Device makers have been scrambling for space in value-based care arrangements even though the pace of adoption of those arrangements has been somewhat tepid. While device makers are not explicitly included in a proposed overhaul of the Stark and Anti-Kickback Statute (AKS) regulations, providers may soon be more engaged in these arrangements, thus providing device makers with more opportunities even if they are not included in the rewrite of the related regulatory provisions.
In August the FDA was skeptical about Sarepta Therapeutics Inc.’s injectable Vyondys 53 (golodirsen), but that changed swiftly Friday with the agency’s accelerated approval for the Duchenne muscular dystrophy (DMD) follow-on therapy, the first treatment specifically for this subtype.
Those who believe the U.S. Supreme Court must revisit the patent subject matter eligibility problem may get their wish. While Solicitor General Noel Francisco advised the Court that it should not hear the Berkheimer case, he nonetheless said that Athena v. Mayo might avail the Supreme Court of the appropriate fodder for resolving the ongoing subject matter eligibility problem.
Irving, Texas-based Caris Life Sciences Inc. has launched an AI-based genomic profiling test to better characterize cases of cancer of unknown primary origin (CUP) and atypical cases and offer appropriate treatment options. Known as the MI GPS (Genomic Profiling Similarity) Score, the analysis is based on an AI analysis of a 592-gene panel of all the clinically relevant genetic biomarkers for cancer.
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.
RSS
