In a feat of both synthetic biology and theranostics, researchers have engineered cells to release anti-inflammatory cytokines in the presence of high levels of both tumor necrosis factor (TNF) and interleukin-22 (IL-22). Read More
Astrazeneca plc expanded its reach in the global respiratory market with a $575 million deal to acquire the core respiratory assets of Takeda Pharmaceutical Co. Ltd. The transaction included the expansion of rights to roflumilast, marketed as Daliresp in the U.S. and Daxas elsewhere, a once-daily oral PDE4 inhibitor approved to treat chronic obstructive pulmonary disease (COPD). Read More
Shares of Array Biopharma Inc. (NASDAQ:ARRY) climbed 20.6 percent to $4.62 on Wednesday following news that its MEK inhibitor, binimetinib, improved progression-free survival (PFS) for patients with advanced NRAS-mutant melanoma compared to chemotherapy during the phase III Nemo study. Read More
Calming FDA qualms by way of trial changes, Advaxis Inc. reached an agreement with regulators to lift the clinical hold on three compounds and Wall Street responded nicely, sending shares (NASDAQ:ADXS) to a closing price Wednesday of $10.92, up $2.62, or 31.5 percent. CEO Daniel O'Connor told BioWorld Today that, after talks with the agency, the firm has agreed to implement risk mitigation measures such as study protocol inclusion/exclusion criteria, post-administration antibiotic treatment and patient surveillance measures, though he declined to go into detail. Read More
Regen Biopharma Inc., of San Diego, said it has identified a series of compounds that interact with the company's newly identified immune checkpoint NR2F6. It is the first of a series of steps in developing small molecules, which the company plans to use as a basis for creating a checkpoint inhibitor pill. Read More
Psioxus Therapeutics Ltd., of Oxford, U.K., said it started a study to test its oncolytic virus candidate, enadenotucirev, in combination with Keytruda (pembrolizumab, Merck & Co. Inc.) in patients with carcinomas. The SPICE (Study of Pembrolizumab In Combination with Enadenotucirev) trial aims to assess the ability of enadenotucirev to reverse resistance to checkpoint inhibitors for certain tumor types, including metastatic colorectal cancer. The trial is expected to run until 2017. Read More
The FDA said it is eliminating the risk evaluation and mitigation strategy (REMS) for rosiglitazone-containing type 2 diabetes drugs, which are sold as Avandia, Avandamet and Avandaryl, by London-based Glaxosmithkline plc. Read More
Sunesis Pharmaceuticals Inc., of South San Francisco, priced underwritten offerings of about 9.5 million shares of its common stock at a price of 84 cents each and 20,200 shares of its nonvoting series B convertible preferred stock at $840 each. Sunesis expects to receive combined gross proceeds of about $25 million from the offerings. Read More
