Immunex Corp.

With HRSA's approval of eight manufacturer rebate plans, hospitals enter the 60-day readiness period before the January 1, 2026, launch. DEERFIELD BEACH, Fla., Oct. 31, 2025 /PRNewswire/ -- The Craneware Group convened leaders from 25 major U.S. health systems, alongside representatives from Beacon/ESP (Berkeley Research Group) and Apexus, the HRSA 340B Prime Vendor, at its U.S. headquarters this week to align on readiness for the now-approved 340B Rebate Model Pilot Program. On October 30, 2025, the Health Resources and Services Administration (HRSA) formally approved eight manufacturer plans—including Bristol Myers Squibb, AstraZeneca, Merck, Boehringer Ingelheim, Novo Nordisk, Pharmacyclics, Immunex, and Janssen—each designating the Beacon platform (operated by Berkeley Research Group) as their processing system. The program officially begins January 1, 2026, activating the 60-day readiness window now underway. "With HRSA's announcement, the clock has officially started," said Lidia Rodriguez-Hupp, Chief Customer Officer at The Craneware Group. "Over the next two months, hospitals, TPAs, and technology partners must use this window to finalize testing, validation, and configuration. If you're a customer of The Craneware Group, you're already positioned to participate—no new vendor, no new software." Readiness in Action During the forum, The Craneware Group demonstrated 340B rebate functionality within Trisus®, its cloud-based data platform, and outlined key operational themes now confirmed under HRSA's pilot framework: Discount Priority: 340B rebates are prioritized over Medicare Fair Price (MFP) when both apply to the same dispense. Continuity: 95% of 340B processes remain unchanged; the pilot applies to a small subset of high-spend NDCs. Payment Timelines: Expected benchmarks are 10 days (340B) and 14 days (MFP) after rebate request or MTF release. Integration: For pilot NDCs, claims flow through Beacon; TCG delivers the necessary workflows, reconciliation, and transparency directly within the Trisus® platform. Rebate-Ready with The Craneware Group TCG confirmed that its customers can participate in the 340B Rebate Pilot without procuring additional software or new vendor contracts. The rebate workflow is demo-ready today. "Our customers shouldn't have to chase compliance and 340B benefits through new vendors or disconnected systems," added Rodriguez-Hupp . "Trisus delivers the rebate workflow within the same environment hospitals already trust for charge capture, compliance, and financial analytics." What the HRSA Decision Means The HRSA announcement marks the transition from policy planning to operational execution. All approved manufacturers will maintain 340B wholesaler accounts at WAC pricing, while covered entities will request rebates through Beacon after dispensing eligible drugs to 340B patients. The 60-day readiness period—from October 30 to January 1—is the industry's final opportunity to configure systems, test file layouts, and validate eligibility before the pilot begins. Next Steps Hospitals and covered entities can schedule live demonstrations of The Craneware Group's 340B rebate workflow and register for upcoming readiness webinars at The Craneware Group | 340B Rebate Resource Center. About The Craneware Group For over 25 years, The Craneware Group (AIM:CRW.L) is the trusted partner to more than 2,500 U.S. hospitals and health systems. Through its cloud-based Trisus® platform, the company unifies clinical, financial, and operational data to drive performance, compliance, and long-term sustainability. With 14 Best in KLAS® awards and a rapidly expanding Azure Marketplace presence, The Craneware Group is transforming the business of healthcare. Learn more at or follow @TheCranewareGroup on LinkedIn. Editor's Note The Health Resources and Services Administration (HRSA) approved eight manufacturer plans for participation in the 340B Rebate Model Pilot Program effective January 1, 2026. All approved manufacturers have selected the Beacon platform (Berkeley Research Group) as their processing system. The 60-day readiness window from October 30 to January 1 represents the transition from planning to execution—a moment The Craneware Group is preparing its customers to meet. SOURCE The Craneware Group WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Fred Ramsdell made headlines last week when he missed the phone call to tell him he won the Nobel Prize in Physiology or Medicine because he was backpacking near Yellowstone National Park. Ramsdell, Mary Brunkow and Shimon Sakaguchi were awarded the prize for their research on the cells that keep the immune system under control, known as regulatory T cells, or Tregs. Calling from the freshly snow-covered mountains of Montana, Ramsdell spoke with Endpoints News on Monday about winning the Nobel, cell