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Will the FDA rise to the occasion and admit their natalizumab mistake?

When Anita Louise Smith enrolled in an experimental drug trial in 2002 in Colorado, she had a diagnosis of multiple sclerosis but no symptoms and was looking to reduce the chances of being ravaged by the disease.

7 Mar 2006

Pharmaceutical brochures don't always present accurate data

A study published in the journal BMC Family Practice found that three out of twenty promotional brochures studied contained data that was different from the original study on the effects of the drug.

7 Mar 2006

Artificial intelligence addresses the problem of confusing drug names

Was that Xanex or Xanax? Or maybe Zantac? If you're a health care professional you'd better know the difference--mistakes can be fatal.

7 Mar 2006

5,000 rare diseases need drugs, but Europe only approves a handful each year

Only seven per cent of drug applications for treating people with rare diseases were approved in Europe between 2000 and 2004, despite the fact that there are currently more than 5,000 conditions needing medication.

6 Mar 2006

Next-generation drug development: risky and costly, but worth it

Generic drugs, which drive a $40 billion dollar generics industry expected to hit $60 billion by 2007, account for 53% of all prescriptions filled in the United States today.

6 Mar 2006

Topical therapies show promise for Psoriasis

Psoriasis, a chronic skin condition characterized by thick, red, scaly patches that itch and bleed, not only makes the activities of daily life difficult, but also can affect a person's emotional well being.

6 Mar 2006

UCB submits application to FDA for new treatment in Crohn's disease

UCB has announced the submission of a Biologics License Application (BLA) to the United States Food and Drug Administration (FDA) for the approval of CIMZIA (certolizumab pegol, CDP870) for the treatment of patients with Crohn's disease.

6 Mar 2006

FDA grants priority review for Revlimid

Celgene Corporation announced that the U.S. Food and Drug Administration (FDA) has granted a Priority Review designation to its Supplemental New Drug Application (sNDA) for REVLIMID (lenalidomide) for the treatment of relapsed or refractory multiple myeloma.

6 Mar 2006

Study shows Differin Gel works well in combination with systemic or other topical agents

Findings from the M.O.R.E. (Measuring Outcomes in A Real World Experience) Trial presented at the 64th annual meeting of the American Academy of Dermatology (AAD) show that Differin Gel 0.1% is a topical retinoid preparation that, when combined with other acne products, dramatically improves the efficacy of an acne regimen.

6 Mar 2006

FDA gives greenlight for new treatment of head and neck cancer

The U.S. Food and Drug Administration has approved colon cancer drug Erbitux to treat head and neck cancer after results of a large clinical trial showed the drug prolonged survival by 20 months.

5 Mar 2006

Pfizer acquires worldwide rights to Exubera

Pfizer has announced that it has acquired the sanofi-aventis worldwide rights to Exubera (inhaled human insulin). Pfizer received approval last month to market Exubera in the United States and the European Union for the treatment of adults with type 1 and type 2 diabetes.

1 Mar 2006

FDA approves Rituxan (Rituximab)

Rituxan is the first treatment for RA that selectively targets immune cells known as CD20-positive B-cells. Through this unique mechanism of action, Rituxan may affect multiple pathways by which B-cells are believed to contribute to the initiation and development of RA.

1 Mar 2006