The FDA has approved Tercica's Increlex (mecasermin [rDNA origin] injection) for the long-term treatment of growth failure in children with severe primary IGF-1 (insulin-like growth factor-1) deficiency (IGFD) or with growth hormone gene deletion who have developed neutralizing antibodies to growth hormone. Increlex is identical to IGF-1, the natural hormone produced in the body that has a broad range of activity central to growth and metabolism.
Drug approved for children with growth failure
FDA approves Glaxo's flu vaccine
CMS to publish proposed rule for competitive bidding for DME
CMS will publish a proposed rule regarding competitive bidding for durable medical equipment (DME), off-the-shelf orthotics, and enteral nutrition. Medicare will do business only with providers who win the bids in 2007. Speaking to attendees at the NACDS Pharmacy and Technology conference, Laurence Wilson, CMS director of the chronic care policy group, said, "We want to maintain a level playing field for suppliers. Once CMS receives comments through a 60-day comment period, we'll move to a final rule. CMS is also working on developing quality standards. We expect to see those before the rule comes out in late October or early November, but it could be at the same time that the rule comes out." For public input, visit http://www.cms.hhs.gov/.
Genentech, FDA announce updated toxicity information on Herceptin
Genentech and the FDA have notified healthcare professionals of updated cardiotoxicity information related to the use of Herceptin (trastuzumab), obtained from the National Surgical Adjuvant Breast and Bowel Project (NSABP) study (B-31), a randomized, phase III trial that was conducted in 2,043 women with operable, HER2-overexpressing breast cancer. This study demonstrated a significant increase in cardiotoxicity in patients who were randomized to the Herceptin-containing arm as compared with patients receiving chemotherapy alone. For more information, visit http://www.fda.gov/medwatch/safety/2005/safety05.htm#Herceptin.
Medicare regions to have 11 to 23 Rx plans
Each of the Medicare Part D regions will have between 11 and 23 Rx drug plans, according to CMS. Each region, except Alaska, will also have at least one plan with premiums below $20. CMS is completing its review of Rx plans, including access to drugs at pharmacies convenient to beneficiaries' homes. The list of approved Rx plans will be released in mid-September.
NDC Health to be sold to two companies
NDC Health has agreed to be broken up and sold to Per-Se Technologies and Wolters Kluwer. Per-Se, a business services and information technology firm, will pay $664 million for NDC's pharmacy-data transmission and provider financial services business. Publisher Wolters Kluwer will pay $382 million cash to buy NDC's data-mining service for drug companies.