therapy for autoimmune diseases, and the evolving state of basic science research. Ramsdell currently serves as scientific advisor to Sonoma Biotherapeutics, a company he co-founded and where he was previously chief scientific officer. Before that, he was chief scientist at the Parker Institute for Cancer Immunotherapy. This interview has been substantially edited for length and clarity. Lei Lei Wu: I’ve seen how you were out backpacking and completely offline, and then your wife’s phone exploded with texts when you guys finally got service. What has the past week been like for you? Fred Ramsdell: It’s been surreal. Obviously, I certainly didn’t expect this. Hundreds of text messages and emails and phone calls from good friends — that’s just been unbelievable at a personal level, probably more touching than winning the award. It’s been a lot of fun. Like I said, shocking, but I still get to take my dogs for a walk in the woods. So that’s all cool. Wu: How did you become interested in studying science and later immunology? Ramsdell: John Freitas, my high school teacher, instilled the interest and the curiosity of how things worked. And so high school was it. Actually my first year in college, I was a theater major. I wasn’t good enough to make a living at it, so I quickly pivoted and really went into science. Immunology was a course at UC San Diego from a famous immunologist, and I just got hooked. At that point it was like, I have to do this. Wu: Do you still do theater? Or did you do theater for a while after that? Ramsdell: No, I did not, and I don’t. But I will say that it made me comfortable enough to be able to talk in front of people. I can actually have a conversation in front of 1,000 people; it doesn’t bother me. Wu: A big trend these past few years has been doing CAR-T therapy for autoimmune disease, and I saw Sonoma is doing CAR-Treg therapy. Are these complementary approaches or competing approaches? Ramsdell: I try not to think of them as competing, although some could. Our therapy is Treg therapy, but it’s CAR-Treg therapy. So most of the CAR-T therapies out there for autoimmunity right now are cells directed at CD19 to get rid of the B cells. I grew up in an era where B stood for boring and T stood for terrific. I know that’s not true, but I’m still surprised at how good some of those therapies will seem to work. It’s great for patients. Ours is definitely, I will say, orthogonal rather than complementary or competing. It’s just different. Whether it’ll be better or worse, I don’t know. But what we’re trying to do is use the natural mechanisms the body uses to control autoimmunity in most of us who don’t have autoimmune diseases. Whereas the existing ones that are moving forward, the CD19 ones, are ablating an entire chunk of the immune system. Wu: Going back to your Nobel research, you and Mary did this while you were at a biotech company Celltech, right? As somebody who writes about biotech, the way we typically characterize things is: Basic research happens in academia, and then a biotech comes in and turns that into treatments. But that’s not what happened here. How do you think of the relationship between biotech and basic science research that leads to breakthroughs? Ramsdell: It has evolved over time. There were a few places, if you go back to the ‘80s and ‘90s, that did this. In the biotech world of that era, we needed new opportunities. Remember, the genome wasn’t sequenced. We didn’t understand a lot of the genes. It was like the Crayola box, and we only had eight colors instead of the 64, right? So we’re all trying to find our own 63rd color, some unique thing that was really important. We knew we were missing a lot of stuff. How you found that stuff took some creativity, but we knew we were missing all these things that controlled the immune system. There was a race to find those things, and inevitably, you had to do a lot of basic research. Today, there’s much more, and we have all 64 colors, or most of them. So now it is about, how do we actually manipulate the system in ways that work? It’s a little more technological now than it is biological. Wu: Thinking about the science environment today, where less basic research is happening at federally funded areas: What does that mean for the future of finding the scientific breakthroughs that you have been part of? Ramsdell: I benefited enormously, personally, professionally. But I think that the community — not just scientific, but hopefully the broader community — has benefited as well from support from the federal government, and state governments and tons of philanthropy. Setting political ideology aside for a second, America has been the bastion of biomedical research. We’ve been the shining light in the entire world for discovering new things and then being able eventually to translate them into