The new drug
application submission is based on results from AG221-C-001, a single-arm phase I/II study of enasidenib in patients with advanced hematologic malignancies with an IDH2 mutation.
On the other hand, some new drugs
are, in fact, more effective than currently available therapies and make a real difference for the patient.
Short-term data suggest that some of the new drugs
increase rates of diabetes and heart disease and some older drugs promote movement and neurological disorders.
The FDA recently approved several new drugs
, and several more are slated to be approved this year.
Some of the patients in the trials already had cross resistance to Prezista when the trial began (due to their extensive resistance to other protease inhibitors), and it got worse on the average, as they used the drug--showing the importance of having more than one active antiretroviral, instead of introducing new drugs
one by one as they become available, and then often losing them to resistance.
In 1999, in response to these concerns, the European Medicines Agency (EMEA) began drafting guidance that outlined an environmental risk assessment procedure to accompany pharmaceutical companies' applications to market new drugs
If the FDA seems to be getting overly picky, demanding more and more tests before approving a new drug
, CEOs should remember that old medical advice: An ounce of prevention is worth a pound of cure.
The challenge for salvage therapy is to coordinate 2 or more such programs so that salvage patients have access to 2 or more new drugs
at the same time.
Local physicians say the study reinforced their belief in proceeding with caution when considering new drugs
That increase has enabled pharmaceutical firms to bring new drugs
to market earlier in their patent lives and enabled U.
In fact, most of Bailey-Boushay Houses's patients require skilled care because they could not tolerate or comply with the new drug
In fact, the total amount for drugs spent in the United States increased 27 percent between 1995 and 1997, related both to higher utilization and the increasing unit cost of new drugs