Drugs

Judge Tosses $200 Million Verdict After Finding Merck Misconduct

A Northern California federal judge has tossed out a Merck $200 million jury verdict against Gilead Sciences after finding misconduct by the company and one of its expert witnesses. The case, Gilead Sciences v. Merck & Co., involved assertions by Merck that two of its patents cover sofosbuvir, and that Gilead’s sales of Sovaldi and Harvoni, which contain the active ingredient sofosbuvir, infringed those patents.

In March, after an an eight-day trial, a jury found that the patents were not invalid, and awarded Merck $200 million in damages for sales of Sovaldi and Harvoni. After the verdict, Gilead presented additional evidence that showed the witness, a now-retired Merck scientist, offered “dishonest and duplicitous testimony” that led the jury to rule on Merck’s behalf. The judge ruled that the new evidence “reflects a pervasive pattern of misconduct by Merck and its agents constituting unclean hands, which renders Merck’s ’499 and ’712 Patents unenforceable against Gilead.”

Merck says it will appeal the 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