Drugs

FTC Wants AbbVie AndroGel Appeal Denied

The Federal Trade Commission (FTC) has asked the Supreme Court to deny an AbbVie request that it hear its appeal of a federal district court decision that the company’s patent lawsuits against Teva and Perrigo over ANDAs for its AndroGel testosterone treatment were sham suits intended to delay generic competition. An online post from IP Watchdog says the FTC first says that since the 3^rd Circuit Court of Appeals upheld only part of the district court’s ruling and remanded the case for further proceedings, the high court could simply refuse to hear the appeal because the case is still moving forward in the lower courts. The 3^rd Circuit affirmed the sham suit finding but reversed the district court finding that AbbVie’s settlement with Teva constituted an illegal reverse payment agreement.

If the Supreme Court rejects the position that the case is not ready for high court action, the FTC then argues that both the district and circuit courts properly found subjective intent in the circumstantial evidence of the case, particularly in that AbbVie’s attorneys were very experienced with patent matters and would know that litigation would delay generic competition.

Although AbbVie had settled the 2011 Teva and Perrigo suits, the FTC sued the company in 2014, alleging that its suits were shams meant purely to delay market entry of AndroGel generics.

A Pennsylvania federal court ordered the company to pay $448 million in disgorgement.

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