CSPC Pharmaceutical Group Ltd. has received clearance from China’s National Medical Products Administration (NMPA) to conduct clinical trials of antibody-drug conjugates (ADCs) SYS-6005 and SYS-6043.
A year after Generate Biomedicines Inc. pulled off its $273 million series C financing round, the Flagship Pioneering-spawned and AI-powered protein therapeutics firm drew investment of an undisclosed amount from the Samsung Life Science Fund Dec. 18.
The BioWorld Biopharmaceutical Index (BBI) closed November with a modest 3.58% gain for the year, a sharp decline from its 16.92% rise in September and peak of 25.19% in August. The BBI has now fallen behind the Nasdaq Biotechnology Index, which posted a 6.27% year-to-date gain, and the Dow Jones Industrial Average, up 19.16% at the end of the month.
Onconic Therapeutics Inc., a subsidiary of Jeil Pharmaceutical Co. Ltd., saw its shares (KOSDAQ:476060) ascend for two consecutive days after debuting with a ₩20.15 billion (US$13.89 million) IPO on the Korea Exchange Dec. 19. Seoul, South Korea-based Onconic’s Kosdaq IPO offered about 1.55 million shares at ₩13,000 each, which was lowered from its original price band of ₩16,000 to ₩18,000 per share after demand forecasting.
A new method to diagnose skin cancer was validated for the first time in clinical trials that show Dermr Health Solutions Pty Ltd.’s non-invasive microneedle patch collects near-equivalent genetic information compared to a skin biopsy without pain or cutting.
Iomx Therapeutics AG has submitted a clinical trial application (CTA) for IOMX‑0675, a dual‑targeting, fully human antibody designed to address the key immune-regulatory LILR receptor family expressed on myeloid and lymphoid immune cells.
Recent research has established that Insulin-like Growth Factor 2 mRNA Binding Protein 3 (IGF2BP3) RNA-binding protein is involved in leukemia development, particularly in the KMT2A-translocated B-acute lymphoblastic leukemia (B-ALL) subtype.
A principal investigator and a former biopharma executive are the latest to reach settlements with the SEC to resolve charges of insider trading involving drug companies. Sai-Hong Ignatius Ou, of the University of California Irvine, agreed to a judgment ordering him to disgorge more than $1.5 million and to pay a civil penalty of the same amount. In a separate, unrelated settlement, Curt Dewitz, a former executive of an undisclosed biopharma company, agreed to disgorge about $70,383 in unlawful profits.
Ottimo Pharma Ltd. is equipped to file an IND and take its lead bifunctional antibody into phase II development, after closing a $140 million series A. The round will accelerate development of jankistomig, which targets the PD-1 immune checkpoint whilst inhibiting tumor angiogenesis by neutralizing vascular endothelial growth factor (VEGF).
A Chinese player entered the U.S. non-small-cell lung cancer (NSCLC) arena as the U.S. FDA cleared Xcovery Holdings Inc.’s Ensacove (ensartinib) as a first-line therapy for adults with anaplastic lymphoma kinase (ALK)-positive locally advanced or metastatic disease who have not previously received an ALK-inhibitor. Xcovery, of Palm Beach Gardens, Fla., is a subsidiary of Betta Pharmaceuticals Co. Ltd, of Hangzhou, China.
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