Food and Drug Administration (FDA)
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The FDA calendar has only one PDUFA data scheduled for the next couple weeks. On Thursday, April 11, the U.S. Food and Drug Administration (FDA) and Merck & Co. have a target action date for their supplemental Biologics License Application (sBLA) for Keytruda
“Men with breast cancer have limited treatment options, making access to medicines such as Ibrance critically important,” stated Bret Miller, founder of the Male Breast Cancer Coalition.
The Pennsylvania-based company disagrees with the FDA’s analysis of its clinical data and will seek to work with the agency for approval.
In January 2019, the U.S. Food and Drug Administration (FDA) updated a 2015 draft guidance on rare diseases.
Amgen is suing Novartis, alleging a breach of the partnership and seeking to terminate the 2015 contract. Novartis, in response, filed a lawsuit accusing Amgen of inappropriately attempting to end the alliance.
Phase 1/2 pheNIX Trial Would Represent First PKU Gene Therapy to Enter the Clinic
With the clock winding down on his tenure at the U.S. Food and Drug Administration, Commissioner Scott Gottlieb continues to take aim at a number of concerns he has raised over the past two years, including the dangers of vaping and unsanctioned use of stem cells.
Public perception of the industry can be a bit confusing. Life Science Leader recently pulled together several biopharma executives for a round table discussion of the biopharma industry’s public perception—generally bad—and what might be able to do about it.
A recent report by CBRE Research analyzing U.S. life science clusters, found that Houston, Texas is the third-fastest growing life science market from 2014 to 2017. One doesn’t typically think of Texas, let alone Houston, as being a center for the life sciences. Oil, energy and tech, yes, but not life sciences.
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