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We are creating a place where we can share ideas, provide the perspective of America's biopharmaceutical companies and, most importantly, listen to you.

Ensuring timely reauthorization of PDUFA and BsUFA

By Matthew Norawong  |    May 11, 2022
Today, the House Energy and Commerce Subcommittee on Health will be hosting a markup session on the comprehensive legislative package to reauthorize the human drug user fee programs, including the...   Read More

The accelerated approval pathway: Helping patients with serious or life-threatening diseases

By Andrew Powaleny  |    March 17, 2022
Today, the House Energy & Commerce Committee’s Subcommittee on Health will meet to discuss policy proposals to “encourage innovation and improve oversight” regarding medical innovation. This hearing...   Read More

The importance of timely PDUFA and BsUFA reauthorization

By Lucy Vereshchagina  |    February 3, 2022
Today, PhRMA, along with the U.S. Food and Drug Administration (FDA) and other industry trade associations, will be participating in a congressional hearing with the House Committee on Energy and...   Read More

Biosimilar User Fee Act (III) Performance Goals Letter will help increase options for patients and promote competition

By Richard Moscicki, M.D.  |    September 28, 2021
Last week, the U.S. Food and Drug Administration (FDA) released the Performance Goals Letter for the Biosimilar User Fee Act (BsUFA) III.   Read More

How strengthening the biosimilar marketplace benefits patients

By Andrew Powaleny  |    May 18, 2021
Biologics are medicines that are made from living organisms through highly complex manufacturing processes and include a wide variety of medicines such as therapeutic proteins, monoclonal antibodies...   Read More

IP Explained: Why IP protections are important for biologic medicines

By Tom Wilbur  |    July 18, 2019
Biologics are cutting-edge therapies that treat or cure some of the most challenging and costly diseases. These medicines are created from living organisms through highly complex manufacturing...   Read More

Balancing innovation and competition in the biologics marketplace

By David Korn  |    October 11, 2018
Last month, I presented at the U.S. Food and Drug Administration’s (FDA) Public Hearing on Facilitating Competition and Innovation in the Biological Products Marketplace. The hearing was part of an...   Read More

Spending on medicines grew less than one percent in 2017

By Holly Campbell  |    April 19, 2018
Last year, a record number of new treatments and cures that are transforming care for patients fighting debilitating diseases like cancer, hepatitis C, high cholesterol and more were approved by the...   Read More

Medicare Monday: Billing code basics for biologics in Part B

By Allyson Funk  |    March 20, 2017
We’ve explored the Centers for Medicare & Medicaid Services’ (CMS) flawed policy for reimbursing biologic and biosimilar products before. Today, we’re exploring how proposals from MedPAC would build...   Read More

FDA issues draft biosimilars labeling guidance

By Andrew Powaleny  |    April 12, 2016
Labeling is an important aspect of the U.S. Food and Drug Administration (FDA) prescription drug approval process. FDA-approved prescription drug labeling is the most authoritative mechanism for...   Read More

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