Drugs

RedHill Bio Fast Track for Antibacterial

FDA has granted RedHill Biopharma a fast track designation for RHB-204 and its use as a potential first-line, stand-alone, oral treatment for pulmonary nontuberculous mycobacteria (NTM) disease caused by Mycobacterium avium Complex – a rare disease for which there is no FDA-approved first-line therapy. The company recently began a Phase 3 study evaluating the safety and efficacy of RHB-204 at up to 40 sites across the U.S.

NTM disease is a chronic and debilitating lung disease caused by environmental bacteria found in soil, as well as natural and engineered water systems, the company says. The most common NTM symptoms include fever, weight loss, chest pain, and blood in sputum. “Pulmonary NTM disease can lead to recurring cases of bronchitis and pneumonia and can, in some cases, lead to respiratory failure,” it says. There are about an estimated 110,000 pulmonary NTM disease patients in the U.S.

RedHill Bio describes RHB-204 as a proprietary, fixed-dose oral capsule containing a combination of clarithromycin, rifabutin, and clofazimine. It previously had been granted an FDA Orphan Drug designation and a Qualified Infectious Disease Product designation for the same indication.

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