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In the trial, platelet response, defined as achieving at least 50,000 platelets per microliter or doubling baseline counts, was seen in 65 percent of patients on rilzabrutinib, compared to 33 percent on placebo. percent platelet response in a study published in The New England Journal of Medicine.
Amidst a shifting clinical landscape characterized by increasingly complex trial designs and growing patient subpopulations, many contract research organizations (CROs) have adopted a “one-stop-shop” strategic approach. Moreover, these delays impact getting potentially lifesaving therapies to patients in need.
The surge in MASH cases stresses the need for early diagnosis, timely intervention and precise, reliable methodologies in clinicaltrials to evaluate new therapies effectively. Read on to gain insights from Medpace experts about advancements in imaging, histology and innovative techniques for MASH clinicaltrials.
But scientists have struggled to find effective treatments for many of these diseases since the dawn of modern medicine. CRYOPDP’s global teams are acutely aware of the seismic shift in focusing on cell and gene therapy drug development, and we are dedicated to supporting this emerging wave of new cell and gene therapies,” says Rossi.
Food and Drug Administration (FDA) plays a pivotal role in fostering the development of treatments for rare diseases through its Orphan Products Grants Program. Each year, FDA selects a limited number of clinicaltrials to fund to help sponsors pursue development of medical products for rare diseases and advance their field.
On February 7, at a town hall organised to discuss clinicaltrial designs for gene therapies, FDA experts pushed pharma players to look for ways to establish clinical effectiveness despite the challenges in recruiting patients with rare diseases. GlobalData is the parent company of Pharmaceutical Technology.
The artificial intelligence-driven drug discovery company has dosed its first healthy volunteer in a trial for a candidate to treat idiopathic pulmonary fibrosis.
This process can be daunting, but understanding how to manage feedback effectively is crucial for developing and ultimately gaining approval for new therapies, especially in oncology clinicaltrials. An illustrative example of harmonization between agencies exists via the European Medicines Agency (EMA) and U.S.
Gemini Therapeutics has signed a definitive agreement to merge with Disc Medicine in an all-stock deal to create a clinical-stage biopharmaceutical company. The merged company is expected to be named Disc Medicine, which will have corporate headquarters in Watertown, Massachusetts, US.
Stephanie Manson Brown, VP & Head of ClinicalDevelopment & Scientific Innovation of R&D at Allergan Aesthetics at AbbVie. Allergan Aesthetics is focused on creating products and technologies that drive the advancement of aesthetic medicine. She was honored as a 2023 Healthcare Business Women’s (HBA) Luminary.
The traditional clinicaltrials model is facing scrutiny. VivoSense , a pioneering company in the field of digital health technologies (DHTs) and digital endpoints for clinicaltrials, is aiming to enhance the efficiency and efficacy of clinical research. Clay mentions the economic benefits of digital measures.
Gildeuretinol is the first and only medicine in clinicaldevelopment to treat Stargardt disease by reducing vitamin A dimerization in the eye, without affecting normal vision. It decreased vitamin A dimerization by more than 80% and prevented blindness in a genetic animal model of the disease in preclinical trials.
The approval is based on comprehensive data from the clinicaldevelopment programme of Roctavian, including two-year findings from the international Phase III GENEr8-1 clinicaltrial. The company plans to resubmit a Biologics License Application (BLA) for Roctavian by the end of next month.
GSK expects that the BELLUS Health acquisition will boost its speciality medicines and respiratory pipeline. Camlipixant is being assessed in the CALM Phase III clinicaldevelopment programme, with anticipated regulatory approval and launch in 2026. There are no approved medicines for the disease in the EU and the US.
On March 7, Celadon Pharmaceuticals plc, a leading UK-based pharmaceutical company specializing in cannabis-based medicines, unveiled promising findings from an early economic analysis of its chronic pain clinicaltrial, dubbed CANPAIN.
Relmada Therapeutics said Thursday that its experimental treatment for depression failed to achieve the primary goals of a large clinicaltrial, a significant setback for the company’s only medicine in clinicaldevelopment. Continue to STAT+ to read the full story…
Outsourcing-Pharma caught up with Esther Mahillo, VP of Operational Strategy and Feasibility, Precision for Medicine to talk about advancements in patient enrollment in oncology and rare disease clinicaltrials.
Rezvilutamide is under clinicaldevelopment by Jiangsu Hengrui Medicine and currently in Phase III for Prostate Cancer. Attributes of the drug, company and its clinicaltrials play a fundamental role in drug-specific PTSR and likelihood of approval. Rezvilutamide overview Rezvilutamide is an antineoplastic agent.
In November 2023, at Outsourcing ClinicalTrials Dach in Zurich, our Executive Director, Oncology Strategy Lead, Matt Cooper , presented “Delivering Oncology Studies – Challenges and Considerations.” Umbrella Trial: Examines numerous drugs administered as individual drugs or combinations in a single tumor type.
“It is not a miracle, it has come about through a lot of dedicated research, development, exceptional science and very passionate people working together for the benefit of the patient,” explains Alexandra Brownfield, head of business development at Edinburgh-based RoslinCT. Credit: Phil Wilkinson via RoslinCT.
Rezvilutamide is under clinicaldevelopment by Jiangsu Hengrui Medicine and currently in Phase I for Liver Failure (Hepatic Insufficiency). Attributes of the drug, company and its clinicaltrials play a fundamental role in drug-specific PTSR and likelihood of approval.
