This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
As the CEO of iOnctura, an innovative oncology biopharmaceutical company she co-founded in 2017, Catherine has played a key role in advancing the development of highly targeted small molecules aimed at revolutionising cancer treatment. So, with a huge amount of courage and commitment, I co-founded iOnctura in 2017.
Despite having a final FDA guidance issued in 2017 , evolving drug development and treatment modalities continue to prompt important dialogue to adapt existing methods. One example is the recent interest in psychedelics for the treatment of psychiatric disorders, including major depressive disorder.
Since their first approvals in 2017, autologous CAR T-cell therapies have revolutionised the treatment of blood cancers, offering hope where previous options had failed. Treatment outcomes for large B-cell lymphoma were dismal before CAR T-cell therapies.
The work of June, Levine, Rivire, and Sadelain laid the foundation for a whole new class of treatments. In the early 2000s, both teams began preparing for clinical trials. A similar CAR from another company, Kite Pharmaceuticals (now a Gilead company), was approved by the FDA in 2017 as the second commercial CAR T-cell therapy.
4] It was approved for the treatment of major depressive disorder in the United States in September 2023. [4] 4] It was approved for the treatment of major depressive disorder in the United States in September 2023. [4] 4] It was approved for the treatment of major depressive disorder in the United States in September 2023. [4]
Established in 2017 under the 21st Century Cures Act, the OCE brings together multidisciplinary scientific expertise to accelerate the review and approval of drugs, biologics, and medical devices for cancer care. Provides the Oncology Dosing Toolkit. Sponsors can request Project Orbis for their applications.
Compounds useful as kinase inhibitors (WO 2017/103611 A1). 1] [11] In December 2023, the US Food and Drug Administration (FDA) expanded the indication for pirtobrutinib to include the treatment of adults with chronic lymphocytic leukemia or small lymphocytic leukemia. [7] 6] The same trial was used to assess safety and efficacy. [6]
It is being investigated as a potential treatment for various herpes infections, including those resistant to traditional antivirals like acyclovir. Clinical Trials: Pritelivir is currently in phase II clinical trials, with ongoing research into its effectiveness and safety. PAPER By: Carta, Fabrizio ; et al.
.” Four years earlier, in 2019, Gray had become the first patient with sickle cell anemia — a genetic disorder that causes red blood cells to become sticky and rigid — to receive an experimental treatment using CRISPR genome editing. Dozens more clinical trials, based upon similar gene-editing technologies, are now underway.
5] [7] [8] It is the first approved medication for the treatment of activated PI3K delta syndrome. [5] 5] [7] [8] It is the first approved medication for the treatment of activated PI3K delta syndrome. [5] World Health Organization (2017). 2] [5] It is a kinase inhibitor [2] [6] that is taken by mouth. [2] hdl : 10665/331020.
This has a positive impact on the treatment of patients when reduction of heart rate without decrease in arterial blood pressure is desired. [9] Treatment of phenol 143 with bromo epoxide 144 in the present of K2CO3 afforded ether 145 in 76% yield. 9] It is used as landiolol hydrochloride. IV -Blocker max.
1] It was being developed by Jazz Pharmaceuticals for the treatment of alcoholism , pain , and post-traumatic stress disorder (PTSD) and reached phase 2 clinical trials. [2] Treatment of the oil with hot isopropyl ether (45 mL) provided the title compound as a white solid (1.88 2017 Jan 1:1091581817725272. AP- 453.2;
Alamy Dive Brief: The Food and Drug Administration is easing limitations it imposed around the complex cancer drugs known as CAR-T therapies, removing several onerous requirements as well as loosening restrictions on which facilities can provide treatment.
Salicylic acid is likely the active compound that blocks the enzyme cyclooxygenase , giving aspirin its efficacy, and was used as a treatment for fever and gout before aspirin was developed. He treated fifty people over five years, all of whom he said were either cured or helped by the treatment. 4 A reproduction of the Ebers Papyrus.
3] It was discovered for the treatment of hepatitis C [4] and has since been investigated for use against other viral diseases such as AIDS and COVID-19 , [2] [5] for which it was granted conditional approval in China. [6] It was approved in China in 2021 as a first-in-class treatment for human immunodeficiency virus (HIV).
