AstraZeneca’s emerging markets ambitions take on a new dimension as the company today announced an 18-drug, nine-territory branded generics alliance with India’s Torrent Pharmaceuticals.
Advance Life Sciences has reached an agreement with FDA on an approval path for Restanza (cethromycin), but before the novel once-daily antibiotic can reach the market, the company will have to conduct two superiority trials against an approved macrolide in community-acquired bacterial pneumonia. Restanza’s efficacy fell short in the previous set of non-inferiority trials.
FDA reports that it has not found a clear connection between use of bisphosphonates -- osteoporosis drugs including Fosamax, Actonel, Boniva and Reclast -- and risk of bone fractures just below the hip joint. However, the agency says it is continuing to gather additional information on the issue. Two studies reported at the annual meeting of the American Academy of Orthopaedic Surgeons suggest that bisphosphonates may alter the material properties of the bone potentially contribuing to the risk of atypical fractures.
Rep. Maurice Hinchey, D-N.Y., is proposing legislation that would put a choke hold on FDA's relationship with industry and provide the agency with the authority to further curtail direct to consumer advertising.
