Drugs

China API Supply Disruption Over Coronavirus: Survey

A survey of China-based active pharmaceutical ingredient (API) makers and worldwide users indicates that API suppliers may experience some disruptions during the first quarter due to the coronavirus outbreak and related distribution troubles and travel restrictions. According to a 1/28 In-Pharma Technologist report, a “number of pharmaceutical manufacturers are located in Hubei province, adjacent to Wuhan, where the virus originated, and in Zhejiang province, where there are a number of cases. Pharmaceutical manufacturers based in affected regions are responsible for the production of the diabetes treatment acarbose, antibiotic ciprofloxacin, and various over-the-counter painkillers, such as ibuprofen and paracetamol, amongst other APIs.”

Absent from the report was any discussion of whether the virus could contaminate APIs or finished products coming from China. However, U.S. health officials said on Monday that there is no evidence to support the transmission of virus through imported goods. “In general, because of poor survivability of these coronaviruses on surfaces, there is likely very very low risk of spread from products or packaging that are shipped over a period of days or weeks at ambient temperatures,” Center for Disease Control Center for Immunization and Respiratory Diseases director Nancy Messonnier said in a press briefing. Previous studies have shown that related viruses, SARS and MERS, only live for few hours on the surface of an object. Such viruses are spread typically by respiratory droplets from one person to another.

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