Category: Pharma & Biotechnology

  • 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.

    STAT+ Exclusive Story

    Already have an account? Log in

    STAT+

    STAT+

    This article is exclusive to STAT+ subscribers

    Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts.

    Already have an account? Log in

    View All Plans

    To read the rest of this story subscribe to STAT+.

    Subscribe

  • STAT+: Life Biosciences share glaucoma study updates for its cellular reprogramming drug

    STAT+: Life Biosciences share glaucoma study updates for its cellular reprogramming drug

    NIH funding uncertainty thwarts U.S. researchers, Argenx stumbles, and more biotech news

    Close up of an eye
    Adobe

    Jason is a general assignment reporter, with particular focus on genetic medicine and rare disease. Confidential tips can be sent on Signal at JasonMast.77.

    Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.

    This is the Readout. Please read it.

    And don’t miss us too much Monday, when the newsletter will be paused for the holiday. We’ll be back in your inbox Tuesday.

    STAT+ Exclusive Story

    Already have an account? Log in

    STAT+

    STAT+

    This article is exclusive to STAT+ subscribers

    Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts.

    Already have an account? Log in

    View All Plans

    To read the rest of this story subscribe to STAT+.

    Subscribe

    1. Meghana Keshavan covers biotech and contributes to The Readout newsletter.

    2. General Assignment Reporter

      Jason is a general assignment reporter, with particular focus on genetic medicine and rare disease. Confidential tips can be sent on Signal at JasonMast.77.

  • 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.

    STAT+ Exclusive Story

    Already have an account? Log in

    STAT+

    STAT+

    This article is exclusive to STAT+ subscribers

    Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts.

    Already have an account? Log in

    View All Plans

    To read the rest of this story subscribe to STAT+.

    Subscribe

  • 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.

    STAT+ Exclusive Story

    Already have an account? Log in

    STAT+

    STAT+

    This article is exclusive to STAT+ subscribers

    Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts.

    Already have an account? Log in

    View All Plans

    To read the rest of this story subscribe to STAT+.

    Subscribe

  • STAT+: Roche goes beyond licensing in deal with Chinese biotech

    STAT+: Roche goes beyond licensing in deal with Chinese biotech

    DOJ signals it will start scrutinizing drugmakers, PhrMA sues Trump administration, and more biotech news

    gantenerumab Alzheimer's disease Roche
    Sebastien Bozon/AFP via Getty Images

    Elaine’s stories explore the boom in new obesity treatments, new drug payment models, the ways companies are affected by FDA changes, and the emerging psychedelics drug sector. She co-writes The Readout newsletter, and co-hosts STAT’s weekly biotech podcast, The Readout Loud. You can reach Elaine on Signal at elaineywchen.70.

    Want to stay on top of the science and politics driving biotech today? Sign up to get our biotech newsletter in your inbox.

    Good morning. Let’s get straight to the news.

    The need-to-know this morning

    Roche goes beyond licensing in deal with Chinese biotech

    Over the past few years, pharma companies have flocked to China to license existing drug candidates. Roche is taking a new approach, partnering with Chinese startup Defand Therapeutics to discover new medicines.

    STAT+ Exclusive Story

    Already have an account? Log in

    STAT+

    STAT+

    This article is exclusive to STAT+ subscribers

    Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts.

    Already have an account? Log in

    View All Plans

    To read the rest of this story subscribe to STAT+.

    Subscribe

    1. National Biotech Reporter

      Elaine’s stories explore the boom in new obesity treatments, new drug payment models, the ways companies are affected by FDA changes, and the emerging psychedelics drug sector. She co-writes The Readout newsletter, and co-hosts STAT’s weekly biotech podcast, The Readout Loud. You can reach Elaine on Signal at elaineywchen.70.

  • 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.

    STAT+ Exclusive Story

    Already have an account? Log in

    STAT+

    STAT+

    This article is exclusive to STAT+ subscribers

    Unlock this article — plus in-depth analysis, newsletters, premium events, and news alerts.

    Already have an account? Log in

    View All Plans

    To read the rest of this story subscribe to STAT+.

    Subscribe

  • STAT+: Roche inks drug discovery deal with Chinese biotech, focused on molecular glue medicines

    STAT+: Roche inks drug discovery deal with Chinese biotech, focused on molecular glue medicines

    Allison covers what hot startups are getting up to, and who’s financing them. She is also co-host of the weekly biotech podcast, “The Readout Loud.” You can reach Allison on Signal at AllisonDeAngelis.01.

