Is China's international benchmarking a bigger short-term risk to medicines access?

Bain & Company’s 'Front Line of Healthcare Study' has found that Australians feel more informed and more demanding, but are also struggling with access and affordability.

Australia's life sciences sector is entering a period of heightened legal and regulatory complexity, with nearly four in five industry leaders expecting their class action exposure to grow over the next three to five years, a major new MinterEllison report finds.

Which is worse? A company removes a cancer medicine from the PBS and commits to continuing to supply it to patients for free. Or, an advisory committee that disregards patient and clinician input, rejects a submission, and supports delaying treatment until it is literally too late and the patient is close to death.

Under the deal, the company will receive an upfront payment of US$10 million and is eligible for success-based milestones totalling up to US$330 million plus tiered royalties.

“The decision to discontinue the ZOLADEX monthly (3.6mg) implant from Australia’s Pharmaceutical Benefits Scheme (PBS) reflects the way the PBS currently works, which means that the price offered is too low, making it unsustainable to supply the medicine on the PBS,” the AstraZeneca spokesperson said.

It remains in F1 because a second brand has never been listed. Policymakers have responded to this situation by constructing mechanisms to ensure the pricing impact of the statutory reduction that applies when medicines move from F1 to F2. Has anyone ever asked why, when there are generics in other markets, one has never made it to Australia? The pricing response has been an act of denial.

Paradigm Biopharmaceuticals has announced the completion of enrolment in its pivotal Phase 3 trial of Zilosul injectable pentosan polysulfate sodium for knee osteoarthritis, a milestone that moves the company into the next phase of clinical and corporate catalysts.

The High Court will hear Otsuka's appeal this week in its case against Sun Pharma, arising from the Federal Court's decision that patent-term extensions should be limited to active pharmaceutical ingredients.

Why long-term thinking and planning are the key to success. What is the ten-year goal, and how does a new agreement progress that? Plan for policy and government engagement like it's a product launch. Also, is the problem with the HTA Review the process or the expectation? How a different starting point would have made this outcome positive.

Companies plan product launches over years. They build capability, map the environment, assess risks and opportunities, test and refine their plans, and ground their approach in readiness and reality. Policy campaigns should adopt the same approach.

The survey found that 82 per cent of biotech companies six years and older agreed they would experience a significant impact. 36 respondents (61 per cent) said the proposed changes to the Capital Gains Tax would negatively affect them.

At what point does the sector understand that two decades of an obsessive focus on HTA, its arcane processes and technical inputs, have failed to deliver for patients? Surely, it's time for a new approach and a different discussion focused on taking back some control.

Health Minister Mark Butler is facing a difficult road with his signature reform of the National Disability Insurance Scheme, as state and territory ministers oppose key aspects of the enabling legislation.

The awards dinner held during the ARCS Annual Conference in Sydney marked the first time the prizes were presented under the LifeSciences Australia brand following the organisation’s evolution from ARCS.

ARCS has announced it is now LifeSciences Australia, with the name change part of a strategic push to better support professionals across the expanding life sciences sector.

Sigma, the Australian healthcare wholesaler and owner of the discount pharmacy chain Chemist Warehouse, has signalled its interest in purchasing the UK-based pharmacy group Boots, according to an investor update.

CEO and Managing Director Dr David Foster said, “The expansion of our CRADA with USAMRIID and Geneva represents a major strategic milestone for Island and positions the Company to undertake the efficacy study prior to the pivotal study for Galidesivir.”

Concern over the potential impact of the Trump administration's 'Most Favored Nation' pharmaceutical pricing policy is not confined to countries outside the United States.