Regulatory
The U.S. Food and Drug Administration has two PDUFA dates this week, one for a type of epilepsy and the other for a triple-combination drug for cystic fibrosis. Here’s a look.
The U.S. Centers for Disease Control and Prevention has alerted the country that increased person-to-person spread of novel coronavirus is likely, and that measures to contain the disease will become more and more disruptive to daily life.
Hospitals and laboratories will be able to run the test on Roche’s fully automated cobas 6800 and cobas 8800 Systems, which are already in wide use in the U.S. and internationally.
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.
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.
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