ADVFN - Advanced Financial Network.
HOME» NASDAQ » A » AMGN Stock Price » AMGN Stock News

Amgen Inc. Share News

 Amgen Inc. (mm) Stock Price
AMGN Stock Price
 Amgen Inc. (mm) Stock Chart
AMGN Stock Chart
 Amgen Inc. (mm) Stock News
AMGN Stock News
 Amgen Inc. (mm) Company Information
AMGN Company Information
 Amgen Inc. (mm) Stock Trades
AMGN Stock Trades

WSJ BLOG/Health: FDA Questions Benefit of Amgen Bone Drug in Certain Cases

(This story has been posted on The Wall Street Journal Online's Health Blog at http://blogs.wsj.com/health.) By Jennifer Corbett Dooren The Food and Drug Administration questioned the clinical benefit of using Amgen's bone drug Xgeva to prevent or delay the spread of prostate cancer to the bones. Xgeva is currently approved to delay fractures and other bone injuries in patients whose cancers have already spread to the bones. The company is seeking approval for use of Xgeva to prevent the spread of prostate cancer in a group of men that has not responded to other therapies. Xgeva will be reviewed Wednesday by the FDA's oncologic drugs advisory committee, which is made up of non-FDA medical experts. The FDA today posted a review of Xgeva in preparation for the meeting. Amgen conducted a study of Xgeva in 1432 men with prostate cancer that had not responded to previous therapies, but had not spread to the bones. Many types of cancer spread to the bones and cause tumors to grow, destroying the bone around the tumor, causing fractures and other problems. Half of the men were treated with Xgeva while the other half received a placebo. The study examined the time until men developed bone metastases or died, whichever occurred first. The study showed Xgeva prolonged median bone metastatis-free survival by 4.2 months compared to men in the placebo group. While the FDA said the study met its primary objective, the agency said it was unclear whether the results were "clinically meaningful" given that there was no difference in overall survival between the two patient groups. The agency said the risk-benefit ratio of Xgeva must also take into account the overall toxicity of the drug. One of the side-effects includes a risk of developing osteonecrosis of the jaw, or ONJ, a rare jaw-decay problem. Michael Severino, Amgen's vice president of research and development, said today that the company believes Xgeva does provide a clinically meaningful benefit because it delays the spread of cancer to the bone, which causes significant pain and other problems such as incontinence. Xgeva is also sold under the brand name Prolia as an osteoporosis treatment but is administered at a lower dose and less often than used to treat cancer-related bone complications. Xgeva and Prolia's combined sales in 2011 topped $550 million. The drugs target a protein called RANK Ligand, which helps regulate cells called osteoclasts that break down bone. (This post originally ran on Dow Jones Newswires.) -For continuously updated news from The Wall Street Journal, see WSJ.com at http://wsj.com.

Stock News for Amgen Inc. (AMGN)
DateTimeHeadline
06/22/201618:00:00Amgen Sponsors QB3@953 Incubator For Life Science Startups
06/20/201608:25:00Biotechnology Stocks Under Review - Eleven Biotherapeutics, Relypsa...
06/17/201616:00:00Amgen Appoints Esteban Santos Executive Vice President, Operations
06/15/201616:58:28Annual Report of Employee Stock Plans (11-k)
06/15/201616:51:42Annual Report of Employee Stock Plans (11-k)
06/14/201616:55:30Current Report Filing (8-k)
06/13/201616:00:00Amgen Announces FDA Advisory Committee Meeting To Review ABP...
06/10/201616:00:00New Analyses From Pivotal Phase 3 Studies Show Kyprolis® (Carfilzomib...
06/10/201609:17:28Current Report Filing (8-k)
06/10/201609:00:00Amgen Announces Expiration And Final Results Of Senior Notes...
06/10/201602:30:00BLINCYTO® (Blinatumomab) Improved Overall Survival In Patients...
06/09/201616:18:40Statement of Changes in Beneficial Ownership (4)
06/08/201616:30:00Amgen Announces Erenumab (AMG 334) Significantly Reduces Patients...
06/07/201609:00:00New National Survey Sheds Light On How To Better Engage Students...
06/06/201616:00:00New Phase 3 Secondary Analysis Shows Progression-Free Survival...
06/06/201612:20:00Gilead's New CEO Faces Pressures on Hepatitis C Pills
06/03/201616:15:00Amgen Announces Launch Of KYPROLIS® (carfilzomib) CENTRAL, An...
06/03/201616:00:00Amgen To Present At The Goldman Sachs 37th Annual Global Healthcare...
06/01/201602:30:00Bayer Collaborates with U.S. National Surgical Adjuvant Breast...
05/31/201616:32:17Specialized Disclosure Report (sd)

Amgen Inc. and other NASDAQ stock quotes are delayed by at least 20 minutes.
All other stock price and quote data is delayed by at least 15 minutes unless otherwise stated. By accessing the services available at ADVFN you are agreeing to be bound by ADVFN's Terms & Conditions
Contact Us | Copyright 1999-2015 ADVFN PLC. | Privacy Policy | Investment Warning | Data accreditations | Investor Relations

ADVFNADVFN ItalyADVFN GermanyADVFN FranceADVFN BrazilADVFN JapanADVFN UKADVFN US noad