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AstraZeneca’s Challenge to Price Negotiation Fails in Federal District Court

FDA Law Blog

According to AstraZeneca, the statute defines a qualifying single source drug by reference to its individual “approval,” and “any other reading. contradicts the plain text of the statute and therefore must be set aside.” The court reasoned that no one is entitled to sell to the Government at prices the Government will not agree to pay.

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No Sleep ‘Til District Court: Jazz Sues FDA Over Sodium Oxybate Clinical Superiority Determination

FDA Law Blog

With that decision, Jazz lost its ODE, allowing Avadel’s sodium oxybate product to compete with Jazz’s long before the expiration of the ODE covering Jazz’s most recent product, Xywav, in 2027. 360cc(c), the statute does not permit FDA to promulgate regulations to use clinical superiority to break ODE.

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5th German Conference for Young Researchers in Private International Law in Heidelberg – Conference Report

Conflict of Laws

She deemed this differentiation to be of great importance to assess the applicable law: for extrinsic tokens, the statute of the represented asset must be considered. Hence, a monetary unit is governed by the sovereign that issued the unit. The EU AI Act governs individuals who rely on AI as deployers.

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New California Legislation Would Be a Major Step Forward for Climate Disclosure

ClimateChange-ClimateLaw

Scope 3 Emissions SB 253 would direct CARB to develop standards for GHG emissions reporting by January 1, 2025, with covered entities then required to begin annual reports following these standards in 2026 (for scope 1 and scope 2 GHG emissions) and in 2027 (for scope 3 emissions). [21] 2] See, e.g., Jacqueline M. Vallette and Kathryne M.

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Customs and Trade News Weekly Snapshot

Customs & International Trade Law

Consumer Product Safety Commission (CPSC) The CPSC published a notice announcing that the new eFiling requirements will be effective in stages in 2026 and 2027. The Alcohol and Tobacco Tax and Trade Bureau (TTB) TTB has amended regulations governing some standards of fill of wine and distilled spirits. sanctions.

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