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 ...
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 ...
It’s reported according to businesswire, AriBio recently announced that it has signed a licensing agreement for the exclusive marketing rights of AR1001, an investigational drug for the treatment of early Alzheimer’s disease, in China at a price of up to US$770 million. Considering the market competition and sales strategy of Alzheimer’s disease drugs in China, the licensee requested that no disclosure be made until the agreed time. The agreement includes an upfront non-refundable payment of 120 billion won (approximately US$90 million), with a total transaction value of up to 5.59 billion yuan (approximately US$770 million), including milestone payments and additional royalties. Upfront payments will begin in mid-2024. AR1001 is a phosphodiesterase type 5 (PDE5) inhibitor in development and an investigational oral drug for the treatment of Alzheimer’s disease. Pre-clinical studies have confirmed that AR1001 can inhibit neuronal apoptosis and restore synaptic plasticity, thus having neuroprotective effects. AR1001 also demonstrated a ...
The Companion+ Mobile Safety App will be rolled out to a further 115 users within the UK and US Inizio Engage has announced that it has teamed up with Applied Driving to support its clinical team as well as other lone workers using the Companion+ Mobile Safety App, a safer driving and personal safety solution. The app has been rolled out to 65 mobile employees, with plans to expand to a further 115 users within the UK and US. Developed by Applied Driving, Companion+ is designed to improve driver behaviour while protecting users in a sphere of safety. Comprising safety messages, video or e-learning modules tailored to the user’s specific needs, the app automatically sends triggered training to users after assessing at-risk driving events. “Companion+ will offer our mobile clinical team discreet safety and security, anytime,” said Caroline McGlynn, head of clinical solutions, Inizio Engage. “The… app possesses advanced functionality ...
According to the World Health Organization, TB is responsible for over one million annual deaths Researchers from the National Institute for Health and Care Research’s (NIHR) Southampton Biomedical Research Centre have identified a group of biological markers of tuberculosis (TB) found in high levels among infected patients. Published in the Journal of Clinical Investigation Insight for World TB Day (24 March 2024), findings from the study could advance a simple blood test to speed up the diagnosis of the infection. According to the World Health Organization, TB is the world’s deadliest infectious disease, caused by a bacterium known as Mycobacterium tuberculosis, which is responsible for more than one million deaths each year. Estimated to affect ten million people globally every year, the highly contagious and easily transmitted TB spreads through the air when infected people cough, sneeze or spit, often affecting the lungs. Supported by the NIHR and the UK ...
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