    Roche is digging deeper into the biotech industry in China, striking a new partnership with a drug startup there. But rather than licensing the startup’s clinical-stage medicines, Roche is enlisting it to discover new ones, signaling a potential shift in global drug development. 

    Chinese startup Defand Therapeutics said Thursday that it had signed a collaboration deal with Roche to develop molecular glue medicines. Under the deal, Defand will discover and develop multiple drugs for cancer and immune-driven diseases. The financial terms were not disclosed, but a source with knowledge of the agreement said it could be worth close to $1 billion between the upfront fee and payments Defand could get if it meets various preclinical, clinical, and regulatory goals. 

    Molecular glue therapies are a buzzy new area of drug development, designed to create a sticky, more effective connection onto problematic proteins to destroy them. Development of these drugs has just begun to accelerate, thanks in large part to the data from Revolution Medicines, showing its molecular glue treatment Rasonque nearly doubled the survival rate of patients with pancreatic cancer. 

    STAT+ Exclusive Story

    Already have an account? Log in

    STAT+

    STAT+

    This article is exclusive to STAT+ subscribers

    Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+.

    Already have an account? Log in

    View All Plans

    To read the rest of this story subscribe to STAT+.

    Subscribe

  • STAT+: Biotech companies are struggling to navigate Trump’s new tariffs

    STAT+: Biotech companies are struggling to navigate Trump’s new tariffs

    WASHINGTON — A broad tariff on imported pharmaceuticals took effect at the end of September, and some biopharma companies and the industry group that represents them say many are being left in the dark on how to get exemptions. 

    The Trump administration announced a 100% section 232 tariff in April, impacting imports of patented drugs and their active ingredients. At the time, the White House offered a number of pathways for companies to reduce their tariff burden, including striking a most-favored nation deal to sell drugs in the U.S. at similar prices to other wealthy countries or agreeing to bring production to the U.S.

    Companies that made MFN agreements would have had start paying tariff costs in July, but now aren’t on the hook for payment until early 2029, per their agreements. That exempts many of the biggest U.S. drugmakers, while leaving smaller biotech firms to face the levies.

    STAT+ Exclusive Story

    Already have an account? Log in

    STAT+

    STAT+

    This article is exclusive to STAT+ subscribers

    Unlock this article — plus daily coverage and analysis of the biotech sector — by subscribing to STAT+.

    Already have an account? Log in

    View All Plans

    To read the rest of this story subscribe to STAT+.

    Subscribe

  • Opinion: How CMS plans to fix a major flaw in the 340B drug discount program

    Opinion: How CMS plans to fix a major flaw in the 340B drug discount program

    By Casey B. Mulligan

    Oct. 8, 2026

    Mulligan is the chief economist and chief regulatory officer at HHS.

    Some Medicare patients owe more in coinsurance than the hospital paid for their drug. That arithmetic sounds impossible. It is a consequence of the 340B drug discount program and Medicare’s payment formula. Now the Department of Health and Human Services, where I work, is proposing to narrow that gap.

    Congress created the 340B drug discount program in 1992 to financially support safety net hospitals that serve low-income patients. Drug manufacturers must give them steep discounts. But Medicare, Medicaid, and commercial insurers generally reimburse them at the full amount, allowing these hospitals to keep the spread above the discounted purchasing costs.

    A new report from the Department of Health and Human Services shows other unintended consequences of this well-intended program. The spread grows with the price of the drug. It therefore rewards hospitals for using more and costlier drugs and makes physician practices and infusion clinics more valuable after a 340B hospital acquires them. The patient’s treatment needn’t change. The owner and billing site do.

    The 340B program has exploded: Eligible drug purchases rose from $12 billion in 2015 to $81 billion in 2024, mostly at hospitals, as shown in the report. Those purchases are now larger than net Medicare Part B and Medicaid drug spending overall and, among public prescription drug programs, are smaller only than Medicare Part D.

    A 340B hospital that buys another hospital or a physician practice can register more off-campus clinics and contract pharmacies and capture more spread. Hospital off-campus clinic sites grew from about 7,000 in 2013 to more than 34,000 in 2023, often in neighborhoods that are wealthier and better-insured than that of the parent hospital. Contract pharmacies grew from roughly 1,300 in 2010 to more than 31,000 by mid-2026, dominated by the largest chains.

    With greater bargaining power after acquisitions, hospital systems can negotiate higher commercial prices for health care services, which can in turn raise premiums. Newly acquired hospital outpatient sites can also add facility fees to non-drug services. The effects of 340B show up as larger, more expensive hospital systems and a bigger bill for patients, employers, and taxpayers. The program’s ripple effects contribute to the broader problems facing the U.S. health care system.

