Tag: Pharmalot

  • STAT+: Merck suffers a setback in Europe over its new Keytruda formulation

    STAT+: Merck suffers a setback in Europe over its new Keytruda formulation

    By Ed Silverman

    Oct. 7, 2026

    Pharmalot Columnist, Senior Writer

    Ed’s stories explore prescription drug pricing, affordability and access, as well issues surrounding patents, litigation, and legislation. He is also the author of the morning Pharmalittle newsletter and the afternoon Pharmalot newsletter.

    In a setback for Merck, a Dutch court ruled that the company infringed on a patent pertaining to a subcutaneous formulation of its Keytruda cancer treatment and was ordered to halt manufacturing and marketing of the medication in several European countries, including France, Italy, Sweden, Switzerland, and the Netherlands.

    The ruling came as part of a widening patent infringement dispute with Halozyme Therapeutics over the best-selling cancer treatment. Patients requiring Keytruda will still have access to the existing intravenous version, which is not affected by the patent dispute or court order.

    In a statement, Merck said it “strongly” disagreed with the court’s decision.

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  • STAT+: Pharmalittle: We’re reading about WHO obesity guidelines for kids, DOJ targeting pharma, and more

    STAT+: Pharmalittle: We’re reading about WHO obesity guidelines for kids, DOJ targeting pharma, and more

    By Ed Silverman

    Oct. 7, 2026

    Pharmalot Columnist, Senior Writer

    Good morning, everyone, and welcome to the middle of the week. Congratulations on making it this far, and remember there are only a few more days until the weekend arrives. So keep plugging away. After all, what are the alternatives? While you ponder the possibilities, we invite you to join us for a needed cuppa stimulation. Our choice today is ginseng peach, a favorite from our pantry. Meanwhile, here is the latest menu of tidbits to help you on your way. We hope you conquer the world and have a wonderful day. And as always, please do stay in touch. We appreciate feedback, tips, and criticism. …

    The World Health Organization released its first guidelines addressing the sharp rise in obesity among children and adolescents, Health Policy Watch says. In 2024, 170 million children and adolescents aged 5–19 years were living with obesity, including 70 million children aged 5 to 9 years and 100 million adolescents aged 10 to 19 years. Obesity prevalence in this age group quadrupled since 1990, rising from 2% to 8%. But the WHO does not recommend pharmacological treatment, bariatric surgery, or weight loss devices for children aged 0 to 9 years. For adolescents aged 10 to 19 years, treatment with approved drugs may be considered only when a supervised multimodal lifestyle program has not achieved desired results.  

    Caribou Biosciences is shutting down after failing to raise the money necessary to fund a late-stage clinical trial of its off-the-shelf CAR-T therapy for lymphoma, STAT notes. The biotech, borne from the research lab of CRISPR scientist and Nobel laureate Jennifer Doudna, will discontinue clinical development of its two CRISPR-based CAR-T therapies, including vispa-cel for the treatment of advanced B-cell non-Hodgkin lymphoma. Over the past year, Caribou had worked successfully with the Food and Drug Administration to finalize the design of a Phase 3 trial for vespa-cel. Unfortunately, raising the money to pay for the study proved too difficult.

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  • STAT+: Justice Department targets drugmakers in new directive on combating white-collar fraud

    STAT+: Justice Department targets drugmakers in new directive on combating white-collar fraud

    By Ed Silverman

    Oct. 7, 2026

    Pharmalot Columnist, Senior Writer

    Ed’s stories explore prescription drug pricing, affordability and access, as well issues surrounding patents, litigation, and legislation. He is also the author of the morning Pharmalittle newsletter and the afternoon Pharmalot newsletter.

    In a warning to life sciences companies, the Department of Justice last week issued a new directive for combating fraud that made a point of noting the agency will pursue violations of a federal law that tightly regulates the pharmaceutical industry.

    Typically, the agency has pursued health fraud cases centered on providers, clinics, home health agencies, and hospices. By expressly including the Federal Food, Drug, and Cosmetic Act in the directive, the National Fraud Enforcement Division appears to be placing drug and device makers, among others, more clearly in its crosshairs.

    “This is a subtle but significant expansion of their jurisdiction,” said Kevin Lowell, a member of the Miller & Chevalier law firm, who spent a decade at the DOJ, where he most recently had been a deputy chief in the National Fraud Enforcement Division’s health care fraud section.

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  • STAT+: Pharmalittle: We’re reading about U.S.-funded psychedelic trials, an AstraZeneca R&D center, and more

    STAT+: Pharmalittle: We’re reading about U.S.-funded psychedelic trials, an AstraZeneca R&D center, and more

    By Ed Silverman

    Oct. 6, 2026

    Pharmalot Columnist, Senior Writer

    Rise and shine, everyone, another busy day is on the way. And it is getting off to a pleasant start here on the Pharmalot campus, where clear blue skies and comfy breezes are greeting us. As for the official mascots, they are happily snoozing in their respective corners. As for us, we are firing up the trusty kettle for another cuppa stimulation. Our choice today is honeybush vanilla turmeric. Of course, you are invited to join us. For the full experience, we are now hawking replicas — take a look. Meanwhile, here are a few items of interest. As always, do keep in touch. We appreciate feedback, criticism, and tips. …

    The Trump administration is advancing the first government-funded clinical trials of the psychedelic drug ibogaine to treat opioid addiction and ​post-traumatic stress disorder, Reuters says. The initiative ⁠follows an executive order signed last April by President Trump that dedicated $50 million ​to the federal ibogaine research, as well as recent calls by experts and ​veterans for strict safety standards on psychedelic treatments. The U.S. Food and Drug Administration said it has opened a public docket seeking feedback on trial design, dose selection, patient ​eligibility, safety monitoring, study-stopping rules, and oversight by Nov. 20.

    AstraZeneca’s pivot towards the U.S. market has continued with the opening of a new R&D center in the biotech hotspot of Cambridge, Mass., the centerpiece of a $1 billion investment program in the state, Pharmaphorum explains. The new facility in the Kendall Square area — which is one of the densest biotech clusters in the world, with hundreds of small and large biopharma companies present — covers 570,000 square feet of lab and office space over 18 stories. The center is part of a major investment program by the U.K.-based company that was first announced in 2024 and dramatically expanded to around $50 billion last year.

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