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
This growth has created a competitive landscape where pharmaceuticalcompanies must carefully evaluate and select the right CDMO partner to ensure the success of their projects. Speed and Quality of Development and Production The speed and quality of development and production are critical considerations in selecting a CDMO.
This chart shows the companies which have received the most New Product exclusivities in the past five years. New Product Development is one of the categories for which the FDA…. The post Pharmaceuticalcompanies with the most ‘New Product Exclusivity’ drugs appeared first on DrugPatentWatch - Make Better Decisions.
Identifying branded drugs with a low likelihood of generic entry has become a crucial strategy for companies looking to expand their product portfolio through in-licensing. This approach not only helps maintain market exclusivity but also ensures a steady revenue stream for pharmaceuticalcompanies.
In the face of impending patent expirations, pharmaceuticalcompanies can adopt key approaches to preserve meaningful… The post Strategies to Maximize Product Value Amid Loss of Exclusivity in the Pharmaceutical Industry appeared first on DrugPatentWatch - Make Better Decisions.
This chart shows the companies which have received the most New Product exclusivities in the past five years. New Product Development is one of the categories for which the FDA…. The post Pharmaceuticalcompanies with the most ‘New Product Exclusivity’ drugs appeared first on DrugPatentWatch - Make Better Decisions.
"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 pharmaceuticalcompanies.
High-Throughput Screening: Modern Technology Meets Natural Products Advanced technologies now allow researchers to rapidly test thousands of natural compounds against specific disease targets. The development of Taxol involved multiple patents, including those for the isolation method, synthetic production, and various formulations.
This chart shows the companies which have received the most New Product exclusivities in the past five years. New Product Development is one of the categories for which the FDA… The post Pharmaceuticalcompanies with the most ‘New Product Exclusivity’ drugs appeared first on DrugPatentWatch - Make Better Decisions.
This chart shows the companies which have received the most New Product exclusivities in the past five years. New Product Development is one of the categories for which the FDA grants three years of…
This chart shows the companies which have received the most New Product exclusivities in the past five years. New Product Development is one of the categories for which the FDA… The post Pharmaceuticalcompanies with the most ‘New Product Exclusivity’ drugs appeared first on DrugPatentWatch - Make Better Decisions.
This chart shows the companies which have received the most New Product exclusivities in the past five years. New Product Development is one of the categories for which the FDA…. The post Pharmaceuticalcompanies with the most ‘New Product Exclusivity’ drugs appeared first on DrugPatentWatch - Make Better Decisions.
This chart shows the companies which have received the most New Product exclusivities in the past five years. New Product Development is one of the categories for which the FDA…. The post Pharmaceuticalcompanies with the most ‘New Product Exclusivity’ drugs appeared first on DrugPatentWatch - Make Better Decisions.
This chart shows the companies which have received the most New Product exclusivities in the past five years. New Product Development is one of the categories for which the FDA…. The post Pharmaceuticalcompanies with the most ‘New Product Exclusivity’ drugs appeared first on DrugPatentWatch - Make Better Decisions.
China has emerged as a significant player in the global generic drug active pharmaceutical ingredient (API) market. The country’s vast production capacity, low costs, and strategic location have made it an attractive destination for pharmaceuticalcompanies seeking to source APIs.
For pharmaceuticalcompanies, this shift presents both challenges and opportunities. In today's digital age, social media has transformed how businesses communicate with their audiences. Social media can significantly enhance brand visibility and patient engagement and have an impact on the overall healthcare sector.
This article aims to provide a comprehensive overview of the key aspects of the regulatory framework, highlighting the requirements and challenges faced by pharmaceuticalcompanies seeking to introduce generic drugs into the Japanese market.
Introduction Patent portfolios are critical assets for pharmaceuticalcompanies, providing market exclusivity and protecting revenue streams for drug products. Effective management of drug patent portfolios requires strategic planning, ongoing evaluation, and adaptation to the evolving pharmaceutical landscape.
As the industry continues to see significant growth for drug products developed in prefilled syringe systems (PFS), there is a trend for pharmaceuticalcompanies to evaluate more complex drug molecules, such as biologics.This webinar discusses current trends in the market for injectable drug delivery and outlines current challenges for companies developing (..)
Your Guide to the Ultimate PharmaceuticalProduct Improvement Tool This white paper will review how automating the annual product quality review (APQR) process can help pharmaceuticalcompanies simplify and optimize their product quality review process, to make informed product quality decisions quicker and on a more routine and proactive basis.
These products contain the same active ingredients as their brand-name counterparts but are typically sold at a lower price point. Branded generics can be an attractive option for both consumers and pharmaceuticalcompanies, offering cost savings while leveraging brand recognition. […] Source
Cost estimation in drug product manufacturing is far from straightforward. Striking the right balance between operational efficiency and budget constraints poses a significant challenge for pharmaceuticalcompanies. This balancing act becomes even more []
A robust Quality Management System (QMS) is an important aspect of a Pharmaceuticalcompany as it demonstrates a company’s Senior Management commitment to Quality. QMS instills the mindset that assures that the company will have qualified and trained individuals who focus on “Quality” throughout the lifecycle of the product.
Koblitz Integral to the careful balance Congress struck when passing the Hatch-Waxman Amendments, the patent term extension (PTE) is intended to restore patent life that was consumed during regulatory review of an FDA-regulated product. The Court thus explained that interpreting the patent in 35 U.S.C.
