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Pharmaceutical Industry › Regulatory Reform › Generic Drugs

Troutman Pepper Locke

FTC Holds Its First Listening Session on Practices and Regulations Impacting Pharmaceutical Generic or Biosimilar Competition

Troutman Pepper Locke on

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

A&O Shearman

Council position on EU pharma package adopted

A&O Shearman on

On 4 June, the Council of the European Union (Council) adopted its negotiation position on the proposals for a new regulation and directive that make up the so-called ‘pharma package’. The pharma package now moves to the next...more

Katten Muchin Rosenman LLP

FTC and DOJ Announce Listening Sessions on Lowering American’s Drug Prices

Katten Muchin Rosenman LLP on

On April 15, 2025, President Donald Trump issued  Executive Order No. 14273, “Lowering Drug Prices by Once Again Putting Americans First, ” which outlines a series of targeted actions to lower prescription drug costs and...more

Hogan Lovells

EU Pharma Law Package: Council Position on Reduction of Regulatory Exclusivity Rights

Hogan Lovells on

On 4 June 2025, the Council of the EU adopted its position on the EU Pharma Law Package legislative proposal to revise the EU’s general pharmaceutical legislation. The Council, consisting of all the 27 EU Member States and...more

Skadden, Arps, Slate, Meagher & Flom LLP

A 20-Minute Speech Provides the Clearest Road Map Yet for FDA Policy

Skadden, Arps, Slate, Meagher & Flom LLP on

Key Points - - Who is impacted: Manufacturers of pharmaceutical, biotechnology, medical device and food products. - What is changing: The agency is prioritizing user fee reauthorization, the MAHA initiative and a push for...more

Barnea Jaffa Lande & Co.

Drug registration reform in Israel: processes are being streamlined and timeframes shortened to increase supply and lower prices

Barnea Jaffa Lande & Co. on

We are living in an era of revolutionary medical innovation, particularly in the research and development of medicinal products. Diseases that were once considered incurable, are now treated with drugs, vaccines and...more

Proskauer - The Patent Playbook

President Biden’s Executive Order on Competition Signals Potential Changes Affecting Patents in the Healthcare Sector

Proskauer - The Patent Playbook on

On July 9, 2021, President Biden issued “Executive Order on Promoting Competition in the American Economy” (the “Executive Order”). The Executive Order was billed by the White House as “historic” and comparable to Teddy...more

Akerman LLP - Health Law Rx

Derailing the Gravy Train – Trump Unveils Plan to Reduce Drug Prices

Akerman LLP - Health Law Rx on

Throughout his presidential campaign, President Trump championed the need to allow the government to negotiate drug prices on behalf of the Medicare program. However, that third rail for pharmaceutical companies was not...more

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