By MAGGIE FOX Cancer researchers made a plea for more money Tuesday in a report that said flat funding for the National Institutes of Health is scaring off promising scientists. The 85-page report paints a picture of success that could be jeopardized if the momentum isn’t maintained, and outlines many of the advances made since…
By CQ STAFF The Food and Drug Administration is realigning the offices that review and approve all drug and biologic applications for cancer therapies , the agency announced Monday. The new structure contains four divisions: Hematology Products, Oncology Products 1, Oncology Products 2 and Hematology Oncology Toxicology. Previously there were three sections: Hematology Products, Drug…
By CQ STAFF The Food and Drug Administration is realigning the offices that review and approve all drug and biologic applications for cancer therapies , the agency announced Monday. The new structure contains four divisions: Hematology Products, Oncology Products 1, Oncology Products 2 and Hematology Oncology Toxicology. Previously there were three sections: Hematology Products, Drug…
By ANNA YUKHANANOV U.S. regulators and the drug industry want to extend by two months the deadline for the Food and Drug Administration to approve or reject new drugs. The extended timeline was tucked into the proposed deal the FDA forged with the prescription drug industry on the fees companies pay for drug reviews. The…
By ANNA YUKHANANOV U.S. regulators and the drug industry want to extend by two months the deadline for the Food and Drug Administration to approve or reject new drugs. The extended timeline was tucked into the proposed deal the FDA forged with the prescription drug industry on the fees companies pay for drug reviews. The…
By THOMAS M. BURTON The Food and Drug Administration has reached an agreement with the brand-name drug industry on a five-year plan that will increase industry fees paid to the agency by about 6% and continue to fund the expansion of new drug approvals, according to people familiar with the talks. The relatively smooth negotiations…
By THOMAS M. BURTON The Food and Drug Administration has reached an agreement with the brand-name drug industry on a five-year plan that will increase industry fees paid to the agency by about 6% and continue to fund the expansion of new drug approvals, according to people familiar with the talks. The relatively smooth negotiations…
By LAURA LANDRO When Judith Nakamura tried to see a surgeon to follow up on her treatment for breast cancer recently, she was told it would be a two-month wait. Colleen Sullivan-Moore stepped in and got Ms. Nakamura an appointment the following week. Ms. Sullivan-Moore, at Presbyterian Healthcare Services in Albuquerque, N.M., heads a team…
By LAURA LANDRO When Judith Nakamura tried to see a surgeon to follow up on her treatment for breast cancer recently, she was told it would be a two-month wait. Colleen Sullivan-Moore stepped in and got Ms. Nakamura an appointment the following week. Ms. Sullivan-Moore, at Presbyterian Healthcare Services in Albuquerque, N.M., heads a team…
By DEENA BEASLEY Researchers at the University of Pennsylvania engineered patients’ own pathogen-fighting T-cells to target a molecule found on the surface of leukemia cells. The altered T-cells were grown outside of the body and infused back into patients suffering from late-stage chronic lymphocytic leukemia (CLL), which affects the blood and bone marrow and is…
