Regulatory
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.
Gottlieb said the FDA believes there should be a premarket demonstration that a new opioid is superior to an already-approved opioid.
Assertio Therapeutics, Inc. announced that the United States Court of Appeals for the Federal Circuit has ruled in favor of Assertio with respect to the company’s patent litigation against three filers of Abbreviated New Drug Applications for the NUCYNTA® franchise.
Cystic fibrosis drugmaker Vertex was forced to destroy nearly 8,000 packs of its drug Orkambi after the medication had expired before they could be shipped to the United Kingdom due to a contentious pricing fight.
BioSpace takes a quick look at some of the news coming from biotech and pharma companies from across Europe and Asia.
On March 26, AbbVie announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) approved its Skyrizi (risankizumab) for plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis in adults who haven’t responded to conventional therapies.
First Latin American Approval of Crysvita, the only Treatment that Targets the Underlying Cause of this Rare, Hereditary, Lifelong Disease
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