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Early-phase clinicaltrials, including phase 1 and some phase 2a studies, serve as a pivotal step for biotech companies, laying the foundation for a drug candidate’s journey to market.
According to GlobalData’s recent Niemann-Pick Type C (NPC): Opportunity Analysis and Forecast to 2031 report, the NPC market is expected to see significant growth during 2021–31. This sales growth will be in line with a steadily increasing disease prevalence and the entrance of novel agents into the market.
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.
Patients are the backbone of clinicaltrials, playing an essential role in the drug development process. This engagement is often less understood and is underutilized by sponsors, meaning a significant element of the trial and drug experience is missed during sponsor engagement with the FDA.
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 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. Integrating DHTs Across Drug Development Phases Dr.
In the ever-evolving landscape of pharmaceutical development, the complexity of early phase clinicaltrials is increasing. This surge in complexity is driven by escalating drug development costs, heightened competition and advanced scientific innovations. This is the storm that we find ourselves in the midst of.”
In clinical research, diversity is more than a prerequisite for a successful drug — it’s a critical component that enhances the validity and applicability of clinicaltrial outcomes. Diversity Action Plans have now moved from being a “nice-to-have” to a “must-have” in clinicaltrial designs.
Author: Lona Sheeran, SVP, Clinical Operations, Early Phase At this year’s ClinicalTrials Nexus, I had the privilege of representing Worldwide ClinicalTrials as the sole CRO on a panel discussion: “Reversing the Conversation: What the ClinicalTrial Industry Really Wants from its Service Providers.”
The European Commission (EC) has granted conditional marketing authorisation (CMA) for BioMarin Pharmaceutical ’s gene therapy, Roctavian (valoctocogene roxaparvovec), to treat adults with severe haemophilia A (congenital Factor VIII deficiency).
Hookipa Pharma and Roche have signed a strategic partnership and licence agreement for developing HB-700 and another undisclosed arenaviral immunotherapy. Under the deal, Hookipa will carry out research and initial clinicaldevelopment through Phase Ib for HB-700 to treat KRAS-mutated cancers.
While patients diagnosed with relapsing MS (RMS) have a wide range of marketed treatment options, patients diagnosed with progressive MS, especially primary progressive MS (PPMS), have very limited treatment options. However, the current MS pipeline offers new hope for PPMS patients, with three late-stage agents currently in development.
The trial demonstrated a 42 percent reduction in combined cardiovascular death and recurrent hospitalizations at Month 30, with cardiovascular-related hospitalizations reduced by half. A Marketing Authorization Application has been submitted to the European Medicines Agency (EMA), with a decision anticipated in 2025.
Under the agreement, AstraZeneca will be responsible for the development and marketing of oral therapy for inflammatory and respiratory diseases with a key focus on chronic obstructive pulmonary disease (COPD). This includes an upfront payment of $2m from AstraZeneca. This includes an upfront payment of $2m from AstraZeneca.
Additionally, over a 176-week period, weekly injections of tirzepatide (marketed as Zepbound and Mounjaro) using pooled doses of 5 mg, 10 mg and 15 mg, significantly reduced the risk of disease progression to type 2 diabetes by 94 percent compared with placebo in adult prediabetes patients who were obese or overweight.
There have recently, however, been some notable developments towards improving the care of bronchiectasis patients. These include the ongoing clinicaldevelopment of AstraZeneca’s Fasenra (benralizumab), Insmed’s brensocatib and Novartis’ icenticaftor (QBW251).
Six cannabinoids have recently completed or are undergoing Phase II trials. In 2022, Pfizer acquired the drug, with the promise of accelerating clinicaldevelopment via new, differentiated, and best-in-class approaches, enhancing optimism for further drug development.
The FDA Oncology Center of Excellence (OCE) is committed to further enhancing oncology research and as a result, has recently implemented several projects aimed to revolutionize oncology clinicaltrials. However, Project Optimus emphasizes the importance of dose-finding studies in early clinicaldevelopment.
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’s illegal in most countries including the US and UK but Small Pharma is convinced of its potential as a therapeutic medicine for depression and has already begun clinicaldevelopment. The goal of the trial is for proof of concept of the drug as a wrap-around therapy for Major Depressive Disorder.
The filing also comprised the safety analysis carried out during the course of these studies as well as their open-label extensions and is accompanied by a long-term open-label Phase III C021 safety trial. In the clinicaldevelopment programme, 1,944 epilepsy patients received cenobamate treatment.
The latest approval is based on findings from the Phase III clinicaltrials, HGB-207 (Northstar-2) and HGB-212 (Northstar-3), and the long-term follow-up LTF-303 study. The open-label, single-arm, 24-month Phase III trials enrolled 41 subjects of the age four to 34 years with non-?0/?0 0 genotypes.
Sheila Rocchio highlights four key areas life sciences must improve on as an industry to drive real change in how clinicaltrials are conducted. AI models can be used to monitor trial processes and automate tasks associated with data collection, review and analysis. Next generation of decentralised trials.
