Regulatory
The FDA noted some concerns over the drug’s safety profile. Treatment with selinexor is associated with significant toxicity, the agency noted in its materials.
Significant milestone toward the commercialization of eptinezumab, the first quarterly infusion therapy for migraine prevention
Two-year follow-up data shows 100 percent overall survival and 100 percent event free survival in comparison to a historical standard of care from a historical control group.
AbbVie announced that they have received approval for an additional indication of HUMIRA, a fully human anti-TNF-alpha monoclonal antibody, for the treatment of hidradenitis suppurativa.
Pfizer’s blockbuster rheumatoid arthritis drug Xeljanz, a JAK inhibitor, has been a strong performer for the company, bringing in $1.77 billion in revenue last year. But now the company has indicated it intends to make a change in its post-marketing study due to safety concerns.
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.
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.
Merck’s Keytruda paired with Pfizer’s Inlyta fares better than standard-of-care treatment in patients of advanced renal cell carcinoma.
PRESS RELEASES