> Shares of Adolor surged on the news that the FDA's Gastrointestinal Drugs Advisory Committee will review the new drug application for the pain drug Entereg [1] on Jan. 23. Report [2]
> Backed by a fresh batch of positive, mid-stage data for its experimental therapy to treat a rare hormone condition, Indevus says it will launch Phase III by mid-2008. Release [3]
> Exelixis has earned a $5 million milestone payment from Bristol-Myers Squibb. Report [4]
> Belgium's Galapagos wins up to $2.4 million in upfront fees and research funds in a development deal with Cystic Fibrosis Foundation Therapeutics. Up to $5.7 million in milestones is also on the table. Report [5]
> Protein therapy company Medgenics has raised £3.28 million from a share placing with investors. Report [6]
> AstraZeneca got a bit of a windfall today from the FDA, which granted six extra months of exclusive marketing rights to its Arimidex cancer drug. Report [7]
> New warnings and warning recommendations are flying out of the FDA this week like geese flying south for the winter, partly because of an FDA advisory panel is meeting. Report [8]
> Talk about an outpouring of adverse-event reports. After WFAA-TV in Dallas reported musician Carter Albrecht's violent death [9]--perhaps under the influence of Pfizer's smoking-cessation drug Chantix--more than 5,000 complaints about the med's side effects poured into the FDA. Report [10]
And Finally… Hospital superbugs that can break down antibiotics are so widespread throughout Europe that doctors increasingly have to use the few remaining drugs that they reserve for emergencies. Release [11]
Links:
[1] http://www.fiercebiotech.com/story/fda-wants-more-safety-data-on-entereg/2007-06-11
[2] http://www.rttnews.com/sp/breakingnews.asp?date=11/28/2007&item=57
[3] http://www.fiercebiotech.com/press-releases/press-release-indevus-pharmaceuticals-reports-positive-results-phase-ii-octreotide-im
[4] http://www.fiercebiotech.com/press-releases/press-release-exelixis-receive-milestone-payment-bristol-myers-squibb
[5] http://www.fiercebiotech.com/press-releases/galapagos-and-cystic-fibrosis-foundation-therapeutics-announce-new-drug-discovery-col
[6] http://www.sharecast.com/cgi-bin/sharecast/story.cgi?story_id=1773752
[7] http://www.fiercepharma.com/story/az-cancer-drug-gets-extended-exclusivity/2007-11-29
[8] http://www.fiercepharma.com/story/new-drug-warnings-poised-rollout/2007-11-29
[9] http://www.fiercepharma.com/story/erratic-behavior-triggers-chantix-probe/2007-11-21
[10] http://www.fiercepharma.com/story/fda-gets-5-000-chantix-complaints/2007-11-29
[11] http://www.fiercebiotech.com/press-releases/hospital-superbugs-now-nursing-homes-and-community