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Haemoglobin A1c (HbA1c) is a validated surrogate endpoint for the reduction of microvascular complications associated with diabetes mellitus; reduced HIV-RNA levels serve as an endpoint for HIV disease control; and a reduction in low-density lipoprotein (LDL) cholesterol is used as an endpoint indicating lower likelihood of cardiovascular events.
By integrating Regulus’ expertise in microRNA science with its own deep capabilities in clinicaldevelopment, regulatory affairs, and commercialization, Novartis is well-positioned to accelerate farabursen’s clinical path and potentially bring a first-in-class treatment to ADPKD patients.
The Access to Advanced Health Institute Receives $18 Million Award to Develop a Temperature Stable, Single-Dose Chikungunya RNA Vaccine Through a Phase 1 Clinical Trial Credit: Delaney Brown Photography The Access to Advanced Health Institute Receives $18 Million Award to Develop a Temperature Stable, Single-Dose Chikungunya RNA Vaccine Through a Phase (..)
The development of vaccines for SARS-CoV-2 becomes more difficult due to the viral mutation in its non-structural proteins (NSPs) especially NSP2 and NSP3, S protein, and RNA-dependent RNA polymerase (RdRp).
Regulatory Considerations for Oligonucleotide Drug Development and Safety In 2024, the U.S. It also outlines recommendations for drug-drug interaction assessments during clinicaldevelopment, such as the assessment of appropriate biomarkers that reflect modulation of the target protein.
Pushkal Garg to Lead Unified Research and Development Organization, Signaling Strategic Expansion into Next Phase of RNAi Therapeutics Innovation Alnylam Pharmaceuticals , a global leader in RNA interference (RNAi) therapeutics, has announced the promotion of Pushkal Garg, M.D.,
and Shionogi Limited as shareholders, today announced the positive findings of a pooled analysis of COVID-19-related impacts across the investigational long-acting cabotegravir and rilpivirine clinicaldevelopment programme.
Published June 24, 2025 Gwendolyn Wu Senior reporter post share post print email license Lexeo Therapeutics and two life sciences investors are working together to launch a startup to develop cardiac RNA therapies. But many development hurdles still stand in the way of new medicines for the brain.
In a previous study, we showed that these peptides decorate all cellular RNAs and thus impair the binding of RNA-binding proteins to RNA. Among other discoveries, the group developed inhibitors of the ATR kinase and showed their potential for cancer therapy.
Moderna continues to rise to meet the demands of the pandemic, signing a new deal with the US Government to supply 100 million doses of its messenger RNA (mRNA) vaccine candidate for the prevention of COVID-19.
We are advancing the clinicaldevelopment of mRNA-1273 with our Phase 3 COVE study, which is now fully enrolled with a representative demography of participants across ages, ethnicities and high-risk populations. Moderna is advancing messenger RNA (mRNA) science to create a new class of transformative medicines for patients.
She joined the company in November 2018 with more than 10 years of experience in drug discovery and non-clinicaldevelopment of immunomodulatory drugs in the immuno-oncology space. She has established a track record as a successful leader and entrepreneur in the biotech industry. in North America) in late 2017.
Delivery of therapy is being evaluated through injections of DNA and RNA encoding IL-12, viral vectors, and other exploratory platforms designed to bring IL-12 in close proximity to the tumour and avoid excessive IL-12 in systemic circulation. Some approaches have already reached the clinical trial stage, with others not far behind.
The results from these trials will build the basis for addressing therapy-induced GDF-15-mediated resistance of cancers, a problem that represents a significant challenge across several therapeutic classes, including approaches currently in advanced stages of clinicaldevelopment. in North America) in late 2017.
Based on the positive Phase 1 results reported and the unprecedented need for COVID-19 vaccines, Clover and its partners are confident to enter late-stage clinicaldevelopment for both adjuvanted vaccines. The Phase 1 clinical trial was funded by the Coalition for Epidemic Preparedness Innovations (CEPI).
Next, to see how their tiny models of the human brain respond to various chemicals, the researchers exposed the neural tissue chips to 60 compounds—about half with known neurotoxic effects, and the rest considered harmless to the brain—and measured the activity of 19,000 genes in each organoid by RNA sequencing. Nat Biotechnol.
Now poised to advance a robust therapeutics pipeline to clinicaldevelopment, Nuance will use the funds for ongoing R&D of existing products and business development of potential new assets. Laying down a new track for RNA processing, Remix launched with $81 million in financing. Sigilon Therapeutics .
is a clinical-stage biopharmaceutical company developing novel RNA-modulating drug candidates (designed to be eukaryotic ribosomal selective glycosides) that are formulated to treat rare and ultra-rare premature stop codon diseases. Premature stop codons are point mutations that disrupt protein synthesis from messenger RNA.
These findings give confidence that Clover’s COVID-19 vaccine candidates are suitable for further clinicaldevelopment.” Similar to other enveloped RNA viruses such as HIV, RSV and Influenza, SARS-CoV-2 is also an RNA virus that has a trimeric spike (S) protein on its viral envelope.
“It continues to be critically important to advance potential antiviral treatments to address the devastating impact of COVID-19 globally,” said Dr. Roy Baynes, senior vice president and head of global clinicaldevelopment, chief medical officer, Merck Research Laboratories. “If About Molnupiravir.
