PharmaFocus Today – Page 266 – media

BIO-THERA Signs License and Commercialization Agreement with Macter for BAT1706

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 it has entered into a license and commercialization agreement with Macter International Limited (“Macter”) for BAT1706, an Anviva reference product. The Company announced today that it has entered into a license and commercialization agreement with Macter International Limited (“Macter”) for BAT1706, a biosimilar developed with reference to Avastin® bevacizumab. Under the terms of the agreement, Macter will have exclusive distribution and marketing rights for BAT1706 in Pakistan and Afghanistan. BAT1706 has completed global Phase III clinical studies, demonstrating a high degree of safety, efficacy, and immunogenicity similarity to the originator, and BAT1706 (PuperChi®) has been approved for marketing by the National Drug Administration (NMPA) of China in November 2021, and BAT1706 (Avzivi®) has been approved for marketing by the U.S. Food and ...
- Source: drugdu
- 129
- January 5, 2024
Henlius to Release Clinical Data at 2024 ASCO GI

Shanghai, China, January 3rd, 2024 – Shanghai Henlius Biotech, Inc. (2696. HK) announced that the latest clinical data of two Henlius products, HLX22, an innovative anti-HER2 mAb, and the approved anti-PD-1 monoclonal antibody (mAb) HANSIZHUANG (serplulimab), will be presented in posters at the 2024 ASCO Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco, United States from January 18-20. HLX22 is an innovative anti-HER2 mAb that was introduced from AbClon, Inc. and further researched and developed by Henlius. HLX22 can bind to HER2 subdomain IV at a different binding site from trastuzumab, which allows the simultaneous binding of HLX22 and trastuzumab to HER2. The pre-clinical studies showed that the combination therapy of HLX22 and trastuzumab would inhibit the cell proliferation induced by epidermal growth factor (EGF) and Histidine-Rich Glycoprotein 1 (HRG1) and enhance the antitumor activity in vitro and in vivo. The phase 1 clinical trial of HLX22 demonstrates that HLX22 ...
- Source: drugdu
- 184
- January 5, 2024
Nexletol partners Esperion and Daiichi Sankyo patch up milestone dispute with $125M settlement

After a dispute over milestone payments derailed a 2019 heart med collaboration, Daiichi Sankyo and Esperion Therapeutics have mended fences with a $125 million settlement. Under the new agreement, Daiichi will pay Esperion $100 million in the coming weeks before an anticipated label expansion in Europe for their bempedoic acid products Nilemdo and Nustendi, which are branded as Nexletol and Nexlizet, respectively, in the U.S. The company will pay a further $25 million in the quarter following the European Medicines Agency’s (EMA) decision on whether to add language about a cardiovascular risk reduction to the drug’s label. Meanwhile, European manufacturing and supply responsibilities will change hands from Esperion to Daiichi, which will deliver “significant cost savings and efficiencies” to both companies, the partners said in a joint press release. Going forward, the two companies will expand their collaboration to potentially work on a triple-formulation product using bempedoic acid. Daiichi will ...
- Source: drugdu
- 152
- January 5, 2024
Pfizer rings in New Year with hemophilia B gene therapy nod in Canada

After a pair of high-profile approvals for sickle cell disease gene therapies in the U.S. last month, Pfizer is ushering in the New Year with a regulatory endorsement for its hemophilia B gene therapy north of the border. Health Canada has approved Pfizer’s adeno-associated viral (AAV) vector-based gene therapy, Beqvez, for the treatment of certain adults with hemophilia B, the company said Wednesday. Specifically, the agency endorsed the drug to treat patients with moderate to severe disease who are negative for neutralizing antibodies to variant AAV serotype Rh74. The approval is based on an open-label, single-arm study called BENEGENE-2, which enrolled 45 patients and met its primary goal. In the study, Pfizer’s drug demonstrated noninferiority and superiority to the standard of care, a recurrent Factor IX regimen, on the measure of annualized bleeding rates. Traditionally, patients with hemophilia B have needed to receive routine infusions of Factor IX treatment to ...
- Source: drugdu
- 162
- January 5, 2024
New Protein Risk Predicts Mortality Risk in Heart Failure Patients

Heart failure (HF) is a complex clinical condition characterized by high mortality rates. Existing methods for assessing the biological complexity of HF and determining clinical strategies are somewhat inadequate. High-throughput proteomics has the potential to enhance risk prediction; however, its practical application in managing HF patients requires robust validation and proven clinical advantages. Now, researchers have developed a new protein risk score that offers improved calibration and the potential to assist healthcare providers in more accurately determining the mortality risk in individuals with HF. Researchers from the National Institutes of Health (NIH, Bethesda, MD, USA) have developed and validated a protein risk score to stratify mortality risk in persons with heart failure using a community-based cohort of 7,289 plasma proteins in 1,351 patients with HF using the SomaScan Assay from SomaLogic (Boulder, CO, USA). In the development cohort, the team chose 38 unique proteins for inclusion in the protein risk ...
- Source: drugdu
- 208
- January 4, 2024
Automated Liquid Biopsy Detects Brain Tumor Cells in Children

