Drugs

Leqvio Successfully Lowers LDL-C: Study

Topline results from the Phase 3 V-MONO study found that Novartis’ Leqvio (inclisiran) demonstrated clinically meaningful, statistically significant low-density lipoprotein cholesterol (LDL-C) lowering as a monotherapy versus both placebo and Merck’s Zetia (ezetimibe) in patients who were at low or moderate risk of developing atherosclerotic cardiovascular disease and not receiving lipid-lowering therapy. A company announcement says Leqvio is the only small interfering RNA therapy to lower LDL-C. It is a subcutaneous injection given by a healthcare provider with an initial dose, another at six months, and then every six months.

Leqvio is approved by FDA as an adjunct to diet and statin therapy to treat adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia, to reduce low-density lipoprotein cholesterol.

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