Emphasizing April’s vote of concern about the safety of PI3K inhibitors, the U.S. FDA’s Oncologic Drugs Advisory Committee said privately held Secura Bio Inc.’s Copiktra (duvelisib) is more of a hindrance than a help. The adcom voted 8-4 on Sept. 23 that it sees a detriment in overall survival (OS) and some other safety issues that were revealed in newly updated data for the cancer treatment. Approved in 2018 for treating adults with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma after at least two prior therapies, Secura argued that its data continue to show a statistically significant and clinically meaningful benefit in OS and also in progression-free survival. Read More
The U.S. FDA’s Oncologic Drugs Advisory Committee (ODAC) took up the matter of Oncopeptides AB’s long-storied multiple myeloma (MM) drug, Pepaxto (melphalan flufenamide), and briefing documents ahead of the meeting – which provided little cause for optimism – proved predictive of ODAC’s vote. Shares of Oncopeptides (Stockholm:ONCO) have dropped more than 64% over the past five days as investor jitters worsened. Read More
Sino Biopharmaceutical Ltd. subsidiary Chia Tai-Tianqing Pharmaceutical Group Co. Ltd. has acquired greater China rights to lanifibranor from Inventiva SA in a deal worth up to $307 million. Included in the deal are rights to develop and commercialize the drug in mainland China, Hong Kong, Macao, and Taiwan for the treatment of nonalcoholic steatohepatitis (NASH) and other metabolic diseases. Read More
Alkermes plc’s recent update on sales of the schizophrenia drug Lybalvi (also indicated for bipolar I disorder) along with positive phase III data from Karuna Therapeutics Inc. from tests of Karxt (xanomeline plus trospium) shone more light on the troublesome indication, where Cerevel Therapeutics Holdings Inc. is advancing emraclidine in what could be a registrational phase II study. Read More
Stratosvir Ltd. aims to overcome the drawbacks experienced with oncolytic viruses, using technology based around vaccinia viruses that allow for a systemic injection and with a larger payload capacity. Stratosvir was started up by CEO Chris Ullman and co-founder Antonio Postigo in 2020 with funding from Cancer Research UK and the Deep Science Ventures, tasked with finding new ways of treating solid tumors. Read More
An analyst recently observed that mental health treatments are stuck where cancer was 50 years ago. However, there have been major advancements in developing psychedelic medicines to address that problem. BioWorld staff writer Lee Landenberger talked with James Lanthier, the CEO of Mindset Pharma, which is developing what it calls “next-generation” psychedelic medicines to treat neurological and psychiatric disorders. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Adamis, Alaunos, Almirall, Biomind, Carsgen, DBV, Nanobiotix, Neurona, Nodthera, Revolution, RVAC, Sonnet, Spexis, Telix, Vir. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Astrazeneca, Keymed, Kinnate, Krystal, Merck & Co., Relief. Read More
