World Pharma/Clinical Trial Regulatory (On Dec. 14)

On Dec. 14, 2012, Pfizer Inc. (PFE) and Ligand Pharmaceuticals Incorporated (LGND) announced that the United States Food and Drug Administration (FDA) accepted for review a New Drug Application (NDA) for bazedoxifene/conjugated estrogens (BZA/CE), a potential new medicine for non-hysterectomized women for the treatment of moderate-to-severe vasomotor symptoms (VMS) and vulvar and vaginal atrophy (VVA) associated with menopause, as well as the prevention of postmenopausal osteoporosis. The FDA Prescription Drug User Fee Act (PDUFA) date is October 3, 2013.

On Dec. 14, 2012, European health regulators recommended Roche's breast cancer drug Perjeta for approval, cementing the company's hopes that the drug will become the standard of care for an aggressive, incurable form of cancer. Roche is hoping that combining Perjeta with its older drug Herceptin will become the standard treatment for women with a form of cancer known as HER2-positive, which makes up about a quarter of all breast cancers and has no cure.

On Dec. 14, 2012, in a boost for struggling Lundbeck, and perhaps for college campuses, the European Union has approved its anti-binge drinking drug Selincro. The approval comes from the European Medicines Agency and is the second piece of good news in as many days for the Danish drugmaker, which has been slashing staff and earnings projections this year as it deals with the patent loss of Lexapro, the antidepressant that was its best-selling drug.

On Dec. 14, 2012, Ariad's planned to launch its maiden commercialization effort took hard shape as the FDA announced that it had approved ponatinib for two types of leukemia. Tapped as a likely blockbuster by a number of analysts, Ariad ($ARIA) gained regulatory approval for the targeted treatment a full three months ahead of its regulatory deadline. 

On Dec. 14, 2012, the U.S. Food and Drug Administration approved Iclusig (ponatinib) to treat adults with chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL).

 

Article Link: World Pharma/Clinical Trial Regulatory (On Dec. 14)