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Pharmaceutical giant Eli Lilly said Thursday it will seek approval to add its diabetes drug to the buzzy US weight loss market after achieving promising results in a new clinicaltrial. Tirzepatide, currently approved to treat type 2 diabetes under the name Mounjaro, is taken once a week as an injection.
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.
Designing the Future of Biosimilars: Strategies for Success As the biosimilar market continues to grow, pharmaceutical companies are facing increasing pressure to develop high-quality, cost-effective treatments that meet the evolving needs of patients and healthcare systems. What are your thoughts on the future of biosimilars?
The Subject Expert Committee (SEC), which advises the national drug regulator on matters related to approval of new drugs and medical devices and clinicaltrials, has recommended grant of market authorisation for Telangana-based MSN Laboratories for sleep disorder drug Pitolisant tablets.
The Subject Expert Committee (SEC), which advises the drug regulator on the approval of drugs and clinicaltrials of antimicrobial and antiviral drugs, has recommended waiver of phase III clinicaltrial on Emcure Pharmaceuticals’ application for manufacturing and marketing of HIV drug doravirine 100 mg and its bulk drug in the country.Merck Sharp and (..)
SUMMARY: Over half of all clinicaltrial sites are outside the U.S. 87 % of all subjects in recent biologics trials were enrolled outside the U.S. DTC may or may not work for clinicaltrial enrollment it really depends on the condition and risk as judged by the patient. According to antidote.com. No, not at all.
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.”
Early analysis of a key clinicaltrial showed a potentially increased risk of death in cancer patients who received a combination treatment that included TG Therapeutics' approved medicine, Ukoniq.
Biotechs need to think like marketers to cut through the noise and attract investors. CEOs have to think like marketers to cut through the clutter with all the biotech startups out there. 2wo: Clinicaltrial data releases need to coincide with major medical conferences.
Clinicaltrials have been steadily leaving the UK for years. of patients recruited to global trials were from the UK. Thats not to say we dont still have some clout (the UK ranks fourth globally for Phase II trials ), but the trending outflow needs to be addressed. In 2021, just 2.2%
Before it is released onto the market, the development of any new drug or medical device must undergo rigorous testing , part of which involves clinicaltrials. Clinicaltrials are integral to making sure that any new therapy is both safe and effective for individuals, and volunteers are a vital part of the process.
Clinicaltrials are how researchers advance their knowledge about potential new treatments, including medications, medical devices, and lifestyle interventions. Clinicaltrials are divided into phases , each with a distinct duration, purpose, and number of volunteers needed.
While many market-approved cell therapies available today are autologous products, allogeneic interventions are growing more common. Thus, selecting a CRO with global experience managing cell therapy clinical logistics is critical. Contact us today to discuss your cell therapy trials with our cell and gene therapy experts.
Driven by the effects of the COVID-19 pandemic, the market for decentralized clinicaltrials has seen a push that will lead it to more than triple in size within the next decade.
Ive spent my entire adult life immersed in media, marketing, and advertising, long enough to remember the days before digital advertising in clinicaltrials took over. They… The post Digital Advertising in ClinicalTrials: The Real Secret Sauce appeared first on Imperial Clinical Research Services Blog.
With challenges around the R&D, clinicaltrials, pricing, and market access for these rare disease therapeutics, big pharma often collaborates with specialist biotechnology companies as a method of de-risking the development of gene therapy products.
The Subject Expert Committee (SEC) which advises the national drug regulator on drug approvals and clinicaltrials has recommended grant of permission to drug major Astrazeneca for import and marketing of two strengths of anti-hyperkalaemia therapy drug Lokelma (sodium zirconium cyclosilicate for oral suspension).
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.
Fortunately, advances in clinical research are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide ClinicalTrials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.
Over the past decade, Germany’s share of global clinicaltrial activities has dropped year on year. of trials in 2021 , down from 7.2% Aiming to revitalize the country’s pharmaceutical industry, it signaled a shift from policymakers on clinical research and drug development issues. The country accounted for just 3.9%
Similarly, the EMAs PRIority MEdicine (PRIME) designation and conditional marketing authorization enable accelerated approval for drugs addressing critical and underserved medical needs, provided they meet stringent evidence requirements.
Fortunately, advances in clinical research are providing hope for better treatments and outcomes. With the support of global networks like ours at Worldwide ClinicalTrials (Worldwide), autoimmune and bone health research is accelerating, providing new solutions to patients around the world.
