The U.S. Senate voted 72-18 to confirm Stephen Hahn as the commissioner of the FDA, providing the agency with another commissioner with a deep background in oncology. Hahn succeeds Scott Gottlieb, who stepped down from the post in April and returned to the American Enterprise Institute.
ORLANDO, Fla. – Two preclinical presentations at the 61st American Society of Hematology (ASH) annual meeting could pave the way for using hematopoietic stem cell transplants (HSCT) in patients who are currently too sick to tolerate the procedure, as well as in indications where its toxicities preclude its use.
Researchers are hopeful that within three to five years the first once-a-month oral contraceptive could reach human testing. They achieved an early step on that path with the publication of research testing the long-lasting drug delivery device from Watertown, Mass.-based startup Lyndra Therapeutics Inc. in the Dec. 4 issue of Science Translational Medicine.
The U.S. Environmental Protection Agency (EPA) has posted an advanced notice of proposed rulemaking for control of ethylene oxide emissions (EtO), which would update a 2006 final rule that declared no additional controls for EtO were necessary. However, the agency’s latest proposed rule makes note of several technological advances that allow for greater control of EtO, a fact that could drive a greater regulatory requirement for containment and destruction of EtO emissions at medical device sterilization plants.
Edwards Lifesciences Corp. added more than $20 billion so far this year to its market cap to exceed a $50 billion valuation. Executives worked to convince Wall Street that 2020 and beyond are lining up to be additional banner years for the cardiovascular med-tech giant at the company’s annual investor meeting. While the newly introduced guidance for next year from Edwards was largely in line or a bit better than analysts had anticipated, its share price remained relatively flat on the event.
Policymakers are often as sensitive to overall health care spending as they are to increases in Medicare spending, and the latest report on both brought some good news and some bad news. The good news is that overall health care spending was essentially flat as a share of gross domestic product (GDP) in 2018, but the bad news is that Medicare spending jumped 6.4%, thus renewing the troublesome historical trend of outpacing typical GDP growth.
The Chapel Hill, N.C.-based non-profit Digital Health Institute for Transformation (DHIT) and Tanjo Inc., a machine learning company headquartered in Carrboro, N.C., will launch their Community Health Utility Grid (HUG) Initiative in North Carolina in early 2020. The collaboration aims to improve healthcare outcomes for underserved populations in the state by collecting, analyzing, and sharing individual, household and community level health data.
The patent lawsuit of Athena v. Mayo revisits previous case law where patent subject matter eligibility is concerned, and numerous parties have weighed in urging the Supreme Court to hear the case. However, the U.S. Solicitor General has not responded with its own friend-of-the-court brief, an omission that would seem to take some of the pressure off the Supreme Court to hear the case.
Ann Arbor, Mich.-based startup Endra Life Sciences Inc. started out focused on a photoacoustic imaging tool for mice in the lab, but in recent years it has shifted gears. Now, it aims to secure the go-ahead next year from European and U.S. regulators to launch a thermo-acoustic enhanced ultrasound system designed to quantitatively assess liver fat, known as TAEUS.
The impending resumption of the 2.3% tax on medical devices has industry actively seeking at least a new suspension. Now, the Tax Foundation, of Washington, has issued a report saying that the tax would cost more than 21,000 Americans their jobs and impose a $1.7 billion hit on the U.S. economy.
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