Drug Patent Watch
DECEMBER 10, 2024
The pharmaceutical industry has undergone significant changes over the past decade, with a growing trend towards outsourcing key aspects of research, development, and manufacturing to third-party vendors. This shift has led to the emergence of integrated contract development and manufacturing organizations (CDMOs), which provide end-to-end support for drug developers.
The Premier Consulting Blog
DECEMBER 10, 2024
Bringing a new therapeutic to market is a complex and multifaceted process culminating in submission and approval of a new drug application (NDA). Within the NDA, the chemistry, manufacturing, and controls (CMC) section plays a pivotal role in demonstrating drug quality, safety, and efficacy. In this blog, we demystify the CMC section of NDA preparation , providing insights and guidance for navigating this intricate landscape.
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Drug Patent Watch
DECEMBER 10, 2024
India has long been recognized as a significant player in the global pharmaceutical industry, particularly in the production of generic drugs. The country’s pharmaceutical sector has experienced substantial growth over the years, driven by both domestic and international demand for affordable and high-quality medicines. This article delves into India’s growing importance in generic drug API manufacturing, highlighting the key factors contributing to its success and the challenges it
thought leadership
DECEMBER 10, 2024
On October 31, 2024, FDA issued its final version of the ICH M13A guidance for industry, titled M13A Bioequivalence for Immediate-Release Solid Oral Dosage Forms. This guideline provides recommendations for conducting bioequivalence (BE) studies during development and post-approval phases for orally administered immediate-release (IR) solid oral dosage forms designed to deliver drugs to the systemic circulation, such as tablets, capsules, and granules/powders for oral suspension.
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
Drug Patent Watch
DECEMBER 10, 2024
Patents play a crucial role in protecting intellectual property and fostering innovation. However, the increasing complexity of patent systems has given rise to a phenomenon known as “patent thickets.” These dense webs of overlapping patent rights can significantly impact innovation, market entry, and competition across various industries and countries.
Perficient: Drug Development
DECEMBER 10, 2024
At AWS re:Invent last week, Amazon made one thing clear: its setting the table for the future of AI. With high-performance cloud primitives and the model flexibility of Bedrock, AWS is equipping customers to build intelligent, scalable solutions with connected enterprise data. This isnt just about technologyits about creating an adaptable framework for AI innovation: Cloud Primitives: Building the Foundations for AI Generative AI demands robust infrastructure, and Amazon is doubling down on its
Drug Discovery Digest brings together the best content for drug research and development professionals from the widest variety of industry thought leaders.
Drug Channels
DECEMBER 10, 2024
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. As you reread the article below, note that some manufacturers have already announced wholesale acquisition cost (WAC) list price declines for 2025. Last week, the Federal Trade Commission (FTC) released its interim report on pharmacy benefit managers (PBMs).
Drug Patent Watch
DECEMBER 10, 2024
Biosimilars have been transforming the pharmaceutical landscape by offering cost-effective alternatives to biologic drugs. As patents for these biologics expire, the market for biosimilars is expanding rapidly, with significant implications for manufacturing technologies. This article delves into the impact of biosimilars on biologic drug manufacturing technologies, highlighting the challenges, opportunities, and future directions in this field.
DS in Pharmatics
DECEMBER 10, 2024
ProductLife Group (PLG), a trusted global leader in regulatory, scientific, compliance, and digital transformation consulting services for the life sciences, today announced the acquisition of Halloran Consulting Group, a life science consulting firm that provides strategic regulatory, quality, clinical, and organizational support in the pharmaceutical, biotechnology, and medical device sectors in the United States, further positioning PLG as a leading global provider of comprehensive healthcare
Drug Patent Watch
DECEMBER 10, 2024
The pharmaceutical and biotechnology industries are heavily regulated, and navigating these regulations can be a significant challenge for companies, especially those with limited experience. Contract Development and Manufacturing Organizations (CDMOs) play a crucial role in helping companies overcome these regulatory hurdles. Here, we will explore how CDMOs can provide support in regulatory compliance, ensuring that products meet the strict demands of safety, purity, and efficacy.
