Food and Drug Administration (FDA)
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Regeneron Pharmaceuticals and its developmental partner Sanofi are eying the third quarter of this year to seek regulatory approval for Dupixent (dupilumab) as a potential monotherapy treatment for moderate-to-severe atopic dermatitis in adolescents.
The 2017/2018 influenza season was considered one of the worst, made more so by the ineffectiveness of the season’s flu vaccine. The FDA is focusing partially on simply determining why this year’s flu vaccine missed the mark.
The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter to Evolus for its Biologics License Application (BLA) for DWP-450 (prabotulinumtoxinA), a drug to treat frown lines similar to Allergan’s Botox.
EIP Pharma, based in Cambridge, Massachusetts, closed on a $20.5 million Series B financing. The round was led by Access Industries.
Emulate, Inc. struck a deal with pharma giant AstraZeneca’s Innovative Medicines and Early Development (IMED) Biotech Unit to embed its Organs-on-Chips technology within the laboratories of the IMED Drug Safety organization.
The U.S. Food and Drug Administration (FDA) approved Pfizer’s Retacrit (epoetin alfa-epbx), a biosimilar to Amgen’s Epogen/Procrit (epoetin alfa). The drugs treat anemia caused by chronic kidney disease, chemotherapy, or use of zidovudine in HIV patients.
Shares of Perrigo have yet to rebound following the company’s weekend announcement that it expects the U.S. Food and Drug Administration to issue a Complete Response Letter for its generic version of Teva’s ProAir asthma inhaler.
The Broad Institute of MIT and Harvard is taking bold steps to acquire samples of every drug ever developed in order to test whether or not they could be used off-label to treat other diseases than the ones for which they were manufactured.
Vyriad, based in Rochester, Minnesota, announced it is building out its facility in 25,000 square feet of space it is leasing on the IBM Campus in Rochester.
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