Drugs

Lilly Delays New Studies Under Virus Crisis

Eli Lilly says it is delaying most new study starts and pausing enrollment in most ongoing studies. For ongoing clinical trials where patients are already enrolled, Lilly says these will continue as planned.

“The COVID-19 pandemic has substantially impacted the global healthcare delivery system, including the conduct of clinical trials,” a company release says. “Many healthcare systems have had to restructure operations to prioritize caring for those suffering from COVID-19 and limit or cease other activities. The severe burden on healthcare systems caused by this pandemic has also impaired the ability of many research sites to start new studies or enroll new patients.”

Lilly says that it recognizes that for patients already enrolled in trials, stopping the trial would “disrupt their treatment and potentially diminish the societal value of the research information to which they are contributing. Therefore, we will maintain ongoing studies, but with study-by-study consideration. Study participants currently enrolled in Lilly clinical trials should continue following study protocols and are encouraged to speak with their physician if they have any concerns.”

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