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Drug Safety Articles & Analysis
43 news found
The Food and Drug Administration’s (FDA) recent Roadmap to Reducing Animal Testing in Preclinical Safety Studies marks a pivotal shift toward the adoption of innovative, human-relevant methodologies commonly known as New Approach Methodologies (NAMs). ...
Obtaining the Marketing Authorisation Application (MAA) is a key step in the commercialization of drugs in the EU, and also an important help to promote the global market expansion of pharmaceutical companies. ...
Ace Therapeutics Psychiatry Team is committed to supporting scientists in making groundbreaking scientific discoveries and developing new applications to accelerate drug discovery and the scientific diagnosis and treatment of antipsychotic disorders. ...
Toxicology is another cornerstone of its service suite, crucial for ensuring that new veterinary drugs meet strict safety standards. By conducting meticulous toxicological assessments, CD Formulation identifies potential side effects and toxicities, enabling the refinement of drug formulations before they reach the market. This proactive approach ...
The design of such drug carriers also helps to overcome some of the limitations of conventional drugs such as biostability, water solubility and drug distribution in the body. ...
STEMart, a US-based provider of comprehensive services for all phases of medical device development, announced the launch of its new Force Degradation Services to help pharmaceutical and medical device companies evaluate the stability of their drug candidates and finished products under a variety of stress conditions, ensuring their safety and efficacy throughout ...
BySTEMart
Alfa Chemistry serves as an emerging pharmaceutical research organization with a mission to revolutionize the field of preclinical drug research with its wide range of comprehensive services. With a commitment to quality and excellence, Alfa Chemistry offers pharmacological analysis, drug safety evaluation, pharmacokinetic analysis, and ...
It plays a crucial role in drug design and screening, as it enables modeling and prediction of interactions between proteins and small molecules, allowing customers to better understand drug mechanisms of action and optimize candidate compounds. ...
– a leader in stem cell tissue engineering providing a novel solution in first-in-class drug discovery – announced today a strategic collaboration to market the time-dependent fluorescent assessment of engineered 3D heart tissues using advanced microplate reader technologies. ...
Cardiovascular safety liabilities remain the major cause of costly drug withdrawals (e.g. 52.3 % drug withdrawals were cardiac safety related between 1980-2011). Our engineered heart tissue based phenotypic analyzer enables scientists to address cardiac safety issues and identify their mechanisms for rapid ...
Ezisurg Medical’s staplers have been approved by the Saudi Food and Drug Authority recently. This is the latest achievement made in Ezisurg Medical’s international sector, soon after finishing CE and FDA certification or ...
Destiny Pharma plc (AIM: DEST), a clinical stage innovative biotechnology company focused on the development of novel medicines that can prevent life-threatening infections, is pleased to announce the commencement of an Investigational New Drug (IND) enabling safety study with its novel XF-73 Dermal formulation. This study is the second of two planned ...
“Antengene is currently conducting eight clinical studies of XPOVIOâ in mainland China for the treatment of patients with relapsed/refractory hematologic malignancies or solid tumors, and the drug’s safety and efficacy have already been validated in five registrational trials. Moving forward, we will strive to develop and commercialize more ...
This strategically important decision follows a recent preclinical proof-of-concept study with GS-248 in an advanced model of endometriosis, where disease-modifying properties of the drug candidate were firmly established. These data together with the previously demonstrated favorable clinical safety profile of GS-248 and the significant unmet medical need form ...
Buprenorphine is a medication approved by the U.S. Food and Drug Administration (the “FDA”) to treat OUD as a medication-assisted treatment (MAT). ...
Gesynta Pharma AB today announces results from an exploratory Phase II study of the candidate drug GS-248 in systemic sclerosis patients. GS-248 was well tolerated, exhibited a favorable safety profile, and elicited a potent systemic inhibition of the target enzyme mPGES-1. ...
Earlier this month, CD Formulation announces that it is now capable of providing nitrosamine impurities analysis service for customers who are involved with drug formulation projects and need help from CRO companies like CD Formulation. ...
“We have established an approach that transforms real-world, in-human treatment outcomes and safety data into extensive datasets to better characterize desirable and undesirable interactions between molecular pathways and drugs,” explains Dr. ...
For researchers who are troubled by insoluble or poorly soluble drugs, CD Formulation is now prepared to avail its capability, helping to find the most appropriate approach to assist their drug development projects “While our scientific team creates new ways to revitalize failed or discontinued products for our clients, we also help to develop revitalize ...
In addition, Theramx, which launched EG-Q, is a company that has been certified by the Ministry of Food and Drug Safety, CE certification, and international standard quality such as ISO13485. ...