Search results for "regulatory" in Articles / App Notes
Article
Relationship Building at Top of Mind for Clients
…city and Production (1) show, however, it’s no longer enough for CMOs to lay claim to technology, regulatory compliance, and IP protection expertise, as these increasingly become non-negotiable issue…
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Single-Domain Antibodies for Brain Targeting
Immunogenicity concerns in relation to these strategies are still under investigation by drug regulatory agencies. Favorable properties, such as good expression, thermal stability, and solubility, are…
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Biopharma Outsourcing Activities Update
Outsourcing activity remains strong and unlikely to abate, especially in more traditional areas.
Over the past 11 years, BioPlan’s annual report and survey of biopharmaceutical manufacturing ha…
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Trends in BioPharma Approvals in 2013
Several of those newly approved products underpin particularly noteworthy technical, medical, or regulatory milestones, and are thus the focus of the remainder of this article.
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Outsourcing Trends in Biopharmaceutical Manufacturing
Other problems can arise, such as a lack of consistency in bioprocessing and regulatory documentation, which in turn lead to delays in product development, approvals, and manufacturing.
Trend eigh…
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Drugs, At What Cost?
…ernment austerity programs, blockbuster drugs falling off the patent cliff, and varying medical and regulatory practices worldwide continue to shape the financial outlook of biopharmaceutical compani…
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Trends in Downstream Bioprocessing
These persistent capacity issues could be related to a reluctance on the part of product developers to modify legacy processes, with these developers harboring regulatory concerns that hold them back …
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Report from the Eighth International Plasma Product Biotechnology Meeting Melia Salinas, Lanzarote, Spain
Jan Overs talked about the necessity of regulatory pathways for orphan drugs, but discussed also the complexity of the definition of orphan drugs as well as price and the exclusivity terms.
In t…
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Report from India
Compulsory licensing, patentability, patent enforcement, regulatory approval, and data exclusivity are issues that they will need to grapple with.
The revised drug-pricing policy will encourage …
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The Future of Biopharma
…al methods
• 30% others: product platforms, cost reductions, materials sourcing, supply chain regulatory compliance, biosimilars, etc.
Key Micro-Trends
This relatively evenly distribu…