FDA Law Blog

SEPTEMBER 19, 2023

It merely says that “[t]he Hatch-Waxman Act and FDA regulations set forth the criteria for listing patents in the Orange Book” and that “Brand manufacturers are responsible for ensuring their patents are properly listed.” But it is not always clear which types of patents are eligible for listing in the Orange Book.

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The Pharma Data

JANUARY 17, 2021

In 2020, XPhyto’s German subsidiary, Vektor Pharma TF GmbH (“Vektor”), a leader in the development of transdermal and sublingual drug formulations reported significant advancements in four therapeutic development programs. About XPhyto Therapeutics Corp. XPhyto Therapeutics Corp. SOURCE: XPhyto Therapeutics Corp.

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The Pharma Data

JANUARY 27, 2021

In 2020, XPhyto confirmed successful activation of its peptide-based biosensor program when delivered using Vektor’s sublingual drug delivery platform. Further, Vektor is currently engaged in the development of a sublingual drug formulation for a major European generic drug company.

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XTalks

AUGUST 30, 2022

Due to consistent changes in pharmaceutical regulation, pandemic-related disturbances and the ongoing effects of digitization, visionary leaders could find themselves co-constructing their vision. Thus, futuristic thinking is an important facet of visionary leadership. Therefore, strategic intent is vital when making decisions.

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