First Embryonic Stem Cell Therapy Trial Halted
The world's first clinical trial of a therapy using human embryonic stem cells has been halted and the company conducting the trial is abandoning stem cell research.
California-based Geron said Monday that the decision was not made because embryonic stem cell research lacks promise. Rather, money is scarce and the company decided to concentrate resources on its experimental cancer treatments, which are at a more advanced stage of development, The New York Times reported.
Geron's clinical trial involved the use of embryonic stem cell-based therapy in patients with spinal cord injuries. The trial was approved in 2010 by the U.S. Food and Drug Administration.
"I deeply believe in the promise of stem cells," John A. Scarlett, the company's chief executive, told The Times. "I don't think that promise is in any way, shape or form changed by what we're doing."
Prevnar Effective in Adults: FDA
The pneumococcal vaccine Prevnar 13 is at least as effective in adults as a rival vaccine, according to a U.S. Food and Drug Administration review posted online Monday.
Currently, vaccination with Prevnar is recommended for all infants and young children. But pneumococcal disease -- which causes ear infections, meningitis and pneumonia -- also affects 36,000 older adults each year in the United States and kills 5,000, according to the Centers for Disease Control and Prevention, CBS News and the Associated Pressreported.
Pfizer makes Prevnar and has asked the FDA to expand the vaccine's approval for adults age 50 and older. The only pneumococcal vaccine currently approved for adults is Merck's Pneumovax, which is recommended for all adults 65 and older.
For their review, FDA scientists looked at six studies involving more than 6,000 adults and concluded that Prevnar is at least as effective as Pneumovax, CBS/AP reported.
On Wednesday, an FDA panel of outside experts will discuss the safety and effectiveness of Prevnar in adults and vote on whether it should receive expanded approval. The FDA generally follows the advice of its expert panels.
Kotex Tampons Recalled
About 1,400 cases of Kotex tampons are being recalled due to concerns about a bacteria that can cause dangerous infections, Kimberly-Clark announced Monday.
The company said the tampons' plastic tubing may be contaminated with Enterobacter sakazakii, which can cause vaginal infections, urinary tract infections, pelvic inflammatory disease or other potentially life-threatening infections, msnbc.com reported.
A company spokesman said Kimberly-Clark has not received any reports of illness associated with the products.
The recall covers certain lots of Kotex Natural Balance Security Unscented Tampons Regular Absorbency that were shipped to Walmart, Fry's and Smith's stores in eight states. The 18- and 36-count boxes have SKU numbers of 15063 and 15068,msnbc.com reported.