TOP STORIES
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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Industry News
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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Galderma, a Swiss-based dermatology company that the United States Food and Drug Administration (FDA) has granted breakthrough therapy designation to its investigational therapy, nemolizumab.
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Biopharma N-Glycan Analysis Resource Center
An online resource with useful tools and practical information to find out more about Biopharma N-Glycan Analysis. The site provides useful webcasts, videos, application notes, posters, and more.
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Biopharma News
Sanofi Pasteur will expand clinical development and manufacturing of an adjuvanted recombinant pandemic vaccine at its site in Pennsylvania.
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The rapid-onset CNS neuroactive nasal spray is distributed to patients in microgram doses and activates nasal chemosensory receptors that trigger neural circuits in the brain that suppress fear and anxiety associated with everyday social, work, or performance situations.
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Supplier News
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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GE Healthcare Life Sciences and Advanced Solutions Life Sciences (ASLS) are partnering on 3D-printing of tissues that can be used for discovery and cytotoxicity testing.
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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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MANUFACTURING
Downstream process development and manufacturing play a crucial role to ensure safety, quality, identity, purity, and efficacy.
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OUTSOURCING
The innovative spirit of biotech startups is a driving force behind the development of new therapeutic products, but building a successful biopharmaceutical company from the ground up has its risks and challenges.
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QUALITY
Problems in assuring reliable drug quality and supply dampens progress in bringing lifesaving therapies to market.
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January 15-16, 2020
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The editors examine the technology, practices, and regulatory approval questions facing companies employing single-use technologies for commercial manufacturing.
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