Washington Week: Stem Cells and Diet Pills

WASHINGTON (MedPage Today) — Congress is back from summer recess, and, as promised, a Senate panel made a hearing of embryonic stem cell research its first order of business. Meanwhile, the FDA held three advisory committee hearings this week, handing down recommendations on cough syrup and diet drugs.

Traces of CA Drug Prompts Muscle Builder Recall

WASHINGTON (MedPage Today) — Makers of the supplement ArimaDex — advertised to boost testosterone and build lean muscle mass — voluntarily recalled the product after traces of an aromatase inhibitor used in the treatment of breast cancer was found in an FDA analysis.

FDA Suggests Afib Drug Okay Even Before Vote

WASHINGTON (MedPage Today) — An FDA advisory panel will vote Monday on whether to recommend approval of the investigational anticoagulant dabigatran to prevent stroke in patients with atrial fibrillation.

FDA Says It Will Review Pioglitazone Safety

WASHINGTON (MedPage Today) — The FDA is investigating a possible link between pioglitazone (Actos) and bladder cancer, and, as a result, both of the available thiazolidinediones — pioglitazone and rosiglitazone (Avandia) — are undergoing FDA safety reviews.

Traces of CA Drug Prompts Muscle Builder Recall

WASHINGTON (MedPage Today) — Makers of the supplement ArimaDex — advertised to boost testosterone and build lean muscle mass — voluntarily recalled the product after traces of an aromatase inhibitor used in the treatment of breast cancer was found in an FDA analysis.

FDA Suggests Afib Drug Okay Even Before Vote

WASHINGTON (MedPage Today) — An FDA advisory panel will vote Monday on whether to recommend approval of the investigational anticoagulant dabigatran to prevent stroke in patients with atrial fibrillation.

ONS trial results show promise for treating medically refractory chronic migraines: ONSTIM study

Medtronic, Inc. announced that data from a multicenter, prospective, randomized, blinded, feasibility trial published today show promise for occipital nerve stimulation for treating medically refractory chronic migraines and support the need for further controlled study of the treatment. The study, called Occipital Nerve Stimulation for the Treatment of Intractable Migraine, included severely debilitated patients who [...]

Emisphere’s SNAC drug successful in reducing food intake; increasing satiety

Emisphere Technologies, Inc. today announced that a clinical study found that the company’s proprietary oral SNAC (Sodium N-[8-(2-hydroxybenzoyl) Amino] Caprylate (”SNAC”) additive, in combination with two digestive hormones, was successful in reducing food intake and increasing satiety in healthy male subjects.

Minocycline plus N-acetylcysteine may help treat TBI

Traumatic brain injury (TBI) is a serious public health problem in the United States. Recent data show that approximately 1.7 million people sustain a traumatic brain injury annually. While the majority of TBIs are concussions or other mild forms, traumatic brain injuries contribute to a substantial number of deaths and cases of permanent disability.

Boehringer Ingelheim commences afatinib Phase III clinical trial in advanced breast cancer

Boehringer Ingelheim today announced the initiation of a phase III clinical trial to investigate one of its most advanced oncology pipeline compounds, afatinib, for the treatment of patients with advanced (metastatic) breast cancer. Afatinib is an oral compound (taken as a tablet), which is a next generation, targeted therapy, that irreversibly inhibits both, the epidermal [...]