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The acquisition boosts Sanofi’s pipeline of immuno-oncology product candidates with a lead candidate in development for treating solid-tumor-type cancers.
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Through the acquisition, Merck will gain access to ArQule’s lead investigational candidate, ARQ 531, a novel, oral Bruton’s tyrosine kinase (BTK) inhibitor currently in a Phase II dose expansion study for the treatment of B-cell malignancies.
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2019 PDA Quality Week | Dec. 9-13 | Washington, DC
The Week is comprised of three individual, but contiguous events designed to educate you on all aspects of QRM. Each offering provides a different perspective, starting with a focus on the emerging regulatory landscape, framing the requirements and objectives of the regulations that govern this important but elusive concept.
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Industry News
FDA has an official new leader, following a Senate vote to confirm Stephen Hahn as the agency’s next commissioner.
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With support from academia, patient advocacy organizations, private and nonprofit companies, government organizations, and clinical trial networks funded by the NIH, a new plan was developed to focus on HBV biology, sharing tools and resources, and strategy creation.
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Supplier News
Catalent recently completed the clinical production of Bridge’s opioid addiction development therapeutic product and investigational new drug, BT-219, which will be used with Catalent’s Zydis orally disintegrating tablet technology.
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Through the collaboration, Charles River plans to expand its suite of authentic human cells by utilizing Bit Bio’s target discovery, validation, and screening services to further the development of therapies with a higher chance of success in patients.
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Newron Pharmaceuticals has received communications from the United States Food and Drug Administration (FDA) suggesting it discusses its proposed statistical plan in a Type A meeting.
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Sanofi Pasteur will expand clinical development and manufacturing of an adjuvanted recombinant pandemic vaccine at its site in Pennsylvania.
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Regulatory News
The biologic is a novel bone builder that has a dual effect of increasing bone formation and reducing bone loss.
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According to a consent decree of permanent injunction issued in September 2019, the health and wellness companies must recall and stop distributing products until the companies comply with the Federal Food, Drug, and Cosmetic Act and other requirements included in the consent decree.
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Featured Topics |
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ANALYTICS
As regulatory bodies extend the oversight of E&L testing, companies working with drug products need to make provisions on how to best comply with the evolving expectations.
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QUALITY/REGULATIONS
Applying lessons of raw materials’ characterization and supply-chain control from the semiconductor industry allow more rigorous control of the biopharmaceutical manufacturing process.
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MANUFACTURING
Visualization using virtual and mixed reality can aid with biopharma manufacturing facility design and training.
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PEER-REVIEWED RESEARCH
This article discusses reduced sampling and testing of starting materials or components. Different strategies are presented to reduce the workload at the steps from sampling to release. Viewpoints from the different pharmacopoeias and regulatory authorities, as well as selected literature, are reviewed.
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January 15–16, 2020
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The editors explore novel technologies for the formulation, manufacture,
purification, and delivery of sterile small- and large-molecule drugs including single-use systems, facilities and equipment, contamination issues, and process analytics.
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