Latebreakers: March 19, 2007
Generic drug industry movers and shakers believe 2007 will be the year affordable generic biopharmaceuticals will reach consumers. "We are on the verge of a new revolution in our industry, and that's the creation of a clear and effective abbreviated pathway to biogenerics," GPhA president and CEO Kathleen Jaeger told attendees at GPhA's annual meeting in Phoenix. Rep. Henry Waxman (D, Calif.) and Sen.
Will 2007 usher in biogenerics?
Court issues decision unfavorable to pharmacy benefit managers
NCCN revises anemia treatment guide
Based on study results from Amgen showing that darbepoetin alfa (Aranesp) did not reduce the number of red blood cell transfusions necessary for patients who have active cancer and anemia but are not receiving chemotherapy or radiation therapy, the National Comprehensive Cancer Network (NCCN) has updated its Cancer and Treatment-Related Anemia Guidelines. The network panel added a statement to the "Adverse Effects of Erythropoietic Therapy" section of the guidelines stating that, until new evidence changes the current benefit/risk estimates, physicians should be advised not to administer erythropoietin to patients similar to those in the Amgen trial. The study also showed higher mortality among patients receiving treatment with darbepoetin.
Multiple new indications approved for Lipitor
Government sues Walgreen over bias
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
