Tag: Pharmalot

  • STAT+: Pharmalittle: We’re reading about Sanofi settling an EU antitrust probe, ‘pharma bro’ Shkreli, and more

    STAT+: Pharmalittle: We’re reading about Sanofi settling an EU antitrust probe, ‘pharma bro’ Shkreli, and more

    By Ed Silverman

    Oct. 14, 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 cup of stimulation, which we hope to find shortly since we are on the road. Perhaps we can meet? 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. …

    Martin Shkreli is back, but the U.S. Federal Trade Commission is not happy, STAT says. The agency and seven states asked a U.S. court to hold Shkreli in contempt for “flagrantly and repeatedly” violating a court order banning him from working in the pharmaceutical industry. Shkreli, known as “pharma bro” for imperiously defending his decision to raise the price of a drug by 5,000%, was sentenced to seven years in prison for defrauding investors in 2018. Before his release in 2022, a court banned him from ever working in the industry again, saying he illegally tried to prevent generic competition to the drug. Since then, he became a prolific trader in pharma stocks, broadcasting his analysis in posts and livestreams on X and other platforms.

    European Union antitrust regulators accepted concessions from Sanofi to settle an investigation into an allegedly “misleading” campaign that disparaged the only rival flu vaccine recommended for vulnerable patients at risk for developing the illness, STAT tells us. In doing so, the company avoided being fined. The European Commission had suggested that Sanofi portrayed the Fluad vaccine marketed by CSL Seqirus as inferior to its own Efluelda vaccine in a communication campaign that primarily targeted health care professionals in Germany and France. Sanofi holds a dominant position in both countries, according to the EC.

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  • STAT+: Sanofi avoids fine as EU accepts offer to end antitrust probe over disparaging rival vaccine

    STAT+: Sanofi avoids fine as EU accepts offer to end antitrust probe over disparaging rival vaccine

    By Ed Silverman

    Oct. 14, 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.

    European Union antitrust regulators accepted concessions from Sanofi to settle an investigation into an allegedly “misleading” campaign that disparaged the only rival flu vaccine recommended for vulnerable patients at risk for developing the illness. In doing so, the company avoided being fined.

    The European Commission had suggested that Sanofi portrayed the Fluad vaccine marketed by CSL Seqirus as inferior to its own Efluelda vaccine in a communication campaign that primarily targeted health care professionals in Germany and France. Sanofi holds a dominant position in both countries, according to the EC.

    To resolve the probe, Sanofi committed to a corrective communication campaign rectifying its “possible disparaging behavior” and to refrain from such behavior in the future, according to Teresa Riberta, the European Commission executive vice president for Clean, Just and Competitive Transition. The agreement is legally binding.

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  • STAT+: Many patient, consumer reps on FDA advisory panels have ties to groups funded by pharma, analysis finds

    By Ed Silverman

    Oct. 13, 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.

    Nearly 40% of Food and Drug Administration advisory committee meetings held over a recent 20-year period included either a patient or consumer representative with active ties to an advocacy group funded by pharmaceutical companies, according to a new analysis. And for several committees, the number of such reps exceeded 50%.

    In addition, more than one in 10 advisory committee meetings included a rep who was affiliated with an organization that received funding from the drugmaker whose medicine was being reviewed by the committees. Yet most of these organizational ties were not disclosed at the meetings, raising questions about voting behavior.

    The analysis, which was published in Health Affairs Scholar, noted the FDA has well-established conflict-of-interest policies for its scientific advisory committee members, but policies concerning patient and consumer reps are not as well developed, especially concerning industry funding of advocacy groups whose members appear on committees.

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  • STAT+: Many patient, consumer reps on FDA advisory panels have ties to groups funded by pharma, analysis finds

    STAT+: Many patient, consumer reps on FDA advisory panels have ties to groups funded by pharma, analysis finds

    By Ed Silverman

    Oct. 13, 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.

