The Ebola epidemic continues unchecked for the time being. The World Health Organization reported on Monday that the death toll as of Friday, Aug. 1, stood at 887, with Nigeria reporting its first death from the current outbreak. Read More
Investor jitters about cardiac side effects were quelled and full approval chances bolstered by interim phase III data from Amgen Inc.'s trial testing the second-generation proteasome inhibitor Kyprolis (carfilzomib) when combined with Revlimid (lenalidomide, Celgene Corp.) and low-dose dexamethasone against relapsed multiple myeloma (MM). Read More
Specialty pharma Tesorx Pharma LLC looked to muscle in on the testosterone market by closing a $10 million series B-1 funding from existing and new private investors to prepare for phase III trials of lead compound TSX-002, a first-in-class oral formulation of unmodified testosterone, and to build out its commercial manufacturing facilities to scale up for the pivotal trial and commercial production. Read More
HONG KONG – A small Chinese biopharmaceutical company expects that the support and resources of a traditional Chinese medicine (TCM)and active pharmaceutical ingredients manufacturer will help it develop a stronger biologics pipeline. Read More
On the heels of a letter from five senators urging the FDA and Health and Human Services (HHS) to issue guidance to speed biosimilar development, the agency released a draft guidance Monday to make it easier to determine the date of first licensure of the reference biologic. Read More
Roche AG is deepening its investment in the attractive but challenging field of RNA-targeting antisense therapies by acquiring Santaris Pharma A/S, one of its two partners in the space, for $250 million up front plus an additional $200 million should Santaris meet pre-determined milestones. Read More
Galectin Therapeutics Inc. shares (NASDAQ:GALT) fell 6.3 percent to close at $5.33 Monday, as the company revealed a class action lawsuit filed against it alleging that it paid promoters to issue misleading statements about the company's prospects. Read More
strong>Baxter International Inc., of Deerfield, Ill., said the FDA approved Flexbumin (Albumin [Human]) USP, 5 percent solution for hypovolemia, hypoalbuminemia due to general causes, burns and in patients undergoing cardiopulmonary bypass surgery. Read More
Neuralstem Inc., of Germantown, Md., said the last patient was treated in its phase II trial using NSI-566 spinal cord-derived neural stem cells to treat amyotrophic lateral sclerosis. Read More