Hetrombopag olamine (6), an oral nonpeptide thrombopoietin receptor (TpoR)agonistdevelopedby JiangsuHengruiPharmaceutical, was approved in China in June2021 for treatment of adult patients with chronic primary immune thrombocytopenia (ITP) and severe aplastic anemiawhohave not responded well to other treatments.46Hetrombopag,
As one of the more recent fields to emerge in the clinical space, psychedelics have gained significant traction as a potential treatment for various neuropsychiatric diseases. Psychedelic Research at Worldwide Since 2017, Worldwide Clinical Trials have supported a myriad of sponsors leading the way in psychedelic research programs.
Cancer Treatments, Clinical Trials, and the Motivation to Innovate nbartlett Tue, 06/27/2023 - 20:58 Getting to the Heart of Science with Michelle Newby At the heart of science are stories—stories of courage, challenges, successes, lessons, and people. Q: What was your cancer diagnosis and was treatment options were you given?
Roche is to begin expanding trials of Ocrevus in multiple sclerosis (MS) patients to defend its MS franchise from its rivals. . The company is testing higher doses of Ocrevus against both relapsing MS and primary progressive MS while also studying the treatment in minority populations. Conor Kavanagh.
These findings offer a novel strategy for developing targeted treatments for triple-negative breast cancer, which currently has no approved options. The team also observed that the drug prevented in vitro cancer stem cells from self-renewing, which is a characteristic of aggressive cancer cells that supports treatment resistance.
Up until 2023 around 600 NK cell clinical trials have been reported and some 200 are clinically active and still recruiting patients. The vast majority (65/74; 88%) of those trials involved NK cells without CARs; while only 12 percent were CAR-NK studies. Only three of the CAR-NK studies were for the treatment of solid tumours.
Live Bacterial Products (LBPs) will provide patients with a desirable, credible, safe and effective treatment option. The human microbiome, a complex ecosystem of microorganisms residing within our bodies, has emerged as a promising frontier in the quest for innovative medical treatments.
A new small-molecule drug candidate being tested in an early-stage clinical trial aims to improve patient responses to immunotherapy. AbbVie and Calico discovered the molecule, called ABBV-CLS-484 , after TIDE researchers at Broad identified the PTPN2 gene as a promising cancer immunotherapy target in 2017.
Long-term safety profile consistent with previously completed controlled trials.
Treatment with AXS-07, rapidly, substantially, and durably relieved migraine pain and associated symptoms in this trial. Axsome remains on track to submit an NDA for AXS-07 in the acute treatment of migraine in the first quarter of 2021.
Following an interim analysis of the phase 2 ELARA trial, researchers found that Kymriah met the primary endpoint of complete response rate (CRR) – a standard measure of response to therapy in FL patients. The therapy is a one-time treatment created individually for each patient using their own T cells.
Source link.
United Kingdom Medicines and Healthcare Products Regulatory Agency authorized Clinical Trial Application.
With these important regulatory clearances for our first-in-human clinical trial for INZ-701 in subjects with ENPP1 deficiency, we have transitioned from a research-stage to a clinical-stage company. “We
Up until 2023 around 600 NK cell clinical trials have been reported and some 200 are clinically active and still recruiting patients. The vast majority (65/74; 88%) of those trials involved NK cells without CARs; while only 12 percent were CAR-NK studies. Only three of the CAR-NK studies were for the treatment of solid tumours.
18, 2020 /PRNewswire/ — Camurus AB (NASDAQ STO: CAMX) announced today that the Swiss agency for therapeutic products, Swissmedic, has approved weekly and monthly Buvidal ® prolonged release buprenorphine for the treatment of opioid dependence in adults and adolescents from 16 years of age. LUND, Sweden , Dec. About Buvidal.
PROs in clinical trials are important as they capture the patient’s perspective and ensure that the impact of an intervention is comprehensively evaluated. What are PROs in clinical trials? From a regulatory standpoint, agencies like the U.S. These aspects influence a patient’s perceived health-related quality of life (QoL).
In 2017, the Food & Drug Administration (FDA) approved the first gene therapy for cancer and for inherited diseases, the first multiplex NGS panel for companion diagnostics (CDx), and the first drug targeting a genetic signature though not a disease. Research through WGS and WES has provided novel insights into biological processes.
