Top-line data from Glycomimetics Inc.’s pivotal phase III study of uproleselan in 388 patients with relapsed/refractory acute myeloid leukemia missed its primary endpoint. The data crippled the stock, which closed at the low point of its 10-year existence. Read More
Not long after Ocular Therapeutix Inc. unveiled positive phase I data in non-proliferative diabetic retinopathy with Axpaxli (axitinib intravitreal implant), Eyepoint Pharmaceuticals Inc. offered less-sunny phase II data from the Pavia trial testing Duravyu (vorolanib intravitreal insert), previously known as EYP-1901, in the same indication. Read More
Less than a week ago, executives at Lyra Therapeutics Inc. were looking ahead to “imminent” data from its first phase III study in chronic rhinosinusitis (CRS), testing drug-device candidate LYR-210, a drug-device candidate largely expected to fill a much-needed gap in CRS treatment. On Monday, May 6, they were announcing plans to preserve cash in the wake of the failed Enlighten 1 study, which raised doubts as to the feasibility of the company’s CRS programs, which also include the similarly designed candidate LYR-220. Read More
With round 1 not yet completed, the U.S. Centers for Medicare & Medicaid Services (CMS) already is prepping for round 2 of the Medicare negotiations mandated by the 2022 Inflation Reduction Act. While the negotiation process will expand to Part B drugs in the future, round 2, like the first cycle, will be limited to single-source Part D drugs that account for some of the highest Medicare expenditures. However, the number of drugs selected for the next cycle could grow from the current 10 to up to 15 Read More
The Australian government is investing AU$1.89 billion (US$1.25 billion) in what it is calling a “once-in-a generation transformation” of health and medical research in Australia with $1.4 billion tagged for new research for the Medical Research Future Fund. Read More
Cancer vaccines specialist Infinitopes Precision Immunomics Ltd. announced the closing of a £12.8 million (US$16.1 million) seed round and outlined plans to start a phase I/IIa study of the lead program in the third quarter of this year. Read More
Although the $6.03 billion in biopharma financings raised in April is down from $13.84 billion in financings in March and $22.3 billion in February, the monthly average of $13.29 billion for all financings is up 125% from the average of $5.91 billion a month in 2023. Read More
Based on its analysis of a large cohort of individuals homozygous for the ε4 variant of apolipoprotein E (ApoE4), a multinational team of researchers is arguing that homozygosity for ApoE4 should be considered a genetic form of Alzheimer’s disease (AD). Read More
Recent advances in artificial intelligence (AI) have generated a tsunami of popular dystopian musings, but the U.S. Patent and Trademark Office (PTO) has its own concerns about AI’s impact on intellectual property. Read More
Checking off another item on its PDUFA VII to-do list, the U.S. FDA is releasing a draft guidance on using a logic model framework for risk evaluation and mitigation strategies (REMS). Read More
BioWorld Managing Editor Karen Carey joins the podcast to talk about the numbers from the first quarter of 2024, along with a look back at some 2023 deals and indicators that signal better times are on the way. Financings for the quarter were better than expected, sporting some of the best numbers of the past 13 years. It’s part of a larger trend, Carey says, of investors being a lot pickier about where they put their money and demanding better data. The result is a strengthened market and a better outlook. Read More
The recent cyberattack on Change Healthcare, a part of the Unitedhealth Group, crippled reimbursement claims processing for thousands of providers for several weeks and potentially exposed troves of patient data. Congressional committees are investigating the attack, its scope, and Unitedhealth’s response. Please take a few minutes to fill out this short survey to help BioWorld understand how your company is responding to these threats. You can click through to the questions here. Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: Aeon, Gossamer, Hanall, Kancera, Ventus, Xylocor. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Anneal, Astrazeneca, Biocartis, Bluebird, Catalent, Cellectis, Chiesi, Eiger, Emergent, Gossamer, Lantern,Merck KGaA, Novo Nordis, Oregon, Sentynl, Urogen, Zydus. Read More
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