Shares in Aveo Pharmaceutical Inc. (NASDAQ:AVEO), commonly called Aveo Oncology, fell 36.7% Monday to 57 cents after the FDA dashed hopes that positive interim data from a late-stage study of tivozanib would overcome agency concerns about the drug's efficacy in relapsed/refractory renal cell carcinoma (RCC). Advised by the regulator not to submit an NDA at this time, Aveo now plans to collect more mature data ahead of filing its NDA in the first quarter of 2020. A discussion with the FDA's Oncologic Drug Advisory Committee will likely be required too, the agency said.
How vulnerable is the U.S. biopharma supply if China were to halt exports of active pharmaceutical ingredients (APIs)? No one knows. "We cannot assess the extent of U.S. dependence on China," Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research (CDER), said in testimony to a House subcommittee Wednesday.
Deciding which patients should go into the intensive care unit (ICU) after surgery is a difficult call and typically made entirely at the surgeon's discretion. The result is that surgeons typically err on the side of caution by putting more post-operative patients in the ICU than necessary. To aid in better ICU decision-making, physicians at New York University Langone Hospital System (NYU Langone) developed a machine learning algorithm that combs through a patient's electronic medical record to identify relevant factors to determine if they needed the ICU after surgery.
Amag Pharmaceuticals Inc.'s argument for keeping Makena on the market without having to conduct a new trial went nowhere Tuesday as an advisory committee struggled with conflicting efficacy data for the preterm birth drug that received accelerated approval eight years ago.
The third time is proving not to be so charming for Agile Therapeutics Inc. as it prepares its lead candidate for a date Wednesday with the FDA's Bone, Reproductive and Urologic Drugs Advisory Committee.
Genomic testing firm Veracyte Inc. is eyeing 2021 for the launch of its noninvasive nasal swab classifier for early lung cancer detection and diagnosis, following preliminary clinical data demonstrating high sensitivity in low-risk patients and high specificity in high-risk patients with known lung nodules. The South San Francisco-based company is developing the nasal swab test in collaboration with Johnson & Johnson Inc.'s Lung Cancer Initiative, part of a long-term strategic collaboration that also aims to speed commercialization of Veracyte's Percepta genomic sequencing classifier.
CLEVELAND – The list is out, and a dual-acting osteoporosis drug and a device for expanding the use of minimally invasive mitral valve surgery have come out on top. That's according to a panel of doctors and researchers who develop the highly anticipated Top 10 annual list of medical innovations looking to transform patient care, revealed at the Cleveland Clinic's Medical Innovation Summit.
In another marathon session Tuesday, the third U.S. House committee with jurisdiction over prescription drug pricing issues marked up H.R. 3, the Lower Drug Costs Now Act, clearing the way for a House vote on the partisan measure yet this month.
Radiologists review thousands of images a day. The hope is that artificial intelligence (AI) applications will become useful soon to verify diagnoses, prioritize queued images and even to offer a level of detection and measurement that aren't feasible for humans. One of the latest efforts on this front is by researchers at the University of California at San Francisco (UCSF) and the University of California at Berkeley.
A recent medical journal article says the terminology used by physicians to denote a fatality in the FDA adverse event reporting system has led to underreporting of fatalities associated with two prominent cardiology devices, a predicament the authors say skews the public understanding of these devices' safety profiles.
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