Biologics

Ex-FDA Head Gottlieb Expects Virus Spreading in U.S.

Former FDA commissioner Scott Gottlieb says that while he doesn’t expect the U.S. to see an epidemic level of coronavirus cases, he does see the deadly virus further spreading across the nation, and globally he expects it to get worse. Appearing on CNBC’s Squawk Box 2/5, Gottlieb said the U.S. needs to prepare its response if the virus begins spreading rapidly. “That does not mean that it’s going to become an epidemic in the United States, we can still prevent that,” he added.

China’s health authorities recently said that 24,324 cases have been confirmed in their country and at least 490 people have died there. The World Health Organization hss reoorted 150 coronavirus cases have been reported in about two dozen countries outside of China.

Gottlieb also said that developing a vaccine will not likely help protect the general public in the short term. However, if the virus slows down in the summer like the flu virus, then a vaccine would help if the coronavirus reappears in the fall for a “second wave,” he said.

APCO Worldwide’s greater China region chairman James McGregor told Squawk Box that he expects many businesses in affected areas in China will stay closed for a couple of months. Some companies in China were hoping to reopen next week, after an extended Chinese New Year closure. “People are scared,” McGregor said.

Mass closings and continued travel and shipment restrictions could lead to drug shortages because of the large numbers of active pharmaceutical ingredient and finished-product makers in China. FDA commissioner Stephen Hahn told Politico last week that there have not been any reports yet of disruption of the supply chain or shortages, but the agency is looking ahead and planning for “what could potentially be the most serious of scenarios.” For now, he said, FDA inspections in China are being conducted on a case-by-case basis. “We are taking on an individual-by-individual basis what’s the regulatory need for anything in China ... versus what are the personnel risks associated,” he said.

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