Drugs

Clarametyx Gets Fast Track for Pulmonary Infection Drug

FDA has granted Clarametyx Biosciences both fast track and qualified infectious disease product designations for its lead therapeutic candidate, CMTX-101, and its use in treating chronic bacterial pulmonary infections in people with cystic fibrosis (CF).

The designations follow “encouraging interim results” from Clarametyx’s ongoing Phase 1b/2a clinical trial of CMTX-101 in CF patients, according to the company. The trial, which builds on standard-of-care therapy, is evaluating safety, pharmacokinetics, immunogenicity, and the therapy’s effect on pulmonary burden of Pseudomonas aeruginosa, it says, adding that an interim analysis of the first 21 participants met pre-specified criteria, allowing the study to expand to additional patients and clinical sites.

Clarametyx describes CMTX-101 as an investigational antibody therapy designed to dismantle bacterial biofilms — a key structural component that protects bacteria and contributes to chronic infection and inflammation. By targeting this pro-inflammatory biofilm structure, the therapy aims to boost antibiotics’ and the immune system’s effectiveness, offering potential treatment across a range of bacterial infections. In addition to CF, Clarametyx sees future opportunities for CMTX-101 in conditions such as non-CF bronchiectasis, nontuberculous mycobacterial lung disease, and chronic obstructive pulmonary 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