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 56 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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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...
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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...
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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...
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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...
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