Regulatory
Haselmeier officially announces that it has received Master File Number MAF3202 from the Food and Drug Administration of the United States for its D-Flex product platform, a new generation of injection pen systems for subcutaneous self-administration.
The U.S. Food and Drug Administration granted Eli Lilly and Company and Incyte Corporation Breakthrough Therapy designation for baricitinib for alopecia areata.
This announcement contains inside information for the purposes of Article 7 of the Market Abuse Regulation (EU) No 596/2014.
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.
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