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Last updated on April 17, 2014 at 17:30 EDT

Latest REMS Stories

2011-07-26 15:15:00

MOUNTAIN VIEW, Calif., July 26, 2011 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that it will report financial results for the quarter ended June 30, 2011, on Monday, August 8, 2011, following the close of the U.S. financial markets. Alexza also announced that the resubmission of its AZ-004 New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) is now planned for Monday, August 8, 2011. The Company completed the writing of the NDA...

2011-05-09 15:05:00

MOUNTAIN VIEW, Calif., May 9, 2011 /PRNewswire/ -- Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) today reported financial results for the fiscal quarter ended March 31, 2011, and provided a business update. The net loss for the quarters ended March 31, 2011 and 2010, as reported in accordance with accounting principles generally accepted in the United States, was $8.4 million and $13.4 million, respectively. At March 31, 2011, Alexza had consolidated cash, cash equivalents and marketable...

2011-03-14 08:52:00

TALLAHASSEE, Fla., March 14, 2011 /PRNewswire/ -- LearnSomething today announced the offering of their first Risk Evaluation and Mitigation Strategy(REMS) pharmacy training program for Abstral, an opioid sublingual tablet manufactured by ProStrakan, Inc., and indicated for the management of breakthrough pain in cancer patients. Pharmacies can now contact a LearnSomething representative to facilitate access to the training course required for enrollment in the Abstral REMS program in order...

2010-01-12 06:45:00

WILMINGTON, Del., Jan. 12 /PRNewswire/ -- More than 80 Risk Evaluation and Mitigation Strategy (REMS) plans have been approved by the Food & Drug Administration since their inception in March 2008. Now, pharmaceutical companies must formally assess and report on how well these plans have actually been working in reducing drug risks, a mandated step in the REMS process. This will be the topic of an open industry webinar at 12 noon EST on Wednesday, January 13 entitled "Cracking the Code...

2009-12-03 13:00:00

WILMINGTON, Del., Dec. 3 /PRNewswire/ -- ParagonRx, a Delaware-based company specializing in pharmaceutical risk management and optimal medication use, will host a free webinar on Wednesday, Dec. 9, on the FDA's draft guidance on REMS - Risk Evaluation Mitigation Strategy - programs and its implications for REMS lifecycle management. Dr. Gary Slatko, chief medical officer of ParagonRx and an expert on REMS and risk management programs, will lead the one-hour program beginning at 11 a.m....

2009-10-01 10:42:00

WILMINGTON, Del., Oct. 1 /PRNewswire/ -- Yesterday, the FDA issued very important draft guidance for pharmaceutical and biotechnology companies for formatting, assessing and modifying Risk Evaluation & Mitigation Strategies (REMS) to ensure the safe use of pharmaceutical products. Jeffrey Fetterman and Dr. Gary Slatko, both principals of ParagonRx, have helped many companies prepare REMS and related safety plans. They have previously co-authored two books on the topic and are now...

2009-08-25 12:00:00

WILMINGTON, Del., Aug. 25 /PRNewswire/ -- While many pharmaceutical and biologics companies are getting accustomed to FDA-mandated Risk Evaluation and Mitigation Strategy (REMS) programs for many new and old drugs, most are not adequately preparing for the equally mandatory program evaluations beginning just 1-1/2 years after each REMS is put into effect. That warning has been issued by risk management expert Jeffrey Fetterman, CEO of ParagonRx, a Delaware-based company specializing in...

2009-07-13 13:30:00

WILMINGTON, Del., July 13 /PRNewswire/ -- ParagonRx, a Delaware-based company which specializes in programs for the appropriate use of medications, has launched a new website - www.paragonrx.com - that includes a "REMS Hub" for pharmaceutical and biotech companies needing information and assistance in complying with new FDA requirements to ensure the medical benefits of a drug outweigh its risks and dangerous side effects. "REMS, or Risk Evaluation and Mitigation Strategy, requires a whole...