On July 24, the Department of Justice (DOJ) and Federal Trade Commission (FTC) held the second of three listening sessions focused on competition in the pharmaceutical marketplace as part of the agency's implementation of the...more
7/29/2025
/ Antitrust Provisions ,
Biologics ,
Biosimilars ,
Competition ,
Department of Justice (DOJ) ,
Drug Pricing ,
Federal Trade Commission (FTC) ,
Generic Drugs ,
Healthcare ,
Life Sciences ,
Orange Book ,
Patient Access ,
Pharmaceutical Industry ,
Pharmacy Benefit Manager (PBM) ,
Prescription Drugs ,
Warning Letters
On June 30, the Department of Justice (DOJ) and the Federal Trade Commission (FTC) held the first of three listening sessions focused on ways to lower Americans’ drug prices through competition. The panels are being held as...more
7/2/2025
/ Antitrust Provisions ,
Biosimilars ,
Competition ,
Department of Justice (DOJ) ,
Drug Distribution ,
Drug Pricing ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Healthcare ,
Intellectual Property Protection ,
Life Sciences ,
Patents ,
Patient Access ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prescription Drugs ,
Regulatory Reform
Biotechs have faced several challenging years with slumping valuations and a competitive funding environment. However, the latest slew of retirements and layoffs at the FDA could present their greatest challenge yet....more
5/21/2025
/ Biotechnology ,
Competition ,
Drug Design ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Hart-Scott-Rodino Act ,
Healthcare ,
Life Sciences ,
Patient Access ,
Pharmaceutical Industry ,
Popular ,
Regulatory Requirements ,
Research and Development
As state legislatures introduce legislation expanding the reach of their antitrust laws and state attorneys general ramp up their use of antitrust investigations and litigation, the legal landscape continues to become more...more
2/28/2025
/ Antitrust Provisions ,
California ,
Competition ,
Constitutional Challenges ,
Healthcare ,
Jurisdiction ,
Patents ,
Pharmaceutical Industry ,
Settlement ,
State Attorneys General ,
Unfair Competition
The U.S. Federal Trade Commission (FTC) took the next step in its long-standing effort to encourage lower prices and increase competition in the pharmaceutical industry. As part of the Biden administration’s whole government...more
2/12/2024
/ Bayh-Dole Act ,
Biden Administration ,
Biosimilars ,
Competition ,
Drug Distribution ,
Drug Pricing ,
Federal Trade Commission (FTC) ,
Food & Drug Regulations ,
Generic Drugs ,
Healthcare ,
Healthcare Reform ,
March-in-Rights ,
NIST ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Regulatory Agenda
The Federal Trade Commission (FTC) has released a new Policy Statement addressing one of its long-standing concerns in the pharmaceutical industry: the improper listing of patents in the Orange Book. In an open meeting of the...more
10/6/2023
/ Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
FTC Act ,
Generic Drugs ,
Hatch-Waxman ,
Life Sciences ,
Orange Book ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Policy Statement ,
Prescription Drugs ,
Statutory Violations
Assistant Attorney General Jonathan Kanter, for the Department of Justice’s (DOJ) Antitrust Division, has been openly and repeatedly skeptical of merger remedies and settlements: “Merger remedies short of blocking a...more
Over the past several years, the Democratic commissioners of the U.S. Federal Trade Commission (FTC) have made clear their dissatisfaction with the agency’s historic treatment of pharmaceutical mergers. Now, it appears that...more
The Federal Trade Commission (FTC) has finalized certain amendments to the Hart-Scott-Rodino (HSR) premerger notification regulations clarifying the scope of reportable transactions involving transfers of patent rights in the...more
Recently, the Third Circuit reexamined the test for antitrust standing in Ethypharm S. A. France v. Abbott Laboratories. The importance of the opinion, however, lies not just in the court’s affirmation of the multifactor test...more