FDA Policy/General

Since Our Last Issue ...

St. Jude Children's Research Hospital has agreed to spend $412 million to develop an advanced research center as part of a $1 billion capital expansion at its St. Jude campus. The center is intended to foster an environment where scientists and clinicians will pursue breakthroughs in hopes of accelerating progress in treating and curing catastrophic pediatric diseases.

Roche has agreed to pay $1.9 billion to acquire healthcare tech company Flatiron Health. Founded by two former Google employees, Flatiron developed its Health OncologyCloud platform that includes an electronic medical record for oncology, advanced analytics, patient portal and integrated billing management. Its technology is an aggregating data resource that helps researchers develop real-world evidence in oncology.

Astellas has paid $102.5 million for Universal Cells, a biotech that the company says is developing a platform technology intended to do away with the testing needed to ensure cell therapy products aren’t rejected by a patient’s immune system. It uses recombinant adeno-associated viral vectors to edit the genomes of pluripotent stem cells by switching off human leukocyte antigen expression in a way that does not cause “off-target” DNA cutting — which could lead to unintended effects. The resulting universal donor cells won’t require donor matching or immune-suppressing therapy and don’t stimulate rejection, according to the biotech.

Johnson & Johnson Medical Devices Companies have agree to acquire Orthotaxy, a privately held developer of software-enabled surgery technologies, including a differentiated robotic-assisted surgery solution. The technology is in early-stage development for total and partial knee replacement, and J&J plans to broaden its application for a range of orthopedic surgery procedures.

LivaNova PLC has agreed to acquire TandemLife, a Pittsburgh-based privately held company focused on advanced cardiopulmonary temporary support solutions. The company offers four product systems, all built around a common pump and controller. This allows hospitals to deploy a versatile platform consisting of a single pump and controller upon which all of the company’s products operate.

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

Read more

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