    Nearly 40% of Food and Drug Administration advisory committee meetings held over a recent 20-year period included either a patient or consumer representative with active ties to an advocacy group funded by pharmaceutical companies, according to a new analysis. And for several committees, the number of such reps exceeded 50%.

    In addition, more than one in 10 advisory committee meetings included a rep who was affiliated with an organization that received funding from the drugmaker whose medicine was being reviewed by the committees. Yet most of these organizational ties were not disclosed at the meetings, raising questions about voting behavior.

    The analysis, which was published in Health Affairs Scholar, noted the FDA has well-established conflict-of-interest policies for its scientific advisory committee members, but policies concerning patient and consumer reps are not as well developed, especially concerning industry funding of advocacy groups whose members appear on committees.

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  • STAT+: Pharmalittle: We’re reading about concerns over a rare disease drug, pharma payments to docs, and more

    STAT+: Pharmalittle: We’re reading about concerns over a rare disease drug, pharma payments to docs, and more

    By Ed Silverman

    Oct. 13, 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 cup of stimulation. Our choice today is butter pecan. 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. …

    Two months after the release of an open letter on potential safety issues tied to a rare disease drug sold by Neurocrine Biosciences, patient advocates and some experts are expressing growing alarm over the perceived risks of the therapy, STAT reports. The drug, approved to treat Prader-Willi syndrome, which can cause an insatiable feeling of hunger, has been linked to the deaths of seven people and the  hospitalization of nearly 100 others — all since the treatment, called Vykat XR, was approved 18 months ago. Case reports on those deaths and hospitalizations that were submitted to regulators do not prove causality; many of the Vykat cases involved complex medical issues and multiple medications. But some experts say the evidence is sufficient to conclude Vykat is causing unacceptable harm.

    The gifts and payments that doctors receive from drugmakers increased inappropriate prescribing and the number of prescriptions written, likely leading to rising health care costs, STAT writes, citing a Cochrane review of dozens of previous studies that have explored the influence the pharmaceutical industry has on medical practice. In addition, pharmaceutical advertising or education aimed at doctors may also increase inappropriate prescribing, probably increases the number of prescriptions written, and may increase the costs of prescriptions. But conflict-of-interest policies that restrict or manage interactions between companies and doctors probably improved prescribing practices.

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  • STAT+: Pharma’s free lunches for doctors boost inappropriate prescribing, analysis finds

    STAT+: Pharma’s free lunches for doctors boost inappropriate prescribing, analysis finds

    By Ed Silverman

    Oct. 9, 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.

    The gifts and payments that doctors receive from drugmakers increased inappropriate prescribing and the number of prescriptions written, likely leading to rising health care costs, according to a Cochrane review of dozens of previous studies that have explored the influence the pharmaceutical industry has on medical practice.

    In addition, pharmaceutical advertising or education aimed at doctors may also increase inappropriate prescribing, probably increases the number of prescriptions written, and may increase the costs of prescriptions. But conflict-of-interest policies that restrict or manage interactions between companies and doctors probably improved prescribing practices, the analysis found.

    However, there was not enough evidence to draw clear conclusions on whether free drug samples and other promotions affect decisions to place specific drugs on hospital formularies. These are the list of medicines approved for use and routinely stocked in a hospital or health system.

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  • STAT+: Up and down the ladder: The latest comings and goings

    STAT+: Up and down the ladder: The latest comings and goings

    By Ed Silverman

    Oct. 9, 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.

    Hired someone new and exciting? Promoted a rising star? Finally solved that hard-to-fill spot? Share the news with us, and we’ll share it with others. That’s right. Send us your changes, and we’ll find a home for them. Don’t be shy. Everyone wants to know who is coming and going.

    And here is our regular feature in which we highlight a different person each week. This time around, we note that Q32 Bio hired José Trevejo as chief medical officer. Previously, he worked at Enveda Therapeutics, where he was chief medical officer and head of clinical pipeline strategy.

    But all work and no play can make for a dull chief medical officer.

