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

Amgen: FDA Letter Rejects Expanded Use Of Xgeva For Prostate Cancer

DOW JONES NEWSWIRES Amgen Inc. (AMGN) received a complete response letter from the U.S. Food and Drug Administration rejecting the expanded use of Xgeva in men with prostate cancer that hasn't spread to the bones. According to the drug maker, the FDA letter said the agency can't approve the supplemental biologics license application in its present form because the effect on bone metastases-free survival doesn't outweigh the risks, such as osteonecrosis of the jaw, a rare jaw-decay problem. "We are reviewing the complete response letter and will work with FDA to determine any next steps," said Sean E. Harper, executive vice president of research and development. Xgeva is currently approved to delay fractures and other bone injuries in patients whose cancer has already spread to the bones. It is also sold under the brand name Prolia as an osteoporosis treatment, but is administered at a lower dose. Xgeva's and Prolia's combined sales in 2011 topped $550 million. A federal advisory panel in February rejected Amgen's proposal to expand the bone drug's use, saying it was unclear whether the results were clinically meaningful. Amgen's study of Xgeva in men with prostate cancer that hadn't responded to previous therapies, but hadn't yet spread to the bones showed the drug prolonged median bone metastatis-free survival by 4.2 months. Shares closed Thursday at $70.79 and were inactive premarket. The stock it up 10% so far this year. -By Melodie Warner, Dow Jones Newswires; 212-416-2283; melodie.warner@dowjones.com

Stock News for Amgen Inc. (AMGN)
DateTimeHeadline
06/22/201501:03:00Celimmune to Present Experimental Anti-IL-15 Antibody AMG 714...
06/19/201516:00:00Amgen Presents Open-Label Extension Data From Ongoing Phase 2...
06/18/201517:32:35Amgen Vectibix Trial Promising in Patients With Colorectal Cancer
06/18/201516:01:00Results From Phase 3 Trial Show Vectibix® (Panitumumab) Improves...
06/17/201509:04:025 Healthcare Stocks for Dividend Lovers
06/15/201516:12:43Annual Report of Employee Stock Plans (11-k)
06/15/201516:10:32Annual Report of Employee Stock Plans (11-k)
06/14/201508:03:023 Big Healthcare Trends Wall Street Is Overlooking
06/11/201512:05:033 Things AbbVie Inc.'s Management Wants You to Know
06/10/201519:43:54FDA Advisory Panel Backs Amgen's Cholesterol-Lowering Drug Repatha...
06/10/201517:40:08FDA Panel Recommends Amgen Cholesterol Drug
06/10/201517:29:32FDA Panel Votes to Recommend Amgen Cholesterol Drug
06/10/201508:00:00Amgen To Discuss Details Of Repatha™ (Evolocumab) Biologics L...
06/09/201518:00:16FDA Panel Backs Cholesterol Drug, but Raises Concerns
06/09/201517:52:50FDA Panel Backs Cholesterol Drug, but Raises Concerns
06/09/201508:59:14Regeneron Halted Ahead of FDA Panel Review of Cholesterol Drug
06/08/201516:00:00Amgen To Present At The Goldman Sachs Global Healthcare Conference
06/08/201513:25:31Cholesterol Drugs: 3 Stocks to Watch This Week
06/07/201508:11:03These 3 Ultra-Rare Diseases Are Utterly Terrifying
06/06/201506:00:40FDA Queues Up Review of New Anti-Cholesterol Drugs

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 1999-2007 ADVFN PLC. | Privacy Policy | Investment Warning | Data accreditations | Investor Relations

ADVFNADVFN ItalyADVFN GermanyADVFN FranceADVFN BrazilADVFN JapanADVFN UKADVFN US noad