All patients dosed in a phase IIa trial with Tryptamine Therapeutics Ltd.’s (Tryp) oral psilocybin (TRP-8802) trial reported an improvement in fibromyalgia pain severity, sleep, and pain interference.
Regulatory snapshots, including global submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astellas, Astrazeneca, Bioacrtic, Kelun-Biotech, Ractigen.
Biopharma happenings in Asia-Pacific including deals and partnerships, grants, preclinical data and other news in brief: Aurigene, Bridge Biotherapeutics, Dr. Reddy’s, Hitgen, Kainomyx, KE Sdn, Kelun-Biotech, Merck, Novo Nordisk.
UCB SA is divesting its mature neurology and allergy business in China, selling those products to CBC Group and Mubadala Investment Co. for $680 million so it can refocus on innovation and partnerships in China. The deal includes UCB’s manufacturing site in Zhuhai in Guangdong province.
The U.S. FDA approved 17 drugs in July, down from 28 in June, which marked the third-highest month in BioWorld’s records. On average, the FDA approved approximately nearly 19 drugs per month so far in 2024, compared to 16 per month in 2023, 12.5 per month in 2022, and 17 per month in both 2021 and 2020.
Following the World Health Organization’s escalation of mpox to a public health emergency of international concern on Aug. 14 and the emergence of what appears to be a more severe strain of the orthopoxvirus, the spotlight has focused on a handful of companies working on vaccines and antivirals. Shares of Geovax Labs Inc., Emergent Biosolutions Inc. and Tonix Pharmaceuticals Inc. were all trading up Aug. 19.
Skin biopsies could be a thing of the past thanks to the development of a new non-invasive microneedle patch to pre-screen for skin cancer. Dermr Health Solutions Pty Ltd. founder and CEO Stefan Mazy told BioWorld that the fledgling genomics startup company is pushing the boundaries of science with its Dermr patch that quickly and painlessly extracts live skin cells in 15 seconds, drastically cutting the time and discomfort associated with traditional biopsy procedures.
China’s National Medical Products Administration cleared Ascentage Pharma Group Corp. Ltd. to begin a registrational phase III trial of its BCL-2 selective inhibitor lisaftoclax (APG-2575) in combination with azacitidine for first-line treatment of newly diagnosed patients with higher-risk myelodysplastic syndrome.
Pfizer Inc. is calling on the Australian government to establish priorities for the life sciences sector to attract more investment into research, clinical trials and manufacturing in Australia. The new report recommends that the government issue a life sciences vision akin to the one issued by the U.K. in 2021 to make the country more competitive to attract investment.
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