Search results for " clinical trials"
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
FDA has developed four distinct pathways to speed the progress of promising new therapies through clinical trials, and if results merit, on to approval. Advanced therapies may be eligible for one or m…
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GMP Challenges for Advanced Therapy Medicinal Products
Academics seeking to arrange preclinical and clinical trials for their innovations are so concerned about the complexities of compliance with GMP that they try to avoid having them classified as ATMPs…
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Challenges for biosimilar developers: A conversation with Dr. Howard Levine about new FDA draft guidelines
This is really very, very good news for companies developing biosimilars because if they have clinical trials already underway in Europe, for example, using a European reference standard, those clinic…
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Witnessing Major Growth in Next-Generation Antibodies
“Today there is a whole set of technologies in pre-clinical and clinical trials with tremendous promise,” he notes.
Many therapeutic targets
Oncology continues to be a key focus for next-gener…
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Drug Discovery and Development in India
This is further compounded by regulatory uncertainty following the US Supreme Court’s ruling in 2013 to suspend 157 previously approved clinical trials, Ang adds.
As a result, Indian pharmaceutica…
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Quality by design for biotechnology products—part 1
…ns or glycoengineering as well as fusions to toxin or drug conjugates have emerged and been taken to clinical trials for some targets.
Engineering the protein sequence is also used to reduce the …
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FDA Framework Spurs Advanced Therapies
Greater clarity on the application of existing regulations will accelerate development of cell and gene therapies.
By Cynthia A. Challener
Ibreakstock/Shutterstock.co…
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The Development and Application of a Monoclonal Antibody Purification Platform
A purification scheme to maximize the efficiency of the purification process and product purity while minimizing the development time for early-phase therapeutic antibodies.
The following ar…
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Pandemic Alters Policies and Practices for Drug Development and Regulation
Sponsors gained important advice from FDA on conducting clinical trials during the pandemic from a steady stream of new guidance documents addressing the need for flexibility while maintaining study i…
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CDMOs Driving Emerging Bio/Pharma Success
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• Most new drug candidates are highly targeted at narrow diseases, meaning that clinical trials can be smaller and faster, with less commercial infrastructure.
• Regulatory pathways …