Under the terms of the agreement, Univercells will test in vitro and in vivo a proprietary mRNA vaccine delivered with Altamira’s SemaPhore nanoparticle platform Altamira Therapeutics, a company providing nanoparticle-based technology for efficient RNA delivery to extrahepatic targets has announced that it has entered into a collaboration agreement with Univercells Group to evaluate the use of the Company’s proprietary SemaPhore platform for the delivery of mRNA vaccines. Univercells is a global life sciences company creating platforms for developing and manufacturing biologics, including mRNA vaccines and therapeutics, in a simple, scalable and cost-efficient way. Under the terms of the agreement, Univercells will test in vitro and in vivo a proprietary mRNA vaccine delivered with Altamira’s SemaPhore nanoparticle platform. Should the experiments prove successful, Univercells and Altamira intend to discuss and negotiate a commercial agreement for the development and manufacturing of nanoparticle-based mRNA vaccines using Univercells’ production platform. Covadonga Pañeda, PhD, Altamira’s ...
The agreement includes Cardior’s lead compound CDR132L, currently in phase 2 clinical development for the treatment of heart failure Novo Nordisk and Cardior Pharmaceuticals has announced that Novo Nordisk has agreed to acquire Cardior for up to 1.025 billion Euros, including an upfront payment and additional payments if certain development and commercial milestones are achieved. The agreement includes Cardior’s lead compound CDR132L, currently in phase 2 clinical development for the treatment of heart failure. Martin Holst Lange, executive vice president for Development at Novo Nordisk said, “By welcoming Cardior as a part of Novo Nordisk, we will strengthen our pipeline of projects in cardiovascular disease where we already have ongoing programmes across all phases of clinical development. We have been impressed by the scientific work carried out by the Cardior team, especially on CDR132L, which has a distinctive mode of action and potential to become a first-in-class therapy designed to ...
The self-replicating mRNA molecule could be used in cancer and potentially a broad range of other diseases Strand Therapeutics, a Massachusetts Institute of Technology (MIT) spinout, has developed a new class of advanced mRNA molecules for more targeted and powerful treatments for cancer. The new class of mRNA molecules is designed to sense what type of cells they encounter in the body and express therapeutic proteins once they have entered diseased cells. Most next-generation cancer immunotherapies are based on recombinant proteins, which are challenging to deliver to specific targets in the body and do not remain active for long enough to create a durable response. Strand has developed the world’s first mRNA programming language to improve mRNA molecules’ ability to sense their environment and generate targeted responses where needed most, allowing the company to specify the tissues its mRNAs express proteins in. In addition, the company uses techniques such as ...
Veeda Clinical Research has acquired Heads, a privately held European CRO, which specialises in conducting clinical trials in oncology. Established in 2010, Heads has operational presence in 25 multiple strategically important locations across Europe, North America and Asia Pacific region. Veeda expands its reach to major geographies and adds capabilities of late-sta. ge clinical trial execution with strong focus on oncology with this acqusition The acquisition provides Heads a strong operational platform and an opportunity to expand its expertise and capabilities to the Indian and South-East Asian markets. With this acquisition, Veeda’s global pharma and biotech clients can now avail early to late-phase CRO services across Europe, US, and Asia Pacific. During the integration phase, Heads will continue to offer uninterrupted support to client programs. https://www.vspharma.in/veeda-clinical-research-acquires-heads-a-european-cro/
Drugdu.com expert’s response: The MDR technical documentation required for medical device registration in the European Union typically includes the following components: 1.General Information: Basic product information, manufacturer details, product classification, and product description. 2.Design and Manufacturing Information: Details about the product’s design process, manufacturing process, material selection, assembly process, etc. 3.Performance and Functionality: Expected use of the product, performance indicators, technical specifications, functional descriptions, etc. 4.Risk Analysis: Analysis and assessment of potential risks associated with the product, including descriptions of control measures and risk management plans. 5.Clinical Evaluation: Clinical trial data and assessment results for the product, including trial design, results, safety, and efficacy data. 6.Summary of Technical Documentation: Comprehensive summary and explanation of the above content to ensure the integrity and consistency of the documentation. Additionally, depending on the specific characteristics and classification of the product, other relevant information and documents may be required to ensure compliance with the ...
Don Tracy, Associate Editor Deal includes the novel treatment CDR132L, which is currently in Phase II clinical trials for heart failure. Novo Nordisk announced that it has acquired Cardior Pharmaceuticals in hopes of improving its pipeline in cardiovascular disease management. The acquisition includes Cardior’s top drug candidate, CDR132L, which is currently in Phase II of clinical development for treating heart failure. Under terms of the agreement, Cardor has the potential to earn up to $1.112 billion, including an upfront payment and the opportunity for more payments pending the completion of certain development and commercial milestones.1 “By welcoming Cardior as a part of Novo Nordisk, we will strengthen our pipeline of projects in cardiovascular disease where we already have ongoing programs across all phases of clinical development,” said Martin Holst Lange, EVP, development, Novo Nordisk, in a press release. “We have been impressed by the scientific work carried out by the ...
Parkinson’s disease and a group of related neurodegenerative disorders known as synucleinopathies impact millions globally. These conditions, including Parkinson’s disease (PD), dementia with Lewy bodies (DLB), multiple system atrophy (MSA), and pure autonomic failure (PAF), are progressive neurodegenerative diseases that, despite having some similar symptoms like tremors and cognitive issues, vary in their outcomes and do not benefit from identical treatments. A common feature among them is the accumulation of an abnormal protein in nerve fibers within the skin, known as phosphorylated α-synuclein (P-SYN). Now, neurologists have developed a simple skin biopsy test that can detect this abnormal form of alpha-synuclein with high positivity rates in individuals with such disorders. In the study, neurologists at Beth Israel Deaconess Medical Center (BIDMC, Boston, MA, USA) enrolled 428 people, ages 40-99 years who were either diagnosed with one of the synucleinopathies based on clinical evaluations confirmed by specialists or were healthy volunteers ...
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 ...
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 ...
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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