Shares of Sage Therapeutics have shot up more than 75 percent this morning after the company announced positive topline results for its Phase II treatment for patients with moderate to severe major depressive disorder (MDD).
AstraZeneca today announced positive top-line results of the Phase IV ASCENT trial for Tudorza Pressair (aclidinium bromide 400 μg, twice-daily), a long-acting muscarinic antagonist (LAMA), in patients with moderate to very severe chronic obstructive pulmonary disease (COPD), with a history of cardiovascular disease and/or significant cardiovascular risk factors.
Tokyo-based Astellas Pharma is buying Cambridge, Mass.-based Mitobridge for a total of $390 million. Astellas is pulling the trigger on an acquisition option from a partnership deal the two companies formed in 2013. Under that deal, the two companies collaborated on discovering and developing drugs that target mitochondrial function. The most advanced program from the collaboration is MA-0211, which is presently in Phase I clinical trials for Duchenne muscular dystrophy (DMD). Astellas is an equity investor in Mitobridge already, and is paying $165.5 million in cash in addition to the $60 million in equity it already owns. There is also an additional $225 million in potential milestone payments. John Carroll, with Endpoints News, writes, “For years now, Salk’s Ron Evans—a celebrated serial entrepreneur in scientific circles—has been concentrating on the potential of a new pathway for turning your average couch potato rodent into Mighty Mouse—without exercise…. A couple of ...
The frontrunner in the race to commercialize CGRP migraine medications just picked up some added momentum. Amgen $AMGN has published promising Phase III data that might lend to its approval, keeping the company — and its partner Novartis — ahead of its many competitors in the crowded space.
Codiak intends to use the proceeds of the Series C financing to advance its initial product candidates into clinical trials, and to continue to develop the company's transformational exosome therapeutic platform.
Prometic Life Sciences Inc. (TSX: PLI) (OTCQX: PFSCF) (Prometic) announced positive interim six-month clinical data from its ongoing pivotal IVIG Phase 3 clinical trial in patients suffering from primary immunodeficiencies (PID) following review of the data by the Data Safety Monitoring Board (DSMB), which confirmed no significant safety issues and that efficacy appeared to be comparable to existing commercial IVIG products.
Novartis announced positive topline results from the global MONALEESA-7 trial, the second Phase III trial of Kisqali® (ribociclib) in advanced or metastatic breast cancer. The MONALEESA-7 trial met its primary endpoint of progression-free survival (PFS) in premenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced breast cancer.
Cellectis (Alternext: ALCLS - Nasdaq: CLLS) a clinical-stage biopharmaceutical company focused on developing immunotherapies based on gene-edited allogeneic CAR T-cells (UCART), today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold, previously announced on September 4, 2017, on Phase 1 trials of Cellectis’ UCART123 product candidate in acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cell neoplasm (BPDCN).
In the first randomized controlled trial in pediatric multiple sclerosis, fingolimod (Gilenya) significantly cut relapses compared with interferon beta-1a (Avonex), researchers reported here.
Patient participation in clinical trials for cancer patients has been in decline. Researchers determine the barriers prohibiting participation.
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