Drug Safety Evaluation Articles & Analysis
27 news found
Idiopathic pulmonary fibrosis (IPF) is a devastating disease characterized by progressive scarring of the lungs, which severely impairs lung function over time. Developing effective treatments for IPF has been a challenge for the medical community, as the mechanisms driving this disease are complex and not fully understood. To accelerate drug discovery, animal models that closely mimic the ...
The process of antipsychiatric drug development typically involves several stages, including identifying potential drug targets, conducting preclinical research to test the safety and efficacy of potential drug candidates, and then moving on to clinical trials to further evaluate the drug’s ...
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 ...
A breakthrough in CD formulation has enabled researchers to evaluate the efficacy of oral thin films, ensuring both therapeutic efficacy and safety. ...
CD Formulation, a leading provider of innovative drug delivery solutions, has recognized the critical importance of performance testing to ensure the efficiency and safety of microneedles. ...
These services encompass cell-level screening, identification of cell lines and models, genotyping services for rats and mice, PET-CT services, and flow cytometry services. Drug Safety Evaluation Services One of the core services offered by Alfa Chemistry is drug safety evaluation. This critical ...
In a groundbreaking move to revolutionize the field of biomedical research, Alfa Chemistry recently announced the launch of its highly anticipated custom organs-on-chips service. This cutting-edge technology provides scientists and researchers with an innovative platform to study human organs in a way that was previously impossible, promising to accelerate drug discovery, reduce the need for ...
About the TORCH-2 Trial The TORCH-2 trial (NCT04337463) was designed to evaluate the safety and efficacy of ATG-008 combined with toripalimab (PD-1 antibody) in subjects with advanced solid tumors. ...
In the process of drug development, the evaluation of drug effectiveness is one of the keys to determining whether prodrugs can sufficiently reach the market stage. ...
Bayer recently received U.S. Food and Drug Administration (FDA) approval for darolutamide in combination with docetaxel in mHSPC patients and has submitted applications in mHSPC to the European Medicine Agency (EMA), the Ministry of Health, Labour and Welfare (MHLW) in Japan, and China’s Center of Drug Evaluation (CDE). ...
ByBayer AG
(“Immune-Onc”), a private, clinical-stage cancer immunotherapy company developing novel biotherapeutics targeting myeloid checkpoints, today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has approved the Investigational New Drug (IND) application to initiate a Phase 1 ...
Bayer today announced the U.S. Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for the oral androgen receptor inhibitor (ARi) darolutamide in combination with docetaxel for the treatment of metastatic hormone-sensitive prostate cancer (mHSPC). ...
ByBayer AG
Frontier Biotech (stock code: 688221.SH) announced that the Phase II/III clinical study protocol of FB2001 (generic name: Bofutrelvir) is approved by the Center for Drug Evaluation, NMPA. The study is a worldwide multi-center, randomized, double-blind and placebo-controlled Phase II/III trial to evaluate the safety and efficacy ...
As in the previous study announced in November 2021, the BIT225 treated mice once again had significantly lower viral loads of SARS-CoV-2 in their lungs compared to drug free control animals. BIT225 belongs to a new class of antiviral drugs known as viroporin inhibitors. ...
Profacgen, a state-of-the-art protein service provider located in the USA, provides comprehensive one-stop services for pre-clinical drug development, aiming to evaluate and improve the efficacy and safety of new drug candidates. ...
” KORSUVA™ (difelikefalin) injection was approved by the U.S. Food and Drug Administration in August 2021 for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. ...
All changes in quantity or structure will lead to the heterogeneity of antibody charge distribution, thereby affecting the biological activity, pharmacokinetics, immunogenicity and structural stability of antibody drugs. The existence of charge isomers will affect the activity, binding ability, pharmacokinetics, immunogenicity and structural stability of protein ...
Immunai, a New York-based biotech company, today announced a $215M Series B, increasing the company’s total funding to date to $295M. The new capital will be used to expand Immunai’s “drug actuary” platform for target validation and evaluation. “We have made great progress towards our core mission of understanding the immune system, which we believe is essential to ...
ByImmunai
For solid dosage formulation chemists, it is usually a formidable task to crystalize the moisture adsorption conditions for pharmaceutical substances. To help researchers better solve this problem, CD Formulation avails its position in the industry as a contract service provider and announces to offer hygroscopicity evaluation for custom pharmaceutical formulation projects. Hygroscopicity is a ...
Lyra Therapeutics, Inc. (Nasdaq: LYRA), a clinical-stage therapeutics company leveraging its proprietary XTreo™ platform to enable precise, sustained, and local delivery of medications to the ear, nose and throat (ENT) passages and other diseased tissues, today announced that four abstracts highlighting LYR-210 results in chronic rhinosinusitis and the XTreo™ platform have been ...