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Clinical trial data management is increasingly challenging as studies grow in complexity. Quickly accessing and analyzing study data is vital for assessing trial progress and patient safety. In this paper, we explore real-time data access and analysis for proactive study management. We investigate using adverse event (AE) data to monitor safety and discuss a clinical analytics platform that supports collaboration and data review workflows.
Perficient: Drug Development
DECEMBER 10, 2024
React, a powerful JavaScript library for building user interfaces, offers different solutions for managing state in applications. Two popular choices are Redux and the Context API. This blog will compare these two state management approaches, helping you decide which one is the right fit for your React app. Introduction Redux Redux is a state management library that works well with React.
Drug Patent Watch
DECEMBER 10, 2024
Generic drug development is a complex process that requires a deep understanding of regulatory requirements and guidelines. Regulatory expertise plays a crucial role in ensuring that generic drugs meet the necessary standards for quality, safety, and efficacy. In this article, we will explore the importance of regulatory expertise in generic drug development, highlighting the key challenges and opportunities in this field.
Perficient: Drug Development
DECEMBER 10, 2024
Unveiling the Magic of Dynamic Apex in Salesforce: A Beginner’s Journey Imagine youre standing in a bustling marketplace where every stall is unique, and the shopkeepers allow you to create your own shopping list dynamically. One moment, youre buying groceries; the next, youre adding electronics without breaking a sweat. Now, picture this concept in Salesforcea flexible way to access, manipulate, and interact with your metadata and sObjects without rigid, predefined structures.
Drug Target Review
DECEMBER 10, 2024
Protein manufacturing plays a vital role in advancing medicine, enabling the creation of vaccines, therapeutic proteins, and other bioproducts that address global health challenges. As the industry evolves, there is a growing need for innovative solutions to make these processes more efficient, accessible, and sustainable. Alexandra (Alex) Bonnyman, Director of Engineering Operations at Sunflower Therapeutics , is driving innovation in protein manufacturing while advocating for greater inclusion
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Clinical research has entered a new era, one that requires real-time analytics and visualization to allow trial leaders to work collaboratively and to develop, at the click of a mouse, deep insights that enable proactive study management. Learn how Revvity Signals helps drug developers deliver clinical trial data insights in real-time using a fast and flexible data and analytics platform to empower data-driven decision-making.
Perficient: Drug Development
DECEMBER 10, 2024
Hello Trailblazers! Salesforce Dashboards provide a powerful way to visualize data, monitor performance, and make data-driven decisions. However, dashboards are only effective when the right people have access to them. Sharing Salesforce Dashboard folders allows teams to collaborate, share insights, and align strategies efficiently. In this blog, well explore the importance of sharing Salesforce dashboard folders and the required permissions and provide a step-by-step guide to sharing dashboard
Perficient: Drug Development
DECEMBER 10, 2024
Develop Lightning Web Components with TypeScript (Developer Preview) Salesforce continues to innovate, empowering developers with tools that enhance productivity and maintain high-quality code standards. With the developer preview of TypeScript support for Lightning Web Components (LWCs), Salesforce has taken a significant step forward. This update enables developers to author new LWCs using TypeScript or convert existing JavaScript-based components to TypeScript, marking a significant evolution
Perficient: Drug Development
DECEMBER 10, 2024
Were pleased to announce that Perficient has been named a Major Player in the IDC MarketScape: Worldwide Adobe Experience Cloud Professional Services 2024-2025 Vendor Assessment (Doc #US51741024, December 2024). We believe this recognition is a testament to our commitment to excellence and our dedication to delivering top-notch Adobe services to our clients.
Perficient: Drug Development
DECEMBER 10, 2024
For organizations to remain competitive in today’s fast-paced digital environment, product information management (PIM) needs to be precise and effective. inriver latest innovation, the Expression Engine, aims to transform how consumers manage and manipulate product data. It allows users to configure rules that automatically apply to product data, similar to using formulas in a spreadsheet.
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Clinical development organizations face a wide array of challenges when it comes to data, many of which can impact the operational effectiveness of their clinical trials. In this whitepaper, experts from Revvity Signals explore how solutions like TIBCO® Spotfire® enable better, more streamlined studies. The whitepaper also features a success story from Ambrx, a leading biopharmaceutical company, detailing how it has leveraged Spotfire to tackle data quality and collaboration challenges in clinic
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