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Fresenius Kabi Announces Launch Of TYENNE, A Tocilizumab Biosimilar Referencing ACTEMRA - Life Sciences, Biotechnology & Nanotechnology

On April 15, 2024, Fresenius Kabi announced the U.S. launch of its ACTEMRA biosimilar, TYENNE (tocilizumab-aazg) as an intravenous formulation.

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Section 271(e)(1) Safe Harbor Applies To Importation Regardless Of Intent Or Actual Use - Patent

A divided panel of the Federal Circuit affirmed a district court's grant of summary judgment of noninfringement, holding that importation of two product samples into the U.S. was reasonably related to obtaining FDA approval based on the particular facts of this case.

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2023 False Claims Act Enforcement In Health Care And Life Sciences, Part I - Healthcare

In February 2024, the Department of Justice ("DOJ") announced the results of its 2023 False Claims Act ("FCA") enforcement efforts.

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Crain's New York Op-Ed: New York Needs To Prioritize Rare Disease - Healthcare

We live in an age of scientific miracles. We have an unprecedented ability to identify the causes of disease, and we have access to treatments, and even cures, we could not imagine only a few decades ago.

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Significant Bankruptcy Issue Pending Before U.S. Supreme Court - Insolvency/Bankruptcy

In December 2023, the U.S. Supreme Court heard oral arguments in the case of Harrington v. Purdue Pharma, L.P., Case No. 23-124. Purdue Pharma is the drug manufacturer of the prescription opioid...

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Life Sciences 2024 - Life Sciences, Biotechnology & Nanotechnology

11. COVID-19 and Life Sciences</strong>, the US government has used a wide variety of public procurement and funding strategies for needed medical countermeasures during the pandemic.

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FTC's Campaign Against Improper Orange Book Listings Continues With Amicus Brief In Teva's Challenge Of Amneal Asthma Inhaler ANDA - Antitrust, EU Competition

The Federal Trade Commission ("FTC") has filed an amicus brief in Teva Branded Pharmaceuticals Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC to further the agency's...

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Closing Time: Founder Pitches Online Menopause Care Platform (Podcast) - Healthcare

In this episode, Dr. Alicia Jackson, co-founder and CEO of Evernow, discusses the importance of women's health research and the need for improved menopause care.

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Closing Time Podcast: Basics Of Raising A Seed Round - Healthcare

In episode 24, Halle and Michael discuss the process of raising a seed round. They cover topics such as when to raise a seed round, building relationships with investors...

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A Look Ahead In Life Sciences: What We Are Tracking In Q2 2024 And Beyond - Life Sciences, Biotechnology & Nanotechnology

As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape.

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