Drugs

5 Pharmas Settle Improper Reimbursement Case

Shire, Baxter International, Baxalta, Viropharma and Takeda Pharmaceuticals have agreed to pay $42 million to settle an enforcement action brought under the Texas Medicaid Fraud Prevention Act (TMFPA) involving allegedly improper reimbursements for certain pharmaceuticals. The alleged violations were first brought in a lawsuit filed by a whistleblower under the qui tam provisions of the TMFPA.

“The settlement resolves allegations that the drug manufacturers violated the TMFPA by providing, directly or indirectly, nursing and reimbursement services to Texas Medicaid providers for certain pharmaceutical drugs, as well as by paying clinical nurse educators to refer or recommend the drug Vyvanse to providers from January 2014 to December 2015,” a release from Texas attorney general Ken Paxton 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