The New York Times profiles Pashtoon Azfar, the director of Afghanistan's Institute of Health Sciences, who works for a nonprofit group from Johns Hopkins University that focuses on women and children's health, and "also manages to serve as president of the Afghan Midwives Association." Azfar was the "star" of a recent Capitol Hill briefing about maternal health in Afghanistan. Despite Afghanistan having "the world's second-highest death rate in women during pregnancy and childbirth, " at the briefing Azfar "ran through statistics showing notable increases recently in the country's number of midwives, their education and the percentage of women who give birth with the help of a 'skilled attendant, ' usually a midwife.
Three studies published on bmj.com examine the merits of conservative versus aggressive treatment policies of women with low-grade abnormal results detected by cervical screening. Together they form the Trial of Management of Borderline and Other Low-grade Abnormal Smears (TOMBOLA). The first finds no benefit in referring these women for colposcopy (a detailed inspection of the cervix to detect pre-cancerous cells) compared to regular surveillance. A second paper also questions the benefit of immediate treatment to remove abnormal tissue from the cervix (a procedure known as large loop excision) over the more conservative strategy of taking small tissue samples (biopsies) and recalling women for treatment only if pre-cancerous lesions are confirmed.
QuatRx Announces Further Positive Phase 3 Results For Ophena TM Ospemifene Tablets In Postmenopausal Vaginal Atrophy
QuatRx Pharmaceuticals Company, a privately-held biopharmaceutical company, announced positive top-line efficacy results from the first of two patient cohorts in its second pivotal Phase 3 trial of the investigational compound, Ophena(TM) (ospemifene tablets), for the treatment of postmenopausal vulvovaginal atrophy (VVA). The Company has also successfully completed two long term safety extension studies from its first pivotal Phase 3 studies. QuatRx intends to use these results in support of a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) in early 2010 seeking approval for Ophena(TM), a new SERM (selective estrogen receptor modulator) for the treatment of the symptoms of vulvovaginal atrophy.
Elagolix Successful In Six Month Lilac Petal Study; Safety And Efficacy Confirmed In Patients With Endometriosis
Neurocrine Biosciences, Inc. (Nasdaq: NBIX) announced new six month safety and efficacy results from its fourth Phase II clinical trial using its proprietary, orally-active non-peptide Gonadotropin-Releasing Hormone (GnRH) receptor antagonist, elagolix, in patients with endometriosis. Consistent with previously reported six month (Petal Study) and three month (Lilac Petal Study) results, a favorable safety profile and clinically meaningful efficacy have again been confirmed through month six of the Lilac Petal Study. This newly available data also provides clinical confirmation of Neurocrine's extensive pharmacologic modeling related to the elagolix dose-response continuum.
The Senate Judiciary Committee 's approval on Tuesday of Supreme Court nominee Sonia Sotomayor "cleared the way" for a vote next week in the full Senate, where she is expected to be confirmed, the New York Times reports. The committee's 12 Democrats voted in favor of Sotomayor, with one Republican -- Sen. Lindsey Graham (S.C.) -- joining them in the 13-6 vote (Lewis, New York Times, 7/28). According to Roll Call, Sotomayor's confirmation is not in doubt, as members of both parties have predicted as many as 70 votes in her favor. So far, five GOP senators have said they will support the nomination, including Graham, Susan Collins (Maine), Richard Lugar (Ind.
A US study published online ahead of print in a leading medical journal suggests that complications from H1N1 swine flu could hit pregnant women harder, and that pregnant women infected with the virus are hospitalized at four times the rate of infected people in the general population. The authors recommend that pregnant women infected with swine flu should start antiviral treatment straight away, and those that are healthy should receive the vaccine as soon as it becomes available. The article, which appeared as an online first issue on 29 July in The Lancet is written by Dr Denise J Jamieson, of the Division of Reproductive Health, at the US Centers for Disease Control and Prevention (CDC), in Atlanta, Georgia, and colleagues.