SHANGHAI – Glaxosmithkline plc sent three top global executives to China to deal with an expanding scandal that has seen four executives detained and one confess on national television. Read More
It may be just a jump to the left and then a step to the right, but the time warp that forms between the evolution of clinical science and regulatory science can make the two seem worlds apart. Read More
While investors wait for key data from a Phase II trial with Merrimack Pharmaceuticals Inc.'s HER2 signaling inhibitor MM-121 in breast, ovarian and non-small-cell lung cancer (NSCLC), the company began a Phase II trial with its bispecific antibody, MM-111, which targets the HER2 and HER3 receptors, for advanced gastric, esophageal and gastroesophageal junction (GEJ) cancers. Read More
LONDON – Stem cell therapy specialist Reneuron plc has raised £33 million (US$50.7 million), including a placing to bring in £23.35 million and a £7.8 million grant from the Welsh Government, in a financing package that will enable the company to build its own manufacturing facility and take three lead programs through to proof of efficacy in Phase II. Read More
After pushing shares of Isis Pharmaceuticals Inc. to a 52-week high in late June on the first Phase II data of antisense drug Isis-ApoCIIIRx, investors were more cautious Monday when the company reported additional Phase II data on patients with high to severely high triglycerides on stable doses of fibrates. Read More
Many neurodegenerative diseases are set off by protein aggregation – one protein or another misfolds and clumps up, builds up, and eventually kills brain cells. Read More
• Cel-Sci Corp., of Vienna, Va., said the company is noncompliant with certain listing requirements of the New York Stock Exchange, based on its quarterly report for the period ended March 31, 2013. The company was given an opportunity to maintain its listing by submitting a plan of compliance by August 19, 2013. The company intends to submit such a plan by then. Read More
• Navidea Biopharmaceuticals Inc., of Dublin, Ohio, said results of a post-mortem brain tissue study using its investigational Fluorine-18-labeled beta-amyloid imaging agent, NAV4694, to compare performance characteristics of the NAV4694 to 11C-labeled Pittsburgh Compound-B, in control and Alzheimer's disease brain tissue concluded that, although the molecules share structural similarity, NAV4694 better differentiated amyloid deposition associated with Alzheimer's. Results were presented recently at the Alzheimer's Association International conference in Boston. Read More
• Baxter International Inc., of Deerfield, Ill., said the European Medicines Agency authorized an update to the summary of product characteristics (smPC) for Advate [Antihemophilic Factor (Recombinant) Plasma/Albumin Free Method, or octocog alfa)] to include findings of its Phase IV prophylaxis study, which compared standard and pharmacokinetic (PK)-guided prophylaxis dosing regimens to on-demand treatment with Advate. Read More
