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Takeda Pharmaceuticals USA Inc.

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Latest From Takeda Pharmaceuticals USA Inc.

Judge Jackson’s Patent, FDA Rulings Show She Is ‘Super Smart’ And Would Be Beneficial For Pharma

Supreme Court nominee issued three decisions on Hatch-Waxman regime as district court judge, including case in which she ruled against the FDA’s denial of orphan drug designation and another in which she deferred to the agency’s view on exclusivity. Her analysis of facts may play a role if the court takes up a case on administrative agency deference.

Legal Issues Intellectual Property

Make, Buy Or Partner: Strategic Alliances Continue To Fuel Biopharma Growth

The biopharma market has been highly active throughout the COVID-19 pandemic with a substantial focus on strategic alliances between 2020-H1 2021. Partnership deals present exciting liquidity and risk mitigation opportunities for early-stage companies. Small molecules still comprise the largest segment of partnered drugs, but alliances for other modalities are on the rise.

Business Strategies Commercial

Policies Targeting ‘Rebate Traps’ In Part D May Not Yield Big Savings, Study Suggests

Research on generic drug coverage in Medicare Part D plans finds access unobstructed for majority of lower cost alternatives. However, study may offer incomplete picture, generic and biosimilar advocates say.

Pricing Debate Regulation
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