> In the midst of a controversy over patent-busting compulsory licenses, Thailand's new Food and Drug Administration chief quit after one week on the job. Report [1]
> Seventeen House members asked FDA chief Andrew von Eschenbach to withdraw proposed rules that would allow drug makers to make their own changes to product labels; the reps said they feared the change would limit consumers' access to information about safety risks. Report [2]
> Denmark's Lundbeck reported a 69 percent decline in fourth-quarter profits to $19 million, due to a writedown in value of its manufacturing facility in northern England. Report [3]
> Federal prosecutors fined Florida-based White Broadman $1 million for selling unapproved ED drugs. Report [4]
> The FDA gave its blessing to three new strengths of Endo Pharmaceuticals' Opana ER pain med. Report [5]
> In other Endo news, the company removed Vice President Bill Newbould from his role as company spokesperson after he told a reporter that the company isn't evaluating a possible sale; because he wasn't privy to the discussions, Endo said, Newbould didn't know that the board had worked with financial advisers and consultants on a possible deal. Report [6]
> The breast cancer remedy tamoxifen may be useful against bipolar disorder's mania phase, but side effects could pose difficulties for long-term use, researchers said. Release [7]
> Eisai and its partners MGI Pharma and Helsinn Healthcare said the FDA gave the nod to their Aloxi injection to prevent post-operative nausea and vomiting. Release [8]
> A Russian news service is reporting that Nycomed is looking for a site for a new pharmaceuticals plant in that country. Report [9]
> Renovo's Juvista produced a mixed set of data in two mid-stage trials. Report [10]
> Shire Human Genetic Therapies and a string of smaller drug developers have decided to pull up stakes from Cambridge and head for the suburbs. The exodus is being triggered by a desire to find less expensive digs. Report [11]
> The Boston Globe weighs in with a lengthy look at the tussle over biogenerics--a.k.a. follow-ons and biosimilars. The smart money is betting that at some point in the not-too-distant future Congress will get around to giving the FDA authority to approve biogenerics on a case-by-case basis. Report [12]
And Finally... If the presidential candidates were pharma brands, what would they be named? Hopium, for one. Report [13]
Links:
[1] http://www.iht.com/articles/ap/2008/03/03/asia/AS-GEN-Thailand-Drug-Patents.php
[2] http://www.pharmalot.com/2008/03/more-lawmakers-blast-fda-labeling-proposal/
[3] http://www.marketwatch.com/news/story/danish-drug-maker-lundbecks-quarterly/story.aspx?guid=%7B5B95C0EA%2DA555%2D4769%2DB7D2%2D098A66E6DEBA%7D
[4] http://www.boston.com/news/local/rhode_island/articles/2008/03/03/company_penalized_for_misleading_marketing_of_impotence_drug/
[5] http://www.fiercebiotech.com/press-releases/endo-pharmaceuticals-launch-three-new-dosage-strengths-opana-er
[6] http://www.businessweek.com/ap/financialnews/D8V611AO0.htm
[7] http://www.fiercebiotech.com/press-releases/tamoxifen-may-help-treat-mania-patients-bipolar-disorder
[8] http://www.fiercebiotech.com/press-releases/fda-approves-aloxi-r-palonosetron-hcl-injection-prevention-postoperative-nausea-and-0
[9] http://www.engl.fis.ru/news/?nid=24578
[10] http://www.fiercebiotech.com/story/mixed-data-for-renovo-s-scarring-therapy/2008-03-03
[11] http://www.fiercebiotech.com/story/cambridge-biotechs-head-for-the-cheaper-burbs/2008-03-03
[12] http://www.fiercebiotech.com/story/debate-over-follow-ons-focus-on-market-exclusivity/2008-03-03
[13] http://invivoblog.blogspot.com/2008/03/if-candidates-were-drug-names.html