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FDA Moves to Streamline Biosimilar Development: The Implications for Regulatory and IP Strategy
Updated guidance from the FDA eliminates the need for biosimilar developers to conduct bridging studies for foreign comparators, reducing costs and patent exposure, and possibly limiting patent holders’ insight into looming competition.
FDA Moves to Streamline Biosimilar Development: The Implications for Regulatory and IP Strategy
UK Proposes Updates to Scope of National Security and Investment Act Regime
The UK government has proposed changes to the scope of transactions subject to national security screening under the National Security and Investment Act 2021, expanding and clarifying sensitive sectors. We examine the details and the implications for companies.
UK Proposes Updates to Scope of National Security and Investment Act Regime
Updated guidance from the FDA eliminates the need for biosimilar developers to conduct bridging studies for foreign comparators, reducing costs and patent exposure, and possibly limiting patent holders’ insight into looming competition.
FDA Moves to Streamline Biosimilar Development: The Implications for Regulatory and IP Strategy
The UK government has proposed changes to the scope of transactions subject to national security screening under the National Security and Investment Act 2021, expanding and clarifying sensitive sectors. We examine the details and the implications for companies.
UK Proposes Updates to Scope of National Security and Investment Act Regime
In the wake of the unprecedented pullback of consumer financial services activity at the federal level, states are taking different approaches — with some continuing the Biden administration’s initiatives and others aligning with the Trump administration’s priorities.
Consumer Financial Enforcement: States to Watch in 2026
The Trump administration released its national cyber policy blueprint, signaling a shift toward a more proactive, offense-oriented approach in cyberspace and increased private sector engagement. Skadden attorneys examine the potential impact of the new strategy, including likely legal and regulatory changes.
Trump Administration Releases Cyber Strategy
Consumer Financial Enforcement: States to Watch in 2026
In the wake of the unprecedented pullback of consumer financial services activity at the federal level, states are taking different approaches — with some continuing the Biden administration’s initiatives and others aligning with the Trump administration’s priorities.
Consumer Financial Enforcement: States to Watch in 2026
Trump Administration Releases Cyber Strategy
The Trump administration released its national cyber policy blueprint, signaling a shift toward a more proactive, offense-oriented approach in cyberspace and increased private sector engagement. Skadden attorneys examine the potential impact of the new strategy, including likely legal and regulatory changes.
Trump Administration Releases Cyber Strategy
