Shanghai, China, Mar 12th, 2024 – Shanghai Henlius Biotech, Inc. (2696.HK) announced the investigational new drug (IND) application for clinical trial of HLX6018,a novel anti-GARP/TGF-β1 monoclonal antibody (mAb) independently developed by the company, was approved by the National Medical Products Administration (NMPA) for the treatment of idiopathic pulmonary fibrosis (IPF). HLX6018 is the first innovative product of Henlius in the treatment field of chronic inflammatory diseases. Currently, no mAb targeting GARP/TGF-β1 has been approved for marketing globally. Fibrosis is a pathological process characterised by persistent tissue scars which attributed to excessive deposition of extracellular matrix (ECM). This condition can be induced by a variety of stimuli such as infections, autoimmune reactions, radiation, and tissue injury. Common fibrosis-related diseases include IPF, non-alcoholic steatohepatitis (NASH)/metabolic dysfunction-associated steatohepatitis (MASH), cirrhosis, chronic kidney disease (CKD), myocardial infarction (MI), etc. Among them, IPF is a chronic, progressive interstitial lung disease with unknown etiology, and was ...
The 82nd Annual Meeting of the American Academy of Dermatology (AAD) was held from March 8 to 12, 2024 in San Diego, USA. This is one of the largest and most influential international events in the field of dermatology in the world. on the afternoon of March 10, Professor Zhang Jianzhong, a well-known dermatologist and professor of Peking University People’s Hospital, delivered an oral report in the Late-Breaking Research session of the conference, introducing Hengrui Pharmaceuticals’ innovative drug, Emaxitinib ( SHR0302) in the treatment of moderate-to-severe atopic dermatitis (AD). “Emaxitinib is a highly selective JAK1 inhibitor originally developed in China, which is a major breakthrough for us in the field of innovative drug development.” Prof. Zhang Jianzhong explained that the Phase III clinical study showed that patients with moderate-to-severe AD treated with emaxitinib for 16 weeks showed significant improvement in skin lesions and itching symptoms, and the 52-week long-term follow-up ...
Davy James BeiGene’s Brukinsa is a small molecule Bruton’s tyrosine kinase inhibitor indicated as a monotherapy and in combination with other treatments for various B-cell malignancies. The FDA has granted accelerated approval to BeiGene’s Brukinsa (zanubrutinib) in combination with Roche’s Gazyva (obinutuzumab) for patients with relapsed or refractory follicular lymphoma (FL) following two or more lines of systemic therapy.1 Brukinsa is a small molecule Bruton’s tyrosine kinase (BTK) inhibitor indicated as a monotherapy and in combination with other treatments for various B-cell malignancies, such as chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma; Waldenström’s macroglobulinemia; patients with mantle cell lymphoma (MCL) previously treated with at least one prior therapy; and patients with relapsed or refractory marginal zone lymphoma previously treated with at least one anti-CD20-based regimen.1 Gazyva is a CD20-directed cytolytic antibody indicated in combination with chlorambucil for the treatment of patients with previously untreated CLL; in combination with chemotherapy ...
Given the link established across studies between marketing practices and the opioid overdose crisis, a few strategic steps can form a path forward for clinicians and policymakers. By SUZETTE GLASNER-EDWARDSThe recent series of settlements linked with claims against advertising and pharmaceutical manufacturing companies involved in the sales and marketing of opioid drugs are encouraging, demanding accountability for promoting highly addictive drugs such as OxyContin as non-addictive. These settlements, ranging from $350 to $465 million, provide a source of optimism for those living with opioid use disorders, especially given the inclusion of funding to support the treatment of such individuals. Yet questions about the potential future impact of these criminal and civil suit settlements on the opioid overdose epidemic remain. Coupled with the observation that opioid marketing practices have not shifted in the face of lawsuits in the past, under-recognition of addiction and overprescribing of medications with high addiction potential for ...
BeiGene’s Brukinsa (zanubrutinib) has been granted accelerated approval by the US Food and Drug Administration (FDA) to treat relapsed or refractory follicular lymphoma. The BTK inhibitor has specifically been authorised for use alongside Roche’s anti-CD20 monoclonal antibody Gazyva (obinutuzumab) in adult patients who have received at least two prior lines of systemic therapy. The FDA’s decision was supported by positive results from the mid-stage ROSEWOOD study, which demonstrated an overall response rate of 69% for the Brukinsa combination arm compared to 46% for Gazyva alone. An 18-month duration of response of 69% for the Brukinsa combination was also observed, BeiGene said, adding that safety results were consistent with previous studies of both medicines. Mehrdad Mobasher, chief medical officer, haematology at BeiGene, said: “This accelerated approval of Brukinsa represents an important advancement, offering the first and only BTK inhibitor treatment for follicular lymphoma patients in the US who have either not ...
