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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.
"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.
In the vast realm of pharmaceutical research and development, there’s a fascinating intersection between ancient wisdom and modern science. “Pharmacognosy is the bridge between traditional medicine and modern pharmaceutical science, offering a treasure trove of potential new drugs waiting to be discovered.”
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.
Deal Structuring Deal structuring in pharmaceutical M&A requires a balance of financial, legal, and strategic considerations. These structures are particularly relevant in dealing with uncertainty about the future commercial potential of the target's products.
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. Retrieved from [link] Japan Pharmaceutical Manufacturers Association. Freyr Solutions.
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.
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.
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…
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.
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.
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
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.
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.
Pharmaceutical researchers, in particular, have a keen interest in understanding the unfolding dynamics of this market. Inspired by its success, pharmaceuticalcompanies are pursuing the development of drugs with similar therapeutic profiles, aiming to expand treatment options.
Formulation chemistry is the systematic and step-by-step approach to pharmaceutical development. Nowadays, as the usage of medicines is increasing, pharmaceuticalcompanies are more eager to bring manufacturing a new look in quality and performance. There are different tests to assess the quality of a pharmaceuticalproduct.
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 []
The pharmaceutical industry relies heavily on Contract Development and Manufacturing Organizations (CDMOs) to outsource various stages of drug development and manufacturing. 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.
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.
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.
Environmental Impacts of Traditional PharmaceuticalProduction Traditional pharmaceutical manufacturing is complex, with each phase contributing to environmental degradation. The extraction and synthesis of active pharmaceutical ingredients (API) utilize vast amounts of water and energy.
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.
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.
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!
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!
When a pharmaceuticalcompany completes clinical trials and prepares to launch a medical product, the focus often shifts to regulatory approvals, market access, and commercialization.
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.
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.
Herbert is a highly experienced senior executive with a proven track record in the pharmaceutical industry. The company is using this technology to transform therapies that are administered intravenously, and to enhance injectable products by reducing the volume and frequency of dosing.
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.
03, 2021 (GLOBE NEWSWIRE) — EyePoint Pharmaceuticals, Inc. NASDAQ: EYPT), a pharmaceuticalcompany committed to developing and commercializing innovative ophthalmic products, today announced that Ocumension Therapeutics, a China-based ophthalmic pharmaceuticalcompany traded on the Stock Exchange of Hong Kong (1477.HK),
Multiparameter sensor technologies are transforming workflow oversight, with tangible benefits for productivity and quality. Tools, such as machine learning and other kinds of artificial intelligence, are already being applied across pharmaceutical workflows to identify trends and anticipate issues before they turn into bigger problems.
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.
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