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XELOX therapy, which comprises capecitabine and oxaliplatin, is the standard first-line chemotherapeutic regimen for colorectal cancer. Mathematical modeling combining pharmacokinetics (PK) and toxicodynamics (TD) is a promising approach for optimizing dosing strategies and reducing toxicity.
Cell and gene therapies (CGTs) are one of the fastest growing areas in human therapeutics. Since chimeric antigen receptor T cell (CAR-T) therapy was first approved in 2017, there has been a marked increase of cell and gene therapy studies resulting in significant changes in the way diseases are treated as well as patient outcomes.
The study demonstrated favorable proof-of-concept for LYT-100’s tolerability and pharmacokinetic (PK) profile, which will also enable twice-a-day (BID) dosing of LYT-100 in future studies. The Cmax reduction observed with LYT-100 was 23%, while the Cmax reduction stated in the ESBRIET® (pirfenidone) US Prescribing Information is 49%.
By harnessing the vast amounts of data generated throughout the development pipeline, pharmaceutical companies can accelerate the discovery of novel therapies, optimize clinical trial design, enhance drug safety monitoring, and deliver personalized medicine, ultimately improving patient outcomes and transforming the future of healthcare.
With more than six years of patient experience, a positive benefit-risk profile, strong clinical data and robust real-world data, the totality of evidence solidifies the role of IBRANCE plus endocrine therapy as a treatment for patients with HR+, HER2- metastatic breast cancer.”. PRESCRIBING INFORMATION. in the IBRANCE group and 68.0%
We are in an era of immuno-oncology (IO) revolution with many approved therapies now available to treat a broad range of cancers. For the last several years, the field has worked to unlock the potential of IO therapies for additional tumour types, and has explored options beyond checkpoint inhibitors.
The results, which demonstrate that patients treated with Biogen’s portfolio of MS therapies mount an effective antibody response to COVID-19 vaccination, are being presented at the 37th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) virtual meeting, October 13-15, 2021.
Among the notable contenders are: Semaglutide Analogs : Building upon the success of Ozempic, researchers are exploring analogs of semaglutide, the active ingredient in Ozempic, with enhanced potency and improved pharmacokinetic profiles. While challenges persist, the weight loss drug boom shows no signs of waning.
TEAD proteins are known to be very important in cancer progression TEAD proteins are known to be very important in cancer progression, and there are a number of therapies in development. What are the preclinical characteristics of ISM6331, including its efficacy, safety profile, and drug metabolism and pharmacokinetics (DMPK) properties?
INDIANAPOLIS , May 4, 2021 /PRNewswire/ — Eli Lilly and Company (NYSE: LLY) is donating COVID-19 therapies to Direct Relief, enabling the humanitarian organization to provide COVID-19 therapies at no cost to low- and lower-middle-income countries most heavily impacted by the pandemic.
Human and mouse genetics can inform not only efficacy but also safety. with gene editing or gene therapy, enzyme replacement therapy), agonism (e.g., Trial considerations will ultimately inform nonclinical studies such as GLP tox, and will serve as the basis for timeline and budget discussions around a fundraise.
Omics data, including pharmacogenomics data from 3D-TGAs, provide us with unique information about the molecular mechanisms of disease biology and drug response. Importantly, transcriptomics information shows that certain aspects of a disease change the gene expression profile.
16, 2020 (GLOBE NEWSWIRE) — Arecor Limited (“Arecor” or “the Company”), the biopharmaceutical company advancing today’s therapies to enable healthier lives, today announces that Diabetes Care has published data for the Phase I clinical trial of AT247, its ultra-rapid acting insulin product candidate.
Traumatic brain injury and other tauopathies can have devastating effects on cognitive function and quality of life, yet there are currently no therapies that can halt or slow the rate of decline in these patients,” said Martin Jefson, Ph.D., More information about the study can be found on ClinicalTrials.gov ( NCT04096287 ).
cell and gene therapies), with other therapeutic areas then pushing it further. Because of this, oncology researchers may only have access to minimal existing scientific literature related to cell-based data and animal testing to predict an investigational therapy’s effect on human factors.