Don Tracy, Associate Editor Medication is the first tocilizumab biosimilar approved in the US for both IV and subcutaneous use for autoimmune diseases, such as rheumatoid arthritis and juvenile idiopathic arthritis. Fresenius Kabi announced today that the FDA has officially approved Tyenne (tocilizumab-aazg), a biosimilar referencing tocilizumab (Actemra; Genentech), for the treatment of multiple autoimmune diseases, including rheumatoid arthritis and juvenile idiopathic arthritis. Developed with the focus of being more accessible and affordable for patients, Tynne is the first tocilizumab biosimilar to be approved by the FDA for intravenous (IV) and subcutaneous use. This is Fresenius Kabi’s third biosimilar approved in the United States, following Stimufend (pefilgrastim-fpgk), a biosimilar to Neulasta, and Idacio (adalilmumab-aacf), a biosimilar to Humira.1 “Offering the first FDA-approved tocilizumab biosimilar therapy option in both IV and subcutaneous formulations to people living with autoimmune diseases in the U.S. is a moment of great pride for Fresenius Kabi. ...
Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, age-related diseases, and chronic hepatitis B (CHB), announced today that the latest results from three preclinical studies of the company’s novel drug candidates olverembatinib, MDM2-p53 inhibitor alrizomadlin, FAK/ALK/ROS1 tyrosine kinase inhibitor APG-2449, and EED inhibitor APG-5918, have been selected for presentations at the 2024 American Association of Cancer Research Annual Meeting (AACR 2024). These abstracts are now available on the AACR’s official website. The AACR annual meeting is one of the world’s largest and longest-standing scientific gatherings in the field of cancer research. Covering some of the most cutting-edge advances in all the areas of oncology research and innovation, the annual event attracts tremendous interest from the global cancer research community. This year’s AACR annual meeting will be held from April 5-10 2024, in San Diego, California, USA. These three preclinical abstracts from Ascentage Pharma include: ...
The conventional methods for measuring free cortisol, the body’s stress hormone, from blood or saliva are quite demanding and require sample processing. The most common method, therefore, involves collecting urine over several days. However, this method requires great perseverance from patients, as collecting every drop of urine over several days can be nearly impossible, even if the patients are hospitalized. This often leads to up to 60% variation in urine-free cortisol measurements in individual patients. Now, researchers have developed a new method for measuring cortisol levels directly from a blood sample, marking a significant advancement in the diagnosis and treatment of various diseases. Researchers from Aarhus University (Aarhus, Denmark) have discovered a groundbreaking method for measuring levels of free cortisol directly from a blood sample. This new method is simple and quick, requiring only a few drops of blood. This contrasts sharply with current practices, which are both cumbersome and ...
Akero Therapeutics’ preliminary Phase 2b data show that treatment with its MASH drug, efruxifermin, continued to distance itself from a placebo measured at nearly two years of treatment. The latest Akero data build on six-month results reported in 2022. By FRANK VINLUAN Longer treatment with an Akero Therapeutics drug in development for the liver disease MASH led to better results, including improvement in fibrosis, the liver scarring that is a hallmark of the chronic disorder. Metabolic dysfunction-associated steatohepatitis, or MASH, causes deteriorating liver function that can reach the point of requiring an organ transplant. The fibrosis that develops with MASH is classified in four stages. Stage 4, the most severe, is liver cirrhosis. On Monday, South San Francisco-based Akero reported preliminary results at 96 weeks showing that 75% of patients treated with the highest dose of its drug, efruxifermin, showed improvement of at least one stage of fibrosis without worsening ...
Dialysis patients often develop dialysis-related amyloidosis and exhibit bone and joint disorders that impair their activity of daily living. Blood purification devices consisting of hexadecyl-immobilized cellulose beads aimed at removing the precursor protein, β2- microglobulin (β2-m), are used in the treatment of dialysis-related amyloidosis. Dr. Yamamoto et al. investigated that comprehensive analysis of proteins adsorbed onto blood purification devices revealed the identification of 200 types of proteins, including β2-m. Among these, several molecules, such as lysozyme, were shown to be involved in amyloid fibril formation. I. Background of the study Patients with advanced chronic kidney disease (CKD) require kidney replacement therapy, such as hemodialysis, to manage their condition. Hemodialysis patients often experience various symptoms, leading to a compromised quality of life and reduced activity levels. Itching is a common symptom frequently observed in hemodialysis patients. Although its exact causes remain unclear, a survey conducted in Japan in 2000 found that ...
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