Difficulty in obtaining an accurate diagnosis and treatment for endometriosis leaves many women spitting mad, but they may soon find that saliva is the key to escaping the diagnostic maze. A recent study published in the New England Journal of Medicine validated the Endotest developed by Ziwig SAS based on results from a study involving 200 symptomatic patients monitored in five hospital units and specialized centers in France since November 2021. The findings demonstrateda sensitivity and specificity of more than 95%.
A new study from Dana Farber Cancer Institute, Brigham and Women’s Hospital and Poland’s Medical University of Lodz suggests a simple blood test could detect ovarian and breast cancer without the need for genetic sequencing, paving the way for broader and less costly screening campaigns.
A new study has shown that a uterine bacterium is one cause of endometriosis and that preventing the infection could prevent development of the pathology, in which tissue similar to the lining of the uterus grows in the abdominal cavity.
The U.S. FDA has approved a non-hormonal treatment from Astellas Pharma Inc. to reduce the number and severity of hot flashes. Veozah (fezolinetant), an oral, once-daily compound that targets the neurokinin-3 (NK3) receptor, is approved for treating moderate to severe vasomotor symptoms due to menopause. It’s the first NK3 receptor antagonist the FDA has greenlighted for the indication. The approval came on May 12, well before its May 22 PDUFA date. The PDUFA date was originally set for Feb. 22 but the FDA extended it, saying it needed more time to complete the NDA’s priority review. Veozah’s wholesale acquisition cost is $550 for a month’s supply and should be available by early June.
The U.S. FDA has approved a non-hormonal treatment from Astellas Pharma Inc. to reduce the number and severity of hot flashes. Veozah (fezolinetant), an oral, once-daily compound that targets the neurokinin-3 (NK3) receptor, is approved for treating moderate to severe vasomotor symptoms due to menopause. It’s the first NK3 receptor antagonist the FDA has greenlighted for the indication. The approval came on May 12, well before its May 22 PDUFA date. The PDUFA date was originally set for Feb. 22 but the FDA extended it, saying it needed more time to complete the NDA’s priority review. Veozah’s wholesale acquisition cost is $550 for a month’s supply and should be available by early June.
As it struggles to launch a recently approved drug, Acer Therapeutics Inc. hit pause in its ACER-801 (osanetant) program after top-line data in the phase IIa proof-of-concept study failed to hit statistical significance.
Astellas Pharma Inc.’s fezolinetant met all four co-primary endpoints in the pivotal phase III SKYLIGHT 1 study for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. An oral, nonhormonal compound, fezolinetant targets the neurokinin 3 receptor to reduce the frequency and severity of moderate to severe VMS, or hot flashes, due to menopause.
A multi-institutional team of researchers has reported the development of an anti-IL-8 antibody against endometriosis using recycling antibody engineering technology. The study confirmed the role of the inflammatory cytokine IL-8 in the development of inflammation and fibrosis in endometriosis and showed that administration of IL-8 antibodies in primate models improved endometriosis pathology.
Feeling “ashamed” of having to use metal flesh-piercing forceps to stabilize the cervix during the insertion of intrauterine contraceptive devices, David Finci a gynecologist and co-founder of Aspivix SA, turned to his brother Julien, a medical device engineer, for his thoughts on how to design a more suitable instrument.
Woebot Labs Inc. posted uplifting news for women who have suffered from baby blues and their big brother, post-partum depression. The company recently enrolled the first patient in its pivotal trial of WB001, a digital therapeutic for post-partum depression (PPD). WB001 received U.S. FDA breakthrough device designation in 2021, indicating the acute need for accessible treatment for the common condition.