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The pharmaceutical R&D landscape continues to evolve rapidly with advances in computational technologies and artificial intelligence. This blog post summarizes the critical insights shared during this informative session.
If this Vault Snack leaves you hungry for more, all previous Vault Snacks can be found here and as always, feel free to contact CDD Support — we are available to help you succeed in using CDD Vault.
"Revolutionizing the Pharmaceutical Industry: How AI-Powered Portfolio Management is Changing the Game As the pharmaceutical landscape continues to evolve, companies are under increasing pressure to optimize their portfolios and stay ahead of the competition. link] #pharmaceuticals #portfoliooptimization #AIinpharma"
In recent years, advanced manufacturing has gained traction in the pharmaceutical industry, transforming how drugs are developed, produced, and delivered. In this blog, we explore the concept of advanced manufacturing and outline the FDA programs that play a critical role in promoting innovation while ensuring product quality.
The combination of different active pharmaceutical ingredients (APIs), each with distinct physical and chemical properties, along with the need for precise, efficient drug delivery to the lungs, requires careful CMC planning and execution.
In May 2025, Altasciences attended CPHI Americas in Philadelphia, where industry leaders, innovators, and stakeholders gathered to explore the latest advancements in pharmaceutical development technologies and connect with providers. This blog was originally published in July 2025. Why does that matter? Image Thumbnail_Blog_Lisa-v2.jpg
Specifically, the Court focused on the purpose: to compensate pharmaceutical companies for the effective truncation of their patent terms while waiting for regulatory approval of new drug applications. So the Federal Circuit looked at the the specific context in which that language is used, and the broader context of the statute as a whole.
Contezolid (4), also referred to as MRX-I, is an orally administered oxazolidinone antibacterial agent developed by Shanghai MicuRx Pharmaceutical Co. 34) MicuRx Pharmaceuticals. 35) MSD Pharmaceuticals. SYN Contezolid (Youxitai). 2021, 34, 1348−1354. (33) 33) Hoy, S. Contezolid: First approval. Drugs 2021, 81, 1587− 1591. (34)
iPSC-cardiomyocytes in the preclinical prediction of candidate pharmaceutical toxicity. Internal blog source: 3 Major Challenges With Non-Human Primate Research and How to Solve Them. Lee TYT, Coles JG, Maynes JT. Front Pharmacol. 2024;15:1308217. Ekins S, Clark AM. In silico toxicology: computational methods for predicting toxicity.
Following the completion of a Doctor of Philosophy in Pharmaceutical Sciences from the Université de Montréal, and several years in the CRO industry, he has developed extensive expertise in flow cytometry technologies. Connect with Martin Turcotte on LinkedIn. This blog was originally posted in July 2025.
4] ICH = International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. 6] ICH Harmonised Guideline M7(R2) (2023): Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk. link] [7] H.R.2565
In this blog, we demystify the CMC section of NDA preparation , providing insights and guidance for navigating this intricate landscape. Key components of the CMC section The CMC section of an NDA contains detailed information on the following aspects of the investigational drug: Drug substance or active pharmaceutical ingredient (API).
2] [3] Vamorolone is a novel and fully synthetic glucocorticoid developed by Santhera Pharmaceuticals. 10] Society and culture Legal status Santhera Pharmaceuticals signed an agreement with Catalyst Pharmaceuticals for the North American commercialization of vamorolone in July 2023. [20] McCall, J. 2013, 21, 2241− 2249.
Case Study: How to Ensure Safety While Manufacturing Highly Potent APIs aasimakopoulos Mon, 11/04/2024 - 17:37 Highly potent active pharmaceutical ingredients (API) require careful attention to safety and handling during formulation and manufacturing.
Part 2 Our first blog covered the ABCs of Artificial Intelligence (AI) and AIs evolution. The stakes for AI adoption in the pharmaceutical industry have never been higher. This post discusses key issues pharma executives must consider to ensure responsible, compliant, and successful AI implementation within their organizations.
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.
Pete’s in-depth knowledge of FDA’s internal processes and priorities enhances his ability to advise pharmaceutical, biotech, and other FDA-regulated companies on regulatory compliance, product development, and enforcement risk. He also provides strategic litigation support and proactive counsel on agency engagement.
This blog series celebrates Perficients recognition as a 2025 USA Today Top Workplace. In our last blog, we discussed how Perficient is Shattering Boundaries through our global delivery model and cutting-edge strategies. By building strong relationships , we develop customized solutions that go above and beyond their expectations.
