Omeros Corp. suspended a phase II dose-escalation study of its phosphodiesterase 10 (PDE10) inhibitor, OMS824, in Huntington's disease (HD) over FDA concern about higher-than-expected blood levels of the drug in a concurrent rat study, sending shares in the Seattle company (NASDAQ:OMER) down 12.3 percent to close at $12.12 Tuesday. Read More
Some biopharmas are beginning to view the tumultuous public markets with a wary eye. Infectious disease specialist Viamet Pharmaceuticals Holdings LLC, which filed in July for a $75 million initial public offering (IPO), is looking through the rearview mirror after filing Monday to withdraw its registration statement. Read More
Not even the Federal Circuit can agree on whether it set a new standard for obviousness when it tossed a patent for Bristol-Myers Squibb Co.'s (BMS) hepatitis B drug. Read More
LONDON – New drugs that will help boost the density of bone in conditions such as osteoporosis could be developed as a result of a new understanding of how bone cells interact with each other. Researchers working in Germany have established how the hormone calcitonin regulates bone remodeling via a receptor found on bone cells. Read More
With cell therapy showing more promise lately, Unum Therapeutics Inc.'s series A funding will help advance its platform for cancer treatment based on an antibody-coupled T-cell receptor (ACTR), in which T cells are genetically programmed so that they can go after a variety of cancers via targeting antibodies, and are not restricted by a particular antigen. Read More
TOKYO – Alexion Pharmaceuticals Inc. is looking for Japanese approval for its drug, asfotase alfa, to treat patients suffering from hypophosphatasia (HPP), an ultra-rare genetic bone disorder. Read More
SUZHOU, China – It might be a leadership retreat with golf and sightseeing on the agenda but that only comes after a day of rolling up sleeves and putting heads together to dig into the task of making China a better place for the life sciences industry. Read More
Pluristem Therapeutics Inc., of Haifa, Israel, completed development of its second major production line, enabling it to begin manufacturing a second cell product, PLX-RAD, for planned studies in a range of hematologic conditions. Read More
Boehringer Ingelheim GmbH, of Ingelheim, Germany, and Eli Lilly and Co., of Indianapolis, said the FDA accepted for filing the new drug application for the SGLT2 inhibitor empagliflozin plus immediate-release metformin hydrochloride fixed-dose combination. Read More
Athera Biotechnologies AB, of Stockholm, a Karolinska development company, said it dosed the first healthy volunteers in its phase I study of PC-mAb, a fully human antibody intended to treat patients with cardiovascular disease who are at increased risk of secondary events and death. Read More
Takeda Pharaceutical Co. Ltd., of Osaka, Japan, and Sunovion Pharmaceuticals Inc., of Marlborough, Mass., reported data from several studies at the European College of Neuropsychopharmacology meeting in Berlin, including data showing that the use of Latuda (lurasidone), an atypical antipsychotic for adults with schizophrenia, reduced the risk of patients developing metabolic syndrome in a long-term study. Read More
