“FDA investigators have asked those researchers to share their methods and findings with the agency so that they can ‘investigate potential pancreatic toxicity associated with the incretin mimetics’.”
“This is really a huge advance,” said Dr. Eric Siemers, senior medical director for the Alzheimer’s disease team at Eli Lilly & Company. “Kudos to the F.D.A.”
“Some of the products that are out there now have been tested and they’ve shown to have Tylenol products in them or some kind of penicillin derivatives in there, which could be very dangerous for a patient if they have drug allergies to something like that. It could also be dangerous for patients who are on other medications. There could be interactions that we’re not aware of that could cause unwanted side effects,” Kayley Will, Community Care Resident for Texas Tech School of Medicine says.
“The eyeglass camera captures images, which the video processor translates into pixelized patterns of light and dark, and transmits them to the electrodes. The electrodes then send them to the brain.”
The Food and Drug Administration approves ABUS, a ultrasound machine that detects tumors in women with dense breast tissue.
On Wednesday, the Food and Drug Administration approved an oral pill that treats multiple sclerosis making it the second oral therapy drug available in the US.
Bio SmartBrief notes that the disagreements could sink plans to establish a national system for tracking and tracing pharmaceuticals. A group of drug manufacturers, distributors and pharmacies says tracking drug lots rather than individual packages, as the FDA proposes, would be cheaper and simpler to implement.
Merck is seeking Food and Drug Administration approval for ridaforolimus, a tablet, for use as a maintenance therapy in certain patients with soft-tissue or bone sarcomas who previously had been treated with chemotherapy.
Both companies want government approval to sell drugs to treat versions of soft tissue sarcoma or bone sarcoma.
Bipartisan federal bill would speed up the approval process for drugs that treat life-threatening diseases
The bill is designed to improve outcomes for patients with fatal diseases such as cancer, AIDS, and Alzheimer’s disease.