Drugs

Pieris Pharma Study of Cancer Drug on Hold

FDA has placed a Pieris Pharmaceuticals Phase 1 study of PRS-343 on partial clinical hold while the company conducts an additional in-use and compatibility study requested by the agency. Currently-enrolled patients may continue to receive treatment, the company says, but no new patients can be enrolled until the hold is resolved. PRS-343 is currently being evaluated for treating HER2-positive solid tumors.

The company says the partial hold follows discussions with FDA about the in-use study supporting the technical setup for clinical administration of PRS-343. “Specifically, FDA has requested that Pieris conduct an additional in-use and compatibility study of PRS-343 with various infusion materials under specific conditions to confirm suitability of PRS-343 for administration in clinical settings,” it says. “In its telephonic communication, the agency did not cite any adverse events in connection with its request. In-use and compatibility studies are laboratory-based studies typically conducted to evaluate the impact of product handling on a drug candidate's behavior, including effects of dilution media, hold times, and adsorption to materials such as tubing and infusion bags before administration to patients.”

Pieris describes PRS-343 as a 4-1BB/HER2 fusion protein comprising a 4-1BB-targeting Anticalin protein and a HER2-targeting antibody. Ongoing Phase 1 studies of PRS-343 include a monotherapy study and a combination study with atezolizumab. Based on encouraging initial results from both studies, the company says it is actively working towards initiating a Phase 2 study in combination with ramucirumab and paclitaxel for treating HER2-positive gastric cancer in a second line setting later this 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