FDA Approves Eli Lilly’s Omvoh for Crohn’s Disease, Offering New Hope for Long-Term Symptom Relief

Eli Lilly's Omvoh (mirikizumab-mrkz) has been approved by the FDA to treat adults with moderately to severely active Crohn’s disease, a chronic inflammatory bowel condition affecting nearly 1% of Americans. Crohn’s disease causes symptoms like persistent diarrhea and abdominal pain, and without adequate control, can lead to complications requiring hospitalization or surgery. Already approved for ulcerative colitis, Omvoh targets the interleukin-23p19 protein to reduce gastrointestinal inflammation. The approval is based on the VIVID-1 study, where 53% of Omvoh patients achieved clinical remission at one year versus 36% on placebo, with 46% showing intestinal healing compared to 23% on placebo. The ongoing VIVID-2 study supports sustained benefits with extended treatment. Lilly emphasizes Omvoh’s potential to offer long-term symptom control for patients with both Crohn's disease and ulcerative colitis. Read

In Other News

Novo Nordisk and Valo Health have expanded their partnership to develop treatments for type 2 diabetes, obesity, and cardiovascular disease (CVD), increasing the deal’s value to $4.6bn. The original 2023 agreement focused on up to 11 drug programmes, with Valo receiving $60m upfront and up to $2.7bn in milestone payments. The expanded agreement adds $190m in near-term payments and milestone opportunities for up to 20 drug programmes, plus R&D funding and royalties. Read

A recent study published in?Cell?has shed light on how viral infections can trigger autoimmune diseases through mutations in B cells. Researchers discovered that a combination of three specific mutations in self-reactive B cells can lead to the development of autoimmune conditions following a viral infection. These mutations disrupt the normal immune tolerance mechanisms, causing the immune system to mistakenly attack the body's own tissues. This finding enhances our understanding of the complex relationship between viral infections and autoimmune diseases, potentially guiding the development of targeted therapies to prevent or treat such conditions. Read

Research led by the Kanazawa University Graduate School of Medical Sciences has reported a significant connection between higher green tea consumption and fewer cerebral white matter lesions in older adults without dementia. Findings suggest that drinking three or more glasses of green tea daily may help protect brain health, while coffee consumption showed no significant effect. Read

University of California San Diego researchers have identified a U-shaped association between high-density lipoprotein (HDL) levels and age-related macular degeneration (AMD) risk, with lower incidence of AMD in the middle range and peaks in both the lower and upper ranges. The team also discovered specific genetic variants related to HDL metabolism as contributing factors to AMD. Read

Oxford Drug Design, the Oxford-based AI drug discovery company, has announced further in vivo validation for its first-in-class cancer treatment approach. The company is developing novel treatments using its pioneering AI platform for oncology and other major diseases with unmet needs.A recent in vivo mouse colorectal cancer model study showed a 60% life extension, indicating clear efficacy and dose response, while maintaining an acceptable safety profile. These positive results have led to an expanded mouse study, currently showing further progress. Read

Pfizer?is looking to sell about 700 million ordinary shares in Haleon, its bookrunner J.P. Morgan said on Tuesday, lowering its stake in the British consumer healthcare company to about 7.3% from 15%. The sale represents nearly 7.7% of issued share capital of Haleon, which was created by the merger of GSK?(GSK.L), and Pfizer's consumer healthcare businesses in 2019. It was spun off from the British drugmaker in 2022. Read

Grifols has received a grant from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) to identify plasma-based biomarkers that could indicate a person’s likelihood of developing Parkinson’s disease (PD) years before clinical diagnosis. The initiative, named Chronos-PD, could lead to the discovery of new diagnostic tools and disease-modifying therapeutics.PD affects nearly 1 million people in the U.S. and over 6 million people globally. It occurs when brain cells that produce dopamine stop working or die. Read

A vascular 'fingerprint' on the light sensitive tissue layer at the back of the eye—the retina—can predict a person's risk of stroke as accurately as traditional risk factors alone, but without the need for multiple invasive lab tests, finds research?publishedonline in the journal?Heart.The fingerprint, comprising 29 indicators of vascular health, is a practical and readily implementable approach that is particularly well suited for primary health care and?low-resource settings, conclude the researchers. Read

Johnson & Johnson (J&J) has announced that it will be expanding its neuroscience capabilities by acquiring Intra-Cellular Therapies for approximately $14.6bn.The deal gives J&J access to Intra-Cellular’s central nervous system disorder drugs, including antipsychotic medication Caplyta (lumateperone).The once-daily oral therapy is already approved by the US Food and Drug Administration (FDA) to treat adults with schizophrenia, and depressive episodes associated with bipolar I or II disorder as a monotherapy and adjunctive therapy with lithium or valproate.Schizophrenia and bipolar disorder affect approximately 2.4 million and 6.1 million adults in the US, respectively. Read

