| J&J Announces Drug Recall: Biotech's Latest Business Mishaps The Burrill Report submits: Johnson & Johnson’s (JNJ) McNeil Consumer Healthcare Unit announced a voluntary recall of certain over-the-counter infants’ and children’s liquid medicines because of problems with quality. The company said the recall is not being pursued because of adverse medical events, but instead as a precautionary measure. Some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles. The affected products include children’s Tylenol, Motrin, Zyrtec and Benedry. While the company said the potential for serious medical events is remote, it advised consumers who have purchased these recalled products to discontinue use. The company also said it temporarily suspended production at its Fort Washington, Pennsylvania plant where problems were observed. Bristol-Myers Squibb (BMY) said that the U.S. Food and Drug Administration notified it that it would not approve its Biologics License Application for belatacept in kidney transplantation without additional data. The agency did not ask for additional clinical studies but wanted the 36-month data from the ongoing late-stage studies to further evaluate the long-term effect of belatacept. The company said it will work with the FDA to provide the data as soon as they are available. The Biologics License Application submitted for belatacept included 24-month data from the phase 3 studies. Other requests raised in the letter primarily relate to information to support the manufacturing of belatacept and the proposed risk evaluation and mitigation strategy. Complete Story » seekingalpha.com |
NeoGenomics Provides Early Look at Second Quarter Results (PR Newswire) NeoGenomics, Inc. announced today that it expects to report second quarter revenue of approximately $8.5 million and a net loss of approximately – per share.  Revenues and test volumes increased by approximately 14% and 28%, respectively, compared to last year's second quarter.  These comparisons are impacted by the previously disclosed internalization of certain bladder cancer FISH testing by the Company's largest customer beginning in June 2009.  Excluding this one account, revenues and test volumes grew by approximately 23% and 39%, respectively, versus last year.  Revenue growth in the second quarter was also adversely impacted by further declines in average unit pricing, expanded efforts by large insurance companies to reduce testing and payments to "out-of-network" laboratories, and the overall challenging economy and its corresponding impact on sales force productivity. us.rd.yahoo.com |
Cord Blood America Details Six Months of Success (PR Newswire) Cord Blood America, Inc. , the umbilical cord blood stem cell preservation company focused on bringing the life saving potential of stem cells, a biological insurance policy, to families nationwide and internationally, today announced highlights for the six-month period ended June 30, 2010. us.rd.yahoo.com |
Lawmakers to Question Egg-Farm Executives Lawmakers on Wednesday will question executives from the companies involved in the summer egg recall, while consumer advocates lobby for tougher food-safety regulations. online.wsj.com |
Study Points to New Prostate Drug Researchers report that the drug abiraterone extended survival by an average of 3.9 months among men with cancer that has spread beyond the prostate and for whom other treatments have failed. online.wsj.com |