Search Results for “antibody” – Page 30 – media

BeiGene’s Brukinsa granted FDA accelerated approval for advanced follicular lymphoma

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 ...
- Source: drugdu
- 75
- March 12, 2024
BIO-THERA’s BAT8010 (ADC-HER2) for injection in combination with BAT1006 (HER2) for injection for the treatment of locally advanced or metastatic solid tumors was approved in clinical trial

BIO-THERA Biopharmaceutical Co., Ltd. (SSE: 688177) is a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as “BIO-THERA” or the “Company”. The Company today announced that it has received a Notice of Approval of Drug Clinical Trial from the State Drug Administration of the People’s Republic of China (“SDA”), which approves the application for a clinical trial of the investigational drug BAT8010 for injection in combination with BAT1006 for injection for the treatment of locally advanced or metastatic solid tumors. BAT8010 consists of recombinant humanized anti-HER2 antibody and toxin small molecule topoisomerase I inhibitor, connected by self-developed shearable linker.BAT8010 has highly efficient anti-tumor activity, the toxin small molecule has strong cell membrane permeability, and it can be released and kill nearby cancer cells after ADC kills the cancer cells, generating the bystander effect, effectively overcoming the tumor cells’ heterogeneity of tumor cells. Meanwhile, BAT8010 has ...
- Source: drugdu
- 167
- March 10, 2024
Achieving first full year of profitability, and ushering in a new phase of high-quality development

Henlius (2696.HK) released a positive profit forecast. Based on the preliminary assessment of the unaudited consolidated management accounts for the year ended 31 December, 2023 (the “Reporting Period”) and the information currently available to the Board, it is expected that the company will record a profit for the year of no less than RMB500 million for the Reporting Period. This is the first time for Henlius to achieve full-year profits following the company’s achievement of its first half-year profits for the six months ended 30 June 2023. The full year of profitability is primarily contributed by the continuous growth in sales revenue of the company’s core products HANQUYOU and HANSIZHUANG, as well as cost reduction and efficiency improvement through refined management. Wenjie Zhang, Chairman and Executive Director of Henlius, said: “2023 is a milestone as we reported a full-year profit for the first time. Benefiting from the efficient synergy and ...
- Source: drugdu
- 126
- March 10, 2024
Akeso Announced the First Patient Dosed in Phase III Trial of Cadonilimab(PD-1/CTLA-4) Combined with Chemotherapy versus Tislelizumab Combined with Chemotherapy in First-line Treatment of PD-L1 negative NSCLC

HONG KONG, March 6, 2024 /PRNewswire/ — Akeso Inc. (“Akeso”, 9926. HK) announced the enrollment of the first patient in the registrational Phase III clinical study comparing Cadonilimab (PD-1/CTLA-4 bispecific antibody) combined with chemotherapy versus Tislelizumab (PD-1 antibody) combined with chemotherapy in the first-line treatment for patients with PD-L1 negative (PD-L1 TPS＜1%) non-small cell lung cancer (NSCLC) (NCT05990127). Lung cancer is a prevalent malignancy with significant global incidence and mortality rates. Retrospective studies conducted both worldwide and in China have revealed that PD-L1 negative expression is observed in up to 48% of patients with driver gene-negative NSCLC. Immunotherapy combined with chemotherapy stands as the first-line standard treatment for these patients. However, current treatment approaches provide limited survival benefits for PD-L1 negative patients. Hence, there exists a pressing clinical imperative for novel treatment modalities to enhance patients’ clinical outcomes. Compared to PD-1/PD-L1 monoclonal antibodies, PD-1 monoclonal antibody plus CTLA-4 monoclonal antibody ...
- Source: drugdu
- 96
- March 10, 2024
FDA Approves Opdivo Plus Chemotherapy for Frontline Treatment of Unresectable, Metastatic Urothelial Carcinoma

Davy James Opdivo (nivolumab) plus cisplatin and gemcitabine was found to improve overall survival and progression-free survival compared with chemotherapy alone in patients with unresectable or metastatic urothelial carcinoma.The FDA has approved Bristol Myers Squibb’s Opdivo (nivolumab) plus cisplatin and gemcitabine in the frontline treatment of adults with unresectable or metastatic urothelial carcinoma (UC).1 The regulatory action adds to an array of approved indications for Opdivo, both as a single agent and in combination therapy, including for patients with unresectable or metastatic melanoma; metastatic non-small cell lung cancer; advanced renal cell carcinoma; classical Hodgkin lymphoma; recurrent or metastatic squamous cell carcinoma of the head and neck; locally advanced or metastatic UC; microsatellite instability-high or mismatch repair deficient metastatic colorectal cancer; and hepatocellular carcinoma.2 “This approval marks an important advancement in a historically difficult-to-treat setting, where there has been a need for new and differentiated first-line approaches that may offer patients ...
- Source: drugdu
- 126
- March 9, 2024
CPhI Japan 2024

