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Novo to cut GLP-1 drug prices; Palvella soars on study data

Today, a brief rundown of news from Novo Nordisk and Palvella Therapeutics, as well as updates from Gossamer Bio, Vanda Pharmaceuticals and Pfizer that you may have missed. Novo Nordisk on Tuesday announced plans to lower the U.S. list prices of its diabetes a

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Today, a brief rundown of news from Novo Nordisk and Palvella Therapeutics, as well as updates from Gossamer Bio, Vanda Pharmaceuticals and Pfizer that you may have missed. Novo Nordisk on Tuesday announced plans to lower the U.S. list prices of its diabetes and obesity drugs by as much as 50% starting next year. According to Novo, Wegovy and Ozempic’s wholesale acquisition cost will be $675 per month effective Jan. 1, 2027 — reductions of 50% and 35%, respectively, from their current prices. The cuts apply to all doses and also include Rybelsus , an oral medication Novo sells for diabetes. They don’t affect the costs involved when people bypass insurance and pay for Novo’s drugs in cash. — Ben Fidler Shares of Palvella Therapeutics climbed by nearly 40% Tuesday on positive Phase 3 study results in people with vascular abnormalities known as microcystic lymphatic malformations. Palvella said treatment with its therapy, a type of topical rapamycin gel, hit all main and key secondary goals and will be submitted to U.S. regulators this year. The data could position Palvella’s drug as the first approved for the condition, and “easily tops most expectations,” wrote Mizuho Securities analyst Graig Suvannavejh . The findings also suggest the therapy could be viable in treating other vascular malformations, leaving “significant value still waiting to be unlocked,” he added. — Ben Fidler San Diego-based drugmaker Gossamer Bio lost more than 80% of its market value Monday after disclosing its sole clinical program failed a late-stage study . Gossamer, in collaboration with Chiesi Group , has been developing an experimental medicine called seralutinib across a couple lung diseases. Fresh results from a study focused on pulmonary arterial hypertension showed that, statistically, the medicine was not significantly better than a placebo on a test that evaluates lung capacity and cardiovascular health. Faheem Hasnain , Gossamer’s CEO, noted that this measure was “narrowly missed,” and the overall data “clearly demonstrate seralutinib is an active drug in patients with PAH.” The company therefore believes further discussions with the Food and Drug Administration regarding a potential path forward are warranted. — Jacob Bell The FDA late last week approved a new atypical antipsychotic from Vanda Pharmaceuticals . Now sold as Bysanti , the medication works by inhibiting certain receptor proteins that interact with neurotransmitters like serotonin, dopamine and adrenaline. In the body, Bysanti breaks down into a molecule known as iloperidone, which is also the active ingredient in Vanda’s already marketed therapy Fanapt . The FDA specifically approved the newer product for schizophrenia and for the acute treatment of manic or mixed episodes associated with bipolar I disorder. Vanda said it expects Bysanti to become commercially available sometime between July and the end of September. — Jacob Bell Pfizer will pay as much as $495 million for partial ownership of an injectable obesity medicine developed by Hangzhou, China-based Sciwind Biosciences . The deal announced Wednesday hands Pfizer exclusive commercialization rights in China to the therapy, which is known as ecnoglutide and already approved in the country for Type 2 diabetes. An approval application for weight management has also been accepted by China’s drug regulator. Pfizer has been using dealmaking to acquire obesity assets. Last year, it paid $10 billion to nab Metsera and inked a potentially $2 billion licensing deal with YaoPharma . — Ben Fidler

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Dr. Harrison and Finnish neuroscientist Dr. Miia Kivipelto explore the complex interplay between genetics and lifestyle in Alzheimer's development. Learn how the groundbreaking FINGER study demonstrates potential prevention strategies, and discover the latest evidence on how environmental factors, diet, and chronic conditions influence Alzheimer's risk.

Source: www.biopharmadive.com ↗
02What the Artificial Neuron Cannot Do

Hersam’s next goal is a small circuit — perhaps 10 artificial neurons — where each one fires differently, and together they accomplish what would require thousands of conventional transistors. “ Silicon achieves complexity by having billions of identical devices,” Hersam said. “The brain is the opposite. It’s heterogeneous. The complexity is at the device level.” But Gaudet sees a gap no circuit design can yet fill: Biological neurons grow new connections and prune old ones, strengthening pathways that are used and weakening those that aren’t. Hersam’s lab’s printed neurons — or any other neuromorphic technology that mimics neuronal dynamics — can’t achieve that level of complexity yet. Brown is careful about the distance remaining between these printed neurons and the real thing. “Neurons are just so flexible,” he said. “They can totally change what they’re doing based on whether they’ve learned something and based on your emotional state. There’s a lot of hidden mysteries.” Sangwan suspects the device has more to reveal. “It’s a nonlinear dynamical system,” he said. “We don’t fully know how many different variables you need to explain it. It’s just the beginning.” Hersam, Sangwan, Brown, Holla, and Gaudet reported having no relevant financial disclosures. Disclosure information for study authors is available in the original study publication.

