21 Apr 2026 09:00:00 -0400

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.

Pricing standoff leaves Australian patients in limbo

Wed, 15 Apr 2026 12:00:00 -0400

Regeneron enters radiopharma space via Telix deal

Tue, 14 Apr 2026 12:00:00 -0400

Regeneron Pharmaceuticals Inc. is entering the radiopharmaceutical space via a collaboration with Telix Pharmaceuticals Ltd. to jointly develop and commercialize next-generation radiopharmaceutical therapies.

Regeneron enters radiopharma space via Telix deal

Mon, 13 Apr 2026 12:00:00 -0400

FDA accepts Telix’s resubmitted NDA for brain imaging agent

Fri, 10 Apr 2026 12:00:00 -0400

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.

FDA accepts Telix’s resubmitted NDA for brain imaging agent

Fri, 10 Apr 2026 12:00:00 -0400

Ibio’s IBIO-600 cleared to enter clinic in Australia for obesity

Thu, 09 Apr 2026 09:00:00 -0400

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.

Amplia halts enrollment in phase II pancreatic cancer trial

Tue, 07 Apr 2026 12:00:00 -0400

Amplia Therapeutics Ltd. has halted recruitment in its phase II Amplicity trial in advanced pancreatic cancer due to three dose-limiting toxicities related to the chemotherapy regimen, modified FOLFIRINOX (mFOLFIRINOX), which is being administered in combination with lead compound narmafotinib (AMP-945), a focal adhesion kinase inhibitor.

Alltrna’s AP-003 cleared for trials for stop codon disease

Wed, 01 Apr 2026 09:00:00 -0400

Alltrna has obtained approval in Australia to initiate a phase I trial of AP-003 in healthy volunteers under Australia’s TGA clinical trial notification scheme. AP-003 is a chemically modified, engineered transfer RNA (tRNA) oligonucleotide encapsulated in a clinically validated, liver-directed lipid nanoparticle.

Australia’s R&D reset puts biotech translation in focus

Tue, 24 Mar 2026 12:00:00 -0400

Australia is attempting a once-in-a-generation reset of its innovation system, and biotech industry leaders have lauded the federal government’s independent review into Australia's slipping R&D ranks and its proposals to reverse the decline.

Australia’s R&D reset puts biotech translation in focus

Fri, 20 Mar 2026 12:00:00 -0400

Australia publishes first clinical practice guideline for psychedelics

Tue, 17 Mar 2026 12:00:00 -0400

Australia has released the first clinical practice guideline for the appropriate use of methylenedioxymethamphetamine-assisted psychotherapy for post-traumatic stress disorder, but clinicians caution that evidence, infrastructure and access remain works in progress.

Mixed phase II results still point to path forward for AISA-021

Tue, 10 Mar 2026 12:00:00 -0400

Although Aisa Pharma Inc’s cilnidipine (AISA-021) failed to meet the primary endpoint, multiple secondary endpoints showed statistically significant improvement in treating sclerosis-associated Raynaud's phenomenon, potentially positioning the drug for a phase III program in a disease with no approved oral therapies globally.

Telix advances PSMA radiotherapy challenger to Pluvicto

Tue, 10 Mar 2026 12:00:00 -0400

Australia’s Telix Pharmaceuticals Ltd. is advancing a potential challenger to Novartis plc’s dominant prostate cancer radioligand therapy, Pluvicto (lutetium [177Lu] vipivotide tetraxetan), after reporting that the safety lead-in portion of its global phase III Prostact trial met its primary objectives.

Kivu reports KIVU-305 data, gains clearance to enter clinic

Thu, 26 Feb 2026 08:00:00 -0500

Kivu Bioscience Inc. has announced receipt of Human Research Ethics Committee approval and clinical trial notification clearance in Australia to initiate a first-in-human trial of KIVU-305, its CEACAM5-targeted antibody-drug conjugate.

