Drugs

Appeals Court Affirms Gilenya Patent Blocking ANDAs

The U.S. Federal Circuit Court of Appeals has upheld a lower court decision that found valid a Novartis patent covering a dosing regimen for Gilenya (fingolimod), indicated for treating relapsing forms of multiple sclerosis. The court also affirmed a permanent injunction granted against HEC Pharma until the expiration of the patent in 12/2027. In 2019, HEC Pharma’s and two other generic drug makers’ ANDAs (see earlier story) were granted final approval by FDA.

Novartis has acknowledged that it entered into settlement agreements with a number of ANDA filers that prevent a generic Gilenya launch before an agreed upon and undisclosed date that is prior to the expiration of the dosage regimen patent in 12/2027. The company has confirmed that it expects no generic versions of Gilenya in the U.S. market for at least the next two years.

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