| FDA Ties Tylenol Recall to Contamination Raw materials used to make several lots of children's and infant Tylenol products were contaminated, the FDA said. online.wsj.com |
ERT Industry Poll and Sponsor Endorsement Confirms eC-SSRS is an Effective Method of Suicidality Monitoring in Clinical Trials (PR Newswire) ERT , Â a leading provider of centralized services to global pharmaceutical, biotechnology and medical device companies, announces that a recent survey of over 250 respondents reported that all clinicians polled found the Columbia Suicide Severity Rating Scale to be an effective method for prospectively monitoring suicidality. us.rd.yahoo.com |
Safety Concerns Narrow Potential for Valuable Pfizer Pipeline Candidate EP Vantage submits:As the expiry of Pfizer’s (PFE) precious Lipitor patent looms ever closer, the company has suffered yet another setback in its bid to cover the impending gap, with news last week of further clinical trial suspensions within its phase III programme for tanezumab (PF-4383119), this time in lower back pain and diabetic neuropathy. The FDA cited the same safety concerns that led to the previous suspension of phase III osteoarthritis (OA) trials, where some patients experienced exacerbation of the disease. Now, only cancer-associated pain remains as an active development line for what had been hailed as a potential blockbuster. The unsteady future for tanezumab is reflected in its adjusted sales forecasts, and other big pharma players with similarly classed antibodies will be just as keen to hear the outcome of the FDA and Pfizer’s ongoing investigations.Complete Story » seekingalpha.com |
Is This the Top of the Trading Range or Start of a Breakout? Michael Kudrna submits: Monday saw another gap-up followed by dip-buyers showing up to lead us toward a strong close. Volume was decent for this seasonal slow time with this making four straight positive closes in the S&P 500 and eight out of nine positive closes during this rally. Technically speaking, we are overbought but don’t tell that to the bulls right now as the momentum is impressive. The problem I see is nobody fears the downside anymore and that tells me we could be nearing a top. However, if retail numbers meet or beat expectations Tuesday morning, we could see another strong gap-up and even more bullish behavior while ignoring any other economic fears.Complete Story » seekingalpha.com |
Varian Medical-IMRIS Deal Could Yield Better Radiation Treatments Varian Medical Systems (NYSE:VAR) and IMRIS said Tuesday they have agreed to co-develop a new MR-guided radiation therapy system for use in treating a number of cancers with increased accuracy. Under the terms of the agreement, the two companies will develop a system that combines IMRIS' MR imaging technology with Varian's recently introduced TrueBeam system, to allow for the use of magnetic resonance imaging (MRI) during radiotherapy treatments for cancer.Complete Story » seekingalpha.com |