Regulatory
The current Spinraza cost is $750,000 for the first year and $375,000 for every year after for the life of the patient. It is approved for all forms of SMA.
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.
Across the globe, pharma and biotech companies report deals and pipeline updates, with news from Boehringer Ingelheim, Metrion, Elvie, and more.
The CRL is not totally unexpected, given that last month the company received a multi-disciplinary review (DR) letter from the FDA regarding its New Drug Application.
The U.S. Food and Drug Administration (FDA) approved ADMA Biologics’ Asceniv to treat Primary Humoral Immunodeficiency Disease (PIDD or PI) in adults and adolescents.
Evotec SE announced that it has completed its conversion into a company under European law with its registration in the commercial register of the District Court of Hamburg.
The lynchpin to biotech and pharmaceutical drug development in the United States is arguably the greater Boston area, which includes the white hot square mile of talent and intellectual collaboration found in Kendall Square.
Eisai Co., Ltd. announced that in the 8th meeting of the Data Safety Monitoring Board for the global Phase III clinical studies on the investigational oral BACE inhibitor elenbecestat in early Alzheimer’s disease, the DSMB reviewed safety data including the potential for decline in cognition, and recommended the continuation of the studies.
There are three companies looking for decisions by the U.S. Food and Drug Administration (FDA) this week. All three drugs are either resubmissions or have had to deal with various problems related to manufacturing or incomplete data. Here’s a look.
Cambridge, Mass.-based Sarepta Therapeutics announced data from its interim analysis of muscle biopsy endpoints of its therapy casimersen for Duchenne muscular dystrophy (DMD). The interim data was strong enough to support a probable New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) by mid-year.
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