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
Valentine We recently blogged about a new December 2024 draft guidance about accelerated approval (the December 2024 draft guidance). FDAs withdrawal authority when a confirmatory trial is not conducted with due diligence was expanded to include that FDA could specify the conditions for a postapproval study.
Each year, FDA selects a limited number of clinical trials to fund to help sponsors pursue development of medical products for rare diseases and advance their field. In October, FDA announced seven new clinical trial grants awarded in fiscal year (FY) 2024 – including one for a Phase 3 trial – totaling $17.2
Traditionally, scientists discover enzymes in nature and adapt them through trial and error. He also writes on a blog focused on the intersection of biology and AI at owlposting.com. These molecular machines power various cellular processes, from converting sugar into energy to switching genes on and off.
The Untitled Letter notes that the confirmatory trial for LYTGOBI is currently ongoing and has not been completed; therefore, clinical benefit of LYTGOBI has not yet been confirmed. As a single-arm trial (i.e., The Untitled Letter states that a randomized controlled trial would be needed to assess delay in time to disease progression.
Serious adverse events (SAEs) are among the most critical data points collected during a clinical trial. The post How EDC-Based SAE Reporting Reduces Time to Detection and Response in Clinical Trials appeared first on Crucial Data Solutions. The timeliness and accuracy.
Their unique suitability has made them valuable for evaluating pharmacokinetics, toxicology and safety in drug candidates before human clinical trials. NHP-C cardiomyocytes offer a more predictive and ethical platform, especially for drugs intended to advance from animal testing to first-in-human trials. Toxicology Research.
Attendees were particularly drawn to our integrated solutions, which encompass everything from lead candidates advancing to IND-enabling programs to early-phase clinical trials to full-scale commercial manufacturing. This blog was originally published in July 2025. Image Thumbnail_Blog_Lisa-v2.jpg
Its ability to maneuver persistent drug development challenges, like patient recruitment, trial complexity and rising costs, will ultimately determine its success. This blog explores the value of functional service provider (FSP) models and how they help biotech companies augment their clinical development needs.
Many pharma companies are unsure how to begin aligning with the new expectations, especially around trial design and quality systems. Its a strategic reset that challenges sponsors to design and manage trials with greater purpose, proportionality, and accountability. What needs to change?
In this blog, we demystify the CMC section of NDA preparation , providing insights and guidance for navigating this intricate landscape. By the time of NDA submission, a sponsor should be able to demonstrate that the clinical materials used in pivotal trials are representative of the proposed commercial processes and product.
3] [4] A prodrug of contezolid, contezolid acefosamil, which is formulated for IV administration [5] is in Phase III clinical trials for diabetic foot infection. [6] 3] [4] A prodrug of contezolid, contezolid acefosamil, which is formulated for IV administration [5] is in Phase III clinical trials for diabetic foot infection. [6]
Hoffman, Efficacy and safety of vamorolone vs placebo and prednisone among boys with duchenne muscular dystrophy: a randomized clinical trial, JAMA Neurol. 19] The US Food and Drug Administration (FDA) approved vamorolone based on evidence from a single clinical trial of 121 boys with DMD who were 4 to <7 years of age. Shale, U.J.
In this blog, we outline how the OCE gets involved in product reviews and offer a high-level summary of the programs and resources available for guiding oncology product development. Determining a new products pathway The OCE does not receive regulatory applications directly from sponsors who are developing new cancer therapies.
Effective communication with regulatory authorities is critical for small biotech companies, as it is often the key to success in clinical trials. When small and emerging companies are able to build strong, trust-based relationships with regulators, they often see benefits like reduced development risk and accelerated timelines.
This blog explores the core tensions between generative AI’s potential and the regulatory realities of health care and clinical research. In clinical trials, generative AI accelerates trial designs through protocol optimization and enrollment forecasting, leading to faster and more effective studies.
