In November 2024, BioWorld tracked 180 clinical trial updates, down from 219 in October and 252 in September but up from 92 in August. The month included 13 successful phase III outcomes and five trial failures.
SK Bioscience Co. Ltd. won €50 million (₩75.5 billion, US$52.03 million) up front from Sanofi SA to expand an earlier agreement to develop and commercialize novel pneumococcal conjugate vaccines (PCVs). The first deal resulted in GBP-410 (SP-0202), its pediatric 21-valent PCV candidate that moved into phase III study last week.
China's National Medical Products Administration (NMPA) approved Innovent Biologics Inc.’s NDA for Dovbleron (taletrectinib), a next-generation ROS1 tyrosine kinase inhibitor (TKI), for treating adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have been previously treated with ROS1 TKIs.
SK Bioscience Co. Ltd. won €50 million (₩75.5 billion, US$52.03 million) up front from Sanofi SA to expand an earlier agreement to develop and commercialize novel pneumococcal conjugate vaccines (PCVs). The first deal resulted in GBP-410 (SP-0202), its pediatric 21-valent PCV candidate that moved into phase III study last week.
China's National Medical Products Administration (NMPA) approved Innovent Biologics Inc.’s NDA for Dovbleron (taletrectinib), a next-generation ROS1 tyrosine kinase inhibitor (TKI), for treating adults with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC) who have been previously treated with ROS1 TKIs.
Shares in Zealand Pharma A/S (CO:ZEAL) dropped 22.4% to as low as DKK587 (US$82.16) on Dec. 20, after the U.S. FDA issued a complete response letter (CRL) for glepaglutide in the treatment of short bowel syndrome.
Merit Medical Systems Inc. received an early holiday gift this year, reporting that its Wrapsody cell-impermeable endoprosthesis has received premarket approval from the U.S. FDA and plans to begin commercialization of the device there in 2025.
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.
Clinical data reported by a handful of biopharmas on Dec. 19 sent stocks soaring or plunging, as company leaders laid out next-step plans. Investors showed enthusiasm for Omeros Corp.’s narsoplimab to treat hematopoietic stem cell-transplant-associated thrombotic microangiopathy (TA-TMA), and Roche AG’s Parkinson’s prospect prasinezumab, which is partnered with Prothena Corp. plc.
Investors will get more details during the International Lewy Body Dementia Conference in Amsterdam late next month, but Wall Street is already buzzing about Cognition Therapeutics Inc.’s data from the phase II study with CT-1812 in dementia with Lewy bodies.
RSS
