A highly anticipated obesity-drug candidate from biotech Amgen helped patients shed a significant amount of weight in a midstage study. Subjects taking Amgen's MariTide lost 20% of their body weight compared with those who received placebos, Amgen said Tuesday. Analysts had generally expected the drug to achieve weight reduction of 20% or more. The drug's most common side effects included nausea and vomiting. The news sent Amgen shares gyrating in premarket trading, falling as much as 10%, as investors parsed the company's announcement and awaited more details from a company conference call. Some analysts say the obesity-drug market, now dominated by Eli Lilly and Novo Nordisk's GLP-1 drugs, could eventually reach more than $100 billion in annual sales worldwide, with Amgen taking as much as 10% to 15% of the pie.
In clinical trials, most participants taking Wegovy or Mounjaro to treat obesity lost an average of 15% to 22% of their body weight — up to 50 pounds or more in many cases. But roughly 10% to 15% of patients in those trials were "nonresponders" who lost less than 5% of their body weight. Now that millions of people have used the drugs, several obesity experts told The Associated Press that perhaps 20% of patients — as many as 1 in 5 — may not respond well to the medications. It's a little-known consequence of the obesity drug boom, according to doctors who caution eager patients not to expect one-size-fits-all results.
Those ever-present TV drug ads showing patients hiking, biking or enjoying a day at the beach could soon have a different look: New rules require drugmakers to be clearer and more direct when explaining their medications' risks and side effects. The FDA spent more than 15 years crafting the guidelines, which are designed to do away with industry practices that downplay or distract viewers from risk information. Many companies have already adopted the rules, which become binding Nov. 20. But while regulators were drafting them, a new trend emerged: thousands of pharma influencers pushing drugs online with little oversight. A new bill in Congress would compel the FDA to more aggressively police such promotions on social media platforms.
Opioid overdose deaths have now slowed to the lowest levels nationwide since 2020, according to new estimates from the CDC. This marks the 12th straight month of decline since a peak last year. Around 70,655 deaths linked to opioids like heroin and fentanyl were reported for the year ending June 2024, the CDC now estimates, falling 18% from the same time in 2023. Almost all states, except for a handful in the West from Alaska through Nevada, are now seeing a significant decrease in overdose death rates. Early data from Canada also suggests overdose deaths there might now be slowing off of a peak in 2023 too.
Johnson & Johnson has sued a U.S. government agency over a closely watched dispute focusing on payment methods for some hospitals that participate in a federal drug discount program. In its lawsuit, the company argued that HRSA has wrongfully interpreted a federal law concerning the use of rebates in the 340B Drug Pricing Program. J&J recently sought to change payment terms for its Xarelto blood thinner and the Stelara plaque psoriasis treatment.
U.S. drugmakers and biotechs have come to rely on Chinese partners for manufacturing, research and ingredients. Now, some of them are looking for alternatives as geopolitical tensions rise. Switch-overs in manufacturing, raw materials could mean higher drug prices and slower rollouts.