Drugs

Aurigene Ditches Psoriasis Drug Candidate

Dr. Reddy’s subsidiary Aurigene Oncology says it is stopping the development of its psoriasis investigational drug after reporting results of INDUS-3, a Phase 2b double blind placebo-controlled study conducted in the U.S. “The magnitude of efficacy improvement with AUR101 (versus placebo) in psoriasis is not what we hoped for in the study,” the company says.

AUR-101 is described as a potent, oral RORΥt inverse agonist, with high selectivity across other ROR isoform and nuclear hormone receptors. “While the positive statistical results at 400 mg BID confirm the role of RORγ in psoriasis, other agents, such as IL-17 antibodies as well TYK-2 inhibitors, lead to better results,” Aurigene says. “In view of this, we believe that AUR101 will not add desirable benefit to patients with moderate to severe psoriasis.”

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