Australia’s Therapeutic Goods Administration will begin conducting routine risk-based good clinical practices (GCP) inspections for clinical trials of drugs and biologics. The agency outlined in final guidance how it would prioritize inspections, what the process would look like and how it would report and follow up on inspections.
China’s National Medical Products Administration (NMPA) gave the green light to Pfizer Inc.’s third-generation anaplastic lymphoma kinase (ALK) inhibitor, Lorbrena (lorlatinib), for patients with ALK-positive advanced non-small-cell lung cancer (NSCLC).
After raising $17 million in seed funding, immunotherapy-focused biotech company, LTZ Therapeutics Inc., is announcing plans for the fledgling company whose acronym stands for “Lift to Zenith.” CEO and co-founder Robert Li told BioWorld that the company’s three-tiered immunotherapy platform will focus on reducing immunosuppression, reprogramming innate immunity and modulating adaptive immunity.
Australia’s Therapeutic Goods Administration will begin conducting routine risk-based good clinical practices (GCP) inspections for clinical trials of drugs and biologics. The agency outlined in final guidance how it would prioritize inspections, what the process would look like and how it would report and follow up on inspections.
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.
After failing to meet primary safety and efficacy endpoints in a phase I/II trial for stroke, Teijin Ltd. and JCR Pharmaceuticals Co. Ltd. have terminated a co-development and Japan licensing agreement to develop JTR-161, an allogeneic regenerative candidate containing dental pulp stem cells.
Researchers from the Center for Genome Engineering within South Korea's Institute for Basic Science have developed a new gene-editing platform that could be the final missing piece of the puzzle in gene-editing technology, by making editing of mitochondrial DNA possible.
Inoviq Ltd. and The University of Queensland (UQ) are expanding a collaboration to develop an exosome-based ovarian cancer screening test. Researchers from UQ identified and validated exosomal protein and micro-RNA (miRNA) biomarkers that when combined in its OCRF-7 algorithm showed more than 90% accuracy to detect stages I and II ovarian cancer in an independent 500-sample retrospective case-control study, Inoviq CEO Leearne Hinch told BioWorld.
China’s Amoy Diagnostics Co. Ltd. (Amoydx) signed a development and commercialization agreement under which Amoy will develop multiple companion diagnostics for Astrazeneca plc across China, the E.U. and Japan.
After failing to meet primary safety and efficacy endpoints in a phase I/II trial for stroke, Teijin Ltd. and JCR Pharmaceuticals Co. Ltd. have terminated a co-development and Japan licensing agreement to develop JTR-161, an allogeneic regenerative candidate containing dental pulp stem cells.
