After Sage Therapeutics Inc. reported a phase II failure with oral dalzanemdor, also known as SAGE-718, in mild cognitive impairment related to Parkinson’s disease (PD), Wall Street’s eyes turned to ongoing mid-stage efforts with the same N-methyl-D-aspartate receptor-positive allosteric modulator in Huntington’s disease and Alzheimer’s disease. Read More
Eli Lilly and Co. is planning to file for U.S. FDA approval later this year after reporting that tirzepatide met all primary and key secondary endpoints in two phase III trials in obstructive sleep apnea (OSA). Assuming approval, tirzepatide could become the first drug approved specifically for OSA, while providing potential entry access for Medicare Part D coverage, which is denied for the GLP-1 class of drugs approved as obesity medications. Read More
Having addressed the manufacturing issues that resulted in a few complete response letters, Alvotech Holdings SA and Teva Pharmaceutical Industries Ltd.’s biosimilars partnership is now on a roll, with the U.S. FDA approving the team’s second biosimilar, Selarsdi, less than two months after approving the first one, Simlandi, as an adalimumab interchangeable. Read More
“The development of psychedelic medicines should adhere to the current European regulatory framework, at both the pan-European and member state level. It is imperative that developers understand and thoroughly apply the regulatory guidance and requirements that are in place.” That was the somewhat discouraging opening statement at the stakeholder workshop convened by the EMA to discuss the development and therapeutic use of psychedelic substances to address unmet medical needs in the area of mental health. Read More
Neurotech International Ltd.’s cannabinoid NTI-164 met the primary and secondary endpoints in a phase II/III trial in children with autism spectrum disorder. The company also reported positive top-line data for Rett syndrome in a phase I/II trial. Read More
Oncolytic virus specialist Theolytics Ltd. has raised £19 million (US$23.7 million) in its latest financing round, as it prepares to start phase I development of the lead product, THEO-260, later this year. Read More
BNC Korea Inc. is picking up exclusive commercial rights to Kariya Pharmaceuticals ApS’ dual GLP-1/GIP agonists for Parkinson’s and Alzheimer’s disease in five countries – a move that comes shortly after BNC Korea dropped $1.5 million into the Danish pharma for a 4.5% stake. Read More
Immuneoncia Therapeutics Inc., a joint venture between South Korea’s Yuhan Corp. and San Diego-based Sorrento Therapeutics Inc., is looking to list on the Korea Exchange, having recently passed local technology evaluation. Read More
With the recent hack of Change Healthcare back in the news, a committee of the U.S. House of Representatives took up the subject of cybersecurity, which included only a couple of mentions of medical devices. However, witnesses at the hearing emphasized the role of the federal government in thwarting foreign cybersecurity threats against health care facilities, with John Riggi of the American Hospital Association stating, “we need the [federal] government to go after bad actors overseas.” Read More
Because artificial intelligence is such a new technology it comes with a mountain of unknowns. Integrating it into a pharmaceutical company presents a unique series of challenges, as a new survey from Verix shows. Doron Aspitz, the CEO of Verix, talked about the new findings with the BioWorld Insider podcast and the profound shift that executives face as the new technology takes over an entire industry. Read More
New hires and promotions in the biopharma industry, including: Brainstorm Cell, Domain, Evotec, Lipella, Pelthos, Polaroid, Sensorium, Stoke, Terns, Theradaptive. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Abbvie, ABVC, Atticus, Basilea, Clearmind, Eli Lilly, Essential, FSD, IGM, Imugene, Jaguar, Janssen, Johnson and Johnson, Kincell, Medincell, Neurocrine, Oncox, OSE, Precision, Polyphor, Prevail, Radius, Rgene, Saliogen, Sanofi, Santhera, SATT Conectus, Sentia, Spexis, Spikimm, Ultimovacs, Vanda, Yuva, Zevra, Zylö. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Biorestorative Therapies, Eloxx, Lexeo, Norgine, Petros, Pfizer, Pharmather, Sentynl, Telix. Read More
