Qiagen Completes Second U.S. Submission For Companion Diagnostic To Guide Treatment Decisions In Colorectal Cancer Print E-mail
By Staff and Wire Reports   
Friday, 05 August 2011 19:34
Below is a look at some of the headlines for companies that made news in the healthcare sector on August 5, 2011.

Qiagen NV (NASDAQ:QGEN) announced it has completed its second U.S. submission of the therascreen KRAS RGQ PCR Kit for use as a companion diagnostic paired with Erbitux (cetuximab), a drug for treatment of patients with metastatic colorectal cancer (mCRC).

Erbitux is marketed in the United States by Bristol-Myers Squibb Company  (Public, NYSE:BMY) and Eli Lilly and Company (Public, NYSE:LLY). Merck KGaA (OTC:MKGAY) has the right to market Erbitux outside the US and Canada. QIAGEN submitted a Premarket Approval (PMA) application to the FDA for use of its assay in determining which patients can be expected to benefit from Erbitux in treatment of mCRC.

The first submission of the KRAS assay, earlier in July, paired QIAGEN's molecular test with another drug for treatment of metastatic colorectal cancer. Both therapies are monoclonal antibody EGFR inhibitors expected to target a range of cancers.


Also Friday:


ACCESS PHARMACEUTICALS, INC. (OTCBB: ACCP)
, a biopharmaceutical company leveraging its proprietary drug-delivery platforms to develop treatments in areas of oncology, cancer supportive care and diabetes, has hired Edelman, the leading full service global public relations firm, to support its media outreach initiatives.

Ardea Biosciences, Inc. (Nasdaq:RDEA), a biotechnology company focused on the development of small-molecule therapeutics for the treatment of serious diseases, today reported recent accomplishments and financial results for the second quarter and six months ended June 30, 2011.

Bacterin International Holdings, Inc. (NYSE Amex:BONE), a leader in the development of revolutionary bone graft material and anti-infective coatings for medical applications, achieved its most productive processing month in July.

China Sky One Medical, Inc. (NASDAQ:CSKI), a leading fully integrated pharmaceutical company in the People's Republic of China ("PRC"), today announced that it will conduct a conference call at 9:30 a.m. Eastern Time (ET) on Wednesday, August 10, 2011, to discuss second quarter 2011 financial results.

Dendreon Corporation (Nasdaq:DNDN) today announced that management will present at the Canaccord Genuity Growth Conference in Boston, MA on August 10 at 5:00 PM EDT.

Hospira, Inc. (NYSE:HSP), the world leader in generic injectable pharmaceuticals, today announced U.S. Food and Drug Administration (FDA) approval of gemcitabine injection, a solution form of the drug.

Neuland Laboratories Ltd., (NSE: NEULANDLAB) a pharmaceutical manufacturer providing active pharmaceutical ingredients (APIs), complex intermediates, and contract research and manufacturing services to customers located in 85 countries, today announced financial results for the first quarter of fiscal year (FY) 2012, ended June 30, 2011.

VIVUS, Inc. (NASDAQ:VVUS)
today announced that additional data from the phase 3 QNEXA studies will be presented today during the American Association of Diabetes Educators (AADE) meeting in Las Vegas, NV.   

Sinovac Biotech Ltd. (Nasdaq:SVA), a leading provider of biopharmaceutical products in China, announced today the resignation of Jacob Chik Keung Ho, its Chief Financial Officer, for personal reasons.



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