About four months after varoglutamstat failed in Alzheimer’s disease, Vivoryon Therapeutics NV disclosed data from the Viviad phase IIb study with the same compound in kidney disease that provided cause for hope – and Anne Doering, chief financial officer, said the new data “reinforce our strategic shift.” Read More
The U.S. FDA advised Agenus Inc. to conduct a phase III trial for its immunotherapy combination, botensilimab (bot) and balstilimab (bal), instead of seeking accelerated approval based on phase II data, sending company shares plunging by 58.8% July 18. Read More
Tufts University professor Ken Getz had an everything-you-know-is-wrong moment when he looked at new research showing the costs of delays in drug development and sales. The results prompted more than a few gulps from others. The old numbers are outdated and based on anecdotal evidence, the center concluded, and with the new data, it’s time to hit the reset button. Read More
The bill the U.S. Senate passed to prune biologic patent thickets could be among the first in a legislative thicket aimed at prescription drug prices to make it through the Senate before the year ends. Read More
Aussie biotech Alterity Therapeutics Ltd. released interim data of an open-label phase II trial for lead candidate ATH-434 for treating multiple system atrophy that showed 43% of participants improved, with 29% showing either stable or improved neurological symptoms. Read More
The U.S. House Committee on Ways and Means held a field hearing in the State of Utah, during which committee chairman Rep. Jason Smith (R-Mo.), highlighted the need to continue to incentivize life science research in the U.S. Smith remarked that Republican members of the committee have formed “tax teams” to find ways that the tax code can be tweaked to “better incentivize research and development here in the U.S.,” another sign that the well-being of life science commerce is seen as a macroeconomic imperative in Washington. Read More
Two costs of developing drug candidates have been upended by new research from the Tufts University School of Medicine’s Center for the Study of Drug Development. New data have produced some very different numbers than you might expect in the cost of a single day of a clinical trial and of missing a day to generate prescription drugs sales. The center’s director, Ken Getz, spoke to the BioWorld Insider podcast about updating the outdated numbers and what it means for companies and investors. Read More
From no hope to viable treatments, BioWorld is there to cover the breakthroughs in medicine. Listen to Randy Osborne explain why the BioWorld team is ‘always on the lookout for what's next.’ Read More
Clinical updates, including trial initiations, enrollment status and data readouts and publications: 4D Molecular, Adverum, Alterity, Bayer, Dermaliq, Genentech, Oncodesign. Read More
Biopharma happenings, including deals and partnerships, grants, preclinical data and other news in brief: Acea, Aclaris, Aditxt, Anagenex, Aslan, Cytomed, Eli Lilly, Evofem, Genentech, Relay, Scisparc, Scilex. Read More
Regulatory snapshots, including global drug submissions and approvals, clinical trial approvals and other regulatory decisions and designations: Aicuris, Atara, Longeveron, Mabwell, Orexo. Read More
