Drugs

Orphan Status for Gilead’s Antiviral Remdesivir

FDA approved 3/23 orphan drug status for Gilead’s antiviral drug remdesivir, giving the company seven years of exclusivity for the product, which is one of many being tested as a possible Covid-19 treatment. The Intercept reports that experts say the designation could block supplies of the drug from generic manufacturers and provide a lucrative windfall for Gilead. It notes that White House domestic policy director Josh Grogan, a member of the Coronavirus Task Force, lobbied for Gilead from 2011 to 2017 on issues including drug pricing.

While the orphan drug designation is for drugs that treat illnesses affecting fewer than 200,000 people in the U.S., there is a provision that allows the designation for drugs that treat more common illnesses if the designation comes before the disease reaches that threshold. On 3/24 there were just over 50,000 cases reported in the U.S., although experts say the actual number is likely to be much higher because so little Covid-19 testing has been done.

Gilead announced 3/23 it would no longer provide emergency access to remdesivir, reportedly telling the New York Times that “overwhelming demand” left it unable to process compassionate use requests. Hours later FDA announced its approval of the orphan drug status.

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