The European Commission’s (EC) long-anticipated pharma reform plans in the European Union have finally been unveiled , indicating a focus on improving access to medicines across the bloc while cutting down on market exclusivity. Along with the patent-related changes, the EC is seeking to ease some of the regulatory steps.
Driven by the effects of the COVID-19 pandemic, the market for decentralized clinicaltrials has seen a push that will lead it to more than triple in size within the next decade.
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 expert committee which advises the drug regulator on clinicaltrials and drug approvals has recommended for grant of permission for import and marketing of Swiss multinational pharma major Roche’s ophthalmic drug faricimab intravitreal injection in India, with waiver of local phase III clinicaltrial subject to conditions.
BlueRock Therapeutics, a subsidiary of Bayer AG, is making waves in the treatment of Parkinsons disease by advancing its investigational cell therapy, bemdaneprocel, to a Phase III clinicaltrial. In the Phase I trial, 12 participants received the therapy and were observed for two years. As of 2023, there were approximately 2.7
lower than the previous market day’s close. In December 2022, BioNTech initiated a Phase I clinicaltrial of BNT163 – an HSV vaccine candidate. In the same month, BioNTech also initiated a Phase I clinicaltrial (NCT05581641) of the multi-antigen malaria vaccine BNT165b1— the first candidate from the company’s BNT165 program.
International companies investing in the emerging market of Brazilian pharmaceutical manufacturing will see a higher return on investment than from developed market equivalents, if they choose to compete with local manufacturers to supply Brazil’s growing market and the greater South American region.
While the treatment options for multiple sclerosis (MS) patients are growing each year with the approval of new agents, all of the currently marketed treatments only slow the disease’s progression and sometimes carry risks of severe side effects, such as liver failure or the development of viral infections.
Just as a chef relies on quality ingredients for the perfect dish, marketers depend on cutting-edge research to craft campaigns that resonate with their audience. The Connection Between Pharma Research and Marketing Effective marketing starts with understanding your audience.
The Central drug regulator has issued alert on suspected falsified versions of Glucagon-like peptide 1 receptor agonist (GLP-1-RA) products, an anti-diabetes management drug, in the market. GLP-1-RA […]
In the realm of clinicaltrials, particularly in oncology and rare disease research, SDOH play a pivotal role in shaping patient participation, adherence, and overall outcomes. Integrating eClinical systems can help mitigate these disparities, enhancing the inclusivity and efficacy of clinical research.
The Subject Expert Committee (SEC) that advises the drug regulator of the country has recommended waiver of local phase III and IV clinicaltrials in India for Sanofi Healthcare India’s orphan drug to treat the Pompe disease. The […]
At the beginning of September, Velocity Clinical Research topped Business North Carolina ’s 2024 Fast 40 list. It was our third time receiving the award, which recognizes the fastest-growing mid-market businesses in the state. For a clinicaltrials organization to achieve this level of scale is notable.
(Abdullah Durmaz/Getty Images) In just a few years, brand-name injectable drugs such as Ozempic, Wegovy, Mounjaro and Zepbound have rocketed to fame as billion-dollar annual sellers for weight loss as well as to control blood sugar levels and reduce the risk of heart disease. But the price of these injections is steep: They cost about […]
Your healthcare practitioner can access the sequencing results, and artificial intelligence (AI) and quantum computing will analyse these records and support the practitioner in making future clinical decisions. It could be that you are lucky, and there is already a cancer vaccine on the market that you will get priority for.
India’s advanced wound care market is on the growth trajectory with faster healing & minimised scarring. This is where the positive acceptance of Negative Pressure Wound Therapy (NPWT) that uses a vacuum dressing to ensure healing in acute and chronic conditions in India is gaining popularity.
India’s pharmaceutical market is growing at a healthy rate and is expected to touch 130 billion USD by 2030, said Dr. SV Veeramani, chairman of the Pharmaceuticals Export Promotion Council of India (Pharmexcil) while delivering the keynote address at the Pharmac South Expo 2023 in Chennai on July 14.
The Ayush cluster in Kerala, Care-Keralam Ayurvedic Resource Centre at Koratty in Thrissur, is planning to adopt a multi-pronged strategy to support the small and medium ayurvedic drug manufacturing enterprises (SMEs) by focusing on their production growth and marketing of products.
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