GSK has announced that it will be expanding its gastrointestinal (GI) cancer pipeline by acquiring IDRx in a deal worth up to $1.15bn.The agreement, which includes an upfront payment of $1bn and up to $150m in success-based regulatory approval milestones, gives GSK access to IDRX-42, a highly selective KIT tyrosine kinase inhibitor (TKI) being developed as a first- and second-line therapy for gastrointestinal stromal tumours (GISTs).GISTs are the most common subtype of soft tissue sarcoma, with up to 120,000 patients diagnosed globally every year. Read

Gilead Sciences said on Saturday that it entered into a partnership with Denmark's LEO Pharma to develop programs to treat patients with inflammatory diseases. The Danish company will be eligible to receive up to $1.7 billion in payments which include an upfront payment of $250 million from Gilead. In return, Gilead will have global rights to develop, manufacture, and commercialize the small molecule oral STAT6 (signal transducer and activator of transcription 6) program. Read

Bayer has shared positive results from a late-stage study of its investigational non-hormonal drug in patients experiencing vasomotor symptoms (VMS) as a result of breast cancer treatment. The phase 3 OASIS 4 study has been evaluating the candidate, elinzanetant, as a treatment for moderate-to-severe VMS caused by adjuvant endocrine therapy in women with hormone receptor positive breast cancer or in those who are at high risk of developing breast cancer. Read

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This Week's Popular Group Posts

The Future of Sialic Acid in Therapeutics: The potential of sialic acid extends far beyond basic biology. With its crucial role in immunity, brain health, and cell communication, sialic acid is set to play an integral part in the future of personalized medicine and drug development. Read

SUPRA CARs - A New Frontier in Immunotherapy: SUPRA CAR (separate, universal and programmable chimeric antigen receptor) represents a breakthrough in cancer immunotherapy, providing a highly flexible and precise approach to T cell engineering. Unlike traditional CAR-T cells designed to target a single antigen, SUPRA CAR uses a modular system that separates the antigen binding domain from the T cell signaling domain. This innovative design allows for greater control, versatility and safety in targeting cancer cells. Read

Armored CAR-T Cells - A Revolution in Cancer Therapy: The advent of armored CAR-T cells represents a major advance in cancer immunotherapy, designed to enhance the efficacy of conventional CAR-T cells, especially in the challenging environment of solid tumors. These cells have additional “armor”, such as the ability to secrete cytokines or resist immunosuppressive signals, which enables them to overcome barriers that often limit the effectiveness of first-generation CAR-T therapies. Read

Application of Tumor Resistance Mouse Models in Cancer Drug Development: Tumor resistance mouse models are an important tool in cancer research, providing insights into the mechanisms by which tumors become resistant to therapies and aiding the development of effective cancer drugs.?Read

WHY ARE JOURNAL EDITORS QUITTING? I sold my publishing business last August, 50,000 readers -- mostly orthopaedic and spine surgeons -- and am now organizing a Life Science Research COOP. Why? Because the current pay-to-publish system is bad for science and can't scale in an era of Big Data and AI. Read

Oncology Powerhouses - A $26B Quarter Unveiled: The oncology market is buzzing, with the top 15 cancer treatments raking in a staggering $26 billion last quarter. What’s even more striking? The top 3 alone made up half that figure! Read

Prostate Cancer - Early detection saves lives: Here’s a fact that many people overlook: Prostate cancer is the most common type of cancer among men, particularly in Europe and the Czech Republic.In the Czech Republic alone, over 7,000 new cases of prostate cancer are diagnosed every year, and across the EU, this number surpasses 450,000 annually. Read

AI Scientists Are on the Way: #AI scientists may well become a powerful force in science. Often referred to as “AI scientists” or “autonomous research systems,” these AI systems are designed to perform tasks traditionally performed by human scientists, such as hypothesis generation, experimental design, data analysis, and even interpretation of results. Using advanced machine learning, natural language processing, and robotics, AI scientists can accelerate the pace of discovery and innovation in a variety of fields. Read

PHARMALANE UK?is recognised as one of the?most ???????????????????????????????????????????????????????????????????????????????? and last year’s trend is evident of the same; highly recommended for any types of GxP Audits (GMP, GCP, GPvP and GDP) of various types of suppliers globally. Read