Source: www.medscape.com ↗
03China: Threat or opportunity?

One of the biggest biotech news stories of recent years is China’s continued rise as a biotech and life sciences powerhouse. China conducts a quarter of all clinical trials and drug development and has almost 1,500 new drugs in development.¹ Many China-based biotechs have benefitted from government funds, out-licencing deals with large pharmas and venture capital funding. However, policymakers in the US and EU have concerns about the possible threat to their region’s biosecurity and competitiveness as centres for health and life science research. Given China’s increased importance, ICON Biotech conducted the same biotech sector survey with 100 China-based biotech leaders. The results show that Chinese biotechs face many of the same challenges as biotechs located elsewhere. They share the same funding challenges and burdens associated with increasingly complex clinical trials and regulations.

Source: www.biopharmadive.com ↗
04What Comes Next

With data expected in the fourth quarter of 2026, we are prioritizing histology alongside patient-reported outcomes using the Celiac Disease Symptom Diary, one of only two instruments developed in line with U.S. Food and Drug Administration (FDA) guidance, to capture changes in symptoms such as abdominal pain and nausea. Ultimately, the broader aim is to give gastroenterologists and patients a therapeutic option for a disease that has long been managed without one. The future of drug development will not be defined by statistical significance alone, but by whether new therapies also improve the daily burden of living with celiac disease. “The first therapy to cross the line could change the field,” Geller concluded. “It would help establish celiac as a serious medical condition with options beyond a restrictive diet and open the door for what comes next.” Dr. Paul Lizzul is chief medical officer at First Tracks Biotherapeutics, a clinical ‑ stage biotechnology company advancing antibody therapeutics that modulate immune pathways implicated in autoimmune and inflammatory diseases. Marilyn Geller serves as an advisor to First Tracks Bio. Footnotes Abadie V, Jabri B. IL-15: a central regulator of celiac disease immunopathology. Immunol Rev . 2014;260(1):221-234. https://doi.org/10.1111/imr.12191. Yokoyama S, Watanabe N, Sato N, et al. Antibody-mediated blockade of IL-15 reverses the autoimmune intestinal damage in transgenic mice that overexpress IL-15 in enterocytes. Proc Natl Acad Sci U S A . 2009;106(37):15849-15854. https://doi/full/10.1073/pnas.0908834106. Anthony S, Schluns KS. Emerging roles for IL-15 in the activation and function of T-cells during immune stimulation. Research and Reports in Biology . 2015;6:25-37. https://doi.org/10.2147/RRB.S57685.

Source: www.biopharmadive.com ↗
05Why Muscle Cells Might Do Some Heavy Lifting

Brown was studying gene therapy in the 1990s when he designed a technology to turn mRNA expression on or off in different cells. For the new mouse study, published in Nature Biotechnology , he adapted the technology to turn off mRNA expression in dendritic cells, muscle cells, or liver cells. The researchers then vaccinated the mice with each version, delivering the vaccines both intravenously and intramuscularly. “The results were pretty stunning,” Brown said. When mRNA expression was turned off in muscle cells, T-cell response went down, suggesting muscle cells play a role in immunity. When expression was turned off in liver cells, T-cell expression tripled — indicating liver cells dampen immunity. Turning off expression in dendritic cells had no effect on T-cell activation, though it did reduce the number of killer T cells by as much as half. (Interestingly, no such reduction occurred when the antigen was SARS-CoV-2 spike. Brown is now investigating why different antigens had varying effects.) Knowing all this is crucial for designing effective mRNA vaccines and therapies. That’s because different mRNA therapies require different strategies. Cancer vaccines must boost tumor-fighting killer (CD8+) T cells. For genetic disease treatments, scientists want to avoid triggering the immune system to prevent killing the very cells the mRNA is meant to modify. “Understanding the immunology is extremely important for this class of drug,” Brown said. The finding doesn’t mean dendritic cells aren’t important for mRNA vaccines to work. “It just means that the mRNA doesn’t have to get into those cells to induce an immune response,” Brown said. Instead, the antigen can be transferred to those dendritic cells.

Source: www.medscape.com ↗
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Peptide Therapy Guide Editorial Team

Editorial team for Peptide Therapy Guide.

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