CSL taps Lilly to de-risk IL-6 drug following dismal earnings

Tue, 24 Feb 2026 11:00:00 -0500

CSL Ltd. is out-licensing its interleukin-6 (IL-6) monoclonal antibody, clazakizumab, to Eli Lilly and Co. in a deal that brings CSL $100 million in up-front fees. A CSL spokesperson told BioWorld the deal includes undisclosed milestone payments and sales-based royalties. CSL will retain rights to develop and commercialize clazakizumab for prevention of cardiovascular events in patients with end-stage kidney disease, while Lilly will explore the MAb in all other indications.

Australia launches world-first pediatric mRNA brain cancer trial

Tue, 24 Feb 2026 11:00:00 -0500

A world-first pediatric mRNA cancer vaccine trial is launching in Australia that could open new possibilities for children with aggressive brain tumors.

Omnigeniq’s journey from space science to drug design

Tue, 24 Feb 2026 11:00:00 -0500

A project that started as a bioreactor to assist astronauts in deep space to keep medications safe in a microgravity environment could help pharma companies model how drugs behave in the human body.

CSL taps Lilly to de-risk IL-6 drug following dismal earnings

Thu, 19 Feb 2026 12:00:00 -0500

Omnigeniq’s journey from space science to drug design

Wed, 18 Feb 2026 09:00:00 -0500

A project that started as a bioreactor to assist astronauts in deep space to keep medications safe in a microgravity environment could help pharma companies model how drugs behave in the human body. Omnigeniq unveiled at the J.P. Morgan Healthcare conference the first computer model of a human protein as it exists in the body, confirming that native protein topology can be calculated directly from physics.

Omnigeniq’s journey from space science to drug design

Tue, 17 Feb 2026 12:00:00 -0500

Australia launches world-first pediatric mRNA brain cancer trial

Fri, 13 Feb 2026 12:00:00 -0500

A world-first pediatric mRNA cancer vaccine trial is launching in Australia that could open new possibilities for children with aggressive brain tumors. The Paedneo-Vax trial, funded by Canada’s Providence Therapeutics Holdings Inc., in combination with the Australian Government and philanthropic donors, is the first multisite pediatric study to evaluate individualized mRNA vaccines designed specifically for each child's cancer.

Switching off resistance: Lixa’s bold AMR bet

Tue, 03 Feb 2026 12:00:00 -0500

Lixa Pty Ltd. has formed a partnership with the Global Antibiotic Research & Development Partnership and announced a AU$28 million (US$20 million) series B round to take Neox-121 to the clinic to fight antimicrobial resistance.

Rage Bio enters clinic with inhaled oligonucleotide in COPD

Wed, 14 Jan 2026 09:00:00 -0500

After raising AU$29 million (US$19.44 million) in a series A round, Rage Biotech Pty Ltd. is beginning phase I trials of its lead candidate, RB-042, an inhaled splice-switching oligonucleotide for treating chronic obstructive pulmonary disease (COPD) and other inflammatory lung diseases.

Rage Bio enters clinic with inhaled oligonucleotide in COPD

Tue, 13 Jan 2026 00:00:00 -0500

Rage Bio enters clinic with inhaled oligonucleotide in COPD

Mon, 12 Jan 2026 12:00:00 -0500

TGA considers a policy dealing with device shortages

Mon, 12 Jan 2026 11:00:00 -0500

The COVID-19 pandemic amplified concerns over medical device shortages, prompting the U.S. FDA to develop guidance on the topic in November 2023. Australia’s Therapeutic Goods Administration is eyeing a guidance to address the very same problem, although the agency seems wary of whether to formally develop a guidance on device shortages.

Tessera cleared to begin clinical trial of TSRA-196 in US, Australia

Mon, 12 Jan 2026 08:00:00 -0500

The U.S. FDA has cleared Tessera Therapeutics Inc.’s IND application for TSRA-196, its lead in vivo gene editing therapy for α-1 antitrypsin deficiency (AATD). The Australian Human Research Ethics Committee (HREC) has also granted approval for the company to begin the phase I/II clinical study.