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Worried About a Moody Teen? How can you tell if your moody teenager is just being a teen -- or if you should be concerned that he or she is suffering from mental illness or depression? Elizabeth Bernstein on how to tell the difference. online.wsj.com |
Questcor Pharma: Acthar Approval Seems Likely Sheff Station submits:In the second week in May, the Peripheral and Central Nervous System Drugs Advisory Committee to the FDA held a panel meeting to discuss approval for using Questcor’s (QCOR) Acthar in the treatment of infantile spasms. The meeting went very well as the panel's purpose was to advise the FDA on their opinion of whether or not Acthar should be approved by the FDA for this condition. The vote by panel members was overwhelmingly in favor of an approval for Acthar. What this article will do is discuss the breakdown of the voting and give insight on what can be expected from the FDA on September 11th. Since the panel meeting, the original PDUFA date of June 11 was extended to September 11. The FDA is currently reviewing information regarding labeling, REMS and a potential post-approval commitment that they requested from Questcor. If Questcor obtains FDA approval to add IS to the Acthar label in September, then Questcor expects to launch Acthar, for the treatment of IS, during the Child Neurology Society Annual Meeting on October 4th. An approval of their drug would be the first time that they would be able to promote Acthar for the treatment in infantile spasms. With an approved indication, they can target public education efforts regarding the importance of early diagnosis and effective treatment of IS.Complete Story » seekingalpha.com |
FDA Considers Yanking Abbott's Diet Pill Pharmalot submits: Eight months after their European counterparts told doctors to stop prescribing Abbott Labs’ (ABT) Meridia diet pill, the FDA will now ask an advisory panel meeting this Wednesday whether the drug should be withdrawn from the US market. At issue are cardiovascular risks highlighted in a trial called SCOUT that was released last November, which showed Meridida patients with heart disease had a more than 11 percent risk of cardiovascular risks compared with 10 percent of those on a placebo. Since then, the FDA has been criticized for not moving faster, although the agency had preferred to wait for full results to be issued. And so the advisory committee can now choose among four options: besides recommending withdrawal, the experts can urge continued marketing with the same labeling; continued marketing with revised labeling, such as a black box warning; allow continued marketing, revise the labeling with boxed warnings and limit use; or simply withdraw Meridia from the US market. A recent editorial in The New England Journal of Medicine pushed for withdrawal. “While (Meridia) may improve some cardiac risk factors (e.g. increasing HDL cholesterol), it may have detrimental effect on others (e.g. increasing in blood pressure and pulse rate). No direct evidence supporting that moderate weight loss with (Meridia) reduces cardiovascular morbidity and mortality was found in the published literature. The lack of cardiovascular morbidity and mortality endpoints in obesity trials represents a major gap in knowledge. However, given the modest decrease in body weight associated with sibutramine and the potentially substantial weight regain with discontinuation of therapy, even a small increase in cardiovascular risk seems unwarranted,” writes FDA staffers in briefing documents (pdf).Complete Story » seekingalpha.com |
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