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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.

Nearly 400 cell and gene therapies in development to target a broad range of diseases

By Andrew Powaleny  |    March 10, 2020
In 2017, the U.S. approved its first cell and gene therapy, making the idea of altering a gene to cure or treat a disease a reality. As the increasing pace of R&D propels cell and gene therapy...   Read More

ICYMI: 2019 brings innovative medicines to patients

By Andrew Powaleny  |    January 17, 2020
New reports from the U.S. Food and Drug Administration (FDA) show a total of 55 novel new medicines were approved in 2019. Among these, 48 were approved by the Center for Drug Evaluation and...   Read More

PhRMA comments to Congress on Cures 2.0 call to action

By Anne McDonald Pritchett, PhD  |    December 18, 2019
As new therapies continue to revolutionize the treatment of many diseases, it is positive news that policymakers in Washington are discussing ways to ensure patient access to new treatments and...   Read More

Guest Post: Using the patient voice to go boldly

By Guest Contributor  |    May 30, 2019
Conversations and healthy debate about issues facing our industry and the health care system are critical to addressing some of today’s challenges and opportunities. The Catalyst welcomes guest...   Read More

IP Explained: How Hatch-Waxman successfully balances affordability and innovation

By Tom Wilbur  |    May 22, 2019
For three decades, The Drug Price Competition and Patent Term Restoration Act, more commonly known as the Hatch-Waxman Act, has fostered innovation, spurred competition and helped the United...   Read More

Guest post: Hearing from patients on Rare Disease Day

By Guest Contributor  |    February 28, 2019
Conversations and healthy debate about issues facing our industry and the health care system are critical to addressing some of today’s challenges and opportunities. The Catalyst welcomes guest...   Read More

Rare Disease Day: Unmet medical need inspires biopharmaceutical innovation

By Richard Moscicki, M.D.  |    February 28, 2019
Today is Rare Disease Day, an annual reminder of the incredible community of patients living with a rare disease. In the U.S., rare diseases are classified as conditions that affect fewer than...   Read More

Why state drug importation pilot programs don’t work

By Nick McGee  |    February 8, 2019
Across the country, some states are recirculating failed proposals that would establish state-run prescription medicine importation schemes. Such proposals would allow medicines from foreign...   Read More

Putting 2018 medicine approvals in context

By Andrew Powaleny  |    January 23, 2019
Last year, the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved a record number of novel new medicines with 59 new molecular entities (NMEs). While...   Read More

FDA needs best and brightest to advance a new era of medicine with America’s biopharmaceutical companies

By Richard Moscicki, M.D.  |    October 16, 2018
The U.S Food and Drug Administration (FDA) plays a critical role in protecting and promoting the health of all Americans. Every day, the FDA does important work to ensure the safety, efficacy and...   Read More

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