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A groundbreaking development in the early detection of hepatocellular carcinoma (HCC) has emerged from the halls of Wuhan Union Hospital at Huazhong University of Science and Technology. The imaging agent’s structural design—an antibody fragment labeled with gallium-68—embodies a strategic convergence of immunology and nuclear medicine.
The FDA has approved Datroway (datopotamab deruxtecan-dlnk), a TROP2-directed antibody-drug conjugate (ADC) for adults with unresectable or metastatic HR-positive, HER2-negative breast cancer, developed through a global collaboration between Daiichi Sankyo and AstraZeneca.
That was followed by a full approval for the same patient subset in December 2022, making it the first FDA-approved monoclonal antibody to treat COVID-19. Avtozma was submitted for regulatory approval to the FDA in January 2024 and the European Medicines Agency (EMA) in February 2024.
Given the complexity and widespread impact of autoimmune and bone health conditions, developing new therapies is essential. For instance, drugs like belimumab, a monoclonal antibody, have shown promise in treating systemic lupus erythematosus and lupus nephritis by reducing the overactive immune response.
By inducing bacterial calcification through a sophisticated antibody-polysialic acid conjugate, researchers have demonstrated not only potent antibacterial activity against MRSA but also an intriguing capacity to modulate the host immune system, opening new horizons for combating drug-resistant pathogens. aureus , with polysialic acid (PSA).
This model closely mimics human pathological processes, involving proteinuria, developing crescentic lesions within glomeruli, and a relentless decline in kidney function. The spatial and temporal dynamics of this cluster highlighted its early and sustained involvement in disease evolution from acute injury to fully developed CGN.
The roadmap initially targets monoclonal antibodies (mAbs) and similar biologic therapies drugs engineered to bind precise disease targets before expanding to other drug classes. FDA Commissioner Martin Makary expects that the change could speed up development and reduce animal testing.
By harnessing a synergistic combination of two powerful adjuvants within a single vaccine dose, this method elicits a dramatically enhanced immune response, notably broadening the diversity and potency of antibodies produced.
Given the complexity and widespread impact of autoimmune and bone health conditions, developing new therapies is essential. For instance, drugs like belimumab, a monoclonal antibody, have shown promise in treating systemic lupus erythematosus and lupus nephritis by reducing the overactive immune response.
targeting vaccine ahead of 2025-2026 season Moderna has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use for its updated COVID-19 vaccine targeting the SARS-CoV-2 variant LP.8.1.
This collaborative arrangement allows Bio-Techne to distribute USP’s reference standards for monoclonal antibodies (mAbs) and recombinant adeno-associated viruses (AAVs) alongside its advanced analytical platforms—most notably the MauriceFlex™ system.
BeOne Medicines Showcases Bold Vision and Expansive Oncology Pipeline at 2025 R&D Day BeOne Medicines Ltd., a global oncology-focused biopharmaceutical company, delivered a comprehensive update to investors today during its highly anticipated Research and Development (R&D) Day. Global Head of R&D. “We
NextCure has entered a strategic partnership with Simcere Zaiming, a subsidiary of Simcere Pharmaceutical Group, to develop SIM0505, a new antibody-drug conjugate (ADC) targeting cadherin-6 or K-cadherin (CDH6) for treating solid tumours. Stay proactive with real-time data and expert analysis.
FDA Orphan Drug Designation for Antibody-Mediated Rejection in Solid Organ Transplantation The U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to riliprubart , an investigational immunology therapy developed by Sanofi, for the treatment of antibody-mediated rejection (AMR) in solid organ transplantation.
Kairos is developing therapeutics that reverse cancer drug resistance in cancers such as prostate and lung cancer. The company’s lead candidate, ENV105, is an antibody targeting CD105, which is implicated in cancer cell resistance to various treatments.
Biocytogen Enters into Antibody Licensing Agreement with BeOne Medicines to Accelerate Innovative Drug Development Biocytogen Enters into Antibody Licensing Agreement with BeOne Medicines to Accelerate Innovative Drug Development BEIJING–(BUSINESS WIRE)–Biocytogen Pharmaceuticals (Beijing) Co.,
Most notably, molecular signatures indicative of antibody-mediated rejection emerged as early as Day 10 post-transplant, intensifying up to Day 33. These findings align with prior clinical observations, reinforcing the concept of a rapid yet evolving immune rejection timeline.
XTALKS WEBINAR: Driving Acceleration in Oncology Drug Development and Clinical Trials Live and On-Demand: Thursday, May 15, 2025 , at 10am EDT (4pm CEST / EU-Central) Register for this free webinar to gain insight into leveraging deep therapeutic expertise in oncology. Zongertinibs efficacy extended to various patient subgroups.
Recent advancements in ITP treatments include CM313, an anti-CD38 monoclonal antibody that achieved a 95.5 percent platelet response in a study published in The New England Journal of Medicine. This aligns with previous studies, reinforcing its potential as a well-tolerated treatment option.
The FDA has granted accelerated approval to Regeneron’s BCMA-targeting bispecific antibody linvoseltamab-gcpt, marketed as Lynozyfic, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy.
R&D Deep Dive: Research and Development 2025 Every breakthrough in medicine, every new treatment that changes lives, starts with research. Oncology Life Sciences Industry Report - Oncology Developments in the oncology space in 2024 brought hope to both industry and patients. Medical affairs is evolving.
Biocytogen Enters into Antibody Licensing Agreement with BeOne Medicines to Accelerate Innovative Drug Development Biocytogen Enters into Antibody Licensing Agreement with BeOne Medicines to Accelerate Innovative Drug Development BEIJING–(BUSINESS WIRE)–#Antibody–Biocytogen Pharmaceuticals (Beijing) Co.,
We are thrilled with the results from the EQUATOR study, which mark a major milestone in the development of itolizumab as a first-line treatment option for aGVHD, said Bruce Steel, CEO of Equillium, in the companys news release. The risk limits the number and type of patients who receive HSCT.
