Approval, Pricing Of New Alzheimer’s Drug Targeted In House Investigation
Stat reports that both Biogen, makers of Aduhelm, and the Food and Drug Administration are to be examined. Meanwhile, Axios reports on Aduhelm's price impact on efforts to lower prescription costs and outlines its potential impact on medical standards and budgets.
Stat:
House Leaders To Investigate FDA Approval, Price Of New Alzheimer’s Drug
The top House Democrats on two powerful committees on Friday announced an investigation into the approval and pricing of Biogen’s controversial Alzheimer’s drug, Aduhelm. Both Biogen and the Food and Drug Administration will be under the microscope, House Committee on Oversight and Reform Chair Carolyn Maloney (D-N.Y.) and Energy and Commerce Chair Frank Pallone (D-N.J.) said. (Cohrs, 6/25)
Axios:
New Alzheimer's Drug May Complicate Democrats' Push To Lower Drug Prices
Advocates of lowering prescription drug prices are beginning to use an expensive new Alzheimer's drug to make the case for reform, but actually addressing the therapy's price raises complicated policy challenges. Democrats may be positioning themselves to push policy measures that assign value to drugs and then price them accordingly. If successful, that could be a huge blow to the pharmaceutical industry. (Owens, 6/28)
Axios:
New Alzheimer's Drug May Be A Catastrophe In The Making
The FDA’s approval of a new Alzheimer’s treatment — the first one in almost two decades — should have been a cause for celebration. Instead, it has become a scientific and financial mess. Experts from all corners of the health care world fear the FDA’s decision will undermine medical standards, explode the federal budget and fill millions of desperate people with false hope. (Baker and Herman, 6/28)
In other pharmaceutical and biotech news —
Stat:
In A First For Genome Editing, Intellia Reports Positive Data On In Vivo CRISPR Therapy
In a major milestone for the still-young field of genome editing, Intellia Therapeutics said Saturday that the first six patients to receive a CRISPR-based treatment for a genetic nerve disorder have safely had the DNA inside their liver cells edited. Preliminary results from the study — the first to show that CRISPR-based gene editing can be delivered systemically and performed in vivo, or inside the body — found that the treatment reduced levels of a disease-causing protein by an average of 87% in the higher dose cohort with only mild side effects. The encouraging interim Phase 1 results, presented at a conference on Saturday, were published simultaneously in the New England Journal of Medicine. (Molteni, 6/26)
Albuquerque Journal:
NM Lawsuit Triggers National Concern About Surgical Supplies
The U.S. Chamber of Commerce and other national groups say an environmental protection lawsuit filed in New Mexico could strain medical supplies across the state and country. Their warnings focus on a 41-page complaint filed by New Mexico Attorney General Hector Balderas seeking damages and other relief against a Santa Teresa plant that sterilizes medical equipment. The industry groups say any disruption to the facility’s work could affect medical procedures across New Mexico and the United States. (McKay, 6/25)
The Washington Post:
Prohibited, Unlisted, Even Dangerous Ingredients Turn Up In Dietary Supplements
When buying a dietary supplement, you probably assume that what’s on the label is what’s in the pill. But this assumption doesn’t always hold up, says Pieter Cohen, a physician at Cambridge Health Alliance. In March, Cohen published his 14th paper concerning dietary supplements that contained either prohibited or unlisted ingredients. This time, he and his colleagues analyzed 17 brands of sports and weight-loss supplements sold in the United States, and they detected nine prohibited stimulants in them. Almost half of the brands tested included more than one prohibited stimulant. (Aschwanden, 6/26)
Stat:
Experts Debate The Value Of Digital Coaching For Type 2 Diabetes
Even before the pandemic drove an extreme shift toward telemedicine, diabetes care was leading the march toward digital care. A crop of health care companies including Onduo, One Drop, Lark Health, Omada, Livongo, and Virta Health have built businesses on the idea that virtual coaching and remote monitoring can help people with diabetes keep their glucose levels in healthier ranges. Next year, estimates suggest the market for digital diabetes care will exceed $700 million. (Palmer, 6/28)
Las Vegas Review-Journal:
Company Demands Return Of Drug Planned For Zane Floyd Execution
The makers of ketamine, a drug planned for the execution of convicted killer Zane Floyd, have demanded that Nevada prison officials return the supply before the lethal injection scheduled for next month.
A lawyer for Hikma Pharmaceuticals wrote in a cease-and-desist letter to Attorney General Aaron Ford on Thursday that the Nevada Department of Corrections obtained 50 vials of ketamine illegally. “NDOC’s purchase and intended use of Hikma’s products for capital punishment is in violation of state and federal law, in knowing violation of Hikma’s property and proprietary interests in its products, and these actions will cause significant damage to Hikma’s business reputation and the interests of its investors,” Hikma’s lawyer, Josh Reid, wrote in the nine-page letter obtained by the Review-Journal. (Ferrara, 6/25)
