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
The Drug Controller General of India (DCGI) has added in-vitro diagnostic (IVD) medical devices including those for diagnosis of Covid-19, ribonucleic acid (RNA) and deoxyribonucleic acid (DNA) extraction kits, among others into the Class C risk category under the Medical Devices Rules (MDR), 2017.
The husband-and-wife team who co-founded BioNTech, the biotechnology company that partnered with Pfizer to develop an effective messenger-RNA (mRNA) shot against COVID-19, has predicted that a cancer vaccine could be widely available within the next decade.
A clinicalresearch team from the University of Hong Kong (HKUMed) has used amniotic fluid cells obtained during 16-24 weeks of pregnancy as a novel sample type for RNA-sequencing in prenatal diagnosis to help more families with tailored clinical management.
We are witnessing a revolution in healthcare, driven by advances in genetics, Omics, RNA and CRISPR gene-editing technology, to deliver precision and personalised medicine, said Kiran Mazumdar-Shaw, executive chairperson, Biocon and Biocon Biologics. Biology is opening up new frontiers in medicine.
Carlsbad, California-based Ionis Pharmaceuticals announced it will be sharing promising new trial data for its RNA-targeted prophylactic treatment donidalorsen for hereditary angioedema (HAE) at the 2025 American Academy of Allergy, Asthma & Immunology (AAAAI)/World Allergy Organization (WAO) Joint Congress in San Diego, California.
Among the various regulatory bodies providing oversight on clinicalresearch, only the institutional biosafety committee (IBC) has a purview specific to research involving engineered genetic materials. The post Risk Assessment for use of Engineered Genetic Materials in ClinicalResearch appeared first on Advarra.
Gritstone’s candidate is a self-amplifying messenger RNA vaccine (samRNA), which uses a slightly different technology to the mRNA-based jabs from Pfizer/BioNTech and Moderna. The study in 20 people aged over 60 was run by the National Institute of Health Research Manchester ClinicalResearch Facility (NIHR Manchester CRF).
Alnylam Pharmaceuticals announced promising results from its HELIOS-B Phase III clinical trial evaluating vutrisiran, an investigational RNA interference (RNAi) therapeutic for treating transthyretin amyloidosis with cardiomyopathy (ATTR-CM). As of March 2024, the FDA has approved six small interfering RNA (siRNA) therapies.
“It’s important to make sure that with this increase in clinical trial complexity, we don’t make our trials overly burdensome to sites or patients,” says Markham. Keeping Trials on Track The preparation and analysis of samples within tight clinical trial timelines are crucial.
The study was funded by a clinicalresearch agreement with the NBA and the players’ union – the National Basketball Players Association (NDG) – which together, contributed over $500,000 to fund the Yale study. This is significant because shortages of RNA extraction kits have been a recurrent issue since the beginning of the pandemic.
For example, certain drugs like Favipiravir (RNA-dependent RNA polymerase inhibitor), Chloroquine, and Hydroxychloroquine gained enough media attention claiming it to be “game-changers.”
The two-day conference will bring you high-quality insights and industry connections on the latest clinical trial candidates and a platform for exchanging ideas for tackling the biggest challenge: DELIVERY.
XTALKS CLINICAL EDGE: Issue 2 — Elixirgen Therapeutics’ Interview Xtalks Clinical Edge is a magazine for clinicalresearch professionals and all who want to be informed about the latest trends and happenings in clinical trials.
This approach is facilitated by developing ASOs and RNA interference (RNAi) therapies, which target the various molecular and genetic mechanisms contributing to ALS pathophysiology and disease progression. As we continue to explore current treatments and venture into new avenues of research, there lies hope for those affected by ALS.
Listen to case studies presenting on pre-clinical and clinicalresearch in areas such as oncology and what can be learned for future clinical trials. Interested parties can register for the conference and workshop at: [link]. By attending the conference attendees will have the opportunity to.
Register for this free webinar for expert insights and an engaging discussion surrounding the utilization of electronic health record (EHR) data in clinicalresearch and what the future might hold. Live and On-Demand: Tuesday, August 23, 2022, at 12pm EDT (5pm BST/UK). Gout is a significant therapeutic area for Horizon.
In the past, the majority of drugs evaluated in the clinical pharmacology space were small molecules. Today, there’s been a shift towards more complex, large molecules or biologics like monoclonal antibodies, antibody-drug conjugates (ADCs) and advanced therapies like RNA-based treatments and cell and gene therapies.
As a result, industry and non-industry stakeholders, are on the lookout for advanced platforms that can simultaneously capture the arrangement of multiple biomolecules (DNA, RNA, proteins and others) with single-cell or subcellular resolution. 70+ spatial Genomics solutions are developed by industry and non-industry players.
