Drugs

Paratek Pharma Fast Track for Nuzyra

FDA has granted Paratek Pharmaceuticals a fast track designation for an oral and intravenous formulation of its broad-spectrum antibiotic Nuzyra (omadacycline) for treating pulmonary nontuberculous mycobacterial (NTM) disease caused by both Mycobacterium avium complex and Mycobacterium abscessus. The agency granted the therapy an orphan drug designation for these infections 8/2021.

Paratek is currently conducting a Phase 2b randomized, placebo-controlled monotherapy study to evaluate Nuzyra’s afety and efficacy in patients with NTM pulmonary disease. The study will enroll about 75 patients who are not receiving other antibiotic treatments for their NTM pulmonary disease. The company says the study will take about two years to complete due to the small numbers of patients with the rare disease.

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