Drugs

Subcutaneous Tecentrig Delayed Due to CMC Info

Roche’s Genentech will not be getting FDA approval this month for a subcutaneous formulation of its lung cancer drug Tecentriq (atezolizumab) after the agency requested that the company update the chemistry, manufacturing and controls (CMC) information in the supplemental BLA submission. The approval delay was revealed in a financial filing by Halozyme Therapeutics, Genentech collaboration and license partner. The subcutaneous formulation was developed using Halozyme’s ENHANZE drug delivery technology.

Halozyme says the technology is based on its recombinant human hyaluronidase PH20 enzyme, rHuPH20, which locally degrades hyaluronan in the subcutaneous space temporarily removing a barrier to fluid flow. “Large volume injections may allow some biologics and small molecule drugs that are administered intravenously to be delivered subcutaneously, opening the door to potential benefits for patients, healthcare systems and manufacturers,” it says.

Halozyme says that Roche told it that the CMC information will be updated later this year, with a projected product launch now pushed back until next year.

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