QIAGEN and Incyte Forge Global Collaboration to Develop Companion Diagnostic Panel for Patients With Mutant CALR-Positive Myeloproliferative Neoplasms QIAGEN N.V. This process includes securing appropriate regulatory approvals and developing a clear market access strategy alongside stakeholders, payors, health care providers, and regulators.
Find out more i3 Membrane won the Innovation award for its development of Digital Membrane Chromatography (DMC), a technology that revolutionizes biomolecule purification by utilizing electrical fields instead of traditional chemical methods. Data Insights The gold standard of business intelligence. ” – Kenneth J.
Biopharmaceutical companies developing Alzheimer’s disease innovator drugs have witnessed a flurry of acquisitions over the past few years, surging in total deal value by more than 780% from $2 billion in 2022 to almost $18 billion in 2024. Credit: JLStock via Shutterstock. In December 2024, AbbVie completed the $1.4
However, few medicines are approved for ATTR-wt. GlobalData estimates that vutrisiran’s entrance into the ATTR-wt market will change the treatment paradigm, with the newly approved medicine likely to steal the majority of the patient share from competitors.
Last year, Caris and Merck began a multi-year collaboration to develop first-in-class antibody-drug conjugates (ADCs) for cancer. The partnership supports joint research and therapy development across over 80 tumor types. million oncology patient records with Caris’s molecular profiling data.
These pivotal findings were unveiled at the 85th Scientific Sessions of the American Diabetes Association (ADA) and were concurrently published in The New England Journal of Medicine , underscoring the significant promise of MariTide in the growing field of anti-obesity therapies. This perspective was echoed by Dr. Ania Jastreboff , M.D.,
(Nasdaq: BIIB) has announced the initiation of dosing in its global Phase 3 clinical trial, known as PROMINENT, to assess the safety and efficacy of its investigational anti-CD38 antibody, felzartamab , in adults with primary membranous nephropathy (PMN).
This recommendation marks a critical regulatory milestone for the Sanofi-developed anti-CD38 monoclonal antibody, and the final decision by the European Commission is expected within the next few months.
The innovative research, led by Jian, Wec, Feng, and colleagues, has leveraged advanced viral evolution prediction models alongside immunological insights, enabling the proactive development of antibody therapies that hold promise against an ever-shifting viral landscape.
Vertex was also developing a version of the therapy called VX-264 in which the cells were encapsulated in a protective device designed to protect them from rejection by the immune system, but that failed to hit the mark in early clinical testing and has been dropped. Medical affairs is evolving.
Immune checkpoint inhibitors that release the brakes on T cells, chimeric antigen receptor T-cell (CAR-T) therapy engineered to recognize tumor-specific antigens, and monoclonal antibodies directed at key signaling receptors are at the forefront of these innovations.
Harbour BioMed has entered a strategic partnership with Otsuka Pharmaceutical focusing on the development of HBM7020, a B-cell maturation antigen (BCMA) xcluster [cross cluster] of differentiation 3 (CD3) bispecific T-cell engager aimed at treating autoimmune diseases. Stay proactive with real-time data and expert analysis.
This is a unique opportunity, driven by the urgency stemming from COVID-19, but without continued collective action, we risk losing momentum and letting these capabilities diminish instead of grow,” said Charles Gore, Executive Director of the Medicines Patent Pool. “We mRNA Technology Transfer Programme Moves Into Phase 2.0,
This strategic move transformed Actavis into one of the largest pharma companies globally, with a strong presence across branded, generic and over-the-counter (OTC) medicines. The integration of Shire strengthened Takedas R&D pipeline, increasing its focus on innovative medicines and transformative therapies.
A magnifying glass examining a vintage vaccine vial surrounded by four minimalistic chart icons, symbolizing healthcare, medicine, and analytics in the context of global health monitoring. Biosimilars continue to build as a sector of this market with an estimated 2025 value in the region of US$42 billion (1).
Building on its earlier development as BI 1015550, nerandomilast first demonstrated promising antifibrotic and anti-inflammatory effects in a Phase II trial of 147 patients with IPF. The FIBRONEER-ILD trial enrolled 1,178 patients across more than 40 countries and over 400 locations.
While no specific LMNB2-targeted drugs currently exist, repurposing epigenetic modulators or developing peptides to interfere with LMNB2’s nuclear functions could be promising. Early-stage preclinical models combining LMNB2 suppression with anti-PD-1 antibodies exhibited synergistic tumor regression, highlighting the translational potential.
Other noteworthy safety signals included 52% of patients experiencing low grade CRS (grades 1 or 2) — all cases resolved without progression to severe grade — and a single patient developing grade 1 Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), which subsequently resolved. Source link
Orion Corporation has broadened its partnership with Glykos, focusing on the development of antibody-drug conjugates (ADCs). By GlobalData Learn more about Strategic Intelligence Orion will oversee target selection, research, development and commercialisation of future ADCs, concentrating on solid tumours.
Antibody-drug conjugates (ADCs) have emerged as one of the most promising advancements in precision oncology, combining targeted delivery with the potency of traditional chemotherapies. Over the last decade, ADCs have gained significant traction, with more therapies being approved and a rapidly expanding development pipeline.
Biotechnology company Arvinas said a medicine it advanced with Pfizer succeeded in a large breast cancer study. It doesn’t appear clearly better than other medicines , either, leaving its potential uncertain. For years, researchers struggled to develop an effective method for directing the E3 ligase.
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