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Future of Genzyme / Isis Pharma’s Cholesterol Drug Still Up in the Air
Friday, September 3rd, 2010
EP Vantage submits: Few expected anything less than sterling phase III efficacy data for Genzyme ( GENZ ) and Isis Pharmaceuticals’ ( ISIS ) cholesterol-lowering candidate, mipomersen, at the European Society of Cardiology ( ESC ) congress in Stockholm ( Preview – ESC to throw up more than just the hot topics , August 26, 2010 ). Gleaming rays of light though these results may be, they still failed to penetrate the dark cloud of uncertainty cast by some serious side effects in the liver
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Pfizer Agrees To Acquire Drug Developer FoldRx
Thursday, September 2nd, 2010
Pfizer Inc.
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PhIII: Liver enzymes spike in 7% of mipomersen group
Wednesday, September 1st, 2010
Isis and Genzyme touted a full set of late-stage data on their cholesterol drug mipomersen , underscoring the therapy’s success in hitting its primary endpoint and detailing the issue with elevated liver enzymes seen in a slice of the drug group. Building on their release in early August, researchers found a 28 percent reduction in LDL levels in the drug group compared to a five percent increase among the placebo arm. “Having these data presented is a great milestone for the mipomersen program,” said Paula Soteropoulos, vice president and general manager of Genzyme’s cardiovascular business.
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Novartis set to begin late-stage testing of blood thinner
Monday, August 30th, 2010
Portola Pharmaceuticals’ partner Novartis will begin final-stage testing of the blood thinner elinogrel after researchers found the drug provides more rapid and greater antiplatelet activity than Plavix.
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FDA Committee Rejects Expanded Use of Jazz Drug on Abuse Concerns: Biotech’s Latest Failures
Monday, August 30th, 2010
The Burrill Report submits: A joint advisory committee of the U.S. Food and Drug Administration overwhelmingly voted against the approval of Jazz Pharmaceuticals’ ( JAZZ ) drug Xyreme for fibromyalgia because of concerns that the risks exceed the benefits.
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Vivus’ Qnexa Panel Bodes Well for Arena’s Obesity Drug
Monday, August 30th, 2010
Rockford Coscia submits: This post is a long one but I promise it’s worthwhile for the Arena ( ARNA ) crowd.
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Vanda’s Pipeline Progresses
Sunday, August 29th, 2010
Zacks.com submits: Recently, Vanda Pharmaceuticals Inc. ( VNDA ) announced that it has commenced a late-stage study to evaluate its candidate tasimelteon in patients suffering from non-24-hour sleep wake disorder (N24HSWD). The disorder primarily affects totally blind individuals resulting in abnormal night sleep patterns and chronic daytime sleepiness
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Arena Pharma: Using Options to Trade on FDA’s Decision for Key Obesity Drug
Friday, August 27th, 2010
Joe Kunkle submits: Arena Pharma ( ARNA ) is a Biotech that everyone is watching into the September 16th FDA Panel that will vote on approval of its key obesity drug, Lorcaserin.
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Diabetes Drugs From Takeda, GSK Found to Pose Similar Risks
Friday, August 27th, 2010
The Burrill Report submits: By Michael Fitzhugh People taking Takeda’s ( TKPHF.PK ) Actos or Glaxo’s ( GSK ) Avandia for diabetes face equal heart risks, according to a new study that contradicts earlier reports that suggested Actos was safer. Complete Story
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Somaxon Will Do More Than Just Collect Checks in P&G Deal
Friday, August 27th, 2010
EP Vantage submits: Somaxon Pharmaceuticals ( SOMX ) has finally delivered a deal on Silenor, and it is an unusual one.
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