{"id":441672,"date":"2010-03-18T04:40:28","date_gmt":"2010-03-18T08:40:28","guid":{"rendered":"http:\/\/www.xconomy.com\/?p=69045"},"modified":"2010-03-18T04:40:28","modified_gmt":"2010-03-18T08:40:28","slug":"sequenom-speaks-out-amylin-receives-a-setback-somaxon-awaits-fda-decision-more-san-diego-life-sciences-news","status":"publish","type":"post","link":"https:\/\/mereja.media\/index\/441672","title":{"rendered":"Sequenom Speaks Out, Amylin Receives a Setback, Somaxon Awaits FDA Decision, & More San Diego Life Sciences News"},"content":{"rendered":"\n
Roundup<\/a>, Life Sciences<\/a>, Biotech<\/a><\/div>\n

\t\tDenise Gellene wrote:<\/strong><\/p>\n

Regulatory news dominated the headlines in the past week. We have it summarized for you here.<\/p>\n

—Sequenom<\/strong> (NASDAQ: SQMN<\/a>) said a lack of adequate controls, protocols and supervision were to blame for the mishandled data<\/a> that led the company to scrub its launch of a diagnostic test for Down syndrome. Sequenom shares lost 76 percent of their value last April <\/a>when the company announced that the data needed to support the test had been mishandled.<\/p>\n

—Tomorrow is the deadline for an FDA decision <\/a>on Somaxon<\/strong>’s (NASDAQ: SOMX<\/a>) request to market its experimental insomnia drug doxepin (Silenor). The company has warned investors that approval isn’t likely.<\/p>\n

—The FDA delayed an application from San Diego-based Amylin<\/strong> <\/a>(NASDAQ: AMLN<\/a>) and Indianapolis-based Eli Lilly to start marketing once-weekly exenatide for diabetes. The FDA’s “complete response letter” raised issues around finalizing the prescribing information that guides physicians, along with a Risk Evaluation and Mitigation Strategy (REMS) program and “clarification of existing manufacturing processes,” the companies said.<\/p>\n

—Luke located more than 170 alums of Hybritech<\/strong><\/a>, the company that gave birth to San Diego’s biotechnology industry.<\/a><\/p>\n

—San Diego-based Ligand Pharmaceuticals <\/strong>(NASDAQ: LGND<\/a>) said today that its partner, GlaxoSmithKline, won European clearance to start marketing eltrombopag for idiopathic thrombocytopenia purpura<\/a> (ITP), a rare bleeding disorder in which the immune system attacks platelet cells that help people form clots. The drug is marketed in the U.S\u00a0 as Promacta.<\/p>\n

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Roundup, Life Sciences, Biotech Denise Gellene wrote: Regulatory news dominated the headlines in the past week. We have it summarized for you here. —Sequenom (NASDAQ: SQMN) said a lack of adequate controls, protocols and supervision were to blame for the mishandled data that led the company to scrub its launch of a diagnostic test for […]<\/p>\n","protected":false},"author":2918,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[7],"tags":[],"class_list":["post-441672","post","type-post","status-publish","format-standard","hentry","category-news"],"_links":{"self":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/posts\/441672","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/users\/2918"}],"replies":[{"embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/comments?post=441672"}],"version-history":[{"count":0,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/posts\/441672\/revisions"}],"wp:attachment":[{"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/media?parent=441672"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/categories?post=441672"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/mereja.media\/index\/wp-json\/wp\/v2\/tags?post=441672"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}