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Latham & Watkins LLP

Drug Pricing: FDA Considerations Under Recent Executive Orders and Congressional Bills

Latham & Watkins LLP on

President Trump’s executive orders and legislative proposals from Congress leverage FDA to help lower drug prices, address anti-competitive practices, and accelerate generic drug approvals....more

McDermott Will & Emery

Biden Administration Proposes New Framework for Exercising March-In Rights on Government-Funded Inventions; Drug Pricing May Be...

McDermott Will & Emery on

Under the University and Small Business Patent Procedures Act of 1980 (35 U.S.C. §§ 200-212), commonly referred to as the Bayh-Dole Act, the federal government can exercise “march-in” authority in certain circumstances to...more

Axinn, Veltrop & Harkrider LLP

HHS to Go a March-In'

Axinn, Veltrop & Harkrider LLP on

Following years of discussion and pressure being applied by certain policymakers (including Senate HELP Committee Chair Bernie Sanders), the Biden Administration announced that a framework is being put forward by HHS and the...more

Foley & Lardner LLP

USPTO Underscores Duty of Disclosure Pertaining To FDA Submissions

Foley & Lardner LLP on

The USPTO has issued a Federal Register Notice discussing how the duty of candor and good faith in dealing with the USPTO applies to “information and statements material to patentability … received from or submitted to the...more

MoFo Life Sciences

Skinny Labels Back In Focus After HHS Report On Addressing Drug Prices

MoFo Life Sciences on

Skinny labels are back in focus at the White House. On September 9, 2021, the U.S. Department of Health and Human Services submitted its much-anticipated report to the White House Competition Counsel regarding a...more

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