Drugs

Catalyst Says Jacobus Patent Suit is Settled

Catalyst Pharmaceuticals says it has settled ongoing patent infringement litigation with Jacobus Pharmaceutical Co. and PantherRx Rare. Catalyst had asserted that Jacobus and PantherRx induced infringement by third parties of Firdapse (amifampridine)-related patent rights in their marketing and distribution of Ruzurgi (amiframpridine). Catalyst says that as part of the settlement it is dismissing all claims related to the patent litigation and is acquiring certain Jacobus intellectual property rights, including the right to develop and commercialize Ruzurgi in the U.S. and Mexico.

Catalyst says Ruzurgi is not currently approved for distribution in the U.S. as a result of an FDA decision to convert its pediatric approval to a tentative approval following an 11th Circuit Court of Appeals decision. The court held that FDA’s approval of the Jacobus NDA for pediatric use violated Catalyst’s orphan drug exclusivity for Firdapse to treat Lambert-Eaton myasthenic syndrome.

Catalyst also says Jacobus is withdrawing its request that the Supreme Court review the appeals court decision.

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