Drugs

Gilead Lends Remdesivir to China for Coronavirus Trial

Gilead Sciences is working with Chinese health authorities to begin a randomized, controlled study to determine whether the company’s remdesivir can safely and effectively be used to treat the coronavirus (2019-nCoV) outbreak. In a 2/5 Gilead statement, the company says it is also “expediting appropriate laboratory testing of remdesivir against 2019-nCoV samples.” Gilead says it has also offered its antiviral expertise and resources to help fight the virus.

According to Genetic Engineering & Biotechnology News, China-based news services report that the study has a total of 761 patients in two trials — one to evaluate the drug’s potency on 308 cases with mild or moderate infections, and the other on 453 severely infected patients.

Remdesivir is not approved for use anywhere globally, but the company says it has demonstrated in vitro and in vivo activity in animal models against the viral pathogens MERS and SARS, which are similar coronaviruses. There are also limited clinical data available from the emergency use of remdesivir in treating patients with Ebola, it says.

Gilead describes remdesivir as an antiviral and a novel nucleotide analog prodrug.

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