Search results for " approval" in Articles / App Notes
Article
Pharma Investments Reflect Key Industry Trends
Shrinking facility size, growth of biologics, and emerging market demand influence pharma investments.
Aug 2, 2014
By: Cynthia Challener, PhD
Pharmaceutical Technology
Volume 37, Iss…
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FDA Urged to Preserve Biosimilar Naming Conventions
The Generic Pharmaceutical Association (GPhA) is reporting that 32 organizations, including pharmacies and labor unions, have signed a letter urging FDA to require biologics and biosimilars to have …
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Report: Branded Biopharms Most Exposed to Biosimilar Competition
"But while in Europe more than a dozen products are now commercialized, in the US no company has yet filed for approval of a biosimilar drug since the existence of the FDA's new pathway for biosimilar…
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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?
Generics, market dynamics, and global demand are changing drug spending patterns.
The underlying question for any drug in development is: What price can (or will) patients pay for the needed…
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Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability
As the European Union takes a closer look at its biosimilars guidelines, some key issues are proving difficult to resolve.
The European Union is strengthening its pioneering role in the regulati…
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Biotechnology Innovation and Growth in Israel
Israel's diverse population, high-quality healthcare system, and resilience to global financial stress make it a strong partner for R&D, clinical research, and market growth.
…
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Prescribing Caution for Biosimilars
Until recently, there was no pathway for the development and approval of biosimilar products in the United States. The US Food and Drug Administration is currently developing such a pathway. Even afte…
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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 …
Article
QbD and PAT in Upstream and Downstream Processing
To gain perspective on the implementation of quality by design (QbD) and process analytical technology (PAT) in biopharmaceutical processing, BioPharm International spoke with Clinton Weber, as…