The U.S. House of Representatives passed two spending packages that boosted funds for both the FDA and the NIH, but generic drug makers and device makers saw other benefits. The two bills not only repealed the medical device tax, but also would allow makers of biosimilars and generic drugs to sue brand names for blocking access to the index article, a move intended to tamp down on the cost of small-molecule pharmaceuticals and biotech therapies.
While the U.S. Centers for Medicare and Medicaid Services (CMS) revisits its coverage policy for transcatheter mitral valve repair devices, several physician societies have drafted recommendations for operator and institutional volume requirements that could restrict the number of centers authorized to practice devices such as Abbott Park, Ill.-based Abbott Laboratories’ Mitraclip.
Little more than a month after the FDA's Endocrinologic and Metabolic Drugs Advisory Committee unanimously supported approval of Amarin Corp. plc's fish oil-based Vascepa (icosapent ethyl) for reducing the risk of cardiovascular (CV) events in adults with elevated triglyceride levels, the agency has greenlighted a label expansion for the already-approved medicine, allowing for its adjunctive use in that indication.
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.
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