Drugs

Court Denies J&J Motion Against Pfizer’s Biosimilar

Eastern Pennsylvania federal court has denied a Johnson & Johnson motion to dismiss an antitrust civil action brought by Pfizer over infliximab. The 2017 suit alleges that Johnson & Johnson engaged in anticompetitive practices (exclusive agreements and bundled rebates to shield Remicade from Pfizer’s biosimilar product, Inflectra.

In the ruling, the court says: “Pfizer’s complaint sufficiently alleges that it has suffered an antitrust injury as the result of J&J’s anticompetitive conduct. J&J’s efforts to foreclose Pfizer from the market, as Pfizer has alleged, have led to increased prices for consumers and limited competitive options for end payors, providers, and patients.” It further states that while Johnson & Johnson’s contention that Pfizer’s product has not sufficiently competed with Remicade (due to various factors including no ruling from FDA about its interchangeability) may eventually stand after discovery, the claim itself is not a basis for dismissing the complaint.

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