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Drug Evaluation Articles & Analysis

28 news found

Validating The BLEO-Induced Mouse Model For Drug Discovery

Validating The BLEO-Induced Mouse Model For Drug Discovery

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 human disease are crucial. In this context, a recent study by Petersen et al (2024) has made significant strides in validating a well-known IPF mouse ...

BySCIREQ - an emka TECHNOLOGIES Company


Ace Therapeutics Unveils Model Development Services to Power Up Psychiatric Drug R&D

Ace Therapeutics Unveils Model Development Services to Power Up Psychiatric Drug R&D

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 effectiveness ...

ByAce Therapeutics


CD Formulation Offers Robust Expertise in Pharmacology to Aid Veterinary Drug Development

CD Formulation Offers Robust Expertise in Pharmacology to Aid Veterinary Drug Development

“Our extensive portfolio covers a range of pharmacological services essential for the intricate process of veterinary drug development. By offering tailored solutions in pharmacodynamics, pharmacokinetics, toxicology, and consistency evaluation, we endeavors to addresses the multifaceted challenges faced by veterinarians and researchers,” said the ...

ByCD Formulation


CD Formulation Enables Efficacy Evaluation of Oral Thin Films: Ensuring Therapeutic Efficacy and Safety

CD Formulation Enables Efficacy Evaluation of Oral Thin Films: Ensuring Therapeutic Efficacy and Safety

By conducting comprehensive efficacy evaluations using CD Formulation's advanced formulation techniques, pharmaceutical companies can streamline the drug development process and bring novel treatments to market more efficiently. In addition to enhancing the evaluation of oral thin films, CD Formulation's formulation technology also has the ...

ByCD Formulation


Securing the Integrity of Microneedle Structure Design and Optimization: CD Formulation's Performance Testing Approach   

Securing the Integrity of Microneedle Structure Design and Optimization: CD Formulation's Performance Testing Approach  

Microneedles have emerged as groundbreaking technology in the field of drug delivery, providing a more efficient and painless way of administering medicines. ...

ByCD Formulation


Alfa Chemistry Leads the Way in Tailored Preclinical Drug Research Solutions

Alfa Chemistry Leads the Way in Tailored Preclinical Drug Research Solutions

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 step in the drug ...

ByAlfa Chemistry


Alfa Chemistry: Custom Design Takes Organs-On-Chips to the Next Level

Alfa Chemistry: Custom Design Takes Organs-On-Chips to the Next Level

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 animal testing and ultimately transform the future of medicine. ...

ByAlfa Chemistry


Antengene Highlights Encouraging ATG-008 Efficacy Results From TORCH-2 Study in Combination with PD-1 Antibody in Relapsed/Metastatic Cervical Cancer

Antengene Highlights Encouraging ATG-008 Efficacy Results From TORCH-2 Study in Combination with PD-1 Antibody in Relapsed/Metastatic Cervical Cancer

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. ...

ByAntengene Corporation Limited


Full-Scale PROTAC In Vivo Evaluation Services to Facilitate PROTAC Drug R&D

Full-Scale PROTAC In Vivo Evaluation Services to Facilitate PROTAC Drug R&D

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. ...

ByBOC Sciences


New ARASENS data reinforce strong tolerability profile of darolutamide plus ADT and docetaxel without compromising quality of life for patients with mHSPC

New ARASENS data reinforce strong tolerability profile of darolutamide plus ADT and docetaxel without compromising quality of life for patients with mHSPC

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 Therapeutics Receives China Investigational New Drug (IND) Approval for the Phase 1 Study of IO-108, a Novel Antagonist Antibody Targeting LILRB2 (ILT4), in Patients with Solid Tumors

Immune-Onc Therapeutics Receives China Investigational New Drug (IND) Approval for the Phase 1 Study of IO-108, a Novel Antagonist Antibody Targeting LILRB2 (ILT4), in Patients with Solid Tumors

Multicenter Phase 1 study to evaluate IO-108 as both monotherapy and in combination with pembrolizumab in China Represents the first LILRB2-targeting antibody with IND clearance in China and the company’s fourth IND globally A Phase 1 trial evaluating IO-108 in patients with advanced solid tumors is currently enrolling in the U.S. ...

ByImmune-Onc Therapeutics, Inc.


U.S. FDA accepts supplemental new drug application (sNDA) and grants priority review for darolutamide in combination with docetaxel for metastatic hormone-sensitive prostate cancer (mHSPC)

U.S. FDA accepts supplemental new drug application (sNDA) and grants priority review for darolutamide in combination with docetaxel for metastatic hormone-sensitive prostate cancer (mHSPC)

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


FB2001 (Bofutrelvir) Phase II/III Clinical Trial Protocol Approved by NMPA

FB2001 (Bofutrelvir) Phase II/III Clinical Trial Protocol Approved by NMPA

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 of Bufutrelvir for ...

ByFrontier Biotechnologies Inc.


Report On Activities For The Quarter Ended 31 March 2022

Report On Activities For The Quarter Ended 31 March 2022

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. ...

ByBiotron Limited


Fc Fusion Protein Production Service Now Available at Profacgen

Fc Fusion Protein Production Service Now Available at Profacgen

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. ...

ByProfacgen


Cara Therapeutics Announces Difelikefalin (KORSUVA) Injection Achieves Positive Topline Results in Phase 3 Clinical Study in Japan for the Treatment of Pruritus in Hemodialysis Patients

Cara Therapeutics Announces Difelikefalin (KORSUVA) Injection Achieves Positive Topline Results in Phase 3 Clinical Study in Japan for the Treatment of Pruritus in Hemodialysis Patients

” 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. ...

ByCara Therapeutics.


Creative Proteomics Pronalyse Releases Charge Heterogeneity Analysis Service for Protein Drug Discovery

Creative Proteomics Pronalyse Releases Charge Heterogeneity Analysis Service for Protein Drug Discovery

Pronalyse is a new division of Creative Proteomics, which is an integrated CRO with rich experience in providing drug development services for over 10 years. To assist customers in understanding the changes in protein charge heterogeneity throughout manufacturing and purification, Creative Proteomics Pronalyse offers antibody drug charge variant analysis services ...

ByCreative Proteomics


Immunai Raises $215 Million to Accelerate Development of Its Immune-First Drug Actuary Platform

Immunai Raises $215 Million to Accelerate Development of Its Immune-First Drug Actuary Platform

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 finding the answers to human health and disease,” said Noam Solomon, PhD, CEO and co-founder of ...

ByImmunai


Axial Therapeutics Receives FDA Clearance of IND Application and Initiates Phase 2b Trial for AB-2004, Lead Gut-Targeted, Molecular Therapeutic for the Treatment of Irritability in Autism Spectrum Disorder

Axial Therapeutics Receives FDA Clearance of IND Application and Initiates Phase 2b Trial for AB-2004, Lead Gut-Targeted, Molecular Therapeutic for the Treatment of Irritability in Autism Spectrum Disorder

We are now taking the next major step toward realizing the potential of our innovative gut-targeted therapeutic approach by evaluating AB-2004 in a multi-national, randomized, placebo-controlled Phase 2b trial, which we have just ...

ByAxial Therapeutics Inc.


CD Formulation Unveils Hygroscopicity Evaluation for Drug Formulation

CD Formulation Unveils Hygroscopicity Evaluation for Drug Formulation

As excessive amounts of water will adversely affect the physical and chemical stability of the API and the functionality of the excipients, determining hygroscopicity is therefore a very critical step, especially for drugs that degrade greatly in the presence of water. “Usually, moisture absorption evaluations start from the early stages of ...

ByCD Formulation

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