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The U.S. Food and Drug Administration’s approvals of Enhertu for various metastatic breast cancers last year sparked renewed interest in antibody-drug conjugates (ADCs). These recent approvals demonstrate how precisely engineering ADC components can help overcome the therapeutics inherent shortcomings. Building on this momentum, the industry is addressing acquired resistance, tumor heterogeneity, and off-target toxicity by going beyond conventional formats.In this GEN webinar, experts from ChemPartner, Philip Clarke, PhD, Hu Liu, PhD, and Greg Liang, MD, will provide an overview of some of the innovative platforms that are shaping the next-generation of antibody-drug conjugates. During the webinar, they will use several…

Robert F. Kennedy, Jr. opens the HHS briefing in Washington DC to unveil the agency’s draft guidance for rare disease therapies. (From L-to-R: Tracy Beth Høeg, MD, PhD; Rebecca Ahrens-Niklas, MD, PhD; Robert F. Kennedy Jr.; Judy Stecker; Kiran Musunuru, MD, PhD; and Marty Makary, MD, MPH. [Kevin Davies] WASHINGTON, DC—Nine months after the “Baby KJ” story brought new hope to the rare diseases community, the Department of Health and Human Services (HHS) has issued a draft guidance promoting innovation for rare disease therapies.  The FDA’s Plausible Mechanism Pathway draft guidance is comprised of a series of initiatives designed to increase regulatory flexibility and spur the development of bespoke gene-editing therapies…

Tamarind co-founders: Sherry Liu and Deniz Kavi [Tamarind] The year was 2024. Deniz Kavi, a software engineer at Stanford School of Medicine, recalled the “untenable” research hand-off between wet lab biologists and computational scientists. The rise of models, such as Nobel Prize-winning AlphaFold, which solved the protein structure prediction problem, proposed a powerful inflection point for AI-driven therapeutic development. Yet, much AI tooling was still built for the technical user, requiring command-line access and cloud credentials that bottlenecked implementation in the life sciences lab.  “Most chemists and biologists are not programmers and can’t write code to use these tools,” explained Kavi in an interview with GEN Edge.   At Stanford, Kavi found himself in a constant loop with biology lab mates: emails asking to execute AlphaFold runs, results sent…

Credit: Alfred Pasieka/Science Photo Library/Getty Images The FDA Commissioner’s National Priority Review Voucher (CNPV) Pilot Program was created to accelerate medicines with significant potential to address a major national priority. By design, it allows the agency to compress review timelines from the standard six to ten months down to approximately one to two months for qualifying applications. When Compass Pathways’ synthetic psilocybin program (COMP360) was included on the initial eligibility list but did not ultimately receive a CNPV designation, the decision prompted discussion across the psychedelic sector. The issue isn’t just whether one sponsor received a voucher. It’s about how…

Among the most promising tools of cancer therapy, engineered immune cells known as chimeric antigen-receptor (CAR) T cells have already transformed the treatment of blood cancers. Yet, despite their promise, CAR T cells do have their limitations. For one thing, they’ve so far largely failed against solid tumors, which is to say, most types of cancer. For another, they can inadvertently kill healthy cells along with cancerous ones—or, separately, provoke a systemic immune overreaction—causing serious and sometimes even lethal side effects. To address these challenges, researchers led by Ludwig Lausanne’s Melita Irving, PhD, and Greta Maria Paola, PhD, Giordano Attianese,…

Credit: Mark Kostich/Getty Images In patients with five to 20 brain metastases, stereotactic radiation targeting individual lesions led to significantly better symptom control and preservation of daily functioning compared with hippocampal-avoidance whole-brain radiation (HA-WBRT), according to a Phase III randomized trial published in JAMA Oncology. The findings challenge longstanding practice patterns that favor whole-brain approaches when tumor burden is high and reinforce a broader shift toward precision radiation techniques. A clinically meaningful quality-of-life advantage The trial randomized 196 patients across four U.S. centers to stereotactic radiation or HA-WBRT. Eligible patients had between five and 20 brain metastases and no prior…

Islet of langerhans, light micrograph. This structure (centre), found in the pancreas, secretes the hormones insulin and glucagon, which control blood sugar levels. Magnification: x200 when printed at 10 centimetres wide. [STEVE GSCHMEISSNER/ Science Photo Library/ Getty Images] For decades, scientists have known that the pancreas undergoes microscopic changes as type 2 diabetes develops—but most of those changes are so subtle that classic histopathological exams can’t reliably detect them. What if we had a tool that could zoom in on these faint morphological signals and make sense of them at scale? A team from the German Center for Diabetes Research…

New AI model EVA accelerates drug discovery in inflammation, bridging preclinical research to real-world patient therapies. Drug discovery is always about patience, trial and error. For every promising compound identified in a lab, many fail to become effective therapies for humans. In immunology, this challenge is even greater. Scienta Lab, a Paris-based deeptech startup, is launching a new multimodal AI model called EVA, designed to guide researchers through the maze of preclinical and clinical data, helping them focus on the drug candidates most likely to succeed [1]. Julien Duquesne, CTO and co-founder of Scienta Lab, explains that “the goal is…

This month, we celebrate the 100th issue of the International Probiotics Association (IPA) newsletter. A look back at the inaugural issue reveals an organization clear in its mission from the start: “Greetings from IPA, your place for all things probiotic.” The International Probiotics Association launched its newsletter, “IPA inSight,” in May 2017 (first photo). A redesign and an expansion of focus (second photo) reflect the impressive growth and global reach of IPA, leading to this month’s 100th edition. We’re just getting started! Our Journey Yet IPA’s story begins even earlier. Founded in 1999, the non-profit brought together scientists, manufacturers, and other stakeholders…

Credit: TopMicrobialStock / iStock / Getty Images Plus Fungal infection with Cryptococcus neoformans becomes more deadly in HIV patients who already have tuberculosis (TB), shows research led by the University of Exeter. The scientists showed that the fungus appeared to become more aggressive in the presence of TB-causing bacteria. It multiplied faster and produced extra-large ‘titan’ cells that are harder for the immune system to kill, thickening its outer capsule and became generally harder for the immune system to kill. C. neoformans is an encapsulated yeast that most often starts as a lung infection in people with suppressed immune systems…