AbbVie’s investigational JAK1-inhibitor upadacitinib yielded positive top-line results in a Phase III trial as a monotherapy for rheumatoid arthritis patients. But the drug shows that it is still plagued by some safety concerns.
Hutchison China MediTech Limited (“Chi-Med”) (AIM/Nasdaq: HCM) has initiated the United States Phase I bridging clinical trial of fruquintinib. Fruquintinib is a highly selective and potent oral inhibitor of vascular endothelial growth factor receptors (“VEGFR”) 1, 2 and 3, that has met its primary endpoint in several Phase II and III clinical trials in China for the treatment of colorectal, lung and gastric cancers. The clinical study in the U.S. is a multi-center, open-label, Phase I clinical study to evaluate the safety, tolerability and pharmacokinetics of fruquintinib in U.S. patients with advanced solid tumors. The first drug dose was administered earlier this month. Additional details about this study may be found at clinicaltrials.gov, using identifier NCT03251378.
Ionis Pharmaceuticals, Inc. (IONS) announced today that Roche has exercised its option to license IONIS-HTTRx following the completion of a Phase 1/2a randomized, placebo-controlled, dose escalation study of IONIS-HTTRx in people with Huntington's disease (HD). Roche will now be responsible for all development and commercial activities. IONIS-HTTRx is the first therapy in clinical development designed to target the underlying cause of HD by reducing the production of the toxic mutant huntingtin protein (mHTT). In conjunction with the decision to license IONIS-HTTRx, Ionis earned a $45 million license fee from Roche.
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.
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