Food and Drug Administration (FDA)
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In the seventeenth century, Hungarian Countess Elizabeth Bathory bathed in the blood of young women she murdered in order to sustain her beauty. Blood, albeit more freely given, continues to be an attractive tool for some who want to stave off the effects of age.
The patients were part of a trial assessing Xencor’s mAb14045, a CD123 x CD3 bispecific antibody molecule being evaluated in patients with relapsed or refractory acute myeloid leukemia.
The study found that the majority of patients who were given the powerful painkiller did not have cancer or pain associated with the disease, which is what the drug is indicated to help.
Keytruda failed to show a statistical significance in overall survival and progression free survival in the Phase III trial.
Medtronic plc, the global leader in medical technology, announced it has received Breakthrough Device designation from the U.S. Food and Drug Administration for its Personalized Closed Loop insulin pump system, currently in development.
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.
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.
Merck’s Keytruda paired with Pfizer’s Inlyta fares better than standard-of-care treatment in patients of advanced renal cell carcinoma.
The new designation could speed up the time for approval and could also provide a period of market exclusivity for generics of branded medicines that have no competition.
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