| J&J Had Pattern of Poor Quality Control in Children's Drugs J&J, which has been under fire for recent recalls of over-the-counter medicines, has demonstrated a pattern of poor quality control in manufacturing children's drugs. online.wsj.com |
Meeting Held by Mylan Being Probed The SEC is investigating whether the generic-drug maker disclosed confidential information about coming earnings, allowing participants to snap up shares before a big rally. online.wsj.com |
XOMA Ltd. Q2 2010 Earnings Call Transcript XOMA Ltd. (XOMA)Q2 2010 Earnings CallAugust 10, 2010 4:30 PM ESTComplete Story » seekingalpha.com |
Future of Genzyme / Isis Pharma's Cholesterol Drug Still Up in the Air 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.Nearly half the study population of heterozygous familial hypercholesterolemia (heFH) patients reached LDL-C levels below the standard 100mg/dL threshold, recognized as a goal for patients at an extreme risk of a serious cardiovascular event. However, the issue of raised alanine liver transaminases [ALT] that has dogged the candidate is still giving cause for caution (Safety concerns continue to drag down mipomersen, August 04, 2010). Isis insists the effects are no different to those seen with Lipitor or any other statin-based approach, and that it is not an effect of toxicity, but of mechanism of action. Still, with the companies stating they wish to file as early as the beginning of next year, the outlook for approval remains uncertain. Indeed, the market too remains cautious, with only a meager share price increase for Isis Wednesday.Complete Story » seekingalpha.com |
3 Clear Winners of ESMO 2010 Ohad Hammer submits:The ESMO meeting is the most important oncology conference in Europe. This year in particular, it included very interesting data that affected the sentiment towards many biotech companies. Here, I intend to focus on what I view as three clear winners from the conference: Seattle Genetics (SGEN), Arqule (ARQL) and Dendreon (DNDN). Seattle GeneticsComplete Story » seekingalpha.com |