Adverse Reactions

Enforcement Report. (Source: Food and Drug Administration--Enforcement Report)

MedWorm Message: Register for MedMatcha, MedWorm's medical advertising network, and receive $5 free advertising.

Questcor Pharmaceuticals, Inc. (NASDAQ: QCOR) was a mere 48 hours away from an FDA drug decision for the review of Questcor’s supplemental new drug application for H.P. Acthar® Gel in the treatment of infantile spasms.  The key work now is “WAS” in the reference. The FDA just today informed Questcor that it requires additional time beyond the current action date of September 11, 2010.  During the supplemental new drug application review period, Questcor and the FDA have been updating and modernizing the product label for Acthar, which has not been modified since 1978, when multiple sclerosis was added to the label.  This step of the review process is now complete. Questcor has been notified that the FDA needs some additional time to finalize the wording on the label, ...

Drug Development: Promising skin cancer therapy targets a rogue kinase. (Source: Chemical and Engineering News)

The dismissal would help Sun increase its voting rights in the Israeli generics drug maker to as much as 65% from the 36% it bought in 2007 with an agreement to take control later for Rs 2,116 cr, or $7.75 a share. (Source: The Economic Times Healthcare and Biotech News)

It has emerged this week that UK experts recommended the withdrawal of the diabetes drug rosiglitazone from the British market in July, although this recommendation was not made public at the time.... For complete story visit theheart.org. (Source: theHeart.org)

Immunity to childhood diseases can wane more quickly than in children without the virus, researchers say (Source: The Doctors Lounge - Health News)

MedWorm Message: Register for MedMatcha, MedWorm's medical advertising network, and receive $5 free advertising.

The objective of this study was to assess the evidence for or against the effectiveness of moxibustion as a treatment option for pain. Fourteen electronic databases were searched. Randomized clinical trials (RCTs) testing moxibustion in human patients with pain of any type were considered. Trials using direct or indirect moxibustion were included. Studies comparing moxibustion with other treatments of unproven effectiveness, studies testing moxibustion together with other treatments of unproven efficacy and trials where pain was not a central symptom of the condition were all excluded. The selection of studies, data extraction, and validation were performed independently by two reviewers. Four RCTs met all the inclusion criteria. Others were of poor methodological quality. Two RCTs suggest...

Next-Generation Biotherapeutics Company Will Use Funds to Rapidly Advance Zybody Pipeline GAITHERSBURG, Md., Sept. 8 (HSMN NewsFeed) -- Zyngenia, Inc., a privately held biotherapeutics company focused on next-generation antibody drug development, ann... Biopharmaceuticals, Venture CapitalZyngenia, Zybody (Source: HSMN NewsFeed)

SR One and Biogen Idec New Ventures Join as New Investors SOUTH SAN FRANCISCO, Calif., Sept. 8 (HSMN NewsFeed) -- iPierian, Inc., the leading biopharmaceutical company using patient-derived induced pluripotent stem cells (iPSCs) for drug discovery, ... Biopharmaceuticals, Regenerative Medicine, Venture CapitaliPierian, stem cell (Source: HSMN NewsFeed)

CHICAGO (Reuters) - Drugmaker Wyeth used ghostwriters to play up the benefits and downplay the harm of hormone replacement therapy in articles published in medical journals, a U.S. researcher said on Tuesday. (Source: Reuters: Health)

A health region in Saskatchewan is reporting what appears to be the first human cases of West Nile virus in Canada this summer. (Source: CTV Health)

MedWorm Message: Register for MedMatcha, MedWorm's medical advertising network, and receive $5 free advertising.

Conclusion This large cohort study has established a link between longer use of statins and a reduced risk of rheumatoid arthritis and osteoarthritis. It should be noted that the study compared the incidence of rheumatoid arthritis in people taking different amounts of statins, but did not assess arthritis risk in people who did not use statins. Therefore, this study cannot tell us whether taking the drugs is better at preventing rheumatoid arthritis than taking no statins at all. The study’s design had a number of potential limitations: It is not clear whether the study took into account all possible confounding factors (those linked to the exposure and outcome). One important potential confounder is the cholesterol-lowering action of statin drugs. Lower rates of rheumatoid arthrit...

On a dusty football field in Mathare, one of the largest slums in the Kenyan capital, Nairobi, young boys chase a rough, home-made ball. Their coach, Elias Mwangi, 21, a former drug addict, hopes football will not only keep the boys away from crime but motivate them to avoid behaviours that put them at risk of HIV. (Source: AllAfrica News: HIV-Aids and STDs)

2 out of 5 stars Amlodipine Toxicity in Children Less Than 6 Years of Age: A Dose-Response Analysis Using National Poison Data System Data. Benson BE et al. J Emerg Med August 2010;39:186-193. Abstract The authors analyzed 1251 cases entered into the computerized database of the National Poison Data Collection System as single-agent amlodipine ingestions in children < 6 years of age. The goal was to determine a dose-response relationship for the drug in this population.  On the basis of their data, they conclude (surprise!) that as the dose of amlodipine increases, so do effects.  In addition, they imply that children in this age group who reportedly ingest less than 2.5 mg of amlodipine can be managed at home.Unfortunately, this paper has fatal — even gruesome — methodolo...

Authors: Paravati AJ, Heron DE, Gardner PA, Snyderman C, Ozhasoglu C, Quinn A, Burton SA, Seelman K, Mintz AH Endoscopic endonasal surgery (EES) has been shown to be a feasible approach to cranial base tumors while reducing post-operative morbidity. Using the endoscopic endonasal approach alone or in combination with open approaches may provide advantages over conventional approaches. However, the balance between maximal resection and minimal injury to neurovascular structures frequently precludes gross total resection (GTR). Consequently, adjuvant radiation therapy may be an important option to improve local control (LC) of residual disease. In this retrospective series, we report clinical outcomes, morbidity, and LC of 40 patients with cranial base tumors treated with EES +/- combine...

This article was amended at 18:27 on 8 September 2010Stephen HawkingPhilosophyMathematicsNicholas Blincoeguardian.co.uk © Guardian News & Media Limited 2010 | Use of this content is subject to our Terms & Conditions | More Feeds (Source: Guardian Unlimited Science)

MedWorm Message: Register for MedMatcha, MedWorm's medical advertising network, and receive $5 free advertising.

Ever heard of tea-flavored beverage makers making health claims for their teas which really should only be made for properly brewed tea? It seems the FDA (Food and Drug Administration, USA) has, and is warning both Dr. Pepper Snapple Group about its Canada Dry Sparkling Green Tea Ginger Ale and Unilever Americas over its website claims and labeling for Lipton Green Tea. It accuses them of making unsubstantiated claims, among other things... (Source: Health News from Medical News Today)

The National Clinical Guidelines Centre for Acute and Chronic Conditions have released new guidelines on the early management of unstable angina and non-ST elevation myocardial infarction. British Journal of Cardiology (Source: Medscape Cardiology Headlines)

Shares in ZymoGenetics Inc. soared more than 84 percent in Wednesday trading, one day after the announcement that the Seattle biotech is being bought by drug giant Bristol-Myers Squibb Co. for about $885 million. (BMY) (ZGEN) (Source: bizjournals.com Health Care:Physician Practices headlines)

Shares in ZymoGenetics Inc. soared more than 84 percent in Wednesday trading, one day after the announcement that the Seattle biotech is being bought by drug giant Bristol-Myers Squibb Co. for about $885 million. (BMY) (ZGEN) (Source: bizjournals.com Health Care:Biotechnology headlines)