Nantkwest Inc. and privately held Immunitybio Inc. trotted out positive early interim results from their advanced metastatic pancreatic cancer studies showing median survival rates more than double the historic rates: eight month’s survival compared to only three. “Anything beyond three months has an impact,” Patrick Soon-Shiong, Immunitybio’s CEO and Nantkwest’s executive chairman, told BioWorld, with understatement about one of the toughest to manage indications in medicine. Read More
Citing a lack of efficacy from adding its complement inhibitor Ultomiris (ravulizumab) to best supportive care for patients hospitalized with severe COVID-19, Alexion Pharmaceuticals Inc. paused further enrollment in a global phase III study of the drug. The move, recommended by the trial's independent data monitoring committee, suggested Ultomiris may soon join the list of other therapeutics once tested against COVID-19 but now no longer. Read More
Moncef Slaoui, chief advisor to Operation Warp Speed, the public-private partnership to hurry along a vaccine for COVID-19, cited tough going in the early days of development, as researchers met “a real challenge to engage the population.” During a panel discussion at the virtual 39th J.P. Morgan Healthcare Conference, he pointed to “a double-edged sword, to talk about what a vaccine can do, when we don’t know – and then once you know, you’re going to have to change your message.” Read More
COVID-19 undoubtedly will be the top U.S. health care priority for the 117th Congress and the incoming Biden administration, but that doesn’t mean prescription drug prices are no longer an issue. A raft of new-year price increases, many for already costly drugs, is ensuring drug pricing remains high on the congressional agenda. Read More
Alzheimer’s disease can be divided into multiple subtypes based on gene expression patterns, investigators at the Mount Sinai School of Medicine reported in the Jan. 6, 2021, issue of Science Advances. The work, corresponding author Bin Zhang told BioWorld, is “the first major finding of subtypes in Alzheimer’s disease.” Read More
The latest global regulatory news, changes and updates affecting biopharma, including: HHS posts rule for agency enforcement action; Guidance to help with COVID-19 Mabs; Chinese pharma exec sentenced on U.S. drug charges. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Alexion, Ampio, Atyr, Bicycle, Knopp, Kyorin, Mirum, Nantkwest, Organogenesis, United, Verona. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Astellas, Beximco, Bone, Bridgebio, Cytiva, Debiopharm, Diurnal, Eidos, Fujifilm, Kaleido, Lentigen, Meridian, Miltenyi, Nuclei, Oncternal, Revive, Rigenerand, Siga, Ubiquigent, United Immunity, Xyphos. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Beigene, Innovation, Lexicon, Novartis, Orchard, Theratechnologies, Vor. Read More
