Mabwell announced a supply and commercialization agreement with an Indian pharmaceutical company for 9MW0813 (aflibercept intraocular injection, Eylea® biosimilar). According to the agreement, the cooperative company has obtained the exclusive rights to import, produce, register, market and sell 9MW0813 in India, and has the right to obtain non-exclusive rights in 10 countries, including some countries in South Asia and Africa. 9MW0813 is a biosimilar of Eylea® and has completed phase III enrollment in clinical studies in China. Based on the principles of comparative and incremental development and comprehensive evaluation of drugs, pharmaceutical, non-clinical and clinical comparison results indicate that 9MW0813 is highly similar to the originator product in terms of quality, safety and effectiveness. About 9MW0813 9MW0813 is a recombinant human vascular endothelial growth factor receptor-antibody fusion protein, indicated for diabetic macular edema and neovascular (wet) age-related macular degeneration. 9MW0813 is a biosimilar of aflibercept (Eylea®). It is a fusion ...
WHO has launched a new network for coronaviruses, CoViNet, to facilitate and coordinate global expertise and capacities for early and accurate detection, monitoring and assessment of SARS-CoV-2, MERS-CoV and novel coronaviruses of public health importance. CoViNet expands on the WHO COVID-19 reference laboratory network established during the early days of the pandemic. Initially, the lab network was focused on SARS-CoV-2, the virus that causes COVID-19, but will now address a broader range of coronaviruses, including MERS-CoV and potential new coronaviruses. CoViNet is a network of global laboratories with expertise in human, animal and environmental coronavirus surveillance. The network currently includes 36 laboratories from 21 countries in all 6 WHO regions. Representatives of the laboratories met in Geneva on 26 – 27 March to finalize an action plan for 2024-2025 so that WHO Member States are better equipped for early detection, risk assessment, and response to coronavirus-related health challenges. The CoViNet ...
On March 25th, Jiangsu Ruike Biotechnology Co., Ltd (hereinafter referred to as “Ruike Biotechnology”, stock code: 02179.HK) and Shanghai Rongsheng Biopharmaceutical Co. (hereinafter referred to as “Rongsheng Biopharmaceuticals”) in Shanghai. At the meeting, both parties signed a strategic cooperation agreement on the new adjuvant vaccine project and discussed the details of the project. Adjuvant is an important component in the development of vaccines, and new adjuvants have become the key to the success of innovative vaccine research and development. According to the terms of the agreement, the two parties will jointly carry out the development of new adjuvant vaccines, with Ruike Biologicals providing new adjuvants independently developed based on the new adjuvant technology platform, and Rongsheng Biologicals providing viral antigens independently designed by Rongsheng Biologicals. The project will improve the immunogenicity of existing Rongsheng Bio’s vaccines under development by empowering them with novel adjuvants for the purpose of optimizing immunization ...
On the afternoon of March 25, Yin Li, Secretary of the Municipal Party Committee of Beijing, met with Novartis Global CEO Wansheim, Pfizer Chairman and CEO Eberle, and Danaher Global President and CEO Bjørnen. Yin Li introduced the economic and social development of Beijing and the health condition of its residents. He said that the Beijing Municipal Government attaches great importance to residents’ health, vigorously develops health care, gives full play to the advantages of rich scientific and technological talent resources, and continuously improves the level of medical services for the people in the city. Beijing’s pharmaceutical and health industry has a good foundation and a perfect system. In recent years, it has laid out its biopharmaceutical industry in key areas such as cellular genes, nucleic acid drugs, new antibodies, etc., and has formed international leading source innovative varieties in the fields of antibody drugs and immunotherapy drugs. Beijing’s science ...
The progressive and incurable brain disorder currently affects approximately 100 patients worldwide LifeArc has announced that it has funded a pivotal clinical trial at the University of Cambridge for £750,000 to re-purpose a UK-licensed medicine to treat the ultra-rare genetic disease neuroferritinopathy. The recently launched DefINe trial aims to stop the progression of the disease with an existing drug known as Ferriprox (deferiprone), manufactured by Chiesi Global Rare Diseases. Affecting approximately 100 patients worldwide, neuroferritinopathy is a progressive and incurable brain disorder caused by changes in a gene that produces the ferritin light chain protein. This change can lead to a build-up of iron in the brain, which can cause severe symptoms such as loss of speech and swallowing. With currently no effective treatments available to treat the condition, the new randomised, placebo-controlled trial aims to reduce the iron accumulation in the brain using Ferriprox, an affordable oral tablet licensed ...
