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© 2023 MJH Life Sciences and Pharmaceutical Technology. All rights reserved.
© 2023 MJH Life Sciences™ and Pharmaceutical Technology. All rights reserved.
Challenges, Sustainability, and Big Trends in Outsourcing Today
Understanding is crucial to ensure the right balance in manufacturing technologies and proccesses is achieved.
Obstacles remain before broader application of intensified processes can be implemented.
Limitations in production platforms have impeded continuous manufacturing for advanced therapies.
Considering the differences between small- and large-molecule drug products can help determine analytical testing methods for E&L.
Fundamental Constriction Points in Emerging Therapies
May 27, 2023
Sean Hart, CEO and SCO of LumaCyte, discusses rapid accurate mRNA potency assay possibilities.
May 26, 2023
Myrna Wilson, director, Global Marketing, Strategic Growth and Technical Sales, Pharmaceutical Ingredients, Univar Solutions, discusses the state of the biopharma supply chain, movements in the patent industry, and more.
Challenges to approval decisions have prompted FDA officials to reexamine of the role and composition of the agency’s many advisory committees and to explore options for change.
May 25, 2023
This agreement is intended to be executed and see the impact of any financial transfers by the fiscal year ending March 31, 2024.
FDA has approved the first topical gene therapy product for treating wounds in patients with dystrophic epidermolysis bullosa.
FDA has approved AbbVie’s EPKINLY (epcoritamab-bysp), a bispecific antibody for treating relapsed or refractory diffuse large B-cell lymphoma.
Andrea Lodetti, CEO of Bormioli Pharma, an Italian pharma primary packaging manufacturer, speaks about his company's approach to the US market, supply chain instabilities, sustainability, and more.
In this episode of Drug Digest, Pharmaceutical Technology editors discuss what happens in early phase development, the role of CDMOs, and highlight the benefits and challenges of the outsourcing process.
May 24, 2023
The new CGMP facility is expected to contribute to the development of mRNA therapeutics, with a building designed for the CGMP manufacture of mRNA-based in-vivo gene editing, gene-edited cell therapies, protein replacement therapies, cancer vaccines, and infectious disease vaccines.
Blueprint Medicines’ avapritinib has been approved by FDA for the treatment of indolent systemic mastocytosis.