Drugs

FDA Agrees to PolyPid Phase 3 Study Design

FDA has agreed to a PolyPid Ltd. Phase 3 trial (SHIELD II) design revision evaluating D-PLEX 100 (doxycycline) for preventing abdominal colorectal surgical site infections (SSIs). The revised trial will recruit patients undergoing colorectal resection surgery with large incisions (greater than 20 cm), according to the company. Recruitment into the trial will resume shortly, it says, with an enrollment goal of 550 additional patients beyond the 40 patients already recruited. Total recruitment time is expected to be 12 months and top-line results are due in mid-2024. PolyPid says it will also conduct an unblinded interim analysis once 400 patients complete their 30-day follow-up.

PolyPid says SHIELD II (Surgical site Hospital acquired Infection prEvention with Local D-PLEX) is designed to assess the efficacy and safety of D-PLEX 100 administered concomitantly with standard of care (SoC), which includes prophylactic systemic antibiotics, compared to SoC alone arm, in preventing post abdominal-surgery incisional infections. “The primary endpoint of the trial is measured by the proportion of subjects with either an SSI event as determined by a blinded and independent adjudication committee, reintervention, or mortality for any reason within 30 days post-surgery,” it says. Patient safety will be monitored for an additional 30 days. The trial will enroll patients in centers in the U.S., Europe and Israel.

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