Brain and other central nervous system (CNS) cancers are the primary cause of cancer-related deaths in children, ranking as the second most prevalent form of childhood cancer following leukemia. For treating CNS tumors, healthcare professionals traditionally rely on a series of magnetic resonance imaging (MRI) scans to gauge the effectiveness of treatments such as surgery, chemotherapy, and radiation. However, MRI scans have limitations, particularly in detecting microscopic diseases that might signal residual or recurring cancer cells. To bridge this gap, scientists have been on a quest to identify reliable, tumor-specific biomarkers. Prior research in adults has demonstrated that primary tumors release circulating tumor cells (CTCs) into the bloodstream, suggesting that CTCs could serve as dependable biomarkers for CNS tumors. A recent study conducted by researchers at the University of Texas MD Anderson Cancer Center (Houston, TX, USA) aimed to determine the effectiveness of a liquid biopsy tool designed to detect ...
- Source: drugdu
- 252
- January 4, 2024
Novartis Returns to Voyager Therapeutics to Reach New Gene Therapy Destinations

Novartis is paying Voyager Therapeutics $100 million up front to collaborate on gene therapies for Huntington’s disease and spinal muscular atrophy. The deal builds on a relationship the companies started in 2022. By FRANK VINLUAN Novartis is committing $100 million to Voyager Therapeutics to see if the biotech’s technology can lead to new gene therapies for Huntington’s disease and spinal muscular atrophy. According to deal terms announced Tuesday, the sum is an upfront payment that includes a $20 million equity investment in Voyager. Milestone payments could bring the Lexington, Massachusetts-based biotech up to $1.2 billion more. If the partnership leads to commercialized therapies, Voyager would also receive royalties from sales. Gene therapies reach their bodily destinations carried aboard an engineered virus. The therapy’s genetic cargo is enveloped by a protein shell called a capsid. Voyager’s TRACER technology platform discovers capsids that can target particular types of tissue. In addition to ...
- Source: drugdu
- 284
- January 4, 2024
Longboard Pharma Trial Data Show How It Could Stand Out in the Epilepsy Field

Longboard Pharmaceuticals’ epilepsy drug candidate bexicaserin met the main efficacy goal of its Phase 1b/2a study along with safety data suggesting a potential edge over current treatments. With Longboard now preparing to advance to Phase 3 testing, its stock price soared more than 300%. By FRANK VINLUAN Longboard Pharmaceuticals is chasing much bigger companies already in the market with therapies for rare forms of epilepsy. The biotech has gone from saying its drug could be differentiated to claiming it has best-in-class potential. Longboard now has some early clinical data to help build that case. Longboard drug bexicaserin, formerly known as LP352, was tested in a placebo-controlled Phase 1b/2a study whose main goal is measuring the change in seizure frequency. Preliminary results released Tuesday show the bexicaserin group achieved a median 53.3% reduction in seizure frequency in the 75-day treatment period compared to a 20.8% median decrease in seizure frequency in ...
- Source: drugdu
- 195
- January 4, 2024
Beyfortus® Approved in China for the Prevention of Respiratory Syncytial Virus Infections in Infants

On January 2, 2024, AstraZeneca and Sanofi announced that the long-acting monoclonal antibody Beyfortus® (Nirsevimab/nisevizumab) has been officially approved for marketing by the State Drug Administration of China (SDA) for the prevention of Lower Respiratory Tract Infections (LRTIs) caused by Respiratory Syncytial Virus (RSV) in newborns and infants. The drug is indicated for newborns and infants who are entering or born during the first season of RSV infection. Nisevizumab is expected to be available in China during the 2024-2025 RSV infection season. Nisevizumab is the first and only* approved prophylaxis in China to protect the broader infant population against RSV infection, covering healthy term infants, preterm infants, and infants vulnerable to serious RSV infection due to specific health conditions. Nisevizumab was approved in China based on the results of three pivotal clinical trials and the Chinese clinical development program. For all clinical trial endpoints, a single injection of nisevizumab demonstrated ...
- Source: drugdu
- 170
- January 4, 2024
Tsinghua University, in collaboration with Minhai Biotechnology, discovers a novel immunoprotective mechanism for vaccine clearance of pathogenic bacteria

Vaccine immunization has dramatically reduced the morbidity and mortality of invasive bacterial infectious diseases such as bloodstream infections. Although a large number of studies have demonstrated that immune protection requires vaccine-induced antibody production, human beings still lack a clear understanding of the cellular and molecular mechanisms of how vaccines provide immune protection. The current international consensus is that vaccines provide immune protection by activating phagocytes in the spleen and blood circulation to remove pathogens that invade the bloodstream. Recently, Jingren Zhang’s group and Linqi Zhang’s group at Tsinghua University School of Medicine, together with Haifa Zheng’s group at Beijing Minhai Biotechnology Co., Ltd, published a paper in Science Translational Medicine titled “Liver macrophages and sinusoidal endothelial cells The research paper, entitled Liver macrophages and sinusoidal endothelial cells execute vaccine-elicited capture of invasive bacteria, reveals that the liver is the main organ that executes vaccine-elicited immunoprotection, and elucidates the molecular mechanism ...
- Source: drugdu
- 174
- January 4, 2024

your submission has already been received.

OK

Subscribe

Please enter a valid Email address！

Submit

The most relevant industry news & insight will be sent to you every two weeks.

more

more

Customer Services
Contact Us
Help Center

Buy on Drugdu.com
Browse Product Categories

Free APP

Follow Us

Terms & Conditions | Privacy Policy

粤ICP备16008861号

Copyright © 2016-2018 Drugdu.com. All Rights Reserved.