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President Biden issues sweeping Executive Order to promote competition

On 9 July 2021 President Biden signed a far-reaching executive order intended to promote competition in the American economy. The order targets perceived corporate consolidation and...

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In sharp rebuke to Trump Administration, HHS notice ending Unapproved Drugs Initiative is withdrawn

On November 20, 2020, the U.S. Department of Health and Human Services (HHS) had announced that the Department was terminating the Food and Drug Administration’s (FDA) M...

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China launches test run of its new patent linkage registration platform: what you need to know

Following amendments to China's Patent Law in October 2020, China will shortly launch a new patent linkage system for pharmaceutical patents. In order to use the system, holders...

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Biden Administration supports waiver of WTO IP rights for COVID-19: Next steps for innovators

On 5 May 2021, U.S. Trade Representative Katherine Tai announced that the Biden Administration would support India and South Africa’s request for a World Trade Organization (WTO)...

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Biden signs bill limiting new drug exclusivity awards to innovations in active moiety

On April 23, U.S. President Biden signed into law two bills meant to lower prescription drug prices by limiting new drug exclusivity awards and promoting biosimilars. The Ensuring...

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First steps towards taking into account the organizational impacts of health care technologies

On 31 December 2020, the French National Authority for Health (Haute Autorité de Santé - “HAS”), in charge of health technology assessment of health care products...

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Biden Issues wide-ranging Buy American Executive Order – FAR rulemaking to come

On 25 January 2021, President Biden issued his first Buy American Executive Order (EO), titled Ensuring the Future Is Made in All of America by All of America’s Workers, which is...

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Biotech & Digital Medicine Showcase: Life sciences firms advised on regulatory concerns, investing

Last week, Hogan Lovells partners Alice Valder Curran, Jodi K. Scott, and Jon Layman convened with other industry leaders virtually at this year’s Biotech and Digital Medicine...

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New Orange & Purple Book laws increase transparency of patent information for drugs, biologics

On January 5, 2021, President Trump signed into law H.R. 1503, the "Orange Book Transparency Act of 2020," which amends provisions governing the types of patents and...

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