Policy
A renewal of the FDA’s pediatric rare disease voucher program is couched within a massive $1.2 trillion spending bill the House is set to vote on later this week.
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Only a handful of the top pharmas have signed Most Favored Nation drug pricing deals with the White House, while smaller biotechs continue to hang in limbo.
Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and reshoring U.S. manufacturing also got some attention. Here, BioSpace rounds up more than a dozen initiatives relevant to the biopharma industry.
With five CDER leaders in one year and regulatory proposals coming “by fiat,” the FDA is only making it more difficult to bring therapies to patients.
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Recipharm, a leading contract development and manufacturing organisation, is pleased to note the FDA’s approval of Perrigo’s AB-rated generic of ProAir HFA.
More flexible versions of the COVID-19 diagnostic tests are being developed but, currently, are only available for research.
As a valued member of our BioSpace community, we are eager to hear more from you and other readers in 2020. We want to know how the coronavirus outbreak may be impacting your work and your workplace.
Approval for the combination treatment was based on results from the Phase I/II CheckMate-040 trial in which Opdivo and Yervoy showed an overall response rate of 33% in this patient population.
As the number of diagnosed cases of COVID-19 continue to increase across the globe and more and more governments are urging citizens to self-quarantine, the pharmaceutical and life sciences industry continues to work toward the development of a vaccine and therapies for the respiratory infection that was declared a pandemic by the World Health Organization last week. Here’s a biopharma industry overview as of late March 16.
In a statement issued to the Boston Business Journal, Intarcia expressed both disappointment and a determination to get an approval for ITCA 650.
The Breakthrough Therapy Designation is based on data from a Phase I trial of JNJ-6372 alone and in combination with lazertinib, a novel third-generation EGFR TKI in adults with advanced NSCLC.
The company disclosed that the U.S. Food and Drug Administration placed a partial clinical hold on its Phase I trial for non-Hodgkin lymphoma due to a safety concern.
The U.S. Food and Drug Administration approved Boehringer Ingelheim’s Ofev (nintedanib) for patients with chronic fibrosing interstitial lung diseases with a progressive phenotype.
The U.S. Food and Drug Administration is putting a halt to the sale of alleged treatments for COVID-19 due to concerns about the safety risks these products could have to the public.