Organiser: Informa Markets Time:17 – 19 April 2024 address：3-2-1 Aiakle Koto ku, Tokyo 135 0063 Japan Exhibition hall: Tokyo Big Sight International Exhibition Center Product range: Apis: vitamins, hormones, sulfonamides, antipyretic analgesics, tetracycline, amino acids and their derivatives, chloramphenicol, digestive system drugs, other anti-infective drugs, penicillins, aminoglycosides, lincomycin, cardiovascular system drugs, anti-parasitic diseases drugs, cephalosporins, macrolides, respiratory system drugs, central nervous system drugs, other Western drugs Ingredients Excipients and dosage forms: excipients, flow AIDS, enteric materials, antioxidants, sweeteners, penetration enhancers, preservatives, disintegrators, coating materials, surfactants, sunshades, flavors, filter AIDS, stabilizers, lubricants, plasticizers, solvents, flavor straighteners, coloring agents, clarifying agents, PH regulators, etc Natural extract: plant extract, animal extract, traditional Chinese medicine raw material, functional food raw material, health care raw material, nutrition and health raw material, supplement, dietary fiber, beauty cosmetics raw material Biological product reagents: antibody, nucleic acid/protein synthesis, carrier and construction, cell biology detection, animal/plant protein/antigen/polypeptide, nucleic acid ...
- Source: drugdu
- 174
- March 8, 2024
Gilead Sciences Signs Yet Another R&D Alliance for Multi-Target Cancer Therapies

Gilead Sciences’ partnership with Merus could yield novel antibody drugs capable of binding to three targets simultaneously. The alliance follows a collaboration that Gilead started last year with Tentarix Biotherapeutics, a startup also developing antibodies that bind to multiple targets. By FRANK VINLUAN Bispecific antibody drugs have shown that binding to two targets simultaneously can be a powerful and effective way to treat cancer. Binding to three targets could be even better, and Gilead Sciences is turning to biotech company Merus to find out. Under the collaboration agreement announced Wednesday, Gilead is paying Merus $56 million up front and making a $25 million equity investment in the biotech. Netherlands-based Merus focuses on developing antibody therapies that bind to two or three targets at the same time. This capability could block multiple receptors that drive tumor growth and survival. It could also coax a patient’s immune cells to kill tumors. So ...
- Source: drugdu
- 105
- March 8, 2024
BIO-THERA’s Class 1 New Drug BAT7205 (PD-L1/IL-15) for Injection Approved for Clinical Trials in Locally Advanced or Metastatic Solid Tumors

BIO-THERA Bio-Pharmaceutical Co., Ltd (Stock Code: 688177) has recently received a Notice of Approval of Drug Clinical Trial approved by the State Drug Administration for the Company’s investigational product BAT7205 for injection. BAT7205 is a PD-L1/IL-15 bifunctional antibody fusion protein developed by BIO-THERA and is intended to be developed for the treatment of locally advanced or metastatic solid tumors.IL-15 is a pleiotropic cytokine that is essential for the regulation of many immune functions, particularly the development, proliferation and activation of CD8+ memory T cells and NK cells, and promotes PD-1 inhibitor-naïve CD8 + activation and proliferation of tumor-infiltrating T cells, which is expected to significantly improve the clinical efficacy of PD-1/PD-L1 analogs. BAT7205 consists of recombinant humanized anti-PD-L1 antibody and IL-15/IL-15Rαsushi fusion protein, which can both block the PD-1/PD-L1 immunosuppressive pathway and activate the immune cells through IL-15, thus achieving the synergistic effect of deregulation of immunosuppression and activation of ...
- Source: drugdu
- 171
- March 8, 2024
FDA Approves Sandoz Biosimilars for Two Blockbuster Amgen Bone Drugs

Sandoz drugs Jubbonti and Xgeva are approved for use in all indications covered by the Amgen products, Prolia and Xgeva. But no launch date is planned yet, due to ongoing patent litigation between the two companies. By FRANK VINLUAN A blockbuster Amgen antibody that treats bone conditions is set to face its first biosimilar competition. The FDA on Tuesday approved two Sandoz drugs as interchangeable with and approved for all uses of the Amgen products. The Amgen antibody, denosumab, is marketed as Prolia for the treatment of osteoporosis. A different dose of the antibody is marketed as Xgeva for preventing bone problems in multiple myeloma patients as well as those whose solid tumors have metastasized to the bones. Sandoz’s biosimilar for the osteoporosis indication will be marketed under the name Jubbonti. For cancer, the Sandoz product will be called Wyost. The Amgen and Sandoz drugs work by binding to a ...
- Source: drugdu
- 134
- March 7, 2024
Lundbeck Pharmaceuticals’ “Anti-Parkinson’s Category 1 Chemical Drug” Submits Clinical Application in China

March 4), according to the CDE official website, Lundbeck’s clinical trial application for Class 1 chemical drug Lu AF28996 capsules has been accepted. Currently, the drug is undergoing Phase I clinical trials overseas. Parkinson’s disease is a neurological dysfunction disease with complex symptoms and difficult early diagnosis. It is common in middle-aged and elderly people. At present, the main treatment for Parkinson’s disease is drug therapy, with the purpose of reducing symptoms, delaying the progression, and improving the patient’s quality of life. Lu AF28996 is a dopamine D1/D2 receptor agonist developed by Lundbeck Pharmaceuticals. It is a relatively new anti-Parkinson therapy and is currently undergoing Phase I clinical trials overseas. Among them, a study to evaluate the safety, tolerability, etc. of Lu AF28996 in Parkinson’s patients is expected to be completed in 2025. This time, the approval of Lu AF28996’s clinical trial application in China is expected to bring a ...
- Source: drugdu
- 158
- March 7, 2024

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