April 17, 2010 - FDA Approves New Form of Old Drug For Thrush.
The AP (4/17) and Reuters (4/17, Jacobs) report, development of a new formulation of miconazole (an old, generically available medication) designed to adhere better to oral mucosa for use in adults with oral candida who are greater than age 16.
April 19, 2010 - Hepatitis C Patients Electing To Wait For New Drugs.
Bloomberg News (4/19, Cortez, Kresge) reports that due to tolerability of current treatments, some hepatitis C are waiting for the next wave of treatments expected over the next 18 months.
April 19, 2010 - Gene Mutations May Limit Effectiveness of New Colon Cancer Drug.
Bloomberg News (4/19, Waters) and Reuters (4/19, Fox), report Amgen Inc.'s Vectibix [panitumumab] usefulness may be limited to less than half of colon cancer patients due to various genetic mutations.
April 21, 2010 - FDA Warns Pfizer On Antipsychotic Clinical Trial Involving Children.
A Food and Drug Administration issued warning letter dated April 9 to Pfizer outlined serious violations of protocol in a study of Geodon [ziprasidone] a never antipsychotic medication prescribed to children with “bipolar disorder” symptomatology. Reports were filed by: Bloomberg News (4/21, Larkin), the Wall Street Journal /Dow Jones Newswire (4/21, Dooren), and Reuters (4/21, Heavey). Pfizer is seeking FDA approval of Geodon to treat “bipolar disorder” in patients ranging in age from 10 to 17 years old. This diagnosis is controversial and no standards are established to validate its existence in young children in the 2010 revision of the Diagnostic and Statistical Manual of Psychiatric Disorders.
April 20, 2010 - Failure to Adhere to Clopidogrel Treatment After Cardiac Blood Vessel Stenting May Worsen Risk Of Adverse Outcomes.
“One in six patients who undergo balloon angioplasty to open a clogged artery and who have a stent implanted to keep it open do not fill prescriptions for blood thinners immediately, and their failure to do so doubles their risk of having a subsequent heart attack or dying” as reported by The Los Angeles Times (4/20, Maugh) "Booster Shots" blog. This story was also reported by: WebMD (4/20, Warner), HealthDay (4/20, Edelson), and MedPage Today (4/20, Neale).
April 21, 2010 - Benlysta Fails To Beat Standard Lupus Treatment After 18 Months.
Despite failing to show that their new treatment offered improvement different than standard lupus treatment at 18 months, Human Genome Sciences Inc. and GlaxoSmithKline PLC will continue to pursue licensing approval of this new treatment based on meeting study outcomes at 12 months. Bloomberg News (4/21, Cortez) reported on this story.
