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Amgen Fails to Block Sandoz' Neupogen Biosimilar, Again
The battle is being closely watched for signs that brand-name drug makers may be able to delay the introduction of biosimilars, which are cheaper versions of brand-name biologics.
For the second time this month, Amgen has lost a battle over its effort to block a biosimilar version of its Neupogen drug, a $5.7 billion seller that is used to fend off infections during chemotherapy. This time, the FDA denied a citizen’s petition the biotech filed arguing that Sandoz, which plans to sell a biosimilar, violated federal law by failing to provide it with needed information by a specified deadline.
In its filing, Amgen maintained that Sandoz, which is the Novartis generic drug unit, was required to provide a complete copy of its biosimilar marketing application 20 days after it was submitted to the FDA. The biotech also sought Sandoz manufacturing plans. Moreover, Amgen insisted that the FDA has the power to require companies to provide biosimilar applications to brand-name drug makers.
Read the complete article on The Wall Street Journal: http://on.wsj.com/19FP4Ai
CMS' 340B Repayment Proposal May Harm Vulnerable Hospitals, Reward Those With Higher Revenues
April 26th 2024The 340B hospitals not receiving an offsetting lump-sum payment from CMS following 2018-2022 cuts later ruled unlawful are disproportionately rural, publicly owned, and nonacademic, according to a new study.
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Examining Low-Value Cancer Care Trends Amidst the COVID-19 Pandemic
April 25th 2024On this episode of Managed Care Cast, we're talking with the authors of a study published in the April 2024 issue of The American Journal of Managed Care® about their findings on the rates of low-value cancer care services throughout the COVID-19 pandemic.
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Navigating Health Policy in an Election Year: Insights From Dr Dennis Scanlon
April 2nd 2024On this episode of Managed Care Cast, we're talking with Dennis Scanlon, PhD, the editor in chief of The American Journal of Accountable Care®, about prior authorization, price transparency, the impact of health policy on the upcoming election, and more.
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The Federal Trade Commission's (FTC's) vote to ban most employers from issuing and enforcing noncompete clauses could have varying impacts on the health care workforce; federal regulators vastly under-enforced antitrust laws in the hospital sector during the last 2 decades, resulting in increased health costs; the FDA recently found genetic evidence of the H5N1 bird flu virus in pasteurized commercially purchased milk.
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