PharmaFocus Today – Page 195 – media

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
- 84
- 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
- 119
- 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
- 149
- 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
- 172
- 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
- 194
- 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
- 130
- 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
- 126
- 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
- 125
- January 4, 2024
MediLink Therapeutics and Roche reach exclusive global license agreement to collaborate on the development of next-generation antibody drug conjugates for cancer treatment

Suzhou, China, January 2, 2024 – Suzhou MediLink Therapeutics (“MediLink”) announced today that it has reached a global cooperation and licensing agreement with Roche. The two parties will collaborate to develop a next-generation antibody-drug conjugate product candidate YL211 (“c-MET ADC”) targeting mesenchymal epidermal transforming factor (c-MET) for the treatment of solid tumors. Under the terms of the agreement, Roche will obtain exclusive rights to the global development, manufacturing and commercialization of YL211. MediLink will work with the China Innovation Center of Roche (CICoR) to promote the YL211 project into phase I clinical trials, and Roche will be responsible for further development and commercialization work on a global scale. Roche will pay MediLink an upfront payment and near-term milestone payments of US$50 million, in addition to nearly US$1 billion in potential milestone payments for development, registration and commercialization, as well as future gradient royalties based on global annual net sales. About ...
- Source: drugdu
- 127
- January 4, 2024
World Health Organization adds second malaria vaccine to prequalification list

The World Health Organization (WHO) has said it has added a new malaria vaccine to its list of prequalified vaccines, marking a “significant milestone” in the prevention of the mosquito-borne disease. R21/Matrix-M, developed by the University of Oxford and the Serum Institute of India, is now the second malaria vaccine to be prequalified by the organisation following its prequalification of the RTS,S/AS01 vaccine in July 2022. Malaria places a particularly high burden on the African Region, where nearly half a million children die from the disease every year. Despite high demand, WHO outlined that the available supply of RTS,S has been limited and expects the addition of R21 to result in sufficient vaccine supply for children living in areas where malaria is a significant public health risk. Dr Kate O’Brien, director of WHO’s department of immunisation, vaccines and biologicals, said the decision marked “a huge stride in global health”. “This ...
- Source: drugdu
- 158
- 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.