Pharmaceutical companies often struggle to actively involve patients in the design phase of clinicaltrials but doing so can have huge benefits for the sustainability and success of research. Gaining patient input on marketing and recruitment materials. How the NIHR’s Patient Engagement in ClinicalDevelopment service can help.
Ast ellas Pharma has announced plans to make a strategic investment to back the development of Taysha Gene Therapies’ adeno-associated virus (AAV) development programmes for Rett syndrome and giant axonal neuropathy (GAN). This would allow the companies to boost the development of new therapy options for Rett syndrome and GAN patients.
AbbVie is to begin clinicaldevelopment of an antibody designed to neutralise the SARS-CoV-2 coronavirus after licensing the therapy in from Harbour BioMed and Utrecht University. AbbVie has begun a phase 1 clinicaltrial of the antibody, with clinicaldevelopment beginning in the US and expanding into Europe.
Roche’s idiopathic pulmonary fibrosis (IPF) therapy Esbriet is already being squeezed by its main rival in the market, and could come under renewed pressure if another competitor from PureTech Health gets approved. The first clinical data on the drug in healthy older adults seems to back up that hypothesis. Ofev made $2.34
This prestigious acknowledgment places Cloudbyz among the top-performing companies globally, known for delivering scalable and intuitive CTMS solutions that empower clinical research teams. Our mission is to enable faster, more efficient trials, ultimately supporting the delivery of life-saving therapies.”
Sanofi has agreed a deal with life sciences investor Blackstone to help fund clinicaltrials of a new formulation of Sarclisa for blood cancer multiple myeloma, accelerating its development. Sanofi has partnered with drug delivery specialist Enable Injections to develop the subcutaneous formulation.
Worldwide ClinicalTrials recently conducted a comprehensive research study, where we included 140 key industry-decision makers from biotech and pharmaceutical companies of all sizes. The Advantages of Midsize CROs In contrast to large CROs, midsize CROs like Worldwide ClinicalTrials offer a unique value proposition to the market.
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. Bringing a new cancer drug to market costs an average of $2.8 Bringing a new cancer drug to market costs an average of $2.8
government has provided Moderna with nearly $10 billion in taxpayer money for research and development and the purchase of 500 million doses of this mRNA COVID-19 vaccine. This includes almost the entire cost of clinicaldevelopment. SUMMARY: The U.S. Additionally, Moderna used patents and non-exclusive rights that the U.S.
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.
Under the deal, GSK will obtain an exclusive licence for the development and marketing of tebipenem pivoxil HBr in all countries. Since 2009, Meiji has marketed tebipenem HBr in Japan. Known as Orapenem, it is marketed for the treatment of paediatric infections limited to pneumonia, otitis media and sinusitis.
In the latest episode of the pharmaphorum podcast, Dr Paul Tunnah speaks to head of Patient Engagement at Syneos Health, Marie Emms, and Elligo executive vice president and general manager of Worldwide ClinicalTrials Early Phase Services, Keith Fern. Keith Fern joins Elligo with a decade of proven leadership in the CRO industry.
Belsomra’s first-to-market advantage in the US hasn’t however translated into big annual sales, which have stayed planted just over the $300 million mark since 2019. The class as a whole is, however, trying to break into a low-cost generic market, and almost inevitably is facing pushback from payers.
Amgen announced positive results from a Phase II clinicaltrial evaluating its investigational obesity drug MariTide (maridebart cafraglutide, formerly AMG 133) for the treatment of obesity and overweight in both diabetic and non-diabetic patients. The trial included 465 participants who were either obese or overweight.
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.
Daiichi Sankyo has stepped up its efforts to bring a Japanese COVID-19 vaccine to patients, starting a new clinicaltrial of its mRNA-based candidate DS-5670 that focuses on its use as a booster dose. The post Daiichi makes play for share of Japan’s COVID booster market appeared first on.
Participant recruitment is challenging, especially in those indications in which there are competing clinicaltrials necessitating a comprehensive understanding of the disease research ‘landscape’ and targeted outreach and stakeholder collaboration. Sharing patient experiences is also important for gathering real-world insights.
Injectable antibodies targeting PCSK9 have failed to take off as expected in the cholesterol-lowering market, but Merck & Co hopes to do much better with an oral alternative. In another 14-day trial involving men and women, MK-0616 reduced LDL cholesterol by around 65% from baseline when it was added to background therapy with statins.
The proposed merger is expected to realise at least $50m of net transaction cash proceeds, set to be used to finance the merged entity’s business as well as Phase II trials and operations through the second quarter of 2025. The merger is scheduled to be completed by the third quarter of 2023.
The revolution in clinical research is here, and it’s embodied by a single, powerful word: “patients.” The inclusion of patients during clinicaldevelopment is not only a moral imperative but a strategic necessity in modern medical research.
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