Search Results for “ breast cancer ” – Page 26 – media

Companies prepare for ADC trial readouts at ASCO 2024

As the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting approaches at the end of this month, Merck & Co joined a host of other companies that have announced upcoming data presentations for their oncology clinical studies at the event. The ASCO annual meeting, taking place from 31 May to 4 June, gathers pharmaceutical companies, healthcare providers and experts, to discuss the latest trends in oncology and share new data from ongoing and completed clinical studies. In the last few days, several companies such as Merck & Co, Astellas, and Pfizer have announced upcoming data presentations to look for at the premier cancer conference. In a 15 May press release, Merck & Co announced that it would present data from its Phase III study (NCT06312176), investigating the antibody-drug conjugate therapy (ADC), Sac-TMT (sacituzumab tirumotecan), in previously treated locally recurrent or metastatic triple-negative breast cancer. Pfizer will also be presenting ...
- Source: drugdu
- 114
- May 17, 2024
BIO-THERA BAT1308 (PD-1) in combination with BAT8006 (ADC- FRα) approved for clinical trials in advanced solid tumors

BIO-THERA Biopharmaceutical Co., Ltd. (SSE: 688177), 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, which approves the clinical trial application of the Company’s investigational drug BAT1308 in combination with BAT8006 for the treatment of advanced solid tumors. BAT1308 injection is a humanized anti-PD-1 monoclonal antibody independently developed by BIO-THERA. Its active ingredient is an antibody targeting human programmed cell death protein 1 (PD-1) expressed by Chinese hamster ovary cells, which belongs to the immunoglobulin IgG4κ subtype, and is capable of binding specifically to human PD-1 with high affinity, thus blocking the interaction between PD-1 and its ligands PD-L1 and PD-L2. BAT1308 is able to bind to PD-1 on the surface of T-cells and release the inhibitory effect of ...
- Source: drugdu
- 132
- May 14, 2024
Novartis Set to Acquire Mariana Oncology to Enhance Radioligand Therapy Pipeline

Don Tracy, Associate Editor Deal includes a number of radioligand therapies targeting solid tumors, such as breast, prostate, and lung cancers. Novartis announced that it has acquired Mariana Oncology, a biotech specializing in developing radioligand therapies (RLTs) for cancer treatment. According to the company, the acquisition is expected to enhance Novartis’ existing RLT pipeline and add major research capabilities. These programs target breast, prostate, and lung cancers, and features a leading developmental candidate, MC-339, for small cell lung cancer. As per terms of the agreement, Novartis is expected to make an upfront payment of $1 billion, with further potential payments of up to $750 million upon the completion of pre-specified milestones.1 “The acquisition of Mariana Oncology reflects our commitment to radioligand therapy as one of our company’s key technology platforms and strengthens our leadership in this field,” said Fiona Marshall, president, biomedical research, Novartis, in a press release. “We are ...
- Source: drugdu
- 118
- May 6, 2024
Focusing on China, Novartis Helps Promote the Development of the Radiopharmaceutical Industry

Today, the 2024 Conference on Innovative Development of Radiopharmaceuticals, organized by China Isotope and Radiation Industry Association (CIRIA), was held in Beijing. During the conference, China Isotope and Radiation Industry Association (CIRIA) established the Radiopharmaceutical Branch and held the first meeting of the First Council of the Branch, which was attended by leaders and representatives from research institutes, universities, medical institutions and enterprises in the field of radiopharmaceuticals in China. As a pioneer and “frontrunner” in the field of global radiopharmaceuticals, Novartis not only takes the lead in occupying the R&D plateau of radioligand therapy (RLT) and leading the domestic and international R&D track of RLT, but also actively promotes the construction and improvement of the industry in the field of radiopharmaceuticals based on its own industrial status and international influence. Ms. Luo Ya, Head of Value Access Department of Novartis China, participated in the meeting as Vice Chairman of ...
- Source: drugdu
- 86
- April 24, 2024
Enhertu Gets FDA Accelerated Approval for Unresectable, Metastatic HER2-Positive Solid Tumors

Davy James The approval of AstraZeneca’s and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) for adults with unresectable or metastatic HER2-positive solid tumors adds to the drug’s approved indications in breast cancer, non-small cell lung cancer, and gastroesophageal junction adenocarcinoma. The FDA has granted accelerated approval to AstraZeneca’s and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) for adults with unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive, immunohistochemistry (IHC) 3+ solid tumors who were previously administered systemic therapy and who have no satisfactory alternative treatment options.1 The regulatory action for the HER2-directed antibody-drug conjugate (ADC) adds to Enhertu’s approved indications in breast cancer, non-small cell lung cancer (NSCLC), and gastroesophageal junction adenocarcinoma. “As the first antibody drug conjugate to be granted a tumor-agnostic indication, Enhertu is truly delivering on its potential across metastatic HER2-targetable tumors,” said Dave Fredrickson, executive vice president, Oncology Business Unit, AstraZeneca, in a press release. “This approval also ...
- Source: drugdu
- 128
- April 10, 2024
Hengrui Adebelizumab, SHR-A1811 Combination Chemotherapy for HER2 Expressing Adenocarcinoma of Gastric or Gastroesophageal Bundle Phase Ib/II Clinical Trial Approved

