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The winners and losers of the second Republican debate
Nikki Haley and Donald Trump won. Debating and Ron DeSantis lost.
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5 Takeaways From Another Trump-Free Republican Debate
The party’s front-runner took few hits as his rivals bickered, Nikki Haley delivered an assured performance, Tim Scott reasserted himself and Ron DeSantis took his first debate swipes at Trump.
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Judge Denies Trump’s Request That She Recuse Herself in Election Case
Judge Tanya Chutkan rejected arguments from the former president’s legal team that she could not fairly conduct his trial on federal charges of plotting to overturn the 2020 election.
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House Votes to Strip Defense Secretary of Salary as Right Wing Flexes Muscles
Little more than three days before a government shutdown, the Republican-led House spent the day adding hard-right proposals to a series of doomed spending bills.
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In Michigan, Biden and Trump Offer a Preview of 2024
The candidates’ dueling styles were on clear display as the two men tried to woo voters affected by the United Automobile Workers strike.
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Biden to Create Library Honoring His Friend and Rival John McCain
In a stop in Arizona, a key battleground state in next year’s election, the president plans to embrace the longtime Republican senator and vocal Trump critic.
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Research Security: New NIH Policy Requires Foreign Subrecipients to Share Lab Notebooks & Research Data With the U.S. Prime Awardee
On September 15, 2023, the National Institutes of Health (NIH) moved forward with a controversial new policy requiring foreign subrecipients to provide, at least once per year, copies of lab notebooks, data and documentation that support research outcomes described in a progress report to the prime award recipient. The new policy is in direct response…
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FDA Clarifies Labeling Expectations for Prescription Drug Use-Related Software
On September 19, 2023, the U.S. Food and Drug Administration (“FDA” or “the Agency”) published a draft guidance, Regulatory Considerations for Prescription Drug Use-Related Software (the “Guidance”) which adds a piece to the ever-expanding puzzle that is FDA’s regulatory scheme for digital health products. The Guidance clarifies how FDA plans to apply its drug labeling…
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A Potential Look Into the Future: California Issues First Draft of Cybersecurity Audit and Risk Assessment Regulations
The Board of the California Privacy Protection Agency (the CPPA) held its first meeting since July on Friday, September 8, 2023, and discussed the first public draft of cybersecurity audit regulations and risk assessment regulations. While the CPPA Board expressly announced that the drafts were for board meeting discussion purposes and that it has not…
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Enabling Biotech Genus Claims Defined Only by Function — A Nearly Impossible Goal — Baxalta Incorporated v. Genentech Inc. (Fed. Cir. Sept. 20, 2023)
In the aftermath of Amgen v. Sanofi, courts continue to invalidate genus claims for lacking enablement. Baxalta Incorporated v. Genentech Inc.2 shows that it is nearly impossible to meet the enablement requirement for claims only reciting the activity of an antibody….By: Kilpatrick Townsend & Stockton LLP
