Vivoryon Therapeutics NV disclosed data from the Viviad phase IIb study with varoglutamstat in kidney disease. New analysis of estimated glomerular filtration rate in a subgroup of patients with diabetes revealed a substantially higher treatment effect of >8mL/min/1.73m2/year (p=0.02; varoglutamstat n=20 / placebo n=12) vs. the overall Viviad study group, where the outcome was 3.4mL/min/1.73m2/year (p<0.001; varoglutamstat n=141 / placebo n=117). The drug is an oral and selective inhibitor of human glutaminyl cyclases QPCT and QPCTL. Shares of Munich-based Vivoryon (AMS:VVY) rose to €2.50 (US$2.64), up €0.42, or 20%.

Tufts: Toss out the old drug development delay estimates

Tufts University professor Ken Getz had an everything-you-know-is-wrong moment when he looked at the school’s new research showing the costs of delays in developing a drug candidate. The results prompted more than a few gulps from others. The old numbers are outdated and based on anecdotal evidence, the center contends, and with the new data, it’s time to hit the reset button. Getz, the executive director and a professor at the Tufts University School of Medicine’s Center for the Study of Drug Development, is one of three authors of a new center report on the cost of missing a day to generate prescription drug sales and the cost of a day to conduct a clinical trial. The cost of missing a day to generate prescription drug sales previously had been estimated at $4 million to $5 million. Getz spoke to the BioWorld Insider podcast about updating the outdated numbers and what it means for companies and investors.

Alterity’s ATH-434 shows early response in multiple system atrophy

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 (MSA) that showed 43% of participants improved, with 29% showing either stable or improved neurological symptoms. “I wasn't expecting clinical stability or clinical improvement,” Alterity CEO David Stamler told BioWorld. “Frankly, I was hoping to see target engagement and some evidence of biomarker movement, so to see clinical change is surprising and exciting.”

Congress looking for ‘simple solutions’ to Rx pricing quandary

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. While the 118th Congress is quickly running out of time to get more bills passed, “it’s an election year and we see crazy things happen in an election year,” Chad Landmon, chair of the Hatch-Waxman & biologics practice at Polsinelli PC, told BioWorld, referring to the legislative process. Since both Democrats and Republicans have been focusing on drug prices as a campaign issue for years, Landmon said he could see more bills addressing drug prices being passed in the next few months as lawmakers on both sides of the aisle seek victories they can tout in their campaign talking points.

US Ways and Means Committee eyes tax reform for life science R&D

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 an economic imperative in Washington.

BioWorld Insider Podcast – The cost of delays in development and sales: It’s probably not what you think

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.

Also in the news

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