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CBER’s 2012 Approval Count Is Average, But Its On-Time Review Performance Exceeded Expectations

 
• By Bridget Silverman

FDA’s Center for Biologics Evaluation and Research approved six original BLAs in 2012, a solid if unspectacular showing. But some of the center’s most interesting approvals are products that do not appear on the original BLA count: quadrivalent flu vaccines (supplements to predecessor trivalent products) and hemapoietic cord blood cells (not included under the PDUFA umbrella).

As FDA’s biologics center closes in on a decade since responsibility for therapeutic biologics was transferred to CDER, CBER posted a solid, if undramatic, year for approvals in 2012, with six original BLA approvals under the PDUFA framework.

Six approvals puts the 2012 CBER novel biologic class at the mid-point of CBER BLA activity in recent years, which...

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More from Approvals

Novel Alzheimer’s Drug Blarcamesine Scheduled For High-Stakes EMA Oral Explanation

 
• By Neena Brizmohun

The EMA has scheduled oral explanation meetings this week for Anavex’s blarcamesine and three other products that are nearing the end of the regulatory review cycle. These meetings usually represent the final chance for sponsors to persuade the agency that their product merits approval.

Brazil To Fix Regulatory Reliance Shortfalls & Speed Up Approvals

 
• By Francesca Bruce

Regulatory reliance processes for drug registration and clinical trial application approvals in Brazil have not met their “full potential,” says Brazil’s medicines regulator.

EU Moment Of Truth For Teplizumab, Etuvetidigene Autotemcel & Other Drugs

 
• By Neena Brizmohun

The sponsors of a number of drugs could this week learn whether the European Medicines Agency will recommend in favor of approving their products. And while teplizumab was approved in the US in 2022, Sanofi told the Pink Sheet why it waited to submit the drug for regulatory review in the EU.

Where RWE Studies Stand In India And Bharat Serums’ Plans For The World’s Largest One

 
• By Vibha Ravi

Real-world evidence (RWE) studies in India face challenges like lack of data reliability and uniformity and absence of clear guidelines but firms like Bharat Serums have scored a regulatory win. Pink Sheet examines the RWE landscape and the BSV case study for lessons in beating the odds

More from Product Reviews

Where RWE Studies Stand In India And Bharat Serums’ Plans For The World’s Largest One

 
• By Vibha Ravi

Real-world evidence (RWE) studies in India face challenges like lack of data reliability and uniformity and absence of clear guidelines but firms like Bharat Serums have scored a regulatory win. Pink Sheet examines the RWE landscape and the BSV case study for lessons in beating the odds

Patient Perception-Of-Change Videos Not Efficacy Evidence For Stealth Barth Syndrome Drug

 
• By Sue Sutter

FDA reviewers cited several limitations of the videos, including a lengthy recall period, use of the term “today” in questions, and a lack of standardization in interview conduct.

Forzinity Chronology: Stealth’s Barth Syndrome Drug Bounced Around US FDA Review Divisions

 
• By Sue Sutter

The Pink Sheet’s Drug Review Profile looks at the clinical development and US FDA review timeline for Stealth's elamipretide for Barth syndrome.