Clarient to Present at Three Investor Conferences in May (PR Newswire)
Clarient, Inc. , a premier technology and services resource for pathologists, oncologists and the pharmaceutical industry, today announced that the company is scheduled to make investor presentations at three investor conferences in the month of May. us.rd.yahoo.com |
FDA Questions Safety of 'Female Viagra'
The Food and Drug Administration questioned the effectiveness of a proposed drug for treating low-sex drive in women and raised concerns about how safe the pill would be if used widely. online.wsj.com |
Vivus's Qnexa Gets Thumbs Down From Mixed FDA Panel
Ruthanne Williams Roussel submits:As many will know by now, an FDA briefing panel July 15 recommended against approval of Vivus' (VVUS) obesity drug candidate Qnexa by a vote of 10 to 6. This was originally announced as a vote of 9 to 7, but a new electronic voting system was in use, and it must have been a little confusing, because one panelist later claimed that they had unintentionally voted "Yes" for approval instead of "No" against. (Insert "Jim, I'm a doctor, not an electronic voter!" joke here.) The main concerns cited about Qnexa were:Complete Story » seekingalpha.com |
Investment Opportunities in AML Frontline Therapies
Michael Becker submits:Acute myelogenous leukemia [AML] is a fast-growing cancer of the blood and bone marrow. Unformed cells called myeloblasts, or “blasts,” reside in the bone marrow and normally become a particular kind of cell - a white blood cell, red blood cell, or platelet. In AML, abnormal blasts produce white blood cells that do not function properly. They do not fight infections and, as they build up, they inhibit the production of normal white blood cells, red blood cells, and platelets that the body needs.Standard frontline therapy for AML patients under the age of 60 consists of cytarabine [AraC] combined with an anthracycline [such as daunorubicin or idarubicin] in what is commonly referred to as the 7+3 regimen. While 45% of elderly patients with AML [70+ years old] achieved a complete response [CR] using this regimen, there was no improvement in overall survival and more than a third of patients died within the first eight weeks of treatment according to a recent study published in the journal Blood[i]. This is consistent with the CR rates of 40%–60% with conventional chemotherapy and disease-free survival of less than 20% at three years referenced in the literature[ii].Complete Story » seekingalpha.com |
Hospira Receives Australian Approval for Nivestim
Zacks.com submits: Hospira, Inc.’s (HSP) biosimilar portfolio received a boost when the Australian Therapeutic Goods Administration (TGA) approved its biosimilar filgrastim product, Nivestim. Nivestim received approval for multiple indications such as the prevention of febrile neutropenia and reduction in the duration of neutropenias induced by chemotherapy. Neutropenia refers to the most serious version of hematological toxicity that occurs due to chemotherapy. Moreover, neutropenia could result in reductions in doses of chemotherapy coupled with dose delays compared to the prescribed schedule.Complete Story » seekingalpha.com |