Morning Briefing
Summaries of health policy coverage from major news organizations
Purdue Pharma Sentenced In OxyContin 'Crime Scheme,' Will Dissolve
AP: OxyContin Maker Purdue Pharma Is Sentenced, Set To Dissolve
OxyContin maker Purdue Pharma is set to be dissolved and replaced by a company focused on the public good by the week’s end, as a massive legal settlement resolving thousands of lawsuits takes effect. A federal judge on Tuesday delivered a criminal sentence to the company to resolve a U.S. Department of Justice probe — a last necessary step to clear the way for the settlement. U.S. District Judge Madeline Cox Arleo made her decision after listening to hours of impact statements from people who lost loved ones or struggled with addiction themselves and requested she reject the negotiated sentence. (Mulvihill, 4/29)
More news about addiction —
NPR: RFK Jr. Wants To Treat Addiction On Farms, Without Medication
During a combative Senate hearing last week, Sen. Angela Alsobrooks, a Democrat from Maryland, leaned forward and asked U.S. Health Secretary Robert Kennedy about his vision for a national system of "wellness farms." "You said every black kid can be reparented on a wellness farm, can you admit that you said that?" Alsobrooks said, describing the concept as "dangerous" and "irresponsible." (Mann, 4/29)
In other pharmaceutical developments —
The Wall Street Journal: FDA Turns To AI To Speed Up Clinical Trials
The U.S. Food and Drug Administration seeks to accelerate clinical trials of new medicines by using artificial intelligence to streamline the laborious process of collecting and submitting study data. Typically, medical centers involved in clinical trials pull study data from electronic-health records and enter them manually into a data-capture system. Then, the drug company developing the medicine reviews the data and submits them to the FDA. (Gormley, 4/28)
MedPage Today: FDA Claims 'Manipulated' Data Led To Drug's Approval, Proposes Withdrawal
The FDA said that "manipulated" data supported the approval of avacopan (Tavneos) for anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, and the agency is proposing to withdraw the drug's marketing approval. In a Monday letter to Amgen, which now holds avacopan's rights, the agency's top drug regulator said that new information came to light showing avacopan lacks "substantial evidence of effectiveness," and that developer ChemoCentryx's new drug application (NDA) contained "untrue statements of material facts" -- both legal bases for pulling a drug. (Ingram, 4/28)
Stat: AIDS Group Sues Trump Administration Over Gilead Agreement
An AIDS activist group filed a lawsuit against the Trump administration for failing to disclose a research and development agreement that was at the heart of a settlement between the U.S. government and Gilead Sciences over patents for HIV prevention. (Silverman, 4/28)
Bloomberg: Boehringer Obesity Shot Prompts 16.6% Weight Loss In Trial
Boehringer Ingelheim GmbH said patients using its experimental obesity shot lost 16.6% of their body weight in a large study, disappointing hopes it could outperform Eli Lilly & Co.’s market leader Zepbound. Patients in the trial shed the weight after 76 weeks of treatment with survodutide, compared with 3.2% weight loss for those given a placebo, Boehringer said Tuesday. Key details are still to be reported on side effects, patient dropouts, liver benefit and how much of the weight loss was from fat, which will help determine how competitive the drug can be. (Wind and Kresge, 4/28)
Bloomberg: Canada Approves First Generic Ozempic, Opening Door To Cheaper Diabetes Drugs
Canada has approved its first generic versions of Novo Nordisk A/S’s Ozempic, paving the way for cheaper access to the popular diabetes drugs. On Tuesday, Health Canada assigned drug identification numbers to semaglutide injections made by India-based Dr. Reddy’s Laboratories Ltd., according to its drug product database. Semaglutide is the main ingredient in Ozempic, and Novo’s protection against generics expired in Canada on Jan. 4. Dr. Reddy’s did not immediately respond to a request for comment. (Kresge, Shin, and Heinzl, 4/28)
