United States: Food, Drugs, Healthcare, Life Sciences

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Article
Fresenius Acquires Remaining 45% Stake In MAbxience For Up To €750 Million
Fresenius SE & Co. KGaA has completed its acquisition of the remaining 45% stake in mAbxience Holding S.L., a biosimilar manufacturer, for up to €750 million. The transaction makes mAbxience a wholly owned subsidiary within Fresenius Kabi's Biopharma business, providing the company with greater control over its biosimilar value chain from development through commercialization.
United States Healthcare
GP
Goodwin Procter LLP
Article
The Race For Clinical Trials: Can The FDA’s New Pilot Program Stop The U.S. From Falling Behind?
The United States has lost approximately 10% of its global share of Phase 1 clinical trials since 2015, with China now accounting for 39% of all global trials by 2024. The FDA's new Expedited IND Pilot Program introduces Qualified Research Institutions and rolling submissions to help sponsors reach first-in-human dosing faster domestically. For life sciences companies whose financing depends on rapid trial initiation, this program could fundamentally reshape development strategy and restore U.S. competitive
United States Healthcare
FH
Foley Hoag LLP
Article
PBM Policy And Legislative Update — Fall 2026
Mintz's Managed Care, PBMs & Pharmacies practice examines critical federal and state developments impacting pharmacy benefit managers and the prescription drug supply chain from mid-February through June 2026. This comprehensive quarterly update analyzes legislative activity, regulatory changes, enforcement actions, and emerging market trends affecting PBMs, health plans, pharmacies, manufacturers, and industry stakeholders navigating an evolving regulatory landscape.
United States Healthcare
M
Mintz
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Article
UK High Court Upholds Takeda’s Lisdexamfetamine SPC: Will The CJEU Agree?
The UK High Court has ruled on whether lisdexamfetamine (LDX), a pro-drug with no therapeutic activity before conversion to dextroamphetamine, can be considered an "active ingredient" for supplementary protection certificate purposes. This decision addresses a critical question in pharmaceutical patent law that has produced divergent outcomes across European jurisdictions and is currently before the CJEU in multiple pending referrals.
United States IP
JA
J A Kemp LLP
Article
The Race For Clinical Trials: Can The FDA’s New Pilot Program Stop The U.S. From Falling Behind?
The United States has lost approximately 10% of its global share of Phase 1 clinical trials since 2015, with China now accounting for 39% of all global trials by 2024. The FDA's new Expedited IND Pilot Program introduces Qualified Research Institutions and rolling submissions to help sponsors reach first-in-human dosing faster domestically. For life sciences companies whose financing depends on rapid trial initiation, this program could fundamentally reshape development strategy and restore U.S. competitive
United States Healthcare
FH
Foley Hoag LLP
Article
PBM Policy And Legislative Update — Fall 2026
Mintz's Managed Care, PBMs & Pharmacies practice examines critical federal and state developments impacting pharmacy benefit managers and the prescription drug supply chain from mid-February through June 2026. This comprehensive quarterly update analyzes legislative activity, regulatory changes, enforcement actions, and emerging market trends affecting PBMs, health plans, pharmacies, manufacturers, and industry stakeholders navigating an evolving regulatory landscape.
United States Healthcare
M
Mintz
See more
Article
Fresenius Acquires Remaining 45% Stake In MAbxience For Up To €750 Million
Fresenius SE & Co. KGaA has completed its acquisition of the remaining 45% stake in mAbxience Holding S.L., a biosimilar manufacturer, for up to €750 million. The transaction makes mAbxience a wholly owned subsidiary within Fresenius Kabi's Biopharma business, providing the company with greater control over its biosimilar value chain from development through commercialization.
United States Healthcare
GP
Goodwin Procter LLP
Article
The Race For Clinical Trials: Can The FDA’s New Pilot Program Stop The U.S. From Falling Behind?
The United States has lost approximately 10% of its global share of Phase 1 clinical trials since 2015, with China now accounting for 39% of all global trials by 2024. The FDA's new Expedited IND Pilot Program introduces Qualified Research Institutions and rolling submissions to help sponsors reach first-in-human dosing faster domestically. For life sciences companies whose financing depends on rapid trial initiation, this program could fundamentally reshape development strategy and restore U.S. competitive
United States Healthcare
FH
Foley Hoag LLP
See more
Article
Fresenius Acquires Remaining 45% Stake In MAbxience For Up To €750 Million
Fresenius SE & Co. KGaA has completed its acquisition of the remaining 45% stake in mAbxience Holding S.L., a biosimilar manufacturer, for up to €750 million. The transaction makes mAbxience a wholly owned subsidiary within Fresenius Kabi's Biopharma business, providing the company with greater control over its biosimilar value chain from development through commercialization.
United States Healthcare
GP
Goodwin Procter LLP
See more