News Category: Health & Medical

– Companion diagnostic would be used following potential regulatory approval of entospletinib to screen for NPM1 mutation present in approximately one-third of all patients with AML – Entospletinib is currently being studied in the Phase 3 AGILITY registrational study, with data anticipated in second half of 2023 Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated … Continued

Elacestrant, if approved, would be the first oral selective estrogen receptor degrader (SERD) to be available for patients suffering from 2L and 3L ER+/HER2- advanced or metastatic breast cancer Submission supported by results from the pivotal Phase 3 EMERALD study of elacestrant showing statistically significant efficacy over current standard-of-care (SOC) medications for both the overall … Continued

SELUTION SLR™, MedAlliance’s novel sirolimus-eluting balloon, has received conditional FDA Investigational Device Exemption (IDE) approval to initiate its pivotal clinical trial for the treatment of occlusive disease of the superficial femoral artery (SFA). This comes only a few months after the company received IDE approval for SELUTION SLR in the treatment of below-the-knee (BTK) indications … Continued

Novaliq, a biopharmaceutical company focusing on first- and best-in-class ocular therapeutics based on the unique EyeSol(R) water-free technology, today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for CyclASol(R) (cyclosporine ophthalmic solution), a proposed novel treatment for the signs and symptoms of dry eye … Continued

– FB2001 (Bofutrelvir) is a Coronavirus Mpro inhibitor, which exhibited potent anti-SARS-CoV-2 activity in vitro and in vivo – Phase 1 results show FB2001 to be generally safe and well tolerated. No significant difference was observed between Chinese and American populations. Single-agent antiviral concentrations have been reached in the blood plasma and lung tissues without … Continued

New research reported at the Alzheimer’s Association International Conference(R) ( https://aaic.alz.org/overview.asp ) (AAIC(R)) 2022 covered the breadth of Alzheimer’s and dementia research, including the basic biology of aging and the brain, risk factors and prevention strategies, and caregiving and living well with the disease. Logo – https://mma.prnewswire.com/media/1869584/AAIC22_purple_font_rgb_Logo.jpg AAIC is the premier annual forum for presentation … Continued

Experiences of high blood pressure disorders during pregnancy are associated with an increased risk of vascular dementia and accelerated brain aging, according to studies reported today at the Alzheimer’s Association International Conference(R)) (AAIC(R)) 2022 ( https://c212.net/c/link/?t=0&l=en&o=3611257-1&h=4085809890&u=https%3A%2F%2Fwww.alz.org%2Faaic&a=Alzheimer%27s+Association+International+Conference ) in San Diego and virtually. Photo – https://mma.prnewswire.com/media/1871394/AAIC_Vascular_Dementia.jpg Logo – https://mma.prnewswire.com/media/1869584/AAIC22_purple_font_rgb_Logo.jpg Hypertensive disorders of pregnancy (HDP) — conditions … Continued

EMA accelerated assessment allows a shorter review period for leniolisib from a standard 210 days to 150 days Pharming is on track to submit its Marketing Authorisation Application for leniolisib in H2 2022 Pharming Group N.V. (“Pharming” or “the Company”) (EURONEXT Amsterdam: PHARM) (Nasdaq: PHAR) announces that the European Medicines Agency’s (EMA) Committee for Medicinal Products for … Continued

Socioeconomic deprivation, including neighborhood disadvantages and persistent low wages, are associated with higher dementia risk, lower cognitive performance and faster memory decline, according to several studies reported today at the Alzheimer’s Association International Conference(R) (AAIC(R)) 2022 ( https://c212.net/c/link/?t=0&l=en&o=3608645-1&h=3881122162&u=https%3A%2F%2Fwww.alz.org%2Faaic&a=Alzheimer%27s+Association+International+Conference ) in San Diego and virtually. Socioeconomic status (SES) — reflecting both social and economic measures of … Continued

Preclinical data support the potential of ONA-XR plus estrogen receptor degraders in endocrine resistant disease models Context to initiate Phase 1b/2 clinical trial in Q4 2022 Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a women’s oncology company developing small molecule and immunotherapy treatments for breast and gynecological cancers, and The Menarini Group (“Menarini”) today … Continued