It combines Moderna’s mRNA (messenger RNA) delivery platform with the stabilized SARS-CoV-2 spike immunogen (S-2P) developed by NIAID scientists. principal investigator of the NIAID-funded Infectious Diseases ClinicalResearch Consortium site at Baylor College of Medicine in Houston; Lindsey R. El Sahly, M.D., Baden, M.D.,
“Liquid biopsies have demonstrated promising activity in multiple clinical settings, but the great enthusiasm and expectations around them can be harmful if not adequately managed,” said Dr. El Mustapha Bahassi, PhD, Director, Clinical Laboratory Sciences, at the global clinicalresearch organization (CRO) Medpace.
Molnupiravir (MK-4482/EIDD-2801) is an investigational, orally administered form of a potent ribonucleoside analog that inhibits the replication of multiple RNA viruses including SARS-CoV-2, the causative agent of COVID-19. About Molnupiravir.
This Breast Cancer Awareness Month we’d like to talk about emerging areas in metastatic breast cancer treatment since clinicalresearch has come so far in recent years. The team sequenced DNA and RNA from her tumour and from healthy tissue to find out which unique to her case mutations they needed to target.
Khanani, director of clinicalresearch at Sierra Eye Associates, Reno, Nevada, in Iveric Bio’s news release. RELATED: Apellis’ Syfovre Approved as First Treatment for Geographic Atrophy Despite Uncertain Clinical Benefit What Is Geographic Atrophy? How Does Izervay Work?
Cambridge-based Moderna recently reported encouraging results from a study of another type of personalized cancer vaccine it developed with the pharmaceutical giant Merck; it uses messenger RNA technology to target advanced melanoma. But more work remains before personalized vaccines can be greenlighted.
Over three years ~300,000 patients at high risk of a second cardiovascular event are expected to be treated with inclisiran, a small interfering RNA therapy administered as a 6-monthly maintenance dose ‡ , in the community setting. comments Jules Payne, Chief Executive at HEART UK, the cholesterol charity. About inclisiran.
Clinicalresearch experts from the CRO Medpace shared insights about the operational and regulatory considerations for neuroscience trials with direct CNS administration. Such therapies may involve small interfering RNA (siRNA) or oligonucleotides in viral transfection platforms, large molecules and antibodies.
Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the primary efficacy analysis of the Phase 3 study of mRNA-1273 conducted on 196 cases confirms the high efficacy observed at the first interim analysis.
The study also included communities that have historically been under-represented in clinicalresearch and have been disproportionately impacted by COVID-19. CAMBRIDGE, Mass.–(BUSINESS –(BUSINESS WIRE)–Nov. 16, 2020– Moderna, Inc. at large.
As a class, DARPin® therapeutics have demonstrated over years of clinicalresearch a number of characteristics that enhance their profile as antiviral therapeutics for a global pandemic. ” Collaboration Terms and Share Subscription.
At week 24, results showed that bulevirtide alone or in combination with peginterferon alfa-2a, is associated with a significant HDV RNA decline and improvements in biochemical disease activity. Gilead welcomed William Grossman, MD, PhD, as Senior Vice President, Oncology ClinicalResearch.
Lenacapavir is a potential first-in-class capsid inhibitor that is designed to inhibit HIV replication as it interferes with the disassembly of the HIV capsid core, inhibits the role of capsid proteins during viral RNA/DNA translocation to the nucleus, and disrupts assembly of the capsid core.
By trawling through databases of RNA sequences based on models of […] This growth of the gut’s wall hints at underlying pathways distinguishing beneficial regeneration from the rampant reproduction of a tumor.
This level of homogeneity within the clinical trial population may prevent the identification of variable therapy responses within population subgroups. We are poised to accelerate groundbreaking RNA therapy and vaccines for biopharma customers while becoming the reference lab for the cell and gene therapies of tomorrow.
Related: Iovebi (Inavolisib) Gains FDA Nod for PIK3CA-Mutated HR-Positive, HER2-Negative Breast Cancer Given the role of ESR1 , Bio-Techne launched a highly sensitive ESR1 mutation monitoring assay in December 2024 to track these mutations in ctDNA and exosomal RNA, helping to catch signs of resistance early on.
Gene therapy has shown promise in treating cancers that are particularly difficult to manage such as neuroblastoma and Wilms tumor using CAR-T cell therapy, CRISPR-Cas9 gene editing and RNA-based interventions to target genetic drivers of disease.
Breakthroughs and Advances in Rare Disease Research Recent advances in rare disease research are ushering in transformative therapies for longstanding unmet needs. In hereditary angioedema (HAE), for example, donidalorsen an investigational RNA-targeted prophylactic treatment has demonstrated impressive efficacy.
The company’s candidate vaccine, mRNA-1273, is a synthetic messenger RNA that encodes the stabilized SARS-CoV-2 spike protein. Below are some free webinars you can register for that have delved into the topic: Continuing ClinicalResearch Innovations After COVID-19. Addressing the Rapidly Evolving Vaccine Development Landscape.
We organize all of the trending information in your field so you don't have to. Join 21,000+ 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