Recently, Hengrui Pharmaceuticals’ subsidiaries, Shanghai Shengdi Pharmaceuticals Co., Ltd. and Suzhou Shengdia Biopharmaceuticals Co., Ltd. have received the Approval Notice of Drug Clinical Trial issued by the State Drug Administration, which authorizes to conduct the Phase Ib/II clinical study of Adebelizumab Injection in combination with SHR-A1811 and chemotherapy for HER2-expressing advanced adenocarcinoma of the stomach or the gastroesophageal junction. In 2020, gastric cancer ranked 5th in global cancer incidence and 4th in mortality. Among them, 43.9% of new cases and 48.6% of deaths will occur in China, with 479,000 new cases and 374,000 deaths, both ranking third in China in terms of cancer incidence and mortality. Human Epidermal Growth Factor Receptor (HER2)-positive gastric cancer is a unique subtype of the disease, which requires different diagnostic and therapeutic strategies from HER2-negative gastric cancer. The global reported HER2-positive rate of gastric cancer is 7.3%-20.2%, and the HER2-positive rate of gastric cancer in ...
- Source: drugdu
- 163
- April 10, 2024
FDA Hands Expanded Indication to Gilead’s Vemlidy for Chronic HBV Infection in Pediatric Patients

Don Tracy, Associate Editor Phase II clinical study showed that children as young as six years of age with hepatitis B virus could benefit from treatment with Vemlidy. The FDA has approved an expanded indication for Gilead’s Vemlidy (tenofovir alafenamide), to treat chronic hepatitis B virus (HBV) infection in pediatric patients aged six years and older who weigh at least 25 kg and have compensated liver disease. In 2016, the medication was initially approved for adults with chronic HBV and compensated liver disease, with an extended use approved in 2022 for children aged 12 years and above. Approval for the expanded indication was based on positive results stemming from Gilead’s Phase II clinical trial (Trial 1092) after 96 weeks, showing safety and efficacy in younger children. According to the study data, participants experienced progressive increases in the rates of virological suppression compared to those administered a placebo.1 “Chronic hepatitis B ...
- Source: drugdu
- 88
- April 2, 2024
BIO-THERA’s Phase II Clinical Trial Application for BAT8006 (ADC- FRα) for Injection Approved by US FDA

BIO-THERA Biopharmaceutical Co., Ltd (SSE: 688177), a global science-based and innovative biopharmaceutical company based in Guangzhou, China, hereinafter referred to as “BIO-THERA” or the “Company”, today announced that its Phase II clinical trial application (IND) for BAT8006 (ADC- FRα) for injection has been approved by the U.S. Federal Drug Administration (FDA). The Company today announced that it has recently received approval from the U.S. Food and Drug Administration (FDA) for a Phase II clinical trial (IND) of its investigational drug, BAT8006 for injection, to evaluate its efficacy and safety in patients with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer. Previously, BAT8006 has initiated a Phase I dose-escalation and dose-expansion study in China with phase I data. BAT8006 is an antibody drug coupling (ADC) developed by BIO-THERA targeting folate receptor alpha (FRα), which is intended to be developed for the treatment of solid tumors.FRα is a folate-binding protein located ...
- Source: drugdu
- 129
- March 28, 2024
Hengrui Pharmaceuticals Clinical Trial Approved for Novel PARP Inhibitor HRS-1167 (M9466) Combination Therapy for Advanced Solid Tumors

Recently, Hengrui Pharmaceuticals and its subsidiaries Suzhou Shengdia Biopharmaceutical Co., Ltd. and Chengdu Shengdi Pharmaceutical Co., Ltd. received the Notice of Approval for Drug Clinical Trial approved for issuance by the State Drug Administration, which authorizes the conduct of a clinical trial of HRS-1167 tablets (Merck code: M9466) in combination with injectable SHR-A1921 or in combination with bevacizumab or in combination with abiraterone acetate tablets (I) and Prednisone/Prednisolone (AA-P) for advanced solid tumors in a Phase Ib/II clinical study. In October 2023, Hengrui Pharmaceuticals entered into a strategic cooperation with Merck KGaA of Germany, which obtained the exclusive rights to develop, manufacture and commercialize HRS-1167 (M9466) globally outside of mainland China, which was the first time that Hengrui Pharmaceuticals entered into a strategic cooperation with a large global multinational enterprise. Poly (ADP-ribose) polymerase (PARP) is a class of multifunctional protein post-translational modification enzymes widely found in eukaryotic cells, and plays ...
- Source: drugdu
- 173
- March 18, 2024
Hengrui Medicine’s new “PARP inhibitor” HRS-1167 combination therapy for advanced solid tumors received clinical approval

Recently, Hengrui and its subsidiaries SUZHOU SUNCADIA BIOPHARMACEUTICALS and Chengdu Suncadia Medicine received the “Drug Clinical Trial Approval Notice” approved and issued by the National Medical Products Administration to conduction a Ib/Phase II clinical study for HRS-1167 tablet (Merck code: M9466) combined with SHR-A1921 for injection or combined with bevacizumab or combined with abiraterone acetate tablets (I) and prednisone/prednisolone (AA-P) for the treatment of with advanced solid tumors. In October 2023, Hengrui and Merck reached a strategic cooperation. Merck obtained the exclusive rights to develop, produce and commercialize HRS-1167 (M9466) outside mainland China. This is also the first time for Hengrui to reach a strategic cooperation with large multinational companies. Poly(ADP-ribose) polymerase (PARP) is a multifunctional protein post-translational modification enzyme widely found in eukaryotic cells. It plays a role in maintaining gene stability and maintaining telomere length. Studies have found that PARP inhibitors can hinder DNA damage repair by selectively ...
- Source: drugdu
- 166
- March 15, 2024

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