meaningful therapies for people. Are there problems associated with that? Sure. Do drugs cost too much? Sure. There’s lots of things that go into it, but we certainly moved our ability to identify and treat human conditions better. I think it’s important that we not lose that, and I worry we lose a generation of it. It’s not like we lose a year or two — we lose a generation. That, to me, would be tragic. Wu: I also wanted to ask you about where cell therapy is right now in the industry, because I think the past few weeks, we’ve seen some big companies like Takeda, like Novo [Nordisk] say that they’re not doing cell therapy anymore. What do you make of that? Ramsdell: My first job was at Immunex, back in the early ’90s, and it was before they developed Enbrel, which is one of the treatments for arthritis. At the time, there were a lot of — I will describe them as pundits — but investors, others, who said protein therapies are not viable. They are too expensive, they’re too hard, they’re too variable. You’ll never get reimbursed there. It’s a terrible idea. We at Immunex — and I had nothing to do with the programs — were like, “You guys are wrong. We’re going to prove you wrong.” And they did, and the industry proved everybody wrong. I think cell therapy has some of that same tenor right now that they’re too expensive, but no one’s going to make these things cheap and universally available — until they work. Think of the first cell phone, right? This thing that looked like a brick with a big antenna on it. That was just ridiculous, right? Those were cell phones back in the — I’m going to say ’80s. It was stupid. But without that, you’re not getting an iPhone. Cell therapy was really hot five years ago. Now it’s not so hot, but it wasn’t hot 10 years ago. There’s a cyclical nature to this, and I fully believe that I’ve been seeing that for a long time. History does repeat itself at some level.

Johnson & Johnson’s Tremfya (guselkumab) has obtained approval from the FDA in paediatric plaque psoriasis and psoriatic arthritis. Image credit: marishkaSm via Shutterstock.com. Johnson & Johnson’s (J&J) Tremfya (guselkumab) has received approval from the US Food and Drug Administration (FDA) for paediatric patients with plaque psoriasis and active psoriatic arthritis. This makes the drug the first ever interleukin-23 (IL-23) inhibitor to obtain approval in a paediatric population. It will be available to children six years or older who weigh at least 40kg. The blockbuster monoclonal antibody (mAb) obtained approval based on the results of the Phase III PROTOSTAR (NCT03451851) study, which revealed the drug’s strong capacity to clear psoriatic plaques. During the pivotal trial, it was found that 56% of patients achieved a psoriasis area severity index (PASI) score of 90% or better. PASI is a common measure used in psoriasis-focused clinical trials to measure a patient’s response to treatment. After 16 weeks of treatment, it was also found that 40% of patients receiving Tremfya achieved complete psoriatic clearance – a significant difference from the 4% seen in the placebo group. The drug operates through a dual mechanism, blocking IL-23 while binding to Cluster of Differentiation 64 (CD64) – a key receptor found on cells that produce IL-23. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence Tremfya was first approved in adults with moderate-to-severe plaque psoriasis in 2017 – going on to obtain approval in adults with active psoriatic arthritis in 2020. However, the subcutaneously administered drug also secured FDA clearance for ulcerative colitis (UC) and Crohn’s disease (CD) this year, with analysts at GlobalData – parent company of Pharmaceutical Technology – forecasting that the drug could “set the standard for CD treatment moving forward”. The FDA approval of Tremfya will be welcome news for J&J, as the company named the drug as a significant contributor to the 7.5% increase in global innovative medicine sales seen in 2024. Tremfya was also J&J’s fourth best-selling asset last year, bringing in $3.6bn for the US pharma. While Tremfya is the only IL-12 mAb approved in paediatric patients, there are other therapies approved in the patient population including Amgen subsidiary Immunex’s Enbrel (etanercept), as well as Eli Lilly’s Taltz (ixekizumab) and Novartis’ Cosentyx (secukinumab). Analysts at GlobalData forecast that Tremfya will earn $9.1bn for J&J by 2031. Pharmaceutical Technology Excellence Awards - The Benefits of Entering Gain the recognition you deserve! The Pharmaceutical Technology Excellence Awards celebrate innovation, leadership, and impact. By entering, you showcase your achievements, elevate your industry profile, and position yourself among top leaders driving pharmaceutical advancements. Don’t miss your chance to stand out—submit your entry today! Nominate Now