Preclinical Data Articles & Analysis
175 news found
The ANDA contains information used for the review and approval of a generic drug product, and does not typically require preclinical and clinical trial data, but rather requires the inclusion of information on bioequivalence to the RLD. ...
The Neeka team has completed extensive due diligence on our science, preclinical data package, and our proprietary formulations prior to selecting CanaQuest as their cannabinoid partner for clinical studies and we are looking forward to a long-standing relationship and continuing to put science at the forefront of our company,” said Paul Ramsay, President ...
Bayer presents first Phase 1 results from its most advanced clinical Immuno-Oncology program, aryl hydrocarbon receptor (AhR) inhibitor BAY2416964 New preclinical data on Bayer’s DGK zeta inhibitor being featured in oral presentation in New Drugs on the Horizon session New preclinical data on mutEGFR HER2 program, ...
ByBayer AG
The low potential for blood-brain barrier penetration for darolutamide is supported by preclinical models and neuroimaging data in healthy humans. This is supported by the overall low incidence of central nervous system (CNS)-related adverse events (AEs) compared to placebo as seen in the ARAMIS Phase III trial6 and the improved verbal learning and memory ...
ByBayer AG
Nubeqa now approved for metastatic hormone-sensitive prostate cancer as well as non-metastatic castration-resistant prostate cancer Additional indication based on data from the pivotal Phase III ARASENS trial The Chinese National Medical Products Administration (NMPA) has approved the oral androgen receptor inhibitor (ARi) Nubeqa™ (darolutamide) in combination with ...
ByBayer AG
European Commission granted approval of Nubeqa (darolutamide) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) Approval is based on Phase III ARASENS trial data The European Commission has granted marketing authorization in the European Union (EU) for Nubeqa™ (darolutamide), an oral androgen receptor inhibitor (ARi), plus ...
ByBayer AG
Darolutamide approved for metastatic prostate cancer as well as non-metastatic castration-resistant prostate cancer New approval based on data from the pivotal Phase III ARASENS trial The Ministry of Health, Labor and Welfare (MHLW) in Japan has approved the oral androgen receptor inhibitor (ARi) darolutamide plus ADT in combination with docetaxel in the indication of ...
ByBayer AG
The antibody was transferred to Aulos Bioscience, a Biolojic spinoff that is now conducting clinical trials in Australia and is currently recruiting patients, with hopes of reporting interim data later this year. Computational design of antibodies such as AU-007 is a novel approach that Biolojic Design Founder and CEO Yanay Ofran has been developing for more than 10 years ...
Lurie Comprehensive Cancer Center of the Northwestern University Feinberg School of Medicine, Chicago, USA. “The growing data from the ARASENS trial continue to demonstrate darolutamide’s value in treating patients with mHSPC. ...
ByBayer AG
Kappa and delta opioid agonists have been shown to provide analgesic benefit while sparing toxic mu agonist toxicity1 . Preclinical data supports analgesia from enkephalin without significant opioid tolerance, or drug liking. ...
Efficient transfer of larger gene via ViGeneron’s proprietary technology platforms REVeRT and vgAAV ViGeneron advances its preclinical programs for Stargardt disease and Retinitis Pigmentosa into IND-enabling activities and clinical stage development ViGeneron GmbH, a next-generation gene therapy company, today announced the presentation of ...
CHMP recommendation is based on Phase III data, which demonstrated that darolutamide plus androgen deprivation therapy (ADT) in combination with docetaxel significantly reduced the risk of death by 32.5% compared to ADT with docetaxel alone, with similar overall rates of adverse events between study arms European Commission decision on granting a marketing authorization is ...
ByBayer AG
Dirbas will serve as Chair of the SAB, which provides guidance for ongoing preclinical studies as well as ongoing and planned future clinical trials in the use of UNO to treat solid tumors. ...
(NASDAQ: ORGS) (“Orgenesis” or the “Company”), a global biotech company working to unlock the full potential of cell and gene therapies, and Kurve Therapeutics, a next-generation medtech and drug formulation company, today announced positive preclinical study results for intranasal administration of a cell-based oncolytic virus bearing product. ...
Based on extensive published preclinical data (see www.lixte.com), LB-100 has the potential to significantly improve outcomes for patients undergoing various chemotherapies or immunotherapies. ...
The data were published in an article entitled, “Gaseous Nitric Oxide Tumor Ablation Induces an Anti-Tumor Abscopal Effect,” in the peer-reviewed journal Cancer Cell International (“CCI”). ...
PHILADELPHIA, Dec. 08, 2022 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a women’s oncology company developing novel treatments for breast and gynecologic cancers, announced preliminary Phase 2 data from the ongoing SMILE trial of onapristone extended release (ONA-XR), the company’s novel, first-in-class, potent, ...
Oligomerix, Inc., a privately held company pioneering the development of small molecule therapeutics targeting tau for rare neurodegenerative and Alzheimer’s diseases, today announced the presentation of IND-enabling preclinical data on its lead product candidate OLX-07010 at the annual Clinical Trials on Alzheimer's Disease (CTAD) and Society for ...
Based on extensive published preclinical data (see www.lixte.com), LB-100 has the potential to significantly improve outcomes for patients undergoing various chemotherapies or immunotherapies. ...
Inversago Pharma Inc. (“Inversago”), a clinical stage biotech company with a unique portfolio of peripherally-acting CB1 inverse agonists, today announced that the first patient has been dosed with INV-202 in a Phase 2 clinical trial in subjects with diabetic kidney disease (DKD). The Phase 2 trial of INV-202, a first-in-class, peripherally-acting CB1 inverse agonist, is a ...