Ironwood Pharmaceuticals Inc. is kicking off twin phase III trials of a specially formulated bile acid sequestrant developed to help people with uncontrolled gastroesophageal reflux disease (GERD) minimize symptoms of the ailment, such as heartburn. The trials will test IW-3718, the lead non-guanylate cyclase-C candidate. If successful, they would provide the evidence needed to seek approval for the medicine, which would be marketed as an adjunct therapy to standard-of-care proton pump inhibitors (PPIs). Read More
Privately held Impel Neuropharma Inc. is looking to thrust its lead asset, INP-104, into the highly competitive migraine therapeutics mix as it embarks on the phase III trial of the drug-device candidate. A successful effort could enable an NDA filing by year-end using the 505(b)(2) pathway. Read More
LONDON - Nodthera Ltd. is primed to take on the notoriously difficult target that is the inflammasome, after discovering a series of NLRP3 inhibitors and closing a £28 million (US$40 million) series A to advance into the clinic. Read More
SHANGHAI – Bristol-Myers Squibb Co.'s Opdivo (nivolumab) has become the first PD-1 inhibitor to be approved for patients in China, in a classic example that China' drug lag is real. Chinese lung patients will have access to the cutting edge immuno-oncology (I-O) therapy four years after it was first approved in the U.S. and after it has been approved in 60 countries. Read More
PERTH, Australia – Australian stem cell therapy company Mesoblast Ltd. said its allogeneic mesenchymal precursor cell therapy showed an overall survival rate of 75 percent compared to an expected 30 percent survival rate in its pediatric phase III trial in acute graft-vs.-host disease (aGVHD) at 100 days. Read More
HONG KONG – Xian Janssen Pharmaceutical Ltd. has launched Simponi (golimumab injection), making it the first once-monthly self-injectable anti-TNF biologic for patients with active ankylosing spondylitis (AS) in China. Read More
Apac Biotech Pvt. Ltd., of Gurgaon, India, signed a technology transfer and licensing agreement with Diakonos Research Ltd., of Houston, to test an immunotherapy that targets and activates the tumor antigen-specific CTL response in phase II trials in India for advanced brain and pancreatic cancers. Terms of the deal weren't disclosed. Read More
Ibio Inc., of New York, which develops plant-based biopharmaceuticals, priced a public offering for expected gross proceeds of about $16 million. The offering consisted of 4.35 million shares of common stock priced at 90 cents apiece, 6,300 shares of series A convertible preferred stock and 5,785 shares of series B convertible preferred stock. Read More
Innate immune system activation appears to be linked to late-onset Alzheimer's disease (AD), which has led to speculation that infections might play a role in AD risk. Now, a team from the Mount Sinai School of Medicine has shown that individuals with AD had high levels of two separate herpes viruses in their brain. Read More
