Safety Issue Halts Duchenne Muscular Dystrophy Drug Trial
The Food and Drug Administration stopped the trial of a Sarepta drug, called SRP-5051, after a "serious safety incident." Whistleblower lawsuits; Merck's Seagen deal; Bausch Health; and a $21.7 million donation to help combat breast cancer are also in pharma news.
Stat:
FDA Halts Study Of Sarepta Treatment For Duchenne Muscular Dystrophy
Sarepta Therapeutics said Thursday that it has temporarily stopped a clinical trial of its second-generation medicine for patients with a certain type of Duchenne muscular dystrophy due to a serious safety incident reported by a patient. The Food and Drug Administration placed a clinical hold on the Sarepta drug, called SRP-5051, after a patient in the study experienced a “serious” decrease in blood-based magnesium, a condition known as hypomagnesemia. (Feuerstein, 6/23)
In other pharmaceutical industry and research news —
Stat:
A CVS Whistleblower Lawsuit Comes At A Pivotal Moment For FTC Probe
Three years ago, a former CVS Health executive told a U.S. Senate committee hearing that the company — which has deep tentacles into the Byzantine system for making prescription drugs available — ensures that its customers receive the lowest-cost medicines. “When those lower list prices result in the lowest net cost for the patient as well as for the plan, then absolutely, that is the preferred drug on formulary,” said Derica Rice, who was an executive vice president at the time. He was responding to questions about the ways in which CVS places medicines on its formularies, or list of medicines covered by health insurance, created by its pharmacy benefits unit. But a recently unsealed whistleblower lawsuit argued that, in fact, CVS and its various subsidiaries — the CVS Caremark pharmacy benefits manager, the SilverScript Medicare Part D plan and the CVS chain of pharmacies — conspired to do exactly the opposite. (Silverman, 6/23)
The Wall Street Journal:
Merck Pushes Forward With Potential Deal For Seagen
Merck & Co. is pushing forward with a potential deal for biotech Seagen Inc., according to people familiar with the matter, in what would be one of the largest takeovers of the year. The Wall Street Journal reported last week that Merck was in talks to buy Seagen, which would beef up the pharmaceutical giant’s cancer-drug portfolio, but that no agreement was imminent. The talks have picked up pace and the two companies are scheduled to meet this week, some of the people said Thursday. (Cimilluca, Lombardo and Rockoff, 6/23)
Bloomberg:
Bausch Health Names Hedge Fund Billionaire Paulson Chairman
Bausch Health Cos. has named hedge fund billionaire John Paulson as its new chairman, replacing Joseph Papa, who resigned on Thursday. The pharmaceutical and device company, which focuses on eye care, gastroenterology and dermatology products, said Papa’s resignation wasn’t the result of “any dispute or disagreement.” Paulson, who is also the company’s second-largest shareholder, starts immediately. Shares of Bausch jumped in late trading, gaining about 3% to $7.49 a share at 6:30 p.m. in New York. The Canadian company was once known as Valeant Pharmaceuticals. It rebranded in 2018 in the wake of public outcry over drug price hikes and the conviction of a former executive for accepting a bribe. (Swetlitz, 6/24)
Dallas Morning News:
Susan G. Komen Doles Out $21.7 Million To Fight Breast Cancer’s Biggest Challenges
One of the biggest names in breast cancer research funding is rolling out a $21.7 million funding round to combat the biggest challenges around the disease, which is diagnosed more than 250,000 times a year. Dallas-based Susan G. Komen for the Cure will back 48 new research projects at 26 U.S. medical institutions. That’s in addition to the $93.3 million in active projects the nonprofit is currently funding across 104 research teams. (Wright, 6/23)
