Safety issue halts Duchenne muscular dystrophy drug trial


The Food and Drug Administration has halted a trial of a Sarepta drug, called SRP-5051, after a “serious safety incident.” Prosecution of whistleblowers; Merck’s Seagen Agreement; Bausch Health; and a $21.7 million donation to help fight breast cancer are also making headlines in pharmaceutical headlines.

Stat: FDA halts study of Sarepta treatment for Duchenne muscular dystrophy

Sarepta Therapeutics announced Thursday that it has temporarily halted a clinical trial of its second-generation drug for patients with a certain type of Duchenne muscular dystrophy due to a serious patient-reported safety incident. The Food and Drug Administration placed a clinical hold on the drug Sarepta, called SRP-5051, after a patient in the study experienced a “serious” decrease in blood magnesium, a condition known as hypomagnesemia. (Feuerstein, 6/23)

In other pharma and research news —

Stat: A CVS Whistleblower Lawsuit Comes at a Pivotal Time for FTC Probe

Three years ago, a former CVS Health executive told a US Senate committee hearing that the company – which has deep tentacles in the Byzantine system of prescription drug delivery – guarantees that its customers receive the cheapest drugs. “When those lower list prices result in the lowest net cost to the patient as well as to the plan, then absolutely it’s the preferred drug on the formulary,” said Derica Rice, who was executive vice president at the era. He was answering questions about how CVS places drugs on its formularies, or list of drugs covered by health insurance, created by its drug benefit unit. But a recently unsealed whistleblower lawsuit argued that, in fact, CVS and its various subsidiaries — pharmacy benefits manager CVS Caremark, SilverScript Medicare Part D plan, and pharmacy chain CVS — conspired to make exactly the opposite. (Silverman, 6/23)

The Wall Street Journal: Merck moving forward with potential Seagen deal

Merck & Co. is advancing a potential deal for biotech Seagen Inc., according to people familiar with the matter, in what would be one of the biggest takeovers of the year. The Wall Street Journal reported last week that Merck was in talks to buy Seagen, which would bolster the pharmaceutical giant’s cancer drug portfolio, but that no deal was imminent. Talks have accelerated and the two companies are expected to meet this week, some people said Thursday. (Cimilluca, Lombardo and Rockoff, 6/23)

Bloomberg: Bausch Health Appoints Billionaire Paulson Chairman of Hedge Fund

Bausch Health Cos. named hedge fund billionaire John Paulson as the new chairman, replacing Joseph Papa, who stepped down on Thursday. The pharmaceutical and device company, which focuses on eye care, gastroenterology and dermatology products, said Papa’s resignation was not the result of ‘a dispute or disagreement’ . Paulson, who is also the company’s second largest shareholder, starts immediately. Bausch shares jumped late in the session, gaining about 3% to $7.49 per share at 6:30 p.m. in New York. The Canadian company was formerly known as Valeant Pharmaceuticals. It changed its name in 2018 following public outcry over rising drug prices and the conviction of a former executive for accepting a bribe. (Swetlitz, 6/24)

Dallas Morning News: Susan G. Komen Distributes $21.7 Million To Fight Breast Cancer’s Biggest Challenges

One of the biggest names in breast cancer research funding is launching a $21.7 million funding round to tackle the biggest challenges of the disease, which is diagnosed more than 250,000 times per year. year. Dallas-based Susan G. Komen for the Cure will support 48 new research projects at 26 US medical institutions. This is in addition to the $93.3 million in active projects the nonprofit currently funds across 104 research teams. (Wright, 6/23)

This is part of the KHN Morning Briefing, a summary of health policy coverage from major news outlets. Sign up for an email subscription.

Previous The Bear Plank Alternating Reverse Fly is an Effective Exercise
Next Caspian Terns were calling as we walked through Harriman State Park