Drugs

Indivior Pulls Plug on Schizophrenia Drug Marketing

Indivior says it is discontinuing sales and marketing of schizophrenia drug Perseris (risperidone) due to “expected adverse impacts from increased payor management of the category that crystalized in [the second quarter] and that are expected to make the product no longer financially viable.” The once-monthly subcutaneous risperidone-containing, long-acting injectable was approved in 2018. Its monthly dosing was intended to address treatment adherence, which is a major challenge in schizophrenia due to the disease complexity, according to the company.

The company says it is immediately ceasing all Perseris sales and marketing activities related. “The group believes this action is in the best interests of shareholders due to the highly competitive market and impending changes that are expected to intensify payor management in the treatment category in which Perseris participates,” it says. “Analysis of forthcoming changes suggests that there is no longer a path forward for Perseris that is financially viable. Indivior will continue to supply Perseris for the foreseeable future to avoid disruption to patient care but will no longer deploy a dedicated sales force.”

The action will reduce the company’s headcount by about 130 employees. “Total expected charges related to this action are expected to be approximately $65 million, of which approximately $20 million are expected to be cash related to severance and termination of certain agreements,” it says.

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