Australia is attempting a once-in-a-generation reset of its innovation system, and biotech industry leaders have lauded the federal government’s independent review into Australia's slipping R&D ranks and its proposals to reverse the decline.
Kintor Pharmaceutical Ltd.’s topical androgen receptor antagonist, pyrilutamide (KX-826), met the primary endpoint in a pivotal phase III trial in male androgenetic alopecia, and the company will soon file an NDA with China’s National Medical Products Administration.
U.S. lawmakers and industry experts are raising alarm over China’s expanding dominance across the pharmaceutical supply chain, warning that reliance on Chinese inputs poses a growing national security and public health risk.
Gilead Sciences Inc. said after U.S. market close March 23 that it will acquire privately held Ouro Medicines LLC and its autoimmune BCMA/CD3 bispecific T-cell engager, gamgertamig, in a deal valued at $2.17 billion.
Regulatory snapshots for biopharma and med tech in Asia-Pacific, including global submissions and approvals, and other regulatory decisions and designations: Argo, Belief, Fujirebio, Gyre, H.U. Groupe, Peijia Medical, Sun, Telix.
Australia has released the first clinical practice guideline for the appropriate use of methylenedioxymethamphetamine-assisted psychotherapy for post-traumatic stress disorder, but clinicians caution that evidence, infrastructure and access remain works in progress.
Otsuka Pharmaceutical Co. Ltd. reaped positive results from an open-label phase II study of repinatrabit (JNT-517) in adolescents with phenylketonuria (PKU), a rare disease marked by the inability to break down the amino acid phenylalanine.
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