Shares of Suzhou, China-based Kintor Pharmaceutical Ltd. (HKEX:9939) rose to HKD28.85 (US$3.68), up HKD14.87, or 106%, after the firm reported top-line data from the phase III multiregional trial with proxalutamide in people with mild to moderate COVID-19 infection, regardless of vaccination status or risk factors. Read More
Glaxosmithkline plc and Vir Biotechnology Inc.’s sotrovimab has become the latest COVID-19 antibody to be pulled from the market in the U.S., after the FDA revoked its emergency use authorization (EUA) because of the rise of the omicron BA.2 subvariant. Read More
Investigators at Boston Children's Hospital have demonstrated that SARS-CoV-2 infection of blood monocytes and lung macrophages in the lung could kill the cells via pyroptosis, increasing inflammation and leading to severe COVID-19. Read More
Biopharma financings for the first quarter of 2022 are at a five-year low, with 65.8% less money and 53% fewer transactions than a year ago. The industry raised $13.1 billion through 249 financings, compared with $38.3 billion from 529 transactions in 2021. Read More
The quixotic course of the cancer therapy Ontak continues with new top-line data from Citius Pharmaceuticals Inc. The company’s phase III study of I/Ontak (E-7777), a reformulation of previously FDA-approved oncology treatment Ontak (denileukin diftitox), was consistent with the prior formulation. No new safety signals were identified in treating persistent or recurrent cutaneous T-cell lymphoma. Read More
Shanghai Allist Pharmaceuticals Co. Ltd.’s third-generation EGFR tyrosine kinase inhibitor, furmonertinib, met its primary endpoint in a phase III trial, demonstrating longer progression-free survival vs. first-generation EGFR TKI Iressa (gefitinib, Astrazeneca plc) as first-line therapy for locally advanced or metastatic EGFR mutation-positive non-small-cell lung cancer. Read More
Syncona Ltd. has added £10 million (US$13.1 million) to the £26.6 million it put into the series A round of Resolution Therapeutics Ltd., enabling the company to advance an allogeneic version of the macrophage cell therapy it is developing for the treatment of compensated liver disease. Since the first close of the round in December 2020, the company has been working on process development for the autologous product, and patients have continued to be recruited to a 50-patient phase II study being run by the academic founders of Resolution. Read More
Medicine shortages have been of particular concern during the COVID-19 pandemic, and Australia’s Therapeutic Goods Administration said it would seek to amend regulations to allow imports of overseas substitute drugs if the Australian drug has been discontinued and canceled from the Australian Register of Therapeutic Goods. Read More
Biopharmas raising money in public or private financings, including: Belite, Celsion, Ortho Regenerative Technologies, Polypid, Triana Biomedicines. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Amniotics, BMS, CNS, Starton, Tiziana. Read More
