Regulatory
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.
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.
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.
Following international concern and outrage over a gene editing treatment of human embryos in China, the World Health Organization is taking action.
If the new funding bill is signed by the president, the FDA will have some extra funds to support various initiatives.
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