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  • STAT+: Pharmalittle: We’re reading about a setback for Argenx, Lilly suits over copycat versions of an obesity drug, and more

    STAT+: Pharmalittle: We’re reading about a setback for Argenx, Lilly suits over copycat versions of an obesity drug, and more

    By Ed Silverman

    Oct. 9, 2026

    Pharmalot Columnist, Senior Writer

    And so, another working week will soon draw to a close. Not a moment too soon, yes? This is, you may recall, our treasured signal to daydream about weekend plans. Our agenda is, so far, rather modest. We plan to catch up on our reading, promenade with the official mascots and celebrate the turning of another page on the calendar with our remaining Pharmalot ancestor. We also hope to hold another listening party, where the rotation will likely include this, this, this, this and this. And what about you? This is the time of year when apples and pumpkins grow lonely, waiting for someone to take them to a nice home. So perhaps a drive in the country is in order. This may also be an opportunity to simply enjoy the great outdoors, given the lovely change of scenery that is taking place. Or you could keep busy by strolling city streets and watching life go by. Well, whatever you do, have a grand time. But be safe. Enjoy, and see you soon…

    Argenx disclosed that its blockbuster drug Vyvgart failed to outperform placebo in a Phase 3 trial of patients with Sjögren’s disease, a chronic autoimmune disorder, marking an unusual setback for the company, STAT says. Argenx has racked up a series of wins in autoimmune disorders en route to becoming one of the world’s largest biotechs based on market cap. William Blair analysts had projected $1.4 billion in peak sales from Vyvgart in Sjögren’s disease but described the trial as high risk, in part because Sjögren’s patients often have high placebo responses. The trial was supposed to be completed next year, but it was stopped early after a data monitoring committee determined the primary endpoint would not be met.

    The Food and Drug Administration flagged a potential safety signal after four deaths were reported among patients with treatment-resistant schizophrenia who received investigational evenamide in clinical trials, MedPage Today informs us. In April, the agency halted patient enrollment in a Phase 3 trial for the Newron Pharmaceuticals medicine after the sudden death of a participant. That hold remains in place at U.S. study centers but enrollment continues in other countries, and additional clinical sites are being added. The FDA concern relates to the risk that some sodium channel blockers may trigger arrhythmias that can lead to serious cardiovascular events or seizures.

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  • STAT+: Pharmalittle: We’re reading about PhRMA suing Trump, biotech frustration over tariffs, and more

    STAT+: Pharmalittle: We’re reading about PhRMA suing Trump, biotech frustration over tariffs, and more

    By Ed Silverman

    Oct. 8, 2026

    Pharmalot Columnist, Senior Writer

    Top of the morning to you, and a fine one it is. Clear blue skies are hovering over the Pharmalot campus, where a cool breeze is wafting by and the official mascots are bounding about the grounds in search of critters. As for us, we are engaged in the usual ritual of brewing a cuppa stimulation — our choice today is English breakfast — and foraging for items of interest. On that note, please enjoy the latest menu of tidbits we have assembled for you. As always, we hope your journey is meaningful and productive, and that you conquer the world. And of course, do keep in touch. Our settings make it possible to accept postcards and telegrams …

    The trade group representing brand-name drug makers in the U.S. is suing the Trump administration over a pilot program tying Medicare drug prices to those in peer countries, STAT notes. PhRMA filed a lawsuit asserting that the “most-favored nation” pilot in Medicare Part B exceeds Medicare’s statutory authority. The pilot, called GLOBE, is not expected to have much impact because the administration exempted all but a handful of companies in return for their agreement to voluntary deals to charge Medicaid MFN prices. But it would set a precedent that the industry wants to nip in the bud. PhRMA says the voluntary agreements are acceptable, but the mandatory GLOBE program is not.

    The Trump administration is crafting plans that would allow the temporary sale of certain previously restricted peptides as federal health officials hammer out new regulations around the controversial products, The Washington Post reports. Such a move would allow some compounding pharmacies to dispense certain peptides marketed as new medical treatments and wellness products even as the claims for what they treat have not been fully safety tested. The plan has not yet been announced and timing was unclear, meaning it could still change.

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  • 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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