Sue Lim, who serves as director of scientific review staff of the US FDA's Therapeutic Biologics and Biosimilars Staff, will be leaving the agency at the end of February to start an independent consulting firm.
Leah Christl isn't the only high-level member the US FDA's Therapeutic Biologics and Biosimilars Staff (TBBS) is losing to the private sector this month. Sue Lim, who serves as TBBS' director of the scientific review staff, will be leaving the agency at the end of February to start an independent consulting firm, the Pink Sheet has learned.
An FDA spokesperson told the Pink Sheet that Stacey Ricci, a senior staffer who has been with TBBS for four...
We’ve all been told that walking 10,000 steps a day is the magic number for better health. But what if the real secret to walking more isn’t about counting steps at all? In this article, we explore how focusing on motivation, environment, and mindset can help you build a walking habit that lasts.
The bispecific antibody is the latest example of a growing number of biologics receiving complete response letters related to third-party manufacturing facilities.
A US FDA analysis found that facility inspection issues were the fastest growing factor in the recent rise of complete response letters for biologics licensing applications, in part reflecting the limitations of single-product inspections at contract facilities manufacturing multiple products.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
A US FDA analysis found that facility inspection issues were the fastest growing factor in the recent rise of complete response letters for biologics licensing applications, in part reflecting the limitations of single-product inspections at contract facilities manufacturing multiple products.
Novartis continues to fight tooth and nail to protect its $3bn Entresto brand in the US following the latest FDA approval of a generic version.
A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.
