Australia’s Therapeutic Goods Administration (TGA) is proposing that devices be subject to good clinical practices (GCP) inspections, and it is proposing two approaches to achieve that goal.

Regenerative medicine company Avita Medical Ltd. reported that topline results were mixed for its pivotal trial evaluating the safety and effectiveness of its Recell system combined with meshed autograft for reducing donor skin harvesting in soft tissue reconstructions.

Australia’s Therapeutic Goods Administration (TGA) should better align its definitions and classifications for gene, cell and tissue frameworks with international regulators, stakeholders said.

Pharma companies agree that data is king, since after all, their drugs get approved based on the quality of their data.

Cochlear Ltd. will acquire Danish hearing implant company Oticon Medical A/S for AU$170 million (US$121 million) after parent company the Demant Group said it planned to exit its hearing implants business. Cochlear CEO Dig Howitt said that Oticon Medical is expected to add AU$75 to AU$80 million to Sydney-based Cochlear’s annual revenue, although Oticon Medical is currently “loss making.” In 2021, Demant’s hearing Implants saw revenue of $73 million.