Experts Confirm Favorable Benefit-risk Profile Of Combined Oral Contraceptives

Leading experts in the fields of gynecology, reproductive endocrinology, hematology and epidemiology have affirmed that for most women the low absolute risks of combined oral contraceptives (COCs) are outweighed by the well-established benefits of hormonal contraception…

Denosumab to Get Quick FDA Action for Bone Mets

The FDA has given priority review status to the RANK ligand inhibitor denosumab (Prolia) to reduce skeletal-related events in cancer patients with bone metastases, drug maker Amgen announced.

New Bevacizumab Data Fails to Support Use in Advanced Breast CA

WASHINGTON (MedPage Today) — Adding bevacizumab (Avastin) to chemotherapy drugs doesn’t increase survival or improve symptoms for women with advanced breast cancer, according to FDA documents posted in advance of an advisory panel meeting on Tuesday.

Washington Week: Rosiglitazone Gets Nod from FDA Panel

WASHINGTON (MedPage Today) — An FDA advisory panel endorsed leaving rosiglitazone (Avandia) on the market, while another advisory panel narrowly voted down a new diet drug.

Denosumab to Get Quick FDA Action for Bone Mets

The FDA has given priority review status to the RANK ligand inhibitor denosumab (Prolia) to reduce skeletal-related events in cancer patients with bone metastases, drug maker Amgen announced.

Pacific Shore releases clinical trial results for Burner Balm lip balm

Pacific Shore Holdings, Inc., today announced the release of the highly anticipated clinical trial results for Burner Balm lip balm. According to lead clinical investigator, Dr. David E. Toomey, who has orchestrated a multitude of clinical trials for some of the top pharmaceutical manufacturers in the United States, “Over a twelve week period, 120 study [...]

Amgen granted FDA priority review designation for denosumab BLA

Amgen today announced that the U.S. Food and Drug Administration (FDA) has granted priority review designation to denosumab, a subcutaneous RANK Ligand inhibitor, for the treatment of bone metastases to reduce skeletal related events (SREs) in patients with cancer.

VIVUS Comments On FDA Advisory Committee Panel Meeting On QNEXA® (phentermine/topiramate) Controlled Release Capsules For The Treatment Of Obesity

VIVUS, Inc. (Nasdaq: VVUS) announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S…

ArmaGen® Re-engineers Erythropoietin For Brain Penetration

Human erythropoietin (EPO) is a potent neuroprotective agent for multiple brain disorders, including stroke, brain and spinal cord injury, and Parkinson’s disease. However, EPO drug development for the brain is limited, because EPO does not cross the blood-brain barrier (BBB)…

Takeda Responds To FDA Advisory Committee Recommendation

The U.S. Food and Drug Administration (FDA) Endocrinologic and Metabolic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee held a joint meeting primarily focused on reviewing the cardiovascular (CV) safety of rosiglitazone, as presented by the FDA and GlaxoSmithKline. Following this two day discussion, Takeda Pharmaceuticals North America, Inc…