Search results for " approval"
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Milestones and Moderate Progress in 2012 Drug Approvals
In terms of product approvals, the past year can be considered reasonably successful. Twelve biopharmaceutical marketing applications were approved in the United States and/or the European Union in 20…
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Trends in BioPharma Approvals in 2013
This annual approval rate was equalled only in 2009, a year in which 20 new products came on the market (see Figure 1).
Products…
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Biopharma in 2015: A Year for Approvals and Innovations
Last year’s new drug approvals reached 51, besting every year since 1950. Twenty approvals (39%) went to biological drugs—up from 35% in 2014 and 22% in 2013—which confirms the growing importance of b…
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FDA Approves First Biosimilar
The approval is a groundbreaking decision, as Sandoz is the first pharmaceutical company to have a biosimilar product approved in the United States. Known as Zarzio outside of the US, Sandoz says its …
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Monoclonal Antibodies Key to Unlocking the Biosimilars Market
Development of clear, regulatory approval pathways for biosimilars in emerging markets is creating large, additional opportunities for biosimilar mAbs. Education of physicians, pharmacists, and patien…
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Regulatory Challenges in the QbD Paradigm
Changes within these ranges and limits do not require prior approval. Resolution of nonconformances is faster because the required process knowledge already exists.
REGULATORY IMPLICATIONS OF QBD …
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Bracing for a Future Wave of Advanced Therapies
Buoyed by the regulatory approval of several cell and gene therapy (CGT) products for difficult-to-treat diseases, the US biopharma industry is now bracing for a new wave of CGTs in the near future as…
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mAbs to Watch in 2016
Even before the product’s approval by FDA, BARDA granted Elusys its first delivery procurement order for Anthim so that the agency could add Anthim to its Strategic National Stockpile (SNS) as a count…
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Innovation vs. Capacity: How CMOs Compete
…oducts
• A significant number of new drug application (NDA)/biologic license application (BLA) approvals during the past 10 years, including both new molecular entities and new dosage forms
•…
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Framing Biopharma Success in 2016
In 2015, FDA’s Center for Drug Evaluation and Research (CDER) approved 45 new molecular entity and new biologic license application approvals (2), the second highest annual total. The Center for Biolo…