The FDA’s response to the COVID-19 pandemic has been matched by device makers, but the ID Now molecular test by Abbott Park, Ill.-based Abbott Laboratories has been the target of recent criticism. Tim Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health, said at a May 20 town hall meeting that Abbott has agreed to yet another study of the ID Now, the terms of which were under negotiation at the time of the meeting.
Just days after Clovis Oncology Inc.'s Rubraca (rucaparib) became the first PARP inhibitor approved by the FDA to treat certain cases of metastatic prostate cancer (mCPRC) in third-line care, the agency granted an even broader label in the indication to its first-in-class competitor, Lynparza (olaparib). Endorsement of second-line use of Lynparza in mCPRC and an overall survival (OS) benefit listed in its updated label will help rapidly establish it as "the drug of choice in the [second] line, leaving little commercial opportunities for Rubraca downstream," SVB Leerink analyst Andrew Berens said.
LONDON – Heart disease is now known to be both a cause and an effect of serious COVID-19 infection, with more than 1 in 10 patients who have underlying cardiac conditions being killed by the virus, while others with no previous record of cardiovascular problems are suffering significant COVID-19 induced weakening of their hearts.
Waltham, Mass.-based Thermedical Inc. has received a breakthrough device designation from the U.S. FDA for its saline enhanced radiofrequency (SERF) ablation system and Durablate catheter in the treatment of ventricular tachycardia (VT). The system uses a new means of biological heat to precisely deliver ablation therapy to the heart.
Quidel Corp., of San Diego, has scored another win at the U.S. FDA, receiving emergency use authorization (EUA) for the Lyra Direct SARS-CoV-2 Assay to allow direct sample processing. What’s special about this assay is that it does not require an up-front sample extraction. Instead, it uses a reformulated buffer that replaces that process with a simple 10-minute heat step, saving about 50 minutes in processing time.
Balt USA LLC, of Irvine, Calif., has received a thumbs up from the FDA to begin an IDE trial of its Squid liquid embolic device for the treatment of chronic subdural hematoma (cSDH). The nonadhesive agent offers a minimally invasive option for a disabling neurological condition that often requires brain surgery to correct.
The FDA has granted an emergency use authorization (EUA) for the home sample collection kit made by Austin, Texas-based Everlywell Inc., which can be run on two lab-developed tests. However, the agency has also shut down a Gates Foundation-backed effort in Seattle to develop another home sample collection kit even though the organization behind the effort has been authorized by state health authorities. The FDA announced the news about the Everlywell EUA with the stipulation that the user of the kit has completed an online questionnaire that is subsequently reviewed by a health care professional.
Women, black and Hispanic/Latinx participants were underrepresented in pivotal clinical trials for drugs approved from 2007 to 2017, according to a new report by the Tufts Center for the Study of Drug Development. In the pivotal clinical trials, 44.9% of patients were women. Participants who identified as black or of African descent were the most underrepresented participant group, representing 5.4% of participants in clinical trials.
Only hours after Blueprint Medicines Corp. disclosed an FDA complete response letter for avapritinib in fourth-line gastrointestinal stromal tumor (GIST), Deciphera Pharmaceuticals Inc.’s kinase inhibitor, ripretinib, won the agency’s approval for the same indication, well ahead of its Aug. 13 PDUFA date.
Abbott Laboratories’ ID Now test for the SARS-CoV-2 virus made waves when it was introduced thanks to the rapid turnaround time the molecular test promised. But questions about the test’s performance have surfaced several times in recent weeks. The latest criticism comes from a study conducted at the New York University Langone Medical Center, which claims the diagnostic compared poorly against a competitor. However, the U.S. FDA said that it has questions about the swabs and transport media used in connection with the test. As a result, it will stand pat regarding the ID Now’s place in the emergency use authorization (EUA) program.
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