| Boston Scientific Reports Wider Loss Boston Scientific's first-quarter loss widened, and the medical-device maker cut its full-year guidance following a month-long U.S. sales halt for some implantable defibrillators. online.wsj.com |
Congressional Committee Finds J&J Uncooperative: Biotech's Latest Mishaps The Burrill Report submits: Johnson & Johnson (JNJ) has used delaying tactics in its dealings with a Congressional committee looking into the recent recall of children’s Tylenol and other pediatric medicines, the chairman of the committee told The New York Times. Rep. Edolphus Towns, D-New York and chair of the House Committee on Oversight and Government Reform, said in some instances the company has provided misinformation. J&J has denied these allegations. The newspaper said Congressional investigators may turn to subpoenas to force the company to cooperate. Already, the U.S. Food and Drug Administration, which is investigating violations in quality controls behind the recalls, is considering criminal penalties and other actions against McNeil Consumer Healthcare, the J&J unit that produced the drugs. The U.S. Food and Drug Administration has sent a 12-page warning letter to Pfizer (PFE) for failing to quickly notify the agency of serious and unexpected potential side effects from some of its top drugs including Viagra, Lipitor, Lyrica, Reuters reported. The delays date back to 2004 and have grown worse in recent years, the FDA said. The agency told Pfizer it had not properly documented or investigated reported problems in patients after the drugs were approved for use. The agency has requested a meeting with the company to discuss the violations.Complete Story » seekingalpha.com |
When a Heart Risk Runs in the Family Hundreds of thousands of Americans die of sudden cardiac arrest each year, an occurrence that can run in families. Now, genetic testing can help pinpoint the cause of death to save relatives. online.wsj.com |
The Fight for Market Share in Blood Thinners Is On EP Vantage submits:The latest sets of data from the new oral blood thinners, Xarelto and apixaban, presented at the European Society of Cardiology this weekend made pretty good reading for their developers. Efficacy looked solid and safety manageable, if not better than current therapies; exactly what was needed. Financial analysts expect these two agents to be generating almost $5bn by 2016, consensus data from EvaluatePharma shows. Add the similar anticoagulants also in development such as Boehringer Ingelheim’s Pradaxa and Merck & Co’s (MRK) vorapaxar and the potential market is significantly larger. The fight for market share in this high stakes arena could be hard-won. Complete Story » seekingalpha.com |
The Patchwork of Hope Network: Sewing Together Life After Shingles - Video The American Pain Foundation Proclaims Second Annual Postherpetic Neuralgia Awareness Day feedproxy.google.com |