Antipsychotic Drug Cobenfy Wins FDA Approval For Schizophrenia Treatment
The Bristol Myers Squibb medicine is said relieve symptoms without causing some of the harsh side effects of drugs already in use. Meanwhile, thousands of patients allege in a lawsuit that drugs used for diabetes and weight loss have caused other health problems.
The Washington Post:
FDA Approves New Type Of Antipsychotic Drug, A Potential ‘Game-Changer’
The U.S. Food and Drug Administration late Thursday approved a new kind of drug to treat schizophrenia, a breakthrough after 70 years of incremental innovation that appears to avoid side effects that cause many patients to stop taking their medication. The new drug, Bristol Myers Squibb’s Cobenfy, targets a different area of the brain than traditional antipsychotic drugs to relieve symptoms like delusions without causing patients to gain weight, fall asleep and experience involuntary muscle jerking. (Gilbert, 9/26)
In other pharmaceutical developments —
Stat:
Cassava Sciences And Former Execs, Facing SEC Charges For Misleading Claims, Agree To Fines
Facing charges from the Securities and Exchange Commission for misleading claims related to a controversial Alzheimer’s drug candidate, Cassava Sciences and two of the company’s former executives have agreed to pay fines, the company announced Thursday. The news comes on the same day that the SEC filed charges against Cassava, former CEO Remi Barbier, and former senior vice president of neuroscience Lindsay Burns. (Wosen, 9/26)
USA Today:
Lawsuit: Patients Say Ozempic, Mounjaro Caused Stomach Paralysis
Dana Filmore was terrified of taking Ozempic. Her fear of needles made the idea of injecting herself in the stomach with the drug, which can only be administered under the skin, seem near-impossible. But the antidiabetic pills Filmore was taking weren’t enough to bring her blood sugar down to a healthy level. Her doctor told her that Ozempic, a medication approved by the U.S. Food and Drug Administration to treat Type 2 diabetes, could help. (Kim, 9/27)
CBS News:
New Weight Loss Drugs Spark Eating Disorder Concerns In Teens
There is concern over the newest weight loss drugs sparking eating disorders in teens. Newer GLP-1 weight loss drugs, like Wegovy, have been approved for kids 12 and up and the number of teenagers taking these medications rose nearly sevenfold between 2020 and 2023. But a recent study found that nearly 80% of teens seeking treatment for obesity reported symptoms of depression and eating disorders. (Marshall, 9/26)
NBC News:
New Prescription Drug Price Hikes Hit Black Patients Hard
Prices for prescription pharmaceutical drugs have skyrocketed, disproportionately making them harder for people of color to afford, a new report finds. The advocacy organization Patients for Affordable Drugs released a report this month showing that pharmaceutical companies increased prices on at least 1,000 prescription drugs so far this year, with about half of the price increases being above the rate of inflation. (Bellamy, 9/26)
The Wall Street Journal:
A U.S. Crackdown Targeted A Silicon Valley ‘Pill Mill.’ Secretly, It Had Already Moved To China.
Federal authorities came down hard on Done Global, the California-based telehealth startup that prosecutors allege is an Adderall “pill mill” with a “predatory business model.” Its founder was arrested and most of its U.S. staff have quit, but it’s still pumping out prescriptions to its American clientele. Done’s big secret? Key operations were moved to China. (Winkler, 9/26)
CIDRAP:
UN Calls For Action, Accountability On Antimicrobial Resistance
World leaders today agreed to a wide-ranging set of commitments to address antimicrobial resistance (AMR) through a One Health approach. The commitments are laid out in a political declaration adopted today by 193 United Nations (UN) member states at the UN High-Level Meeting on AMR in New York. It's the second time in 8 years that the UN has addressed the rising threat of drug-resistant infections, which recent estimates suggest have killed more than a million people annually since 1990 and could claim more than 39 million lives by 2050. (Dall, 9/26)