Davy James Regeneron’s PCSK9 inhibitor approved to reduce low-density lipoprotein cholesterol in patients 8 years of age and older with heterozygous familial hypercholesterolemia. The FDA has approved an expanded indication for Regeneron’s PCSK9 inhibitor Praluent (alirocumab) to include patients 8 years of age and older for the reduction of low-density lipoprotein cholesterol (LDL-C) in those with heterozygous familial hypercholesterolemia (HeFH).1 In clinical trials, the fully human monoclonal antibody, which binds and inhibits to circulating PCSK9, has been found to lower LDL-C in patients with hyperlipidemia either as a monotherapy or combined with other lipid-lowering therapies (LLTs).2 “Many children with (HeFH) are able to substantially improve their LDL-C (bad cholesterol) with currently available therapies,” said Mary P. McGowan, MD, chief medical officer of the Family Heart Foundation, in a press release. “But for those children whose LDL-C remains dangerously high, this approval is an important milestone as it gives these children ...
As of March 7, 2024, Biokin Pharmaceutical has received an initial payment of USD 800 million from Bristol Myers Squibb under the development and commercialization license agreement for BL-B01D1. Agreement Signing and EffectivenessOn December 11, 2023, SystImmune, Inc., a wholly-owned subsidiary of Biokin Pharmaceutical, entered into an exclusive licensing and collaboration agreement (hereinafter referred to as the “Collaboration Agreement”) with Bristol Myers Squibb (hereinafter referred to as “BMS”, NYSE ticker: BMY) pertaining to the BL-B01D1 (EGFR×HER3 bispecific ADC) project. Under the terms of the Agreement, the Parties will jointly pursue the development and commercialization of BL-B01D1 in the United States. SystImmune will exclusively be responsible for the development, commercialization, and production of BL-B01D1 within Chinese mainland through its affiliated entities, including manufacturing some drugs for supply to regions outside of Chinese mainland. Conversely, BMS will retain exclusive right to develop and commercialize BL-B01D1 in all other regions globally. The Collaboration ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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 ...
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