News of the Day

This week's discussion starts with the perfect example of why pulling one lever can trigger another. The Senate is considering changes to expand the regulator's power, without any submissions from those most affected. Is it possible to have a common-sense discussion about tobacco excise against the backdrop of an unrelenting crime wave with mounting numbers of innocent victims? Or can those not impacted by the consequences just turn the other cheek? Sound familiar?

A new report from Medicines Australia argues that the Pharmaceutical Benefits Scheme is buckling under a 'twin threat' that could soon tip from crisis-in-waiting to full-blown emergency.

The three discrete reforms give the Commonwealth, through the TGA and the Health Department Secretary, greater capacity to demand information, classify biologicals in groups, and exercise warrantless enforcement powers at clinical trial sites.

The Secretary could vary the definition of 'common characteristics', use their new powers to establish a biological group, and Parliament would have no review rights. Yet the inquiry into this significant expansion of power did not hear directly from the industry.

Professor David O’Neal, of the University of Melbourne and St Vincent’s Hospital Melbourne, said patients and clinicians could not assume glucose readings reliably indicate ketoacidosis risk.

Gilead Australia and New Zealand general manager Arthur Miritis said the move reflects both the company’s commercial interests and a broader policy argument about the conditions needed to bring new treatments to Australian patients.

The near-term test is whether reform meets the review's originally stated objective of modernising and accelerating access to new medicines and other health technologies. That outcome cannot be separated from the institutional response. Can any beneficial reforms hold? The United Kingdom offers a timely example of the risks.

Bristol Myers Squibb Australia and New Zealand general manager Owen Smith said the registration offered another option for adults living with the condition.

ENA Respiratory has welcomed $2.98 million in funding from Biointelect Venturer to support its first Australian study of INNA-051 in adults with asthma, expanding the clinical program for a once-weekly nasal spray intended to strengthen the body’s early defences against common respiratory viruses.

OncoSil Medical has moved to secure a Medicare reimbursement pathway for its targeted internal radiation device in the United States, following the Food and Drug Administration’s humanitarian approval of the treatment for a rare and difficult-to-treat form of bile duct cancer.

Vitrafy Life Sciences has secured its first foothold in the United States cell and gene therapy market through an agreement with Charter Medical to install its cryopreservation technology in the North Carolina company’s Innovation Hub.

Telix Pharmaceuticals has completed enrolment in its pivotal BiPASS trial, moving the Australian company closer to testing whether its gallium-based PSMA PET imaging agents can help determine which men with suspected prostate cancer need a biopsy in the first place.