The market for each target class likely asymptotes with the number of Pharma or large biotech who can clinicallydevelop and commercialize such assets; thus, there is intense focus on the first handful of assets to market. Figure 2 shows pipelines across modalities for some of the competitive targets today.
Caris Precision Oncology Alliance members also have access to the Caris Pharmatech oncology trial network, which can help reduce the time it takes to identify and connect appropriate patients with novel targeted cancer therapies in clinicaldevelopment.
Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today confirmed that the Ministry of Health, Labour and Welfare of Japan (MHLW) and Takeda Pharmaceutical Co., 29, 2020 06:00 UTC. CAMBRIDGE, Mass.–(
Based on these results, the BIIB078 clinicaldevelopment program will be discontinued, including its ongoing open-label extension study. “We Vice President and Head of the Neuromuscular Development Unit at Biogen. About Ionis Pharmaceuticals, Inc.
Immunization of non-human primates (rhesus macaques) with BNT162b2, a nucleoside-modified messenger RNA (modRNA) candidate that expresses the SARS-CoV-2 spike glycoprotein, resulted in strong anti-viral effects against an infectious SARS-CoV-2 challenge.
Dr. Kehua Fan has over 15 years of Business Development, ClinicalDevelopment of innovative drugs and other healthcare industry experience with MNCs and biotech companies. He received his B.S. degree from Henan Normal University, M.S. degree from Chinese Academy of Sciences and Ph.D. from University of New Hampshire.
CureVac and GSK expect to progress the second-generation vaccine candidate into clinical testing in the third quarter of 2021, with the goal of introducing the vaccine in 2022, subject to regulatory approval. CureVac began development of mRNA-based COVID-19 vaccine candidates in January 2020. About CVnCoV. About CureVac.
She has also served as a leader in clinicaldevelopment and medical affairs at AbbVie, Kimberly-Clark and Johnson & Johnson. In those roles, she oversaw the direction, planning, execution and interpretation of clinical trial data.
Sanofi Pasteur, the vaccines global business unit of Sanofi, and Translate Bio (NASDAQ: TBIO), a clinical-stage messenger RNA (mRNA) therapeutics company, today announced the start of the Phase 1/2 clinical trial for MRT5500, an mRNA vaccine candidate against SARS-CoV-2, the virus that causes COVID-19.
About STP705
Sirnaomics’ leading product candidate, STP705, is a siRNA (small interfering RNA) therapeutic that takes advantage of a dual-targeted inhibitory property and polypeptide nanoparticle (PNP)-enhanced delivery to directly knock down both TGF-?1 1 and COX-2 gene expression.
Using the 10X Genomics Chromium platform, we conducted ribonucleic acid (RNA) sequencing on the midbrain’s PAG region in animals treated with SRP-001, ApAP and a vehicle control, focusing on gene expression changes related to pain processing. Dr Bazan is the CEO and Co-founder of South Rampart Pharma, Inc.
Oligonucleotide-Based Techniques Most oligonucleotide therapies act through antisense mechanisms and are directed against various RNA species. According to an article published in Frontiers in Pharmacology , as of October 2023, there were 15 FDA-approved ADCs on the market, and more than one hundred in clinicaldevelopment in the U.S.A.,
Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the presentation of data from the company’s HIV clinicaldevelopment program at the 11th International AIDS Society Conference on HIV Science (IAS 2021) from July 18-21.
Both vaccination regimens resulted in complete protection from subsequent viral ‘challenge’ as reflected by reductions in viral RNA levels that were below the level of detection by day seven post-challenge compared to controls.
Additional safety and neutralizing data are currently being collected/analyzed.
Table 1 – Small molecule drugs approved by the FDA in 2022 and the major reported route of biotransformation *Note: 17 small molecule drugs as classified in C&EN ( [link] i.e. excluding antibody-drug conjugates, antibodies, proteins, radioligands and small interfering RNA).
Clinicaldevelopment kicks off when the company files an IND with the FDA , progressing through Phase I for safety, Phase II for early signs of efficacy, and Phase III for determining full approval.
Given the complex nature of global clinicaldevelopment, the strong foothold of our strategic plans positioned our team to overcome these obstacles. Having a sound global clinicaldevelopment strategy prepares us to get to patients more quickly.
On this basis, and to drive use of the RNA sequencing technology that identifies NRG1 fusions, the drug was purchased by Partner Therapeutics. Of course the larger markets would be in non-NRG1 fusion cancers where HER3 is overrexpressed but Partner Therapeutics does not appear to be supporting additional clinical trials.
Trial design and other details are being evaluated and a comprehensive update on the overall Novartis SMA clinicaldevelopment program will be provided at a future time following further discussions with health authorities. This guidance provides clarity on the path to registration for AVXS-101 IT.
Spending a couple of years practicing on the wards around London, and then moving into management consulting at McKinsey & Company which led her to work in pharmaceutical research and development (R&D). The challenge that we have using bulk BCR RNA,” she continued, “is that an antibody is made up of four components.
We then incubate the cells to mature into ‘pro-regenerative’ macrophages and insert two RNA messages to produce two human proteins that will be expressed at the site of injury when these ‘engineered’ macrophages are given back to the patient. The patient’s own monocytes, a type of white blood cell, are removed via an apheresis procedure.
What are the key findings of Circio’s in vivo proof-of-concept for its circVec circular RNA platform technology compared to conventional mRNA-based expression with DNA vectors? Circular RNA (circRNA) has two major advantages versus mRNA in a vector-expression context.
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