Today’s Top Three in Pharma 060109

Novartis‘ Reclast gets approval for osteoporosis prevention in post-menopausal women – Reclast® (zoledronic acid 5 mg) Injection[*] has been approved by the US Food and Drug Administration (FDA) as the first and only therapy to prevent postmenopausal osteoporosis for two years with a single dose[1]. Reclast, or Aclasta® as it is known outside the US, is already approved in more than 80 countries including the US and EU as a once-yearly infusion for the treatment of postmenopausal osteoporosis. The FDA decision is based on a study involving more than 500 postmenopausal women with osteopenia, or low bone mass, showing that a single infusion of Reclast significantly increased bone mineral density (BMD) at two years compared to placebo…more

J&J‘s Simponi – recent launch darkened by “Dear Doctor” letter – Johnson & Johnson’s Simponi, its successor to Remicade, is off to a bad start: The FDA issued a “Dear Doctor” letter noting that it might kill you if your doc doesn’t know what he’s doing. “Serious fungal infections” are associated with Simponi, the letter states, and if they go unrecognized it can result in death…more

Arzerra (for CLL) gets thumbs-up from FDA review panel – GlaxoSmithKline [NYSE: GSK] and Genmab A/S [OMX: GEN] today announced that the United States Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 10 to three that the ARZERRA(TM) (ofatumumab) data are reasonably likely to predict clinical benefit for patients with chronic lymphocytic leukemia (CLL) whose disease is refractory to fludarabine and alemtuzumab. Ofatumumab is an investigational treatment…more

PLUS – Silver nanoparticles as anti-thrombotic treatment?