Novo Nordisk expects stronger FDA warning for liraglutide
NEW YORK Danish drug maker Novo Nordisk expects the Food and Drug Administration to strengthen warnings for its experimental diabetes medicine liraglutide following two patient deaths from similar drugs, according to Bloomberg.
The FDA demanded stronger warnings on Byetta, a drug developed by Eli Lilly and Amylin Pharmaceuticals, after two patients using the drug died from inflamed pancreases.
Liraglutide is a synthetic form of the hormone GLP-1, which causes the pancreas to make insulin.
Byetta, known generically as exenatide, had worldwide sales of $330.7 million in 2007, according to Eli Lilly financial data.
Survivors from 1918 influenza may hold key to current vaccine
WASHINGTON Researchers have found that survivors of the 1918 influenza pandemic still have antibodies providing resistance to one of the deadliest viruses in modern history, according to the Associated Press.
The researchers did tests on 32 survivors—all aged 92 to 102—and found that the antibodies remained in their bloodstreams. They also manipulated the antibodies into a vaccine and injected it into mice, which became immune to the virus themselves.
This is the longest that cells targeting specific pathogens have lasted in people, the author of the study said.
FDA upholds decision not to approve PreMD’s skin cholesterol test
TORONTO A decision by the Food and Drug Administration to not approve an expanded use for a skin cholesterol test caused maker PreMD’s shares to fall by more than 50 percent Monday, according to Reuters.
The FDA’s decision affirmed a ruling it made in January, in which it cited defects in the design and data analysis of a study used to support the expansion.
The company had tried to overturn the FDA’s initial ruling, which concluded that its clinical trial data were not sufficient to show that the test was “substantially equivalent” to approved cardiovascular risk tests.
The company’s shares were worth 14 Canadian cents Monday. Earlier in the day, they had fallen below 10 Canadian cents.