It may also limit coverage for any future approved treatment in the class. When additional data from this new class of treatments become available, Biogen urges CMS to reconsider today’s decision for all FDA-approved amyloid-beta targeting therapies. ADUHELM is indicated for the treatment of Alzheimer’s disease.
Five Promising Treatment Areas in Early-Phase Drug Development in 2024 aasimakopoulos Wed, 04/17/2024 - 15:52 Early-phase drug development is an ever-changing landscape, as emerging science leads to new promising areas of research for the treatment of human health issues.
Pending Health Canada’s approval, the Phase 1 trial is designed to test the safety, tolerability and pharmacokinetics of ALS-4 in healthy volunteers. ALS-4 is an orally administered drug and thereby aligning with global healthcare policy to actively promote the switch from an IV to oral based antimicrobial treatment 1,2,3.
The trial plans to enroll 99 boys aged 4 to 7 years across 55 sites in 15 countries. The agency previously granted the gene therapy Orphan Drug and Rare Pediatric Disease designations in 2017. Meanwhile, Sarepta Therapeutics reported disappointing top-line results from a phase 2 trial evaluating SRP-9001, its gene therapy for DMD.
Years later, a subgroup analysis of the trial data indicated a potential positive effect in participants who carried two copies of ApoE4 ( Abushakra et al., ALZ-801 is an advanced and markedly improved candidate for the treatment of alzheimer’s disease. 2007 ; Kocis et al., 2016 ; Abushakra et al., 2018; 32(9): 849–861. [2].
WO 2017/208267A1, WO 2020/250133 Al and WO 2022/024072A1, which are hereby incorporated by reference, disclose methods of use of the compound of Formula I for the treatment of Parkinson’s disease, synucleinopathies and Alzheimer’s disease (AD) respectively. amcrasto@amcrasto /////////// Ref [1].
2] As of July 2022, it is in phase 3 clinical trials for major depressive disorder. [2] 2] Like other kappa opioid antagonists currently under clinical investigation for the treatment of major depression, its efficacy may be compromised by the countervailing activation of pro-inflammatory cytokines in microglia within the CNS. [7]
We will explore how GDF-15 impacts the tumour microenvironment and hinders the infiltration of T cells into the tumour, as well as the implications of neutralising GDF-15 to reverse its inhibitory effects and sensitise tumours to anti-PD-1 treatment. T-cell infiltration is a prerequisite for responses to checkpoint inhibitors.
The Phase 1 clinical trial is planned to be conducted in Canada and targeted to recruit up to 48 and 24 healthy volunteers for the single-ascending dose (SAD) and multiple- ascending dose (MAD) cohorts, respectively. This press release is provided “as is” without any representation or warranty of any kind.
Trial Also Met the Primary Endpoint in Patients With Low Levels of Eosinophils. In the subgroup of patients with baseline eosinophil counts less than 300 cells per microliter, the trial met the primary endpoint with tezepelumab demonstrating a statistically significant and clinically meaningful reduction in AAER.
Tedesco Distinguished Chair of Paediatric Haematology and Oncology, are collaborating as co-principal investigators on a new clinical trial, which has been awarded a $2.3 The trial represents an early-stage effort to determine the viability of this approach. million grant from the National Heart, Lung and Blood Institute.
In the HIBISCUS I induction study, in people without prior anti-tumour necrosis factor (anti-TNF) treatment, etrolizumab met the primary endpoint. In contrast, the HIBISCUS II induction study, which also included people without prior anti-TNF treatment, did not meet its primary endpoint.
Our goal is to stand on the shoulders of giants and advance this exciting and new field of medicine, so that it can deliver valuable treatments to patients. That would provide wonderful information as we think about then going into a first-in-human clinical trial. SVRA) in April 2017. from May 2017 until December 2022.
This multi-layered mechanism contributes to the development of immunoresistance against current standard-of-care treatments such as checkpoint inhibitors, chemotherapy, or antibody-drug conjugates (ADCs). Visugromab is a monoclonal antibody – a treatment modality that has been extensively studied and de-risked.
We organize all of the trending information in your field so you don't have to. Join 15,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content