At least six weeks ahead of its assigned PDUFA date, Janssen Research & Development LLC's apalutamide has become the first FDA-approved therapy to treat patients with non-metastatic castration-resistant prostate cancer (nmCRPC), those whose disease has quit responding to medical or surgical treatments that lower testosterone but has yet to spread. Read More
In his second week on the job, Health and Human Services (HHS) Secretary Alex Azar got a crash course on why it's easier to imagine changes to 50-year-old U.S. government programs like Medicaid than it is to make them happen. Read More
A mid-stage trial testing the Galmed Pharmaceuticals Ltd. candidate aramchol (arachidyl amido cholanoic acid) over 12 weeks found it made no apparent difference in liver fat for people with HIV-associated lipodystrophy and non-alcoholic fatty liver disease (NAFLD). While company shares (NASDAQ:GLMD) fell by 45.4 percent on the news, Galmed's chief scientific officer, Liat Hayardeny, told BioWorld that substantial differences in the pathogenesis of fatty liver in HIV and non-alcoholic steatohepatitis (NASH) – the focus of another aramchol trial due to read out next quarter – should quell concerns about any potential read-through. Read More
Inadequately concentrated drug may have caused Tetraphase Pharmaceuticals Inc.'s topline phase III blowup with intravenous (I.V.) eravacycline in complicated urinary tract infections (cUTI), and the company said the results bear no read-through to the same compound's value in complicated intra-abdominal infections (cIAI), for which it's under review in the U.S. and Europe. Read More
HONG KONG – Japan's Santen Inc. disclosed positive top line results from the phase I/II study of its carotuximab candidate, DE-122, for the treatment of wet age-related macular degeneration (AMD). Read More
HONG KONG – Talks of China's market for PD-1/PD-L1 antibodies got even more heated after the CFDA issued guidelines for the submission of new drug applications (NDA) for immunotherapy antibodies last week. Read More
A study has identified common genetic variants in the Chinese population contributing to the risk of developing Alzheimer's disease (AD) that possibly exert functional effects through the immune system, which could have important implications for AD management. Read More
Elanix Biotechnologies AG, of Berlin, Germany, a developer of tissue regeneration products and specialty cosmetics in the field of dermatology and gynecology, said it raised €1.125 million (US$1.39 million) from the sale of 300,019 shares at €3.75 each. Read More
Intercept Pharmaceuticals Inc., of New York, reported that it recorded $129.2 million of worldwide net Ocaliva (obeticholic acid) sales for the full year and $37.3 million for the fourth quarter of 2017. Read More
Scythian Biosciences Corp., of Toronto, said it received approval to list its common shares on the Nasdaq Capital Market. The shares will begin trading on Feb. 22 under the ticker SCYB. Read More
Merck & Co. Inc., of Kenilworth, N.J., said it will be stopping protocol 019, also known as the APECS study, a phase III trial evaluating verubecestat (MK-8931), a small molecule inhibitor of the beta-site amyloid precursor protein cleaving enzyme 1 (BACE1), in people with prodromal Alzheimer's disease. Read More