We now have compelling data showing SLV213 has potent antiviral activity against SARS-CoV-2 as well as data on the safety, tolerability, and pharmacokinetics and pharmacodynamics of SLV213 in several preclinical model systems, including nonhuman primates,” said Felix Frueh, Ph.D., For more information, visit www.selvarx.com.
Mobocertinib is the first oral therapy specifically designed to selectively target EGFR Exon20 insertion mutations. Additional information about Takeda’s EAP is available here. and around the globe.”. Takeda has established an Expanded Access Program (EAP) ( NCT04535557 ) for patients in the U.S. About Mobocertinib (TAK-788).
. “Characteristics of Patients with Hereditary Transthyretin Amyloidosis-Polyneuropathy (ATTRv-PN) in NEURO-TTRansform, an Open-label Phase 3 Study of Eplontersen” Neurology and Therapy. “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 85” WHO Drug Information.
As we had previously indicated, we believe an SVR24 rate of at least 15% would have marked a meaningful first advance in HBV finite therapy, but preliminary results have shown that we will fall short of that mark. ABI-H0731 is a first-generation core inhibitor that is typically administered with NrtI therapy. Assembly Biosciences, Inc.
percent) in patients taking therapy and 36 events (7.0 Bamlanivimab and etesevimab together also demonstrated statistically significant improvements on all key secondary endpoints, providing strong evidence that the therapy reduced viral load and accelerated symptom resolution. The webcast information is available here.
Dosing will be paused in the open-label extension study (GEN-EXTEND) of tominersen while data are carefully analysed to inform next steps on this study. There is no known cure for HD and no approved therapies that treat the underlying cause. About tominersen and the clinical trials. About Roche in Neuroscience.
IBRANCE is indicated for the treatment of adult patients with HR+, HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women or in men; or with fulvestrant in patients with disease progression following endocrine therapy. PRESCRIBING INFORMATION.
phase I trial is a randomized, double-blind, placebo-controlled, single and multiple dose escalation study to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics (biomarkers – FGF19 and C4) of ASC42 in healthy subjects. For more information, please visit www.ascletis.com. Phase I Trial.
Takeda Pharmaceutical Company Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced that it has submitted a New Drug Application (NDA) to the Ministry of Health, Labour and Welfare (MHLW) in Japan for lanadelumab subcutaneous injection, a monoclonal antibody therapy for prophylaxis against attacks of hereditary angioedema (HAE).
Artificial intelligence is now used to map evidence and trends in traditional medicine and to screen natural products for pharmacokinetic properties. For more information, see: who.int/initiatives/who-global-centre-for-traditional-medicine/ . Source link: [link].
As UNITY reported in its press release, this “Phase I, first-in-human, open-label, single-ascending dose study being conducted by UNITY is designed to evaluate the safety, tolerability, and pharmacokinetics of UBX1325 in patients with advanced DME. SUZHOU, China and ROCKVILLE, Md. , 22, 2020 /PRNewswire/ — Ascentage Pharma (6855.HK),
3] While MET inhibitors have recently received accelerated approval in this setting in some regions, the vast majority of patients eventually acquire resistance to these therapies, thus underscoring the need for new treatment options. [4] RYBREVANT™ IMPORTANT SAFETY INFORMATION 7. 4] , [5] , [6]. 8] , [9] , [10] , [11] , [12].
government for its neutralizing antibody therapies authorized for emergency use as a treatment for COVID-19. Important Information about bamlanivimab alone and bamlanivimab and etesevimab together. Authorized Use and Important Safety Information. who require oxygen therapy due to COVID-19, OR.
Food and Drug Administration (FDA) had granted Breakthrough Therapy designation for donanemab based on the Phase 2 data. No additional safety analyses were performed related to the presentations; for information on donanemab’s safety profile, reference the previous publication. In June 2021, Lilly announced the U.S.
Verzenio (abemaciclib) : Abstract # P008 : Patients’ quality of life and side effect perceptions in monarchE, a study of abemaciclib plus endocrine therapy in adjuvant treatment of HR+, HER2-, node-positive, high risk, early breast cancer (Sara M. Accepted as ePoster – Adjuvant Systemic Therapy. Selected for one of the three St.
