Oral Use Articles & Analysis
60 news found
Asundexian is an investigational agent and has not been approved by any health authority for use in any country, for any indication. It is currently being evaluated as a potential once-daily oral Factor XIa (FXIa) inhibitor in thrombosis prevention with the goal to reduce clot formation while leaving the body’s ability to respond to bleeding intact. ...
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
High-volume disease was defined as visceral metastases and/or ≥4 bone metastases with ≥1 beyond the vertebral column/pelvis, as delineated in the CHAARTED criteria. High-risk disease was defined using the LATITUDE criteria, which includes ≥2 risk factors: a Gleason score of ≥8, ≥3 bone lesions, and the presence of measurable visceral metastasis. ...
ByBayer AG
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 anticipated within ...
ByBayer AG
Due to the aging population, the increase in the widespread use of electronic screens (especially during the COVID-19 pandemic), the prolonged use of contact lenses, and the increasing frequency of myopia laser surgery, the global dry eye population has risen rapidly in recent years, especially amongst younger age groups. ...
Observed only mild and transient adverse events, with no use of emergency epinephrine Observed 98.4% patient compliance to date with novel OMIT therapeutic modality Safely started patients on dose 4, potentially reducing the time to reach maintenance by several weeks NEW YORK, Oct. 26, 2022 (GLOBE NEWSWIRE) -- Intrommune Therapeutics, Inc., a New York-based, clinical stage ...
These injections can also help patients get off oral medications they were using for pain relief and they can help postpone surgery. ...
Uncontrolled gout occurs when people living with gout continue to have high levels of uric acid and gout symptoms despite the use of standard oral urate-lowering ...
Data from a new post-hoc analysis from FIDELITY evaluated the effects of Kerendia on kidney and CV outcomes by use of glucagon-like peptide-1 receptor agonists (GLP-1RA) at baseline. ...
ByBayer AG
Founded in 2020 in response to the COVID-19 pandemic, Virusight, which is an AI software company, was created to develop an accurate, real-time virus diagnosis solution. The company uses unique spectral acquisition and analysis technology, for pathogenic diagnosis. The company is currently in the midst of developing and testing revolutionary COVID-19 rapid tests, based on ...
About the ARASENS Trial1 The ARASENS trial is the only randomized, Phase III, multi-center, double-blind, trial which was prospectively designed to compare the use of a second-generation oral androgen receptor inhibitor (ARi) darolutamide plus androgen deprivation therapy (ADT) and chemotherapy docetaxel to ADT plus docetaxel (a guideline recommended ...
ByBayer AG
Oral surgery technically refers to any operation taking place on a person’s gums, teeth, or their surrounding oral spaces. ...
Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for the oral androgen receptor inhibitor (ARi) darolutamide in combination with docetaxel for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). ...
ByBayer AG
The Phase 1 study met all of its primary and secondary endpoints; in all subjects dosed with STAR-LLD, the plasma lenalidomide concentration (AUC) was 57% lower with STAR-LLD continuous subcutaneous (SC) delivery compared to once-daily Revlimid oral delivery. STAR-LLD was well tolerated in all subjects with no drug-related toxicity or adverse events. ...
This maintenance period allows for the evaluation of safety after long term use of INT301. Additionally, the amendment allows for the inclusion of a Double-Blind Placebo Controlled Oral Food Challenge (DBPCOFC) at the end of treatment. ...
The Ministry of Health, Labor and Welfare in Japan has approved the use of the oral Factor Xa inhibitor rivaroxaban (Xarelto™) (2.5 mg twice daily, used in combination with aspirin 81-100 mg once daily) to treat patients with peripheral artery disease (PAD) after revascularization. ...
ByBayer AG
NEW YORK, June 01, 2022 (GLOBE NEWSWIRE) -- Intrommune Therapeutics, Inc., a New York-based, clinical stage biotechnology company developing a patient-friendly treatment platform for peanut and other food allergies, announced the addition of Nandini Murthy as Head of Regulatory. “Ms. Murthy has proven to be an invaluable asset to Intrommune since joining the organization as a consultant ...
Prelude Corporation (PreludeDx, a leader in molecular diagnostics and precision medicine for early-stage breast cancer, announced today that its study in 926 DCIS patients demonstrating the clinical utility of DCISionRT? was selected for an oral presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting. ...