Journal Articles
Journal Article
The life sciences industry is shifting its dealmaking focus from high-cost acquisitions to smaller and more targeted deals. Even big pharmaceutical companies are moving away from mega mergers, which are a huge undertaking, and switching toward early-stage assets and smaller deals that allow them to manage risks and large investments.
Journal Article
The eCTD v4.0 standard has been available to be used for submissions to any ICH-participating regulatory agency since 2015, when it reached Step 4 in the International Council on Harmonisation (ICH) process. However, 10 years later, only Japan and the US have begun optional use of the new version.
Journal Article
In an era marked by heightened competition and financial pressures, managing a biopharmaceutical company has become increasingly challenging. The industry is known for its high business costs, which stem from stringent regulatory requirements, complex manufacturing processes, and the need for rigorous quality control (QC). Companies must strike a delicate balance between maintaining high standards and reducing expenses.
Journal Article
Pharmaceutical companies increasingly rely on Contract Development and Manufacturing Organizations (CDMOs) to bring efficiency, flexibility, and innovation to their operations. As partnerships with CDMOs become critical to achieving business objectives, it is imperative for pharma companies to choose the right partners and manage these relationships effectively. To shed light on how pharma companies can optimize CDMO collaborations, we spoke with Annette Boland, a seasoned Quality & Compliance Executive at PharmaLex, a Cencora Company.
Journal Article
Local affiliates face significant time demands, often with very limited resources. These demands are perhaps most keenly felt in pharmacovigilance (PV). In many markets, requirements can include assurance of 24/7 cover, local presence, and local language.
Journal Article
Strategies for ensuring revenue from mature drugs are much more complex than with newer products, and an uncertain regulatory future means that they may become more complicated in the coming years. Pharmaceutical Executive spoke with Kirsten Jacobs, PhD, chief strategy officer at PharmaLex, about strategies pharma companies can consider.
Journal Article
The use of contract development manufacturing organisations (CDMOs) is now the established norm in the pharma/medtech supply chain. The CDMO model provides cost-effective, reliable and compliant solutions with speed to market for critical healthcare products. It takes advantage of core competencies/experience from the contract giver (eg, brand development, marketing, etc) and contract acceptor (eg, manufacturing excellence, quality operations, etc) to allow for targeted focus on key operational pillars to ensure overall programme success and synergies.
Journal Article
The EU legislation for substances of human origin (SoHOs) has been revised, bringing blood products, tissues and cells under one regulation.
Journal Article
Combination-product growth has surged globally as both physicians and patients request fewer invasive procedures in favor of user-friendly treatment delivery options.
Journal Article
Advances in the cancer treatment space have renewed hope for breakthroughs with personalized cancer vaccines (often also called personalized immunotherapies). More recently, there have been promising results in a number of areas, including pancreatic cancer, melanoma, and non-small cell lung cancer (NSCLC).{1} According to analysts, significant growth is expected for cancer vaccines, with one report noting that the global market for cancer vaccines should grow from $10.21 billion in 2023 to $30.16 billion by the end of 2033.{2}
Journal Article
The steps to commercialization readiness are complex, multi-faceted and often left too late in the launch strategy of a pharmaceutical product. This can be particularly problematic in Europe where the diversity of national legislation can make supply chain logistics very challenging. Among the issues faced, particularly for non-EU countries, are defining the product’s logistics, identifying stakeholders who will be involved in the supply chain in Europe, and ensuring that all these individuals are ready to assume their roles soon after the product’s approval (Marketing Authorization) with the relevant Licences and Quality Technical agreements in place.
Journal Article
One of the biggest challenges when launching a product in the EU is understanding the complex regulatory landscape. Besides the overarching European legislation, each country has its own national requirements for the supply of medicinal products.