FDA
On Tuesday, Novo Nordisk said the FDA approved its Biologics License Application for Esperoct (turoctocog alfa pegol) formerly known as N8-GP, for the treatment of children and adults with hemophilia A.
Intercept Pharma plans to seek regulatory approval in the U.S. and Europe in the second half of this year.
KnipBio Inc. announced it has received Generally Regarded As Safe designation from the US Food and Drug Administration Center for Veterinary Medicine for its KnipBio Meal aquafeed ingredient for salmonids and other finfish species.
Two of the three drugs that were up for review in mid- to late-February received much earlier approval in December 21, the day before the federal government shutdown. The shutdown ended on January 25, 2019.
Novartis announced that the FDA approved the company’s Egaten to treat fascioliasis in patients six years of age and older. Novartis also inked a multi-target and multi-year collaboration with AbCellera.
Darzalex (daratumumab) for intravenous infusion is approved in the U.S. in combination with bortezomib, melphalan and prednisone for patients with newly diagnosed multiple myeloma (MM) who are ineligible for autologous stem cell transplant.
It’s not exactly breaking news that biopharma companies are increasingly turning toward machine learning and artificial intelligence (AI) to improve drug development. What is big news is how resoundingly it might improve on traditional methods.
On Feb. 12, a U.S. Food and Drug Administration (FDA) advisory committee will debate whether to recommend Johnson & Johnson’s esketamine spray for major depression. It may be an uphill battle, although any positive results in this extremely difficult-to-treat patient population will no doubt be taken into account.
Alexander (Sasha) Opotowsky, associate professor at Harvard Medical School and a cardiologist at Boston Children’s Hospital and Brigham and Women’s Hospital took time out to speak with BioSpace about advances in heart health, congenital heart disease (CHD), biopharma, and the Adult Congenital Heart Association (ACHA).
Despite having achieved a record net sales of $477 million driven by the success of its powerhouse medication Adcetris in 2018, as well as a 58 percent increase in sales during the fourth quarter in comparison to the previous year, Seattle Genetics stock fell as the results did not meet analysts’ expectations.
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