Designed to better manage risk, patient safety, and data integrity in clinical trials, the updated guideline is expected to be adopted by regulatory authorities worldwide. Read on to explore how ICH E6 (R3) may affect your ongoing and future trials—and use the following 10 critical categories of questions to assess your readiness.
691TiP PYNNACLE phase II trial of rezatapopt (PC14586) in solid tumors with a TP53 Y220C mutation[J]. 2025 Jan 6;15(1):1000. Content Brief] [4]. Schram A M, et al. Annals of oncology, 2024, 35: S535-S536. //////////Rezatapopt, PC 14586, 5W59S33KC9 AS ON JUNE2025 4.45 amcrasto@gmail.com
By: Juliane Mills, Senior Director, Therapeutic Strategy Lead, Rare Disease The rise of patient-led clinical research, particularly in rare disease, represents a significant shift in the clinical trial landscape. Previously, organizations had limited influence on the direction of basic research, clinical trial designs, and data ownership.
Regulatory Risks of Wearables in Clinical Trials Are Real (and Avoidable) Wearables have become indispensable in modern clinical trials, tracking. The post Ensuring Regulatory Compliance When Using Wearables in Clinical Trials appeared first on Crucial Data Solutions.
LAKHS VIEWS ON BLOG WORLDREACH AVAILABLEFOR YOUR ADVERTISEMENT join me on Linkedin Anthony Melvin Crasto Ph.D – India | LinkedIn join me on Researchgate RESEARCHGATE join me on Facebook Anthony Melvin Crasto Dr. | Facebook Twitter FACEBOOK join me on twitter Anthony Melvin Crasto Dr. | twitter +919321316780 call whatsaapp EMAIL.
Certain statements in this blog may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. To everyone who has joined, invested in, advised, or supported Korro Bio: thank you for believing in this vision and for driving it forward with passion and integrity.
The Post-Market Shift: From Sites to Data Streams Phase IV trials used to mean tracking long-term outcomes by continuing to. The post Modern Post-Market Trials Will Be Driven by RWD – Is Your EDC Ready? appeared first on Crucial Data Solutions.
There are also drugs the Assessment identifies as being used off-label without high-quality evidence or for uses that are approved but without rigorous true placebo-controlled trials (namely vaccines) and/or with known safety concerns. We will continue to monitor these developments as they come.
Now that we have more of a breadth of data where we can look at claims data and bibliometric data such as publications, claims, and trials, its really enabled us to uncover people that we might not have known in our territories. Beyond just expanding the pool of advisors, this approach has also led to more diverse perspectives.
LAKHS VIEWS ON BLOG WORLDREACH AVAILABLEFOR YOUR ADVERTISEMENT join me on Linkedin Anthony Melvin Crasto Ph.D – India | LinkedIn join me on Researchgate RESEARCHGATE join me on Facebook Anthony Melvin Crasto Dr. | Facebook Twitter FACEBOOK join me on twitter Anthony Melvin Crasto Dr. | twitter +919321316780 call whatsaapp EMAIL.
Clinical Trials: Pritelivir is currently in phase II clinical trials, with ongoing research into its effectiveness and safety. Clinical Trials: Pritelivir mesylate is currently under extensive study to evaluate its efficacy and safety profile, with promising results in early clinical trials. Johnston, C. 2016.18189.
In this blog, we review why these decisions are so important, outline key scenarios for when to slow down versus hit the brakes on a program, and discuss the technical considerations that may sway the outcome. This is particularly relevant for complex drugs or programs facing unexpected delays or costs during clinical trials.
Metabolite formation For quantitation, before Phase 1 clinical trials, generally MS or UV/DAD are used, however beyond Phase 1 quantification is mostly performed using authentic standards or radiolabeling of the drug.
We knew that expertise in the science of small trials comes with years of experience of conducting drug reviews, and that certain review teams within CDER and CBER have more experience overcoming the well-known challenges in rare diseases. Youll kill innovation. Youll kill investment in those innovative ideas. Its incurable.
1] Pimicotinib is under investigation in clinical trial NCT05804045 (Study of Pimicotinib (ABSK021) for Tenosynovial Giant Cell Tumor (MANEUVER)). 5] Following with pimicotinib for tenosynovial giant cell tumor treatment in phase III, pimicotinib has also entered into a phase II trial in June 2023 for cGVHD treatment in China. [6]
1] It was being developed by Jazz Pharmaceuticals for the treatment of alcoholism , pain , and post-traumatic stress disorder (PTSD) and reached phase 2 clinical trials. [2] nM, and both analgesic and anti-inflammatory effects in animal studies comparable to those of the cyclooxygenase inhibitor naproxen. [1] Int J Toxicol.
Meanwhile, Annex 2, which provides guidance on pragmatic and decentralized clinical trials as well as trials incorporating real-world data, is expected to be finalized by ICH later in 2025. Below, we explore some of the key themes seen in the changes.
LAKHS VIEWS ON BLOG WORLDREACH AVAILABLEFOR YOUR ADVERTISEMENT join me on Linkedin Anthony Melvin Crasto Ph.D – India | LinkedIn join me on Researchgate RESEARCHGATE join me on Facebook Anthony Melvin Crasto Dr. | Facebook Twitter FACEBOOK join me on twitter Anthony Melvin Crasto Dr. | twitter +919321316780 call whatsaapp EMAIL.
For more than 35 years, Advarra has been committed to protecting the rights and welfare of clinical trial participants while helping to improve healthcare outcomes, advancing medical knowledge, and bringing innovative, life-extending treatments to market that benefit millions of patients worldwide.
Section #3: Human Trials Finally, the guidance provides a quick overview of clinical study recommendations. However, as we noted above, the CMC topics covered in this draft guidance will be covered in Part 2 of this blog coverage. For gene therapy products, the use of quantitative and sensitive assays such as qPCR are recommended.
This blog explores practical ways to fix focus visibility issues and improve user experience. The tool offers a 30-day free trial, a downloadable version,and a web-based option for scanning websites and pages for accessibility testing.
In Jarkesy , SCOTUS ruled that the SEC lacked the Constitutional authority to impose civil penalties on defendants absent a jury trial. Both arose from executive agencies collecting money. That common thread makes for a stronger challenge because taxation and revenue are not traditionally executive branch functions.
As such, we can offer our readers a special 10% discount. The discount code is: D10-999-FDA25. You can access the conference brochure and sign up for the event here.
Despite including guidance on confirmatory trials and FDAs authority to require them, the Agency decided to publish an additional guidance focused solely on how it is interpreting the authority to require that such trials be underway prior to accelerated approval or within a specified time period after the date of accelerated approval.
They included grants in 2020 and 2022 that supported the development of networks of recovery researchers working to establish key measures for the field, as well as clinical trial planning grants that establish the foundation necessary to conduct future large-scale clinical trials to understand the effectiveness of various recovery support services.
With the available information, a product undesignated voucher would seem to provide the most flexibility and allow companies to pivot from one program to another in the event of unforeseen circumstances, such as ambiguous clinical trial results or problems with a manufacturing facility. Easily interpreted clinical trial endpoints (e.g.,
However, in a Bayer management meeting to discuss whether acetylsalicylic acid should go forward to clinical trials, Dreser asserted that it was a direct cardiac poison and opposed it progressing to trials. Dreser had the right to veto any drug going to clinical trials, so this is where the story of aspirin could have ended.
In our latest blog post, we delve into the compliance hurdles that generic drug developers face, and the valuable lessons learned from these experiences. From navigating complex regulatory landscapes to ensuring the integrity of clinical trials, the stakes are high for generic drug manufacturers.
Yet, many people are unaware of the essential role of institutional review boards (IRBs) in protecting clinical trial participants by ensuring compliance with human subject protection requirements. Advancement in treatment of diseasesfrom cancer to diabetes to rare diseaseshave all come about because of clinical trials.
We organize all of the trending information in your field so you don't have to. Join 15,000+ 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