Comments for FDA Calendar Updates: BDSI, SVNT Deadlines Approach at http://www.biomedreports.com , comment 1 to 4 out of 4 comments http://www.biomedreports.com Thu, 24 May 2012 19:42:27 +0100 FeedCreator 1.7.3 http://www.biomedreports.com/200906121294/fda-calendar-updates-bdsi-svnt-deadlines-approach.html#comment-269 WASHINGTON, June 12 (Reuters) - Savient Pharma's (NASDAQ:SVNT) proposed gout drug Krystexxa appears effective, but serious heart complications and other safety issues are a concern, U.S. health regulators said in a memo released on Friday. Click on the link below for briefing documents at the FDA website for the upcoming advisory panel meeting. http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisDrugsAdvisoryCommittee/ucm165710.htm The Food and Drug Administration's review of two company studies raised several concerns, including a greater number of patients taking Krystexxa who suddenly died or had heart failure as well as allergic reactions, wrote Dr. Bob Rappaport, head of the FDA division that handles such rheumatology drugs. Savient is seeking U.S. approval for the drug to treat patients whom other therapies have not helped. The agency "does not dispute the efficacy" of Krystexxa at the currently proposed dose regimens of every two or four weeks, Rappaport said in the memo, which was released ahead of a public meeting on Tuesday to discuss whether to recommend approval of the drug. At the meeting, agency officials will ask the panel whether Savient has enough data to determine whether the benefits of the drug outweigh its risks. The FDA usually, but not always, follows its panel recommendations. - Mike Havrilla Fri, 12 Jun 2009 05:11:32 +0100 http://www.biomedreports.com/200906121294/fda-calendar-updates-bdsi-svnt-deadlines-approach.html#comment-211 Check out Savient (SVNT) in the pre-market this morning. Up big on release of FDA briefing docs and positive comments from FDA. - Todd Wagner Fri, 12 Jun 2009 00:17:43 +0100 http://www.biomedreports.com/200906121294/fda-calendar-updates-bdsi-svnt-deadlines-approach.html#comment-209 hi ACUR Their main technology Aversion is up for FDA approval by June 30th! - titi Thu, 11 Jun 2009 16:18:38 +0100 http://www.biomedreports.com/200906121294/fda-calendar-updates-bdsi-svnt-deadlines-approach.html#comment-208 Do you have any list of company schedule for approval from June to December 2009 - Phong Thu, 11 Jun 2009 13:46:54 +0100