18, 2021 /PRNewswire/ — Genkyotex SA , a subsidiary of Calliditas Therapeutics AB (publ) (“Calliditas”) (Nasdaq OMX – CALTX; NASDAQ – CALT), today announced positive Phase 1 data demonstrating a favorable safety and pharmacokinetic profile of high-dose setanaxib, Genkyotex’s lead asset. STOCKHOLM , Jan.
The first trial will be conducted as a Phase 1, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacokinetics of the intravenous liposomal formulation of ibrexafungerp in healthy subjects. For more information, visit www.scynexis.com. The study will be conducted in South Africa.
. “We continue to conduct research that seeks to provide additional insights into the safety, efficacy and clinical utility of our approved and investigational migraine therapies,” said Michael Gold , M.D., Evaluation of the Pharmacokinetic Interaction and Safety of Coadministered Atogepant and Topiramate. 2:45-2:55 a.m.
Previous human pharmacokinetic (PK) study showed significantly better PK profile when compared to market leading product.
For further information, please contact: Orexo AB (publ.).
For more information about Orexo please visit, www.orexo.com. This information was brought to you by Cision [link].
COMMONLY USED PAIN MODELS As pain models continue to expand, there are still many tried and tested ways to achieve the most accurate results possible, such as pain stimulation, pharmacodynamics (PD), and pharmacokinetics (PK) for early phase analgesic trials.
Of note, The Phase 1b study is a double-blind, placebo-controlled clinical trial evaluating the safety, tolerability and pharmacokinetics of PF-07304814, a phosphate prodrug that when administered intravenously is metabolized to the active compound PF-00835321, shown to be a very potent inhibitor of the SARS-Cov2 3CL protease in preclinical studies.
Priority Review is granted to therapies that the FDA determines have the potential to provide significant improvements in the treatment, diagnosis or prevention of serious conditions.
For more information visit www.chiesiglobalrarediseases.com.
For more information www.chiesi.com.
Galactosidase-A enzyme.
Bayer is advancing its oncology R&D efforts in three scientific areas that have the potential to address unmet needs in cancer patients: next-generation Immuno-Oncology, Targeted Radionuclide Therapies and Precision Molecular Oncology. Data from all three areas of scientific focus will be showcased during this year’s meeting.
This approval is based on results from a multicenter, open-label, actively controlled clinical trial evaluating DALVANCE in pediatric patients from birth to less than 18 years of age with ABSSSI and 3 pharmacokinetic studies. IMPORTANT SAFETY INFORMATION. Please click here for the Full Prescribing Information.
Of the 22 patients enrolled in the BRIDGE study, the majority of treatment emergent adverse events were mild or moderate in severity, with two patients (9.1%) withdrawing from the therapy due to hypersensitivity reaction that was resolved. For more information visit www.chiesiglobalrarediseases.com. Galactosidase-A enzyme.
For more information about the use of bamlanivimab and etesevimab together for the treatment of mild to moderate COVID-19 in high-risk patients under the FDA’s emergency use authorization, contact Lilly’s 24-hour support line at 1-855-LillyC19 (1-855-545-5921). Important Information about bamlanivimab and etesevimab together.
Several clinical sites are screening patients for the Phase 1 a/b multicenter, open-label, dose escalation study of safety, pharmacodynamics, and pharmacokinetics of CG-806 in ascending cohorts (3+3 design) to determine the maximum tolerated dose or recommended dose in patients with relapsed or refractory AML. About CG-806.
Treatment choices are limited, and commonly used off-label therapies are not always effective or may result in prolonged, deep sedation. A therapy that quickly and effectively reduces agitation, without causing excessive sedation, is needed to speed up recovery time and improve patient outcomes. NEW HAVEN, Conn.,
For more than a decade, we’ve listened to the HAE community to further understand the need for long-term, preventive targeted therapies and have committed our resources to developing treatment options,” said Neil Inhaber, M.D., Please consult local prescribing information for more information. Interactions. Adverse Reactions.
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