PhaSER will provide 8HUM mouse models for the TDI to accelerate a pipeline of novel therapeutic targets PhaSER Biomedical has announced its long-term partnership with the Sanders Tri-Institutional Therapeutic Discovery Institute (TDI) to advance the institute’s pre-clinical drug discovery research. Based in the US, the TDI comprises the Memorial Sloan Kettering Cancer Center, Rockefeller University and Weill Cornell Medicine. The TDI, first formed in 2013, aims to provide academic investigators with access to industrial-scale tools and techniques, to more effectively accelerate drug discovery and bring new cures to patients with the greatest medical need. As part of the ten-year agreement, PhaSER will provide 8HUM mouse models for TDI to use to accelerate and improve drug discovery on a pipeline of novel targets in a variety of therapeutic areas. PhaSER’s 8HUM unique mouse models aim to transform the ways drugs are metabolised in humans and use multiple applications in drug discovery ...
Merck drug Winrevair is the first in a new class of pulmonary arterial hypertension therapies that address a key signaling pathway behind the disease. The drug comes from Merck’s $11.5 billion acquisition of Acceleron Pharma. By FRANK VINLUANPulmonary arterial hypertension, a disease that leads to worsening lung and heart problems that eventually become life-threatening, is treated with drugs that alleviate symptoms. FDA approval of a new Merck drug marks the first for a therapy addressing an underlying cause of the disease. The Tuesday approval of the Merck drug covers the treatment of adults whose pulmonary arterial hypertension (PAH) is at intermediate or high risk of progression. The drug, known in development as sotatercept, will be marketed under the brand name Winrevair. Hypertension—high blood pressure—is common. PAH is a rare form of hypertension that specifically affects the arteries carrying blood from the right side of the heart and into the lungs. ...
Don Tracy, Associate Editor Reportedly, the oral weight loss pill VK2735 showed promising signs of effectiveness and a tolerable safety profile. Today, Viking Therapeutics announced promising results from a Phase I trial of VK2735, an investigational oral tablet targeting both GLP-1 and GIP receptors for the treatment of metabolic disorders, such as obesity. Results from the 28-day trial show that patients administered VK2735 experienced up to 5.3% weight loss, Additionally, 57% achieved more than 5% in weight loss resulting from treatment with VK2735, a major difference compared to those treated with a placebo. The tablet’s safety profile was reported to be well tolerated, with most adverse effects (AEs) being mild and no serious AEs reported.1 “These Phase I results highlight VK2735’s promising early weight loss and tolerability profile when dosed as an oral tablet,” said Brian Lian, PhD, CEO, Viking, in a press release. “We believe these data indicate that ...
Kidney failure poses a significant threat to life if not adequately treated, yet precise diagnosis often eludes patients, leaving them uncertain about the best treatment approach. Now, a groundbreaking advancement by scientists has led to the discovery of a new technique for examining genomic data that could offer an accurate diagnosis for those suffering from unexplained kidney failure. Researchers from Newcastle University (Newcastle upon Tyne, UK) used data from the Genomics England 100,000 Genomes Project to establish a diagnosis for patients facing unexplained kidney failure. They discovered that certain segments of these patients’ genomes were absent, as a result of which their conditions went undiagnosed with standard genetic analysis techniques. The researchers have now identified this missing gene and found the mutations within it, allowing them to classify this as NPHP1-related -related kidney failure. For their study, the team reviewed the genetic sequencing data of 959 individuals with advanced kidney ...
Amyotrophic lateral sclerosis (ALS, also known as Lou Gehrig’s disease) and frontotemporal dementia (FTD) are two progressively neurodegenerative conditions that damage essential nerve cells. ALS compromises nerve cells in the brain and spinal cord, leading to movement impairment, while FTD damages brain areas responsible for personality, behavior, and language. Studies indicate that in ALS or FTD patients, TAR DNA-binding protein 43 (TDP-43) malfunctions. This disruption prevents the correct splicing of ribonucleic acid (RNA), essential for generating proteins necessary for nerve growth and function. Instead, RNA strands become riddled with erroneous code sequences, known as “cryptic exons,” which are linked to an elevated risk of developing ALS and FTD. The timing of this anomaly in the disease progression of ALS and FTD was previously unknown. Now, researchers from Johns Hopkins Medicine (Baltimore, MD, USA) have developed a method for identifying a specific protein, hepatoma-derived growth factor-like 2 [HDGFL2], linked to TDP-43 ...
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