|FDA OKs Endo Gel, warns Smith & Nephew.|
|By Staff and Wire Reports|
|Friday, 31 December 2010 20:14|
Endo Pharmaceuticals Holding Inc (NASDAQ:ENDP), which holds U.S. marketing rights to the gel, and ProStrakan Group PLC's (LON:PSK) Fortesta testosterone gel, to treat men with low levels of the hormone, has been approved by the FDA. One of the concerns of the FDA was the gel rubbing off onto other people such as women and children. The gel is applied with one finger to each thigh to prevent this. Shares of Endo closed at $35.22 on the Nasdaq.
Smith & Nephew (NYSE:SNN), orthopedic device maker, failed to establish adequate manufacturing validation procedures and was warned by the FDA on their hip replacement device. Certain required tests were not performed, and the company failed to establish and maintain procedures to correct the problems as stated in a letter dated December 21, 2010 from the FDA. FDA inspectors found the manufacturing problems with the R3 Ceramic Acetabular Systems during an inspection of the company's facility in Tuttlingen, Germany.
AdCare Health Systems, Inc. (NYSE Amex: ADK), a recognized innovator in senior living and health care facility management, has completed the acquisition of Mountain Trace Nursing Center, a 106-bed nursing facility in Sylva, North Carolina for $6.1 million, with the closing effective on January 1, 2011.
GeckoSystems Intl. Corp. (PINKSHEETS:GOSY) reported today that their board of directors recently authorized a 185,000,000 share buy back representing over 25% of the prior number of issued and outstanding shares.
Kraig Biocraft Laboratories, Inc. (PINKSHEETS: KBLB) announced today the release of a new video featuring interviews with the Company CEO and a member of the scientific team further outlining the Company's technology and vision for 2011.
Medical Marijuana Inc (PINKSHEETS:MJNA) announces that its division, The Hemp Network® www.thehempnetwork.com, has made an agreement with a Guatemalan Cooperative for the production and manufacture of Hemp-related products.
mPhase Technologies, Inc. (OTCBB: XDS) announced today that it will recommence active efforts in January of 2011 to secure federal funding for its scalable smart reserve cell technology, one of the line items included in the Fiscal Year 2011 Defense Appropriations bill that was passed in the United States House of Representatives.
Ophthalmic Imaging Systems (OIS) (OTCBB: OISI), a leading ophthalmic digital imaging and informatics company, today announced that OIS EMR VERSION 4.1.7 is 2011/2012 compliant and was certified as a Complete EHR on December 28, 2010 by the Certification Commission for Health Information Technology (CCHIT®), an ONC-ATCB, in accordance with the applicable ELIGIBLE PROVIDER certification criteria adopted by the Secretary of Health and Human Services.
Sinovac Biotech Ltd. (Nasdaq:SVA), a leading provider of biopharmaceutical products in China, announced today its common shares will be listed on the NASDAQ Global Select Market effective January 3, 2011.