Biologics

FDA Funds Biosimilar Research to Boost Development/Review

FDA has awarded the Biologics & Biosimilars Collective Intelligence Consortium (BBCIC) a $1.3 million grant to support biosimilars research and a study focused on increasing the efficiency of biosimilar drug development and review. The study is entitled “Improving the Efficiency of Regulatory Decisions for Biosimilars and Interchangeable Biosimilars by Leveraging Real-World Data (RWD) to Produce Real-World Evidence (RWE),” the group says.

“The challenges in using real-world data and the relevance of real-world evidence for regulatory decision-making about biosimilars is a major obstacle in the industry," BBCIC executive director Cate Lockhart is quoted in a release as saying. The study will “leverage volumes of RWD produced by digital sharing and storage of healthcare information (medical claims and electronic health records, e.g.),” BBCIC says. “The high volume of this digital data, along with revolutions in big-data analysis, provide a new opportunity to use RWD to produce RWE that can improve the regulatory science around the development and review of biosimilar drugs.”

The BBCIC is collaboration of managed care organizations, integrated delivery systems, pharmacy benefit management firms, research institutions and pharmaceutical companies. It is described as the only research network dedicated to post-marketing assessment of biosimilars.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome