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...
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The FDA Office of Minority Health and Health Equity: Working to advance health equity through diversity in research
By Guest Contributor | May 12, 2021
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...
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2020 FDA approvals show innovation despite COVID-19 pandemic challenges
By Andrew Powaleny | January 26, 2021
A new report from the U.S. Food and Drug Administration (FDA) notes that the Center for Drug Evaluation and Research (CDER) approved 53 novel drugs last year. These figures are in addition to...
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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...
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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...
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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...
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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...
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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...
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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...
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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...
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