Drugs

Translating In Vitro Antiviral Activity in Covid Drugs

FDA says that since the beginning of the Covid-19 pandemic it has been working to facilitate the development and availability of drugs for use by patients, doctors, and health systems as expeditiously as possible. In an online paper, CDER says several therapies are being tested in clinical trials to evaluate whether they are safe and effective in combating Covid-19.

“Significant effort by scientists to identify drugs with antiviral activity against the SARS-CoV-2 virus has led to investigations involving new drugs or FDA-approved drugs for other indications,” the agency says. “Identification of these potentially effective candidates is occurring at an unprecedented speed, and a necessary step in this process is translating in vitro antiviral activity to appropriate clinical dosing regimens. This step is complex and multifactorial, but essential to finding the right products, administered at the right doses, to the right patients, at the right time for successful treatment of Covid-19.”

The paper says that adequate and well-controlled clinical trials will ultimately determine appropriate treatment modalities for Covid-19 and will identify the stages of infection and disease at which these treatments are effective, with which administration routes, and at what dosing regimens. “Sound pharmacokinetic modeling and accurate in vitro to in vivo translation of data will be crucial for the appropriate design of dosing regimens administered in these trials,” the paper concludes.

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