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Regeneron controversies

Controversies tied to this brand in public sources. A listing is not a finding of fault.

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  1. 2021

    Amgen files Supreme Court petition in patent dispute

    Lawsuit filed

    Amgen Inc. and its subsidiaries filed a petition for certiorari with the U.S. Supreme Court against Sanofi Aventisub LLC, Regeneron Pharmaceuticals Inc. and Sanofi-Aventis US, LLC. The petition concerns the written-description requirement for patents and the level of detail required.

    Source excerpt

    • On Monday a petition for certiorari was filed to the Supreme Court of the United States by Amgen Inc. and its subsidiaries against Sanofi Aventisub LLC, Regeneron Pharmaceuticals Inc. and Sanofi-Aventis US, LLC.
    Source

  2. 2021

    Humana sues Regeneron over alleged Eylea pricing scheme

    Lawsuit filed

    Humana filed suit against Regeneron, alleging that Regeneron and the Chronic Disease Foundation engaged in a scheme involving Eylea that defrauded Medicare and its contracted payors. The complaint alleged that Regeneron inflated Eylea's price and provided illegal kickbacks to the foundation; these are allegations, not a stated court finding.

    Source excerpt

    • Humana Inc. filed suit against Regeneron Pharmaceuticals, Inc. Thursday in the Southern District of New York over allegations that the pharmaceutical company engaged in a scheme with the Chronic Disease Foundation. The plaintiff claims that as a result of this purported scheme, which they believe is a “sham charity,” the two parties defrauded Medicare and its contracted payors out of hundreds of millions of dollars.
    • The plaintiff said that Regeneron inflated the price of Eylea and then provided illegal kickbacks to the CDF, which then used the tainted donations they received from Regeneron to cover cost-sharing obligations for patients so that they would continue to choose Eylea rather than its less expensive alternatives.
    Source

  3. 2021

    Shareholder advisers criticize Regeneron executive payouts

    Public backlash

    Shareholder advisory groups Glass Lewis and Institutional Shareholder Services criticized Regeneron’s upfront executive stock awards as excessive and questioned whether they were in shareholders’ best interests. The article also reports substantial shareholder opposition to the company’s executive payouts in recent years.

    Source excerpt

    • The investor advisory group Glass Lewis said it was “highly concerned” at the New York-based firm’s decision last year to ditch annual stock options.
    • Institutional Shareholder Services, another advisory group, also expressed concern: “The awards are excessive in value, replace annual grants for a relatively long period of time, and provide multiple opportunities for the same shares to be earned.”
    • The US drugmaker Regeneron, whose Covid treatment was hailed as a “cure” by Donald Trump last year, has come under fire from two influential shareholder advisory groups over “excessive” payouts made to its top executives ahead of its annual meeting on Friday.
    Source

  4. 2020

    DOJ files civil lawsuit against Regeneron over patient charity payments

    Lawsuit filed

    The US Department of Justice filed a civil lawsuit against Regeneron, alleging that the company illegally paid a patient group to cover costs for Medicare patients receiving its Eylea treatment. Regeneron said the allegations had no merit and that it would defend the case.

    Company response

    • Denial — Regeneron

      Regeneron said there was no merit to DOJ's allegations.

    Source excerpt

    • The civil complaint, filed in the US District Court in Massachusetts, alleges that Regeneron violated the anti-kickback statute, which prohibits drug companies from paying — directly or indirectly — for Medicare patients to use their drugs.
    Source

  5. 2020

    Sanofi stops Kevzara COVID-19 clinical trials

    Corrective action

    Sanofi stopped clinical trials of Kevzara for COVID-19 after tests found adverse effects, including pneumonia and death in some patients. The company said it no longer planned further COVID-19 clinical studies of the drug. The event was reported in connection with Regeneron, the brand associated with Kevzara.

    Source excerpt

    • Sanofi has stopped the clinical trials of Kevzara, one of the drugs being tested to treat COVID-19.
    • On Tuesday, Sanofi said it had no longer plans to conduct further clinical studies for Kevzara in COVID-19
    • It manufactures Kevzara in partnership with American firm Regeneron.
    Source

  6. 2020

    U.S. sues Regeneron over alleged Eylea kickbacks

    Lawsuit filed

    The U.S. Justice Department sued Regeneron, accusing the company of making kickback payments related to Eylea through a copay foundation. The case alleges false claims and seeks treble damages; the allegations are not established as findings in this article.

    Source excerpt

    • The company is accused of “funneling tens of millions of dollars through a co-pay foundation, the Chronic Disease Fund (CDF),” and liberating Medicare patients from paying co-pays for the drug.
    • The Justice Department sued Regeneron Pharmaceuticals, Inc. on Wednesday for making kickback payments for macular degeneration drug Eylea.
    • The Justice Department seeks an award of treble damages as a result of Regeneron’s allegedly false claims.
    Source