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Home » Topics » North America » U.S.

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U.S. White House

Device tax falls as Trump signs FY 2020 spending bills

Dec. 23, 2019
By Mark McCarty
The much-maligned medical device tax was finally laid to rest Dec. 20, as President Donald Trump signed a spending bill that included a permanent repeal of the tax. The 2.3% excise tax on devices was brought into the statute via the Affordable Care Act (ACA), and its repeal brings much-needed breathing room to small device makers.
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Blocks spelling out 2019, 2020, trends

Med tech exits year with top performance, tax repeal; enters 2020 facing China tariffs, Medicare for All, increasing FDA control

Dec. 20, 2019
By Karen Carey
Wells Fargo Securities LLC recently published The MedTech Manual – 2020 Outlook, in which it says the medical device sector “will continue to be a port in the storm because the political focus will remain on drug pricing and increasing access to [health care].” Overall, the industry has performed quite well in comparison with other health care sectors during 2019. The financial firm’s senior analyst Larry Biegelsen and colleagues wrote that they expect the medical device sector to continue moving in a positive direction despite Medicare for All (MFA) rhetoric and an upcoming presidential election.
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Injection syringes

U.S. spending bill to ease upcoming transition for ‘deemed’ biologics

Dec. 19, 2019
By Mari Serebrov
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.
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Insulin vials and syringe

U.S. spending bill to ease upcoming transition for ‘deemed’ biologics

Dec. 19, 2019
By Mari Serebrov
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.
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FDA Approved stamp

FDA grants accelerated approval for Padcev to treat urothelial cancer

Dec. 19, 2019
By Lee Landenberger
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.
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guardant-health-G360-12-19.png

Guardant360 liquid biopsy quickly identifies targetable mutations in breast cancer

Dec. 19, 2019
By Annette Boyle
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.
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Medtronic Device: Autoguide Stealthstation

FDA gives nod to Medtronic’s Stealth Autoguide system for cranial procedures

Dec. 18, 2019
By Liz Hollis
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.
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U.S. drug import illustration

FDA begins construction of Rx drug import routes

Dec. 18, 2019
By Mari Serebrov
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.
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How it would work: Importing drugs from Canada

Dec. 18, 2019
By Mari Serebrov
The FDA’s proposed rule would, for the first time, implement Section 804 of the Federal Food, Drug and Cosmetics Act (FDCA), which allows certain small-molecule drugs approved in Canada to enter the U.S. market – if the Health and Human Services secretary certifies that the drugs would pose no additional risk to public health and safety and that they would result in a significant reduction in cost.
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U.S. flag, stethoscope

Spending bills would end drug sample blocking, repeal device tax

Dec. 17, 2019
By Mark McCarty
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.
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