Today’s guest post comes from Kylie Hall, Director of Product Management at ConnectiveRx. Kylie explains how new ways of harnessing patient data can transform the way pharmaceuticalcompanies interact with patients and providers—and ultimately help improve adherence. Read on for Kylie’s insights.
Today’s guest post comes from Kylie Hall, Director of Product Management at ConnectiveRx. Kylie explains how new ways of harnessing patient data can transform the way pharmaceuticalcompanies interact with patients and providers—and ultimately help improve adherence. Read on for Kylie’s insights.
Intense competition in oncology may lead companies to seek opportunities in less crowded fields, assessing the number of competitors and the status of competing therapies. Therapeutic areas with fewer competitors or novel targets can be attractive, offering companies the chance to establish leadership and differentiate their products.
Listen on Join us in this engaging episode to explore the critical elements of successful product launch training execution. Discover the key factors to consider when planning and executing product launch training, along with valuable insights on measuring sales performance. Tune in now!
Drug discovery and development for these drug products is often carried out by academic investigators rather than by biopharmaceutical or pharmaceuticalcompanies, said Patrizia Cavazzoni, acting director of the Center for Drug Evaluation and Research, in announcing the draft’s release. Suz Redfearn. Source link.
Listen on Join us in this engaging episode to explore the critical elements of successful product launch training execution. Discover the key factors to consider when planning and executing product launch training, along with valuable insights on measuring sales performance. Tune in now!
Adds 185,000 litres of biopharmaceutical production capacity High degree of digitalization and automation through smart technologies and artificial intelligence applications Multi-product setup enables production of a large variety of molecule formats Investment of more than 700 million EUR, creating 500 new jobs.
Evaluating CDMO performance is a critical step in this process, ensuring that the chosen partner can meet the required standards and deliver high-quality products. This includes drug substance and drug product development, clinical trial logistics, product labeling, supply chain management, commercial packaging, and more.
Inspired by its success, pharmaceuticalcompanies are pursuing the development of drugs with similar therapeutic profiles, aiming to expand treatment options. Key Players and Challenges For pharmaceutical giants like Novo Nordisk and Eli Lilly, 2024 presents both opportunities and challenges.
Takeda PharmaceuticalCompany Limited ( TSE:4502/NYSE:TAK ) (“Takeda”) today announced that it has completed the asset transfer associated with a portfolio of select non-core products in Japan to Teijin Pharma Limited (“Teijin Pharma”) for JPY 133.0 billion 1.? This asset transfer agreement was announced in February 2021.
How ProPharma Can Help You Ensure Compliance with the New HTAR Requirements The new Health Technology Assessment Regulation (HTAR) will set new requirements for pharmaceuticalcompanies seeking registration and market access in the European Union (EU) for their products.
These structures are particularly relevant in dealing with uncertainty about the future commercial potential of the target's products. Emerging Markets Emerging markets, particularly in Asia and Latin America, have become increasingly attractive destinations for pharmaceutical M&A activity.
Informa Connect’s Compliance Congress for Specialty Products. Up your compliance game at this important event serving the unique sector of Specialty Products, the 7th annual Virtual Compliance Congress for Specialty Products. June 22-24, 2021 | Virtual Event www.informaconnect.com/specialty-compliance/.
With cellular rejuvenation, our goal is to improve healthspan so as to maximise the number of healthy and productive years one has in their lifetime, not just their total number of years. a commercial stage pharmaceuticalcompany. acquired by Teva Pharmaceuticals in 2014.
The PPD clinical research business of Thermo Fisher Scientific conducts an annual survey of more than 150 leaders at pharmaceuticalcompanies around the globe to assess trends in drug discovery and development, including preferences around outsourcing and functional service provider (FSP) utilization.
In it, language was used to assign a specific percentage in relation to the product’s efficacy. FDA said that the use of this specific statistic was misleading in that it did not use a validated methodology and did not agree with the means used to describe efficacy in the PI for the product.
The introduction of the EU health technology assessment (HTA) Regulation (EU) 2021/2282 and US Inflation Reduction Act (IRA) created a need for pharmaceuticalcompanies to develop strategies to generate data through diverse patient data sources and use complex methodologies while keeping pace with evolving evidentiary requirements for their products (..)
When pharmaceuticalcompanies develop a new drug product for the market, there are many different steps a potential product must go through to determine and control its safety, manufacturability, effectiveness and reliability. CMC is done during […]
Nowadays, as the usage of medicines is increasing, pharmaceuticalcompanies are more eager to bring manufacturing a new look in quality and performance. It involves designing, analyzing, and controlling manufacturing by taking timely measurements to ensure final product quality, efficacy, and safety.
NASDAQ: BIIB) for Avonex® (interferon beta-1a) and Tecfidera® (dimethyl fumarate), select products in the drug maker’s leading multiple sclerosis (MS) portfolio.
SAN JUAN, Puerto Rico , Oct. Originally launched in 2017, this was the first publicly disclosed value-based agreement to serve Medicaid populations.
A robust Quality Management System (QMS) is an important aspect of a Pharmaceuticalcompany as it demonstrates a company’s Senior Management commitment to Quality. QMS instills the mindset that assures that the company will have qualified and trained individuals who focus on “Quality” throughout the lifecycle of the product.
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