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FDA warns over use of robotically-assisted surgical devices

Last week, the U.S. Food and Drug Administration (FDA) issued a safety communication to remind patients and health care providers that the safety and effectiveness of...

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Snow Phipps Group v. KCAKE Acquisition: DE addresses MAE based on COVID-19 impact

In Snow Phipps Group, LLC v. KCAKE Acquisition, Inc. (C.A. No. 2020-0282-KSJM), the Delaware Court of Chancery ordered specific performance of a US$550 million acquisition, rejecting the...

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In re Appraisal of Regal: deal-price-less-synergies valuation method is “first among equals”

The court’s decision in In re Appraisal of Regal Entertainment Group (C.A. No. 2018-0266-JTL (Del. Ch. May 13, 2021)) is the most recent in a line of cases confirming that the...

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LDC Parent v. Essential Utilities: DE court on who should resolve purchase price adjustment dispute

In LDC Parent, LLC v. Essential Utilities, Inc. (C.A. No. N20C-08-127-MMJ-CCLD (Del. Super. Apr. 28, 2021)), the Delaware Superior Court held that a post-closing purchase price adjustment...

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SEC approves Nasdaq’s board diversity rules

On August 6 the SEC approved the Nasdaq Stock Market’s proposal to amend its listing rules to require operating companies listed on its U.S. exchanges to provide annual disclosures...

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FDA leads global work on continuous manufacturing approaches to up quality, supply chain resilience

Under FDA's leadership, the International Council for Harmonisation (ICH) recently published Q13 draft guidelines on continuous manufacturing (CM) to advance the brand and generic drug...

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Manichaean Capital v. Exela Tech: DE courts rule on “reverse veil piercing” claims

In Manichaean Capital, LLC v. Exela Tech., Inc. (C.A. No. 2020-0601-JRS (Del. Ch. May 25, 2021)), the Court of Chancery ruled as a matter of first impression in Delaware that plaintiffs...

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Federal Circuit affirms GSK labeling carve-out ruling in favor of innovator

Earlier this month, in GlaxoSmithKline LLC v. Teva Pharmaceuticals USA, Inc., a panel of the U.S. Court of Appeals for the Federal Circuit (CAFC) affirmed (2-1) upon rehearing its...

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Global Payments Newsletter, August 2021

Key developments of interest over the last month include: Brazil: Central bank publishes details of push towards Phase 2 of Open Banking United Kingdom: PSR launches Digital Payments...

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