Isis Pharmaceuticals Inc. initiated a six-month global phase III study of ISIS-APOCIIIRx, a triglyceride-lowering drug it plans to submit for FDA review in 2016. About 50 patients with the rare genetic condition familial chylomicronemia syndrome (FCS) will participate in the trial, which will measure as its primary endpoint percent change in fasting triglycerides from baseline at 13 weeks. Read More
NEW DELHI – India's Central Drugs Standard Control Organisation (CDSCO) announced plans to set up an online system for submission of information on clinical trials. Read More
HONG KONG – A team of Korean researchers has used gene knockout techniques in mice to gain an improved understanding of the role played by the thalamic reticular nucleus (TRN) in absence seizures, which may lead to the development of effective new treatment methods for that form of epilepsy. Read More
The fact that U.S. markets were preparing to enter the long Labor Day weekend didn't stop two more biotechs from stepping out with initial public offerings (IPOs). Rhythm Pharmaceuticals Inc., which filed its S-1 as Rhythm Holding Co. LLC prior to its expected conversion from a Delaware limited liability to a Delaware corporation and an official name change, is seeking to raise $86.25 million. Read More
Amgen Inc., of Thousand Oaks, Calif. has submitted a biologics license application (BLA) to the FDA for evolocumab, its proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor for the treatment of high cholesterol. Read More
Takeda Pharmaceutical Co. Ltd., of Osaka, Japan, said it completed its postmarketing commitment and submissions of data from a 10-year epidemiology study to regulatory authorities for pioglitazone-containing medicines, including diabetes drug Actos (pioglitazone HCl). Read More
Oncomed Pharmaceuticals Inc., of Redwood City, Calif., said the FDA removed the partial clinical hold on enrollment in the firm's vantictumab (anti-Fzd7, OMP-18R5) phase I trials. Read More
