Drug pricing is dead, for now

Drug pricing has been a top congressional concern for years now — but momentum toward legislation that would have major implications for the biopharma industry has screeched to a halt in the wake of the coronavirus pandemic. Now, lowering prescription drug costs is on the legislative back burner, STAT’s Lev Facher reports.

“Come Nov. 30, when hopefully things are in a better place public health-wise, I still think there will be momentum there to get this done,” said Ben Wakana, the executive director of the advocacy group Patients for Affordable Drugs Now.

Gilead opens up about remdesivir and Covid-19

Gilead CEO Dan O’Day penned an open letter over the weekend about his company’s efforts to develop the therapy remdesivir as a treatment for Covid-19. Many people have reached out to Gilead, begging for access to the drug for their loved ones.

“I can only imagine how it must feel to be in that situation,” O’Day writes. “We are used to seeing numbers and statistics in the news on a daily basis but we all know that behind each of those numbers is a real and often heartbreaking human story.”

The company has been “working with the greatest sense of urgency and responsibility” and with “unprecedented speed” to test the drug in clinical trials, O’Day said. So far, Gilead has provided remdesivir to more than 1,000 people under the auspices of the FDA’s compassionate use program — but last week began transitioning to an expanded access system.

“We know that patients and their families around the world are waiting,” O’Day said.

A precision trial for an amyloid-targeting drug

Biogen’s aducanumab isn’t the only potential Alzheimer’s treatment that targets amyloid plaques. Another drug, crenezumab, is testing the amyloid hypothesis — but its maker, AC Immune, has a pretty novel approach to trial design.

Rather than offering the drug to a wide range of people who show symptoms of Alzheimer’s, AC Immune is only recruiting folks with a genetic mutation called E-288 that almost certainly will lead to early onset of the disease. With such a hyper-specialized patient pool, the company hopes to examine whether prevention of plaque buildup might ameliorate future neurodegeneration.

The study’s being conducted in Colombia, and should generate results by early 2022.

A modest win for heart failure

Heart failure has historically been a difficult condition to treat for the 6.5 million Americans who have it — with more clinical trials failing than succeeding. However, an experimental drug called vericiguat from Merck and Bayer has cut hospitalizations for heart failure by 10%, according to a study published Saturday in the New England Journal of Medicine.

“I think we need to sit back and acknowledge that we have another win in the treatment of heart failure,” one of the investigators said of the drug during a webcast of the American College of Cardiology, which is holding its annual meeting remotely this week.

The results may still be underwhelming to both doctors and investors, STAT’s Matthew Herper writes. The effect of the drug, after all, is still rather modest — and only just met the criteria for statistical significance.

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lunes, 30 de marzo de 2020