FDA Policy/General

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Eli Lilly has acquired ARMO BioSciences at a price of $50.00 per share in cash (27.5 million outstanding shares). The transaction gives Lilly promising clinical immunotherapy asset, pegilodecakin, to its oncology portfolio.

Roche has agreed to acquire all outstanding shares of Cambridge, MA-based Foundation Medicine that will bring its sequencing diagnostics platform under the Roche umbrella. In December, Foundation Medicine gained FDA approval for its sequencing diagnostics test for solid tumors that can detect cancer-causing mutations in 324 genes.

Astellas has paid $102.5 million for Universal Cells, a biotech that the company says is developing a platform technology intended to do away with the testing needed to ensure cell therapy products aren’t rejected by a patient’s immune system. It uses recombinant adeno-associated viral vectors to edit the genomes of pluripotent stem cells by switching off human leukocyte antigen expression in a way that does not cause “off-target” DNA cutting — which could lead to unintended effects. The resulting universal donor cells won’t require donor matching or immune-suppressing therapy and don’t stimulate rejection, according to the biotech.

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