Drugs

Ainos Responds to Clinical Hold on Covid Therapy

Ainos has responded to an FDA clinical hold on its low-dose oral interferon (IFN)-alpha formulation, Verona, by seeking to begin a Phase 2 trial of the drug for mild Covid-19 symptoms. If given the green light, the company says the Phase 2 multicenter, parallel, randomized study will be conducted in Taiwan during the third quarter this year.

The submission comes on the heels of the “successful manufacturing of a GMP clinical batch of our Veldona investigational new drug,” the company says. “We are confident that our response robustly and comprehensively addresses the issues raised by the FDA, and we anticipate receiving its feedback in due course.”

Ainos says Veldona is designed to enhance a patient’s immune response and boost their ability to fight viral infections, while also potentially reducing the side effects and risks caused by high-dose interferons and other small molecule drugs. Previous studies have demonstrated that Veldona could inhibit respiratory virus infection, including influenza A, it says.

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