Cabazitaxel May Improve Metastatic Prostate Cancer Survival...many more updates.

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Dr.Shruti Bhat, an Expert in Pharmaceutical industry, brings to you some highlights from current pharma and clinical research news, views and data.

Heartburn Drug Renamed To Avoid Medicinal Mix-Ups.
Press reports that, Takeda Pharmaceuticals will change the name of a heartburn drug that has repeatedly been confused by pharmacists with drugs meant to treat cancer and other ailments." The drug, Kapidex (dexlansoprazole), has been mistaken for "Casodex [bicalutamide], a prostate cancer drug, and Kadian [morphine extended-release], a narcotic pain reliever." The newly-named Dexilant will "begin appearing on store shelves in late April 2010.

Cabazitaxel May Improve Metastatic Prostate Cancer Survival.
According to a study presented at the Genitourinary Cancers Symposium, "cosponsored by the American Society for Clinical Oncology (ASCO), the American Society for Radiation Oncology, and the Society of Urologic Oncology," the Sanofi-Aventis prostate cancer drug cabazitaxel "increased survival by 30%...compared with the standard therapy of mitoxantrone" when "used as a second-line therapy" in men with metastatic disease. Researchers found that "men in the cabazitaxel group had a median survival of 15.1 months, compared with 12.7 months for men in the mitoxantrone group." The researchers noted that cabazitaxel's overall survival benefit was "consistent across subgroups."

FDA Approves Mylan Generic Gastrointestinal Drug.
Mylan Pharmaceuticals Inc. has received final Food and Drug Administration approval for 300-milligram Ursodiol capsules, the generic version of Watson Pharmaceutical's gastrointestinal drug Actigall."

Hydroxychloroquine May Help Delay Skin Damage In SLE Patients.
According to a study published in March issue of Arthritis Care & Research, "treatment with hydroxychloroquine (Plaquenil) may help delay the occurrence of skin damage in patients with systemic lupus erythematosus (SLE)." In a study of "580 patients who had not yet developed skin damage at baseline," researchers found that use of hydroxychloroquine "was associated with a longer time until integument damage -- defined as scarring alopecia, extensive skin scarring, and skin ulcers -- was present." Moreover, "the cumulative probability of damage at five years was 5% for those taking hydroxychloroquine, compared with 24% for those who were not on the drug."

FDA Approves Pre-Filled Injection Pens Of Somatropin.
The FDA approved pre-filled injection pens of the endogenous growth hormone disorder drug somatropin (Norditropin) for adult and youth patients." The Norditropin FlexPro "produces an audible click that tells patients the medication has been dispensed," and is a single-use device and does not require reconstitution to administer. The drug is indicated for children who have growth failure attributed to insufficient endogenous growth hormone, short children with Noonan or Turner syndrome, children born short who have not grown enough by two to four years, and adults with growth hormone deficiency due to pituitary disease, hypothalamic disease, surgery, radiation therapy, trauma, or those with childhood-onset growth hormone disorders.

FDA Approves Weekly Immune-Replacement Therapy.
CSL Ltd., the world's second-biggest maker of treatments derived from blood, won US clearance to sell Hizentra (IgPro20), "a weekly immune-replacement therapy for people with genetic disorders that lead to frequent infections." The drug "contains 20 percent immunoglobulin, or antibodies, and is intended as a replacement for CSL's older Vivaglobin product, which contains 16 percent and was previously the only self-administered immune treatment approved in the US." An FDA letter said that the drug Hizentra "did not raise concerns or controversial issues" that would warrant a review by outside advisers.

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