Search Results for: COMBINATION PRODUCTS 6 Guidelines to
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COMBINATION PRODUCTS - 6 Guidelines to Follow When Developing Combination Products January 13, 2017
Winston Brown explains how companies can reduce the risk and impact that regulatory uncertainty can play by, in advance of pursuing development, understanding the regulatory landscape and then developing a regulatory compliance strategy that is appropriate and suitable for the combination product as a system.
INHALATION THERAPY - An Overview to Drug-Nebulizer Combination Development With Biologics November 30, 2021
Hernan Cuevas Brun, MBA, says biologic drugs are increasingly being investigated for delivery with inhalation therapy, which has initiated more in-depth discussions about the implications of formulation development and their pairing with adequate inhaled devices for more efficient treatment outcomes.
Commercial Prospects for Immuno-Oncology Development Across Oncology Indications in Untapped Cancer Types or in Combinations November 15, 2018
Immuno-Oncology (IO) development is booming across the 8MM (US, France, Germany, Italy, Spain, UK, Japan, and China) with IO agents...COMBINATION PRODUCTS - Human Factors & Combination Products March 2, 2015
Richard Featherstone explains how manufacturers of combination products are being asked to provide rigorous data on the safety of product when intended users use them. These challenges are not going to diminish, but with a focused approach and some sound HF principles, manufacturers can navigate the challenges successfully.
1/16/2013 January 14, 2013
BIND Biosciences & Amgen Sign Worldwide Development & Commercialization Agreement BIND Biosciences recently announced it has entered into a global...SPECIAL FEATURE - Excipients: Advanced Biologics Require Innovative Excipient Science March 29, 2024
Contributor Cindy H. Dubin speaks with several leading companies to discuss novel and functional excipients being developed, the role they will play in reformulations and new formulations, and their versatility in drug delivery.
SPECIAL FEATURE - Improving Bioavailability & Solubility: The Never-Ending Quest February 29, 2024
Contributor Cindy H. Dubin speaks with several companies to review their innovative technologies in this annual report on bioavailability and solubility.
SPECIAL FEATURE - Outsourcing Analytical Testing: AI Could Transform Analytical Labs January 29, 2024
Contributor Cindy H. Dubin presents how today’s leading analytical testing service providers are taking advantage of AI and other types of automation and innovative technologies.
Henlius & Sermonix Announce Strategic Collaboration & Exclusive License Agreements for Novel Endocrine Therapy Lasofoxifene January 11, 2024
Sermonix Pharmaceuticals Inc. and Shanghai Henlius Biotech, Inc. recently announced a strategic collaboration agreement in which Henlius will receive exclusive...SPECIAL FEATURE - Injection Devices: Designing in Sustainability, Usability & Digitization for Patient Compliance September 5, 2023
Contributor Cindy H. Dubin, in this exclusive annual feature, highlights how leading device and drug companies are working to address the challenges of usability, sustainability, and technology to increase patient compliance.
2023 Analytical Testing eBook – Analytical Testing Evolves With the Pharma Industry August 14, 2023
In this fourth annual Analytical Testing e-book, learn more about Alcami, Stevanati Group, and West and their current contributions and offerings in the outsourcing analytical testing market, as it continues to be a time and money saver for bio/pharma companies.
WACKER, CordenPharma, LMU & HU Berlin Train Machine Learning Algorithm for the Formulation of RNA Actives March 31, 2023
Together with Munich’s Ludwig Maximilian University (LMU) and the Humboldt University of Berlin (HU Berlin), Wacker Chemie AG and CordenPharma...EXTRACTABLES & LEACHABLES - Detecting the Unknown With Extractables & Leachables Analysis March 1, 2023
Derek Wood, Xiaochun Yu, PhD, and Aaron Lamb review how a new generation of extraction, identification, and quantification tools, now recognized as approved methods by regulatory bodies, are changing the E&L testing landscape.
2022 Analytical Testing eBook – Service Providers Offer Innovation August 23, 2022
Learn more about the technologies from Alcami, Associates of Cape Cod, Stevanato Group, and West in this exclusive 2022 Drug Development & Delivery Analytical Testing e-book.
Kymanox Announces First Fellow Position August 1, 2022
Kymanox Corporation recently announced Izi Bruker, PhD, MPH, ASQ has been named as the first Fellow of Kymanox. This highly...2022 Respiratory Drug Development eBook - Demand Accelerates Devices July 8, 2022
This fourth annual Drug Development & Delivery Respiratory eBook highlights the pMDI development path, as well as the importance of a holistic approach to that development that includes the patient and all stakeholders across the product’s life cycle.
Hepion Pharmaceuticals Announces Clinical Collaboration With HepQuant in Phase 2b NASH Trial May 3, 2022
Hepion Pharmaceuticals, Inc. recently announced it has entered into a clinical collaboration with HepQuant, a Denver-based, privately held company with...CELL & GENE THERAPY - State of the Industry – Where is C> Headed? April 5, 2022
Bill Vincent believes if the industry wants to keep moving up the steep growth curve, then capacity and raw materials must be readily available. The innovations in therapies, platforms, and processes will all come with time, money, and increasing availability of resources.
Fortress Biotech, Cyprium Therapeutics & Sentynl Therapeutics Announce the Initiation of Rolling Submission of an NDA for Treatment of Menkes Disease December 7, 2021
Cyprium Therapeutics, Inc., a Fortress Biotech, Inc. partner company, with support from its licensing partner Sentynl Therapeutics, Inc., a wholly owned subsidiary of Cadila Healthcare Limited, recently announced the initiation of a rolling submission of a New Drug Application….
2021 Analytical Testing eBook - Bioanalytical Testing is Fastest Growing Sector September 20, 2021
In this annual Drug Development & Delivery analytical ebook, we present best practices in stability studies as well as the benefits of UPLC optimization…..
