Genentech Inc., a unit of the Roche Group, received the confirmation on lead hematology candidate GA101 (obinutuzumab) it's been awaiting since an interim analysis at the end of January showed marked improvement in progression-free survival (PFS) in a Phase III trial in previously untreated chronic lymphocytic leukemia (CLL). Read More
Continuing the trend of biotech's upsized initial public offerings (IPOs), Agios Pharmaceuticals Inc. bumped up both the number of shares offered and priced $2 above its proposed range for gross proceeds topping $106 million. Read More
SHANGHAI – Vowing to conduct an independent investigation and commit new resources to the case, Glaxosmithkline plc CEO Andrew Witty said the company's ongoing troubles in China are unlikely to spread to other countries. Read More
In Wall Street's view, the outcome of another meeting between the FDA and Sarepta Therapeutics Inc. apparently did not bring enough about the path to a new drug application (NDA) filing for eteplirsen, the exon-skipping therapy for Duchenne muscular dystrophy (DMD). Read More
The European Medicines Agency (EMA) and the pharmaceutical industry look to be set on a collision course regarding the vexed issue of access to clinical trial data, following the joint publication of a set of principles on the topic by the Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA). Read More
At one level, a new study published today is hardly a surprise: it shows that the processing of amyloid precursor protein (APP) is one of the major pathways changed in individuals with Alzheimer's disease. Read More
• Prescience Labs LLC, of Potomac, Md., said the FDA has approved its investigational new drug application for Phase I clinical evaluation of its anti-cancer drug 3-bromopyruvate (PSL-001) in patients with primary and/or metastatic liver cancer. The study will evaluate the dosing regimen of the drug to determine the maximum tolerated dose based on the safety data. Read More
• Insite Vision Inc., of Alameda, Calif., reported top-line results from a Phase III trial of Azasite Plus and Dexasite for moderate-to-severe blepharitis. The drugs did not meet the primary endpoint of complete resolution of all signs and symptoms. They did show statistically significant improvements in signs and symptoms at 15 days. Insite Vision will meet with the FDA on Aug. 19, 2013 to review the results of the DOUBle Phase III study. Read More
• The Medicines Co., of Parsippany, N.J., reported net revenue of $172.8 million for the second quarter, besting analyst estimates of $168.7 million, though earnings per share of 30 cents missed expectations by 4 cents. The company posted net income of $18.1 million. Read More
• Merck & Co. Inc., of Whitehouse Station, N.J., said the FDA has accepted