SINGAPORE-- Australia's Therapeutic Goods Administration (TGA) has updated guidance on the release of medicine products from the last manufacturer in the supply chain responsible for certifying the quality before the products are released onto the Australian market.
Researchers at Curtin University's Biotechnology and Drug Development Research Laboratory in Perth, Australia, are developing a microcapsule formulation that they say improves the drug delivery and absorption of diabetes drugs.
Hospira is recalling another product manufactured at a plant in Australia which last year received an FDA warning letter. The Lake Forest, IL-based company is voluntarily recalling 3,306 vials of the cancer drug dacarbazine because of discoloration, according to the most recent FDA Enforcement Report.
The biosimilars market has attracted some big companies with even bigger claims about their ability to drive down manufacturing costs, with Samsung and its ambition to undercut biologic prices by 50% the standout example. Now a small Australian biotech is trumpeting the cost-saving it can realize after marrying its expression technology to the scale of the Serum Institute of India.
Australian survivors of the deadly meningococcal B strain are mounting pressure on the country's Pharmaceutical Benefits Advisory Committee to include Novartis' Bexsero, the only approved vaccine for the disease, on its national immunization plan when it meets next month.
Whooping cough is back with a vengeance, and the culprit may be the changing nature of the bacterium that causes the highly infectious disease.
Australia accounts for nearly half of the global supply of opium poppy plants that produce the ingredients needed for pain drugs. But drugmakers are in the midst of a political fight there as they press the government to expand production from the island of Tasmania to Australia's mainland.
Germany's Fresenius Kabi has a grant from a state government in Australia and plans to build a new manufacturing plant there.
DSM Pharmaceutical Products had lined up a client for its new biologics plant in Australia even ahead of it opening. But as it officially goes online, it has added yet another deal to the roster.
Australia is paying for Bristol-Myers Squibb's melanoma drug Yervoy. And Yervoy is expensive. So, Australian officials plan to monitor patients treated with it to see whether the drug lives up to its promise. It's an unusual move--and unprecedented in Australia.