The Center for Medicare and Medicaid Innovation ("CMMI") is set to reshape value-based care. In the third of a three-part series highlighting this new direction, this summary is focused on CMMI's efforts regarding drugs,...more
6/13/2025
/ Centers for Medicare & Medicaid Services (CMS) ,
CMMI ,
Data Collection ,
Data Management ,
Digital Health ,
Drug Pricing ,
Health Insurance ,
Healthcare ,
Healthcare Reform ,
Life Sciences ,
Medicaid ,
Medical Devices ,
Medicare ,
Patient Access ,
Pharmaceutical Industry ,
Value-Based Care
China's State Council issued new Anti-Monopoly Guidelines for the Pharmaceutical Sector (the "Guidelines") effective January 24, 2025. The Guidelines provide a comprehensive framework for the State Administration for Market...more
2/3/2025
/ Acquisition Agreements ,
Anti-Monopoly ,
Antitrust Provisions ,
China ,
Competition ,
Enforcement Actions ,
Healthcare ,
Life Sciences ,
Merger Agreements ,
Merger Controls ,
Merger Reviews ,
Monopolization ,
Pharmaceutical Industry ,
Resale Price Maintenance (RPM) ,
State Administration for Market Regulation (SAMR) ,
Unfair Competition
On March 22, 2024, the Federal Trade Commission ("FTC") filed an amicus brief in Teva Branded Pharmaceutical Products R&D, et al. v. Amneal Pharmaceuticals of New York, LLC, et al., 2:23-cv-20964, U.S. District Court for the...more
5/2/2024
/ Federal Trade Commission (FTC) ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Intellectual Property Protection ,
Life Sciences ,
Medical Devices ,
Orange Book ,
Patent Infringement ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Popular ,
Teva Pharmaceuticals
The FDA recently published a proposed rule to create national licensing standards for Wholesale Drug Distributors and Third-Party Logistic Providers....more
2/10/2022
/ Drug Distribution ,
Drug Wholesaling ,
Food & Drug Regulations ,
Food and Drug Administration (FDA) ,
Healthcare ,
Licensing Rules ,
Life Sciences ,
Listing Standards ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Rules ,
Regulatory Agenda ,
Regulatory Reform ,
Regulatory Standards ,
Supply Chain
Last week, the Patient Right to Know Drug Prices Act ("Act") became law. The Act requires pharmaceutical companies to disclose to antitrust agencies agreements between biologic and biosimilar companies that relate to the...more
10/19/2018
/ Antitrust Division ,
Disclosure Requirements ,
Federal Trade Commission (FTC) ,
Hatch-Waxman ,
Life Sciences ,
Manufacturers ,
Medicare Prescription Drug Improvement and Modernization Act (MMA) ,
Patents ,
Pharmaceutical Industry ,
Popular ,
Prescription Drugs