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The US Food and Drug Administration (FDA) has released a new draft guidance titled Expedited Program for Serious Conditions Accelerated Approval of Drugs and Biologics Guidance for Industry refining the accelerated approval pathway for drugs and biologics targeting serious or life-threatening conditions. This guidance focuses on improved accountability, earlier confirmatory studies and greater clarity on novel endpoints.
Biosimilars have faced significant challenges in their analytical characterization. This process involves a comprehensive analysis of the biosimilar’s molecular structure, biological activity, and other quality characteristics to demonstrate similarity to the reference product. The emphasis on analytical and functional testing through sophisticated technology is crucial in overcoming these challenges.
Speaker: Simran Kaur, Co-founder & CEO at Tattva Health Inc.
AI is transforming clinical trials—accelerating drug discovery, optimizing patient recruitment, and improving data analysis. But its impact goes far beyond research. As AI-driven innovation reshapes the clinical trial process, it’s also influencing broader healthcare trends, from personalized medicine to patient outcomes. Join this new webinar featuring Simran Kaur for an insightful discussion on what all of this means for the future of healthcare!
In the vast realm of pharmaceutical research and development, there’s a fascinating intersection between ancient wisdom and modern science. This intersection is where pharmacognosy meets drug patents, creating a unique landscape that shapes the future of medicine. But what exactly is pharmacognosy, and how does it relate to the complex world of drug patents?
December 9, 2024— Crucial Data Solutions is proud to announce that our groundbreaking innovation, TrialKit AI, has been recognized with. The post TrialKit AI: Revolutionizing Clinical Research Analytics with AI appeared first on Crucial Data Solutions.
Speaker: Simran Kaur, Founder & CEO at Tattva Health Inc.
The healthcare landscape is being revolutionized by AI and cutting-edge digital technologies, reshaping how patients receive care and interact with providers. In this webinar led by Simran Kaur, we will explore how AI-driven solutions are enhancing patient communication, improving care quality, and empowering preventive and predictive medicine. You'll also learn how AI is streamlining healthcare processes, helping providers offer more efficient, personalized care and enabling faster, data-driven
How to increase efficiency and flexibility in buffer production for biopharmaceutical manufacturing? ZETA presents an innovative solution that saves space and reduces costs. Learn more about the future of buffer production!
Contents About the Study Why Participate? Your Rights Who Can Participate? More Study Details About The Research Center Research Center: The University of Rochester Medical Center Location: This study will be conducted virtually and is open to the United States Lead Researcher: Wil Pigeon IRB: This study has been reviewed and approved by the University of Rochester Institutional Review Board About the Study Are you a Veteran struggling with both insomnia and depression?
Because of the potential for product shortages at pharmacies, the FDA has not only given industry more time for compliancebut time to catch up on boosting the supply chains interoperable efforts.
This is a sponsored message. Clinical Trial Management Systems (CTMSs) are software platforms that provide clinical research sites and research study staff with the ability to manage all operational aspects of a clinical trial, both at the study protocol level and participant level. A CTMS platform can help streamline study start-up processes, provide real-time visibility into the status of a study, improve collaboration through automated workflows, and optimize financial management processes.
On Wednesday, December 11, Hyman, Phelps & McNamara, P.C. (HPM) and Riparian LLC will co-host a webinar on an important CMS rule imposing penalties for misclassification of drugs and other reporting errors under the Medicaid Drug Rebate Program. (See our post on this rule here.) The Webinar will explore the CMS rule and provide actionable recommendations for manufacturers on how to navigate the new requirements.
In the third part of his video interview with Pharma Commerce Editor Nicholas Saraceno, Joe Lipari, director of product management, Systech, predicts the probability that these DSCSA compliance deadlines put forth by the FDA will be met.
The latest episode of the DDW Highlightspodcast is now available to listen to and watch below. DDWs Megan Thomas narrates five key stories of the week to keep DDW subscribers up-to-date on the latest industry updates. This weeks leading news stories all shine a light on innovation within drug discovery, including a potential best-in-industry weight loss drug, a gold-based compound that shrinks tumours by 82%, and a second-generation CAR-T therapy.
This week, Im rerunning some popular posts while I prepare for Fridays Drug Channels Outlook 2025 live video webinar. Click here to see the original post. During Friday's webinar, Ill share some updated thoughts on biosimilars and PBMs private label products. The Humira biosimilar market just took another step forwardbut remains far from its ideal state.
You might be wondering what EAA stands for and why it matters to your brand. Its an abbreviation for the European Accessibility Act , an initiative by the European Union (EU) to make products and services more accessible to individuals with disabilities and the elderly across the EU. This directive highlights the EU and its 27 member states commitment to accessibility, as demonstrated by their ratification of the United Nations Convention on the Rights of Persons with Disabilities.
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.
105 
Let's personalize your content