One sentence buried more than 1,500 pages into a fiscal 2020 spending bill the U.S. Senate passed Thursday could open the door to a broader range of insulin biosimilars. The provision, requested by the FDA, expands the definition of a “biological product” to include chemically synthesized polypeptides. The provision, requested by the FDA, expands the definition of a “biological product” to include chemically synthesized polypeptides.

A mere 26 months after the first patient was enrolled in its pivotal phase II study and about three months ahead of its PDUFA date, the FDA granted accelerated approval for Padcev (enfortumab vedotin-ejfv) to treat adults with locally advanced or metastatic urothelial cancer who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery or in a locally advanced or metastatic setting.

The Guardant360 assay accurately detected genomic alterations that permit patient matching to targeted therapies, according to a presentation of the plasmaMATCH study at the 2019 San Antonio Breast Cancer Symposium. The study is the largest ever performed for a liquid biopsy.

Dublin-based Medtronic plc reported Wednesday that the U.S. FDA has given the green light to its Stealth Autoguide system. The company said it is the first cranial robotic platform that integrates with its enabling technology portfolio to create an end-to-end procedural solution.

The FDA took concrete steps Wednesday in mapping out import routes for prescription drugs by issuing a notice of proposed rulemaking and a draft guidance. If finalized, the proposed rule, for the first time, would implement a 20-year-old provision of the Federal Food, Drug and Cosmetics Act that gives the Health and Human Services (HHS) secretary the authority to authorize the import of certain small molecule drugs from Canada. However, the proposal is getting pushback from Canada.

The U.S. House of Representatives passed two spending packages that boosted funds for both the FDA and the NIH, but device and generic drug makers saw other benefits. The House legislation would allow makers of biosimilars and generic drugs to sue brand names for blocking access to the index article, but also repealed the medical device tax, a change that would bolster development of the novel therapies that are the industry’s lifeline. Both spending bills carry numerous provisions related to the health care economy and will go to the Senate for passage, hopefully before the government runs out of money Dec. 20.

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.