| FDA Considers Action Against J&J The FDA is considering "additional enforcement actions" that might include criminal penalties against the Johnson & Johnson unit that makes Tylenol. online.wsj.com |
Curis Plunges on Failed Trial, Better News May Come by Year's End Jason Chew submits: Curis (CRIS) released results Wednesday for its hedghog pathway inhibitor GDC-0449 in a pivotal Phase II colorectal trial run by Roche (RHHBY.PK). The company said its drug failed to extend the time of disease progression or death in patients with metastatic colorectal cancer. Curis stock plunged from Tuesday's close of $3.26 to $1.69, a 48% drop.This reaction is more akin to that of the failure of a drug. This is not the case. GDC-0449 has only failed a single indication in a complex multi-drug combo trial. This does not predict failure in the 18 other trials for this drug, where it has shown much promise in a broad range of indications including basal cell carcinoma, childhood medulloblastoma, and ovarian cancer. Cancer is not a single disease, it is very heterogeneous, where each indication may be driven by different or multiple mechanisms. One drug will not be effective for all indications.Complete Story » seekingalpha.com |
J&J Borrows at Record-Low Rates Johnson & Johnson sold $1.1 billion of bonds at the lowest rates ever for 10-year and 30-year corporate debt securities, illustrating how eager investors are to buy corporate bonds at a time of record-low yields on government debt. online.wsj.com |
Arena's Lorcaserin: Weighed Down by Qnexa and Meridia Joseph Krueger submits: Before the FDA review panel’s of Vivus’s (VVUS) drug Qnexa, I expressed significant doubt that the panel review would be positive based primarily on the safety issues surrounding one of its ingredients topiramate here. The safety issues had to do with contraindications between topiramate itself as well as contraindications with the other ingredient phenteramine. I made the following statements:With so many contraindications and side effects of phentermine and topiramate, who can safely use Qnexa? Given the FDA’s historic stance on the safety of weight loss drugs, and the long list of potential safety issues with phentermine and topiramate, is it likely that the FDA will allow its marketing?I concluded (accurately) that Qnexa efficacy was never in question, and that these safety concerns would be the outstanding issues that would prevent Qnexa approval (PDUFA date is Oct 28, 2010). After the review panel vote, it appears that the only hope for Qnexa approval in October is that the FDA feels the safety risks are worth the clear weight loss benefit.Finally, I finished up this discussion with this statement: Investors should also consider the effects of any VVUS events could have on other companies developing obesity drugs. The outcome of the Qnexa panel review will have an impact on the trading of Orexigen (OREX) and Arena Pharmaceuticals (ARNA) obesity drugs up for review before the end of the year. In this brief analysis, I compared Orexigen's (OREX) Contrave to Arena’s (ARNA) Lorcaserin and hypothesized how the Qnexa panel could affect the share prices of OREX and ARNA. I stated: Between these three drugs, Qnexa is perhaps the most effective but also by far the one facing the most potential safety concerns. A favorable review for Qnexa is logically likely to rally VVUS but also OREX and especially ARNA stocks as it would demonstrate the review panel’s willingness to endorse an effective weight loss drug even in the face of potential side effects. An unfavorable Qnexa review is logically likely to cause a short term gut-response sell off in both of these stocks. However, a little further out I would expect ARNA not to recover (due to the safety concerns) but a rally in OREX could occur (due to its strong efficacy and very safe profile) as it demonstrates a continued concern over safety, and the elimination of its competitors.Complete Story » seekingalpha.com |
ICON Announces Appointment of Cathrin Petty to Board of Directors [Business Wire] - ICON plc, , a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced the appointment of Cathrin Petty as a non-executive Director. us.rd.yahoo.com |