To answer these two questions, regulatory authorities around the world require medical product manufacturers to conduct Phase I, also known as early phase clinicaltrials. Dr. Cohen has more than 30 years of healthcare experience which includes his work on clinicaldevelopment. To learn more, visit [link].
AstraZeneca has resumed UK trials for its coronavirus vaccine, after the country’s medicines regulator gave the all-clear following a safety scare. A UK safety committee has concluded its investigations and recommended to the country’s Medicines and Healthcare products Regulatory Agency (MHRA) that trials are safe to resume.
Since the advent of modern medicine, the scientific community has developed more than 3,000 drugs for thousands of diseases. As a provider of end-to-end clinicaldevelopment solutions, we plan to leverage our expertise to refine drug-disease matches identified by Every Cure’s use of AI and data analysis.
Estimates based on publicly available information suggest more than 40 percent of all new therapies in development are cancer treatments. Given this hotbed of activity, innovation in the space to drive faster decisions and more efficient trials is intense.
COVID-19 has transformed the way we think about patient participation in trial design – but there are still many barriers to overcome in improving engagement. Speakers at the NIHR’s recent virtual event for the pharma industry discussed best practices for bringing patient insights into research.
Enrolling for clinicaltrials has become more challenging in recent years, with trial competition, increasingly complex protocols, and precision medicine targeting more niche patient populations. The integration of trial planning and execution data will be a key win for clinicaldevelopment.
With COVID-19 forcing a shift towards decentralised trials, two digital health firms – Medable and Seqster – have teamed up to offer ways to also incorporate real-world data into remote study designs. . Patients want clinicaltrials to fit into their real-world experience, not the other way around,” according to Longmire.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended granting approval for AstraZeneca and Merck’s (MSD outside the US and Canada) Lynparza (olaparib) as adjuvant therapy for high-risk early breast cancer patients.
Recruiting participants is perhaps the most challenging aspect of any clinicaltrial, regardless of the therapeutic area. Yet this one piece is also the most vital, with a trial’s ability to enroll and retain participants being a key predictor of a study’s future success. What is ClinicalTrials For All?
VLA15 is the only vaccine for Lyme disease in clinicaldevelopment, according to GlobalData, the parent company of Pharmaceutical Technology. The Phase III trial announcement comes at a notable time, as the number of Lyme disease cases is growing over the long term in several countries, including the UK and the US. of Valneva.
Medical imaging specialist Median Technologies has launched a new business unit that will provide decision-making tools – underpinned by artificial intelligence – for sponsors of clinicaltrials in oncology. The post Median Tech debuts AI-focused unit for cancer trial support appeared first on.
The first UK patient has enrolled on Pfizer’s phase 3 trial for its Duchenne muscular dystrophy (DMD) gene therapy. The first patient was recruited in The Newcastle upon Tyne Hospitals NHS Foundation Trust, one of three UK sites for the clinicaltrial and part of 55 globally, across 15 countries.
Camrelizumab is under clinicaldevelopment by Jiangsu Hengrui Medicine and currently in Phase I for Solid Tumor. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.
The number of advanced therapy medicinal product (ATMP) clinicaltrials in the UK continues to increase year on year with 154 ongoing trials observed in 2020, demonstrating the appeal of that market for the clinicaldevelopment of ATMPs, shows a new report.
The UK could be the first country to carry out a COVID-19 “challenge trial” where healthy volunteers are deliberately infected with coronavirus to test vaccines, according to press reports. That vaccine is top of the World Health Organization’s list of vaccines in clinicaldevelopment, which shows there are 38 potential shots in human trials.
UK-based Small Pharma has launched on the Toronto’s TSX Venture Exchange, raising 58 million Canadian dollars (around £34m) to developmedicines based on N,N-dimethyltriptylene (DMT) to treat depression. The goal of the trial is for proof of concept of the drug as a wrap-around therapy for Major Depressive Disorder.
Fordyce founded Vera in 2016 as an entrepreneur in residence at Kleiner Perkins Caufield and Byers, took the company public in 2021 and has advanced its lead molecule through a successful Phase II trial in IgA nephropathy. Along the way, Dr. Fordyce has built a world class team of drug developers and raised over $1 billion in capital.
FAP-2286 marks the first peptide-targeted radioligand therapy aiming at FAP to enter clinicaldevelopment, along with the respective imaging agent. The therapy candidate is currently under evaluation in the Phase l LuMIERE clinicaltrial.
KFA-115 is under clinicaldevelopment by Novartis and currently in Phase I for Melanoma. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.
(LAI-287 + semaglutide) is under clinicaldevelopment by Novo Nordisk and currently in Phase III for Type 2 Diabetes. GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data.
HanAll Biopharma and Daewoong Pharmaceutical will combine their resources and knowledge to develop NurrOn’s ATH-399A and other compounds targeting Nurr1 [nuclear receptor-related 1 protein] to treat neurodegenerative disorders. They will help to progress ATH-399A towards a Phase I trial.
MK-0616 has been shown to reduce LDL cholesterol by a similar margin to injectables sold by Amgen and Sanofi/Regeneron – as well as Novartis’ longer-lasting RNAi therapy Leqvio – in two clinicaltrials reported at the American Heart Association (AHA) meeting. For now though, any threat from Merck’s drug is speculative.
Sandoz, a Novartis division, today announced progress in the late-stage clinicaldevelopment program for its proposed biosimilar aflibercept. Sandoz will begin enrolling the first patient in MYLIGHT, a clinical Phase III confirmatory efficacy and safety study, shortly 1. source Link.
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