FDA Policy/General

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Johnson & Johnson Medical has agreed to acquire German software company Surgical Process Institute, a firm focused on standardizing and digitalizing surgical workflows in operating rooms. Surgical Process provides software solutions designed to improve patient outcomes and operating room efficiency by reducing variability in surgical procedures. Financial terms of the transaction have not been disclosed.

Amneal Pharmaceuticals and Impax Laboratories have agreed to merge in an all-stock transaction. The combined company, to be named Amneal Pharmaceuticals, will have a generics business that will rank as the 5th largest in the U.S. gross revenue.

Eli Lilly has agreed to invest $72 million in an insulin manufacturing project at one of its Indianapolis facilities. The investment will be used to replace an existing insulin vial filling line and allow Lilly to meet growing demand for its insulins, including Humalog (insulin lispro) and Humulin(human insulin), while upgrading to state-of-the-art technology and preparing for its insulin pipeline.

Smith & Nephew has agreed to acquire Rotation Medical Inc., a developer of a tissue regeneration technology for shoulder rotator cuff repair, for $125 million up front and up to $85 million over the next five years based on financial performance. “The Rotation Medical Rotator Cuff System is described as a device that “balances biomechanics and biology to enhance the body’s natural healing response. The bioinductive implant helps tendons heal by inducing growth of new tendon-like tissue, offering the potential to prevent tear progression and reduce the incidence of re-tears. The system also includes a set of disposable arthroscopic instruments that enable reproducible procedures.”

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