    Medicare payment for Part B drugs is typically based on average sales price (ASP). Beginning in 2018, the first Trump administration narrowed the spread in Medicare by paying hospitals for 340B drugs’ ASP minus 22.5% rather than the usual statutory standard of ASP plus 6%, based on an earlier estimate of their average minimum discount.

    Overall outpatient drug payments rose nearly 15% a year from 2015 through 2017. Once the lower rate was fully in effect, inflation-adjusted payments largely plateaued. Payments for the affected 340B drugs held near $7 billion from 2019 through 2021. It is clear that Medicare payment policy influences outpatient drug spending.

    The Supreme Court ruled in 2022 that HHS couldn’t vary payment rates by hospital group without first conducting the acquisition-cost survey required by statute. The court didn’t find that hospitals were economically entitled to the markup. It found that HHS lacked a procedural prerequisite. After the lower rate ended and ASP plus 6% returned for these drugs, annual payments for the affected drugs rose from $7.1 billion in 2021 to $10.7 billion in 2023 — a $3.6 billion increase. Overall outpatient drug payments rose from $14.3 billion in 2021 to $17.6 billion in 2023.

    Restoring the higher rate meant paying hospitals more for the same drugs. The $3.6 billion increase combines that direct payment effect with induced changes in hospitals’ dispensing quantities and drug manufacturers’ underlying prices. The larger spread also strengthens hospitals’ incentive to choose costlier drugs and move treatment into 340B billing sites.

    Off-campus hospital departments benefited too. From 2021 to 2023, payments for their affected 340B drugs rose about $800 million even as claims fell and the number of beneficiaries remained similar. Although these amounts do not tell us how many practices hospitals acquired because of the markup, they indicate the additional financial incentives for acquisitions.

    On April 18, 2025, President Trump directed HHS to obtain the cost information the statute requires. CMS surveyed hospitals from January through April 2026 and has proposed paying for affected 340B drugs at ASP minus 33.4% in 2027. CMS estimates that Medicare drug payments would fall by $4.55 billion in the first year and beneficiary drug copayments by $1.15 billion.

    For a drug with an ASP of $1,000, a beneficiary’s standard 20% coinsurance would fall from $212 to $133.20. The prescription hasn’t changed. The patient’s share of the hospital’s bill has. Narrowing the spread also weakens the incentive to steer patients toward costlier drugs and to acquire physician practices and infusion clinics — the very behaviors that have made care more expensive.

    There’s an important lesson here. A small, well-intended discount for safety net hospitals became a large institutional subsidy with expensive unintended consequences. Under the proposed rule, hospitals would still receive their 340B drug discounts. What would change is Medicare’s payment for those drugs at affected hospitals. Congress provided for a survey of hospitals’ acquisition costs, and CMS says its proposed rate would “more accurately align Medicare payments with hospital drug acquisition costs.”

    Medicare patients should not pay coinsurance as though the discount did not exist.

    Casey B. Mulligan is the chief economist and chief regulatory officer at HHS.

  • STAT+: PhRMA sues over Trump policy mandating lower drug prices in Medicare

    STAT+: PhRMA sues over Trump policy mandating lower drug prices in Medicare

    Pilot program known as GLOBE is intended to test ‘most-favored nation’ policy

    Close up stock news photo of medicare advantage membership cards
    Jenny Kane/AP

    By John Wilkerson

    Oct. 7, 2026

    John Wilkerson, a Washington correspondent, is the author of D.C. Diagnosis, a twice-weekly newsletter about the politics and policy of health and medicine.

    John writes about the politics of health care, and he is the author of the twice-weekly D.C. Diagnosis newsletter. You can reach John on Signal at John_Wilkerson.07.

    WASHINGTON — The brand drug industry’s main trade group is suing the Trump administration over a pilot program tying Medicare drug prices to those in peer countries.

    The Pharmaceutical Research and Manufacturers of America said Wednesday that it had filed a complaint in the U.S. District Court for the District of Columbia 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. 

    STAT+ Exclusive Story

    Already have an account? Log in

    STAT+

    STAT+

    This article is exclusive to STAT+ subscribers

    Unlock this article — plus daily coverage and analysis of the pharma industry — by subscribing to STAT+.

    Already have an account? Log in

    View All Plans

    To read the rest of this story subscribe to STAT+.

    Subscribe

    1. John writes about the politics of health care, and he is the author of the twice-weekly D.C. Diagnosis newsletter. You can reach John on Signal at John_Wilkerson.07.