Generic Drugs

Former Pharma Executive Pleads Guilty to Antitrust Conspiracy

by Samantha McGrail

The Department of Justice announced that a former generic pharmaceutical executive pled guilty last week for his role in criminal antitrust conspiracy from March 2013 to June 2015. According to court...

Congress’ Think Tank Digs Into Drug Patenting Practices

by Ana Mulero

A new Congressional Research Service report on Wednesday delved into the deluge of proposals that have been set forth to address drug pricing and drug patenting practices. The report is a high-level...

Biogen Triumphs Over Patent Challenge of Multiple Sclerosis Drug

by Samantha McGrail

Biogen recently won an ongoing patent dispute over its multiple sclerosis (MS) drug, Tecfidera, which pulled in nearly $4.4 billion in revenue in 2019, according to a decision from the US Patient and...

CMS Moves to Foster Access to Generics, Biosimilars in New Rule

by Ana Mulero

The Trump administration put out a proposed rule on Wednesday that aims to foster access to generics and biosimilars through a push for price transparency around pharmaceutical drugs administered under...

FDA, FTC Join Forces on Biologics Competition

by Ana Mulero

The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) on Monday issued a set of four joint goals to support a competitive US marketplace for approved biological products,...

FDA Breaks Down Barriers to Prioritizing Generic Drug Approvals

by Ana Mulero

The Food and Drug Administration issued updates to its policy on prioritization of generic drug applications to make better use of the agency's limited resources. The Manual of Policies and...

USMCA Approval Signals Drug Pricing Changes Ahead

by Ana Mulero

The Senate’s January 16 approval of the US-Mexico-Canada (USMCA) Agreement was well-received by industry groups who argued for it to serve as a template for ongoing trade deal negotiations to...

CA Proposes Single Market for Drug Pricing, Manufacturing Hub

by Ana Mulero

The state of California is set to propose, as early as this spring, two initiatives to establish a single market for drug pricing within the state and a new contracting program for generic...

USMCA Makes its Way to Full Senate Vote After Lobbying Win

by Ana Mulero

The Senate Finance Committee passed the US-Mexico-Canada (USMCA) Trade Agreement of 2019 on Tuesday, in a 25-3 vote. Other senate committees are now are set to debate the trade agreement, beginning...

Drug Price Hikes Undeterred Despite Legislative Proposals

by Ana Mulero

Drug prices increased for 686 drug products during the first few weeks of 2020, the latest data from the Centers for Medicare and Medicaid Services shows, signaling it’s business as usual for...