United States: Food, Drugs, Healthcare, Life Sciences

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Welcome to the Mondaq Food, Drugs, Healthcare, Life Sciences homepage, here you will find thought leadership articles, podcasts, videos and webinars providing insights covering topics such as Food and Drugs Law, Healthcare, Life Sciences, Biotechnology and Nanotechnology.
Article
Proposed Medicare Payment And Compliance Changes For Hospital Outpatient And Ambulatory Surgical Center Services
The Centers for Medicare & Medicaid Services has proposed sweeping changes to hospital outpatient and ambulatory surgical center payment systems for 2027, including a dramatic reduction in 340B drug payments from ASP +6% to ASP -33.4% and new mandatory attestation requirements for provider-based status. These proposals would fundamentally reshape hospital revenue streams through payment cuts, site-neutral policies, and enhanced compliance oversight.
United States Healthcare
SM
Sheppard, Mullin, Richter & Hampton LLP
Article
District Court Vacates USDA Approval Of Five State SNAP Pilot Projects Restricting Purchases Of Certain Foods And Beverages
On June 22, 2026, the U.S. District Court for the District of Columbia granted summary judgment to a group of Supplemental Nutrition Assistance Program (SNAP) participants challenging U.S. Department of Agriculture (USDA) approvals of state SNAP pilot projects in Colorado, Iowa, Nebraska, Tennessee, and West Virginia.1
United States Healthcare
HL
Hogan Lovells Cadwalader
Article
CMS Issues Far-Reaching Calendar Year 2027 Home Health Proposed Rule
The Centers for Medicare & Medicaid Services has proposed sweeping changes to Medicare enrollment rules that would dramatically expand federal enforcement authority across all provider types. Beyond routine home health payment updates, the rule introduces retroactive revocations, new denial grounds based on geographic fraud risk, and mandatory private equity ownership disclosures that could fundamentally reshape compliance obligations for hospitals, physician practices, and medical equipment suppliers.
United States Healthcare
HK
Holland & Knight
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Article
District Court Vacates USDA Approval Of Five State SNAP Pilot Projects Restricting Purchases Of Certain Foods And Beverages
On June 22, 2026, the U.S. District Court for the District of Columbia granted summary judgment to a group of Supplemental Nutrition Assistance Program (SNAP) participants challenging U.S. Department of Agriculture (USDA) approvals of state SNAP pilot projects in Colorado, Iowa, Nebraska, Tennessee, and West Virginia.1
United States Healthcare
HL
Hogan Lovells Cadwalader
Article
“2” Does Not Provide Written Description Support For “1”: Federal Circuit Affirms District Court’s Invalidation Of Patent
The Federal Circuit examined whether a provisional patent application's disclosure of a C2-C12-alkyl group could support a later patent claiming a C1-C12-alkyl structure, when an intervening public disclosure by a competitor revealed the C1-alkyl compound. The court's decision hinged on whether alleged typographical errors in the provisional application could establish written description support for the broader claim scope.
United States IP
FH
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
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Article
Enanta Pharmaceuticals, Inc. V. Pfizer Inc. (D. Mass. 22-cv-10967; Fed. Cir. 25-1427).
The Federal Circuit affirmed a district court's invalidity ruling on Enanta Pharmaceuticals' COVID-19 treatment patent, centering on whether a provisional application's reference to "C2-C12 alkyls" provided adequate written description support for later claims covering C1 alkyls. The appeal raised critical questions about typographical errors in patent specifications and the boundaries of written description requirements when expanding chemical compound definitions between provisional and utility patent app
United States IP
LA
Lando & Anastasi
Article
Celltrion And Teva’s TRUXIMA® Becomes First Interchangeable Rituximab Biosimilar In U.S.
The FDA has granted interchangeability designation to TRUXIMA® (rituximab-abbs), making it the first rituximab biosimilar to achieve this status in the United States. This milestone allows pharmacists to substitute TRUXIMA® for the reference product RITUXAN® without prescriber intervention, potentially expanding access to this treatment for conditions including non-Hodgkin lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis.
United States Healthcare
GP
Goodwin Procter LLP
Article
Podcast - Building Value Through Strategic Seed Investing
Strategic seed capital works best when investors help founders see what their technology can become - not just what it does today. Dr. Gopal Chopra, founding partner of Validare Capital, shares how his background as a neurosurgeon, entrepreneur and investor informs the firm's approach to early-stage investing, targeting companies that can be built quickly and efficiently with lean teams while addressing critical market needs across life sciences and data analytics.
United States Finance
HK
Holland & Knight
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Article
Proposed Medicare Payment And Compliance Changes For Hospital Outpatient And Ambulatory Surgical Center Services
The Centers for Medicare & Medicaid Services has proposed sweeping changes to hospital outpatient and ambulatory surgical center payment systems for 2027, including a dramatic reduction in 340B drug payments from ASP +6% to ASP -33.4% and new mandatory attestation requirements for provider-based status. These proposals would fundamentally reshape hospital revenue streams through payment cuts, site-neutral policies, and enhanced compliance oversight.
United States Healthcare
SM
Sheppard, Mullin, Richter & Hampton LLP
Article
District Court Vacates USDA Approval Of Five State SNAP Pilot Projects Restricting Purchases Of Certain Foods And Beverages
On June 22, 2026, the U.S. District Court for the District of Columbia granted summary judgment to a group of Supplemental Nutrition Assistance Program (SNAP) participants challenging U.S. Department of Agriculture (USDA) approvals of state SNAP pilot projects in Colorado, Iowa, Nebraska, Tennessee, and West Virginia.1
United States Healthcare
HL
Hogan Lovells Cadwalader
See more