Retrieved 9 July 2025. ^ “KalVista Pharmaceuticals Announces FDA Approval of Ekterly (sebetralstat), First and Only Oral On-demand Treatment for Hereditary Angioedema” (Press release). “International nonproprietary names for pharmaceutical substances (INN): recommended INN: list 87” WHO Drug Information.
And, going into detail about the primary effectiveness endpoint, FDA raised concerns about claims allegedly exaggerating the speed of action for Zenrelia (i.e. that it is effective on Day 1) and insinuating misleading comparative claims.
We intended to learn from nature (genetics) and use pharmaceuticals properties to drive patient benefit. Certain statements in this blog may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended.
Unlock the Secrets to a Successful Generic Drug Launch Are you a pharmaceutical executive looking to bring a generic version of a popular medication to market? In today's highly competitive pharmaceutical industry, generic drug launches can be a game-changer for companies looking to increase market share and revenue.
Increasingly, patients and patient-led organizations are playing a pivotal role in shaping drug development, underscoring the importance of collaboration between patient organizations, CROs, and pharmaceutical and biotechnology companies. Discover more about this industry shift in our blog.
Pharmaceutical companies may, at times, find themselves at an impasse during development, facing weighty decisions about whether to slow down or hit the brakes on a development program. These decisions are complex, multi-dimensional, and can have significant impact on the future of the company.
Qualified person (QP) certification and declaration are distinct in their objectives within pharmaceutical and biotech industries. However, their similar names and overlapping functions can lead to confusion – particularly for those outside the EU/UK regulatory framework.
Salt Formation: The pritelivir free base is then reacted with methanesulfonic acid to form the mesylate salt, which is the active pharmaceutical ingredient (API). Amide Coupling: The resulting carboxylic acids are coupled with thiazolyl sulfonamides using amide coupling conditions to form the pritelivir molecule. Click here to purchase.
Unlocking the Secrets to Patenting Drug Combinations: Strategies and Challenges As a pharmaceutical professional, you know how crucial it is to stay ahead of the curve when it comes to patenting innovative treatments. In our latest blog post, we dive into the strategies and challenges of patenting drug combinations.
Mastering the Art of Drug Patent Portfolio Management As a pharmaceutical professional, you know how crucial it is to navigate the complex landscape of drug patents. In our latest blog post, we dive into the best practices for drug patent portfolio management. But what does it take to excel in this field?
"Compliance in Generic Drug Development: A Critical Component of Success As the generic drug industry continues to grow, ensuring compliance with regulatory requirements has become a top priority for pharmaceutical companies.
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.
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. mL, 3 Eq, 10.3
Come together with leaders from the pharmaceutical, biotechnology, and diagnostic industries to unpack huge changes at the American Conference Institutes 23rd Advanced Summit on Life Sciences Patents , which is scheduled to take place from May 19-20, 2025 at the New York Bar Association in New York, NY. The discount code is: D10-999-FDA25.
Over the years, Advarra has reviewed a wide range of clinical research studies and worked every day alongside leading pharmaceutical manufacturers, medical researchers, and healthcare institutions. Without clinical research, these medical breakthroughs would remain out of reach for patients.
Kennedy stated that payment of these user fees by industry “creates a barrier to entry to smaller firms and puts bureaucrats’ purse strings in the hands of the pharmaceutical industry.” Kennedy does not say what the alternative to user fees would be given current budget realities.
The Unsung Heroes of Generic Drugs: The Importance of Quality Assurance As we navigate the complex world of pharmaceuticals, it's easy to overlook the behind-the-scenes efforts that ensure the quality and safety of the medications we rely on. Share your thoughts in the comments below!
stating that he would advise President Trump to ban pharmaceutical advertising on TV. In addition to his letter to FDA, Senator Durbin has introduced bipartisan legislation aimed at addressing deceptive advertising practices by the pharmaceutical industry. Department of Health and Human Services Secretary, Robert F. Kennedy Jr.,
This tour to engage with pharmaceutical and biotech CEOs is unprecedented. The stated purpose of them is to gather direct input from biotechnology and pharmaceutical leaders on how the FDA can modernize its regulatory framework to better support innovation and patient access to safe and effective therapies.
rFC testing is designed to ensure the safety of pharmaceuticals, biologics and medical devices that are introduced into humans or other animals. In this blog, we look at the rFC test and examine how microplate readers can help support this test for endotoxins.
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My goal is not only to tell the story of a pharmaceutical staple but to share what my decades-long work in evidence synthesis in epidemiology has taught me about researching scientific history. In this article, Eichengrün stated that he was appointed, in 1895, to establish and manage a pharmaceutical laboratory at Bayer.
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