Search results for " approval"
Article
Moving Biosimilars Forward in a Hesitant Market
…s interchangeable, [which requires] switching studies as part of the clinical arms of the biosimilar approval, at least in some cases, to demonstrate that the product is, in fact, interchangeable.”
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Article
ADC Development Robust Despite Lackluster Performance
Pfizer’s product, Mylotarg (gemtuzumab ozogamicin), was approved in 2017, nearly a decade after an initial approval in 2000 (2). Soon after its first approval by FDA in 2000, Pfizer voluntarily withdr…
Article
Regulatory Requirements for Safe and Efficient Biologic Drug Development
…cks for companies developing new therapeutics
7:12 - Best practices to navigate the regulatory approval path
9:44 - The impact of filing accelerated review applications on process develop…
Article
The Evolving Role of Starting Materials in Cell and Gene Therapy
By Brad Taylor, Dominic Clarke
The number of product approvals for cell and gene therapies is rising steadily. Earlier this year, FDA issued a statement revealing that there are already…
Article
Process Development: What May Lie Ahead in 2018?
Continued Growth
New drug approvals are on an upward trajectory. While only 22 new drugs were approved in 2016, FDA gave its thumbs up to 46 new drugs in 2017 (of which approximately one-quarter w…
Article
Innovative Therapies Require Modern Manufacturing Systems
More biosimilars are poised to come to market in 2016 following FDA approval of the first such therapy in 2015. At the same time, though, the development of such innovative and targeted therapies heig…
Article
Biopharma Seeks Balance
To increase the potential for approval, companies need to provide better “packages” that describe how the drug works, said Scott Gottlieb, FDA commissioner, at the 2018 BIO convention in Boston on Jun…
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Drug Quality Key to Innovation and Access
As 2016 came to a close, FDA officials reported that new drug approvals for the year would fall far short of the near-record set in 2015, raising concerns about current incentives and regulatory proce…
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The Bullish Outlook for Biosimilars
In contrast to these other markets, the United States has surprisingly been a laggard in establishing a formal path for biosimilar approval. FDA is still developing its final regulations and guideline…
Article
Witnessing Major Growth in Next-Generation Antibodies
Commercial potential
Typically, it takes 10-12 years or more between the advent of a new technology and the first approval, sometimes several decades for complex technologies, according to Paul Ca…