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Life Sciences Biosimilars Competition

Sheppard Mullin Richter & Hampton LLP

FTC's Campaign Against Improper Orange Book Listings Continues with Amicus Brief in Teva’s Challenge of Amneal Asthma Inhaler ANDA

The Federal Trade Commission (“FTC”) has filed an amicus brief in Teva Branded Pharmaceuticals Products R&D, Inc. v. Amneal Pharmaceuticals of New York, LLC to further the agency’s efforts to promote and protect generic drug...more

Smart & Biggar

2022 mid-year highlights in Canadian life sciences IP and regulatory law

Smart & Biggar on

In the first half of 2022, Rx IP Update reported on a number of developments in Canadian life sciences IP and regulatory law. The Rx IP Update team at Smart & Biggar has collected the top stories from January to July and...more

Proskauer - Life Sciences

Calls for USPTO to Adopt Policies to Modulate Drug Pricing

In the wake of the nomination of Kathi Vidal as Director of the USPTO, there will be significant attention paid to the agency’s responses to calls from both the executive and legislative branches to remake the agency’s...more

Jones Day

Executive Order on Promoting Competition in the American Economy: A Focus on Patent and Drug Law to Reduce Health Care Spending

Jones Day on

Each year, Americans spend more than $1,500 per person on prescription drugs. Critics calling for measures to lower prescription drug costs often cast blame on alleged abuses of patent and competition laws. To address these...more

Akin Gump Strauss Hauer & Feld LLP

President Biden’s ‘Promoting Competition’ Executive Order: Key Health Care Actions to Follow

As has been widely reported, earlier this summer, President Biden issued Executive Order (EO) 14036, “Promoting Competition in the American Economy.” The EO provides insight into how the Biden-Harris administration plans to...more

Proskauer - Life Sciences

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

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

Haug Partners LLP

Can Biologics Manufacturers Face Antitrust Risk For Pointing Out That Biosimilars Are Different?

Haug Partners LLP on

Biologics are revolutionizing the pharmaceutical industry, and in doing so, garnering an increasing share of antitrust attention. In recent years, the FTC, FDA, and antitrust plaintiffs’ bar have raised concerns about a...more

Goodwin

Biden Executive Order Targets Competition in Healthcare, Life Sciences to Spur Economic Activity

Goodwin on

On July 9, 2021, President Joe Biden issued an Executive Order (the “Order”) designed to promote competition in the American economy. The Order describes the administration’s concerns with competition in several markets,...more

McDonnell Boehnen Hulbert & Berghoff LLP

FDA Continues to Approve Biosimilars

The prevailing attitude in many quarters is that the Biologics Price Competition and Innovation Act (BPCIA) has not facilitated approval of drugs biosimilar to reference biologic drug products with sufficient alacrity and has...more

Orrick, Herrington & Sutcliffe LLP

More Affordable and Innovative Medicines and Treatments in Europe – Has the Competition Enforcement Met the 2009 Objective?

A decade ago, the European Commission conducted a thorough sectoral inquiry into the European pharmaceutical sector that identified antitrust shortcomings impeding access to more affordable and innovative medicines and...more

Hogan Lovells

Administration presents plans to lower drug prices

Hogan Lovells on

On May 11, 2018, President Trump and Department of Health and Human Services (HHS) Secretary Alex Azar delivered highly anticipated speeches regarding the administration's plan to reduce drug prices. ...more

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