Hair Care :: Cure for baldness in skin cell injections
Scientists have been celebrating amazing results using skin cells known as fibroblasts to treat burns victims after the method was first used to reduce lines and wrinkles on the face.
Company
Obesity :: Arena obesity drug APD356 proves effective in weight loss
Arena Pharmaceuticals Inc. said its experimental obesity drug was effective in helping patients lose weight in a short-term, mid-stage clinical trial, sending its shares up more than 22 percent.
Breast Cancer :: Breast Cancer study boosts Avastin
Biotech company Genentech Inc. and Swiss drug maker Roche Holding AG said that an interim analysis of clinical trial data showed that cancer treatment Avastin met its primary endpoint of increasing survival rates in breast cancer patients.
Hepatitis :: New treatment for Chronic Hepatitis B
The Food and Drug Administration (FDA) announced the approval of Baraclude (entecavir) tablets and oral solution for the treatment of chronic hepatitis B in adults.
Brain cancer :: Temodar – temozolomide approved for glioblastoma multiforme
The Food and Drug Administration (FDA) has granted approval of a new indication for Temodar (temozolomide). The drug, used concurrently with radiotherapy and as maintenance therapy after radiotherapy, can extend the lives of adult patients newly diagnosed with glioblastoma multiforme (GBM), the most common form of malignant brain cancer.
Smallpox :: New plasma-derived product to treat complications of smallpox vaccin
FDA has approved Vaccinia Immune Globulin Intravenous (VIGIV) — the first intravenous human plasma-derived product available to treat certain rare complications of smallpox vaccination. VIGIV, licensed to DynPort Vaccine Company LLC, in Frederick, Md., is made from the pooled plasma of donors who received booster immunizations with the licensed smallpox vaccine — Dryvax. This plasma contains increased levels of protective antibodies against the vaccinia virus, the live virus used in the currently available smallpox vaccine. The vaccinia virus is similar to the smallpox virus, but does not cause smallpox.
Multiple sclerosis :: Tysabri, a New Drug for MS multiple sclerosis
The Food and Drug Administration (FDA) issued a public health advisory to inform patients and health care providers about the suspended marketing of Tysabri (nataluzimab) while the agency and the manufacturer evaluate two serious adverse events reported with its use.
Leukemia :: Clolar approved for childhood leukemia
Genzyme Corp. announced that its drug Clolar has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of children with difficult or relapsed acute lymphoblastic leukemia (ALL).
Guidance for Generic Drugs
The Food and Drug Administration (FDA) announced that a Guidance for Industry entitled “Listed Drugs, 30-Month Stays, and Approval of ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003: Questions and Answers”.
HIV :: Ranbaxy withdraws all its antiretroviral medicines from WHO prequalificat
Ranbaxy Laboratories Limited India has informed the World Health Organization (WHO) that it is voluntarily withdrawing all its antiretrovirals (all the product dossiers under assessment and all prequalified products) from WHO prequalification. This action was taken after the company found discrepancies in the documentation relating to proof of the products’ bioequivalence with originator medicines. The company has already presented WHO with a plan indicating proposed dates for the submission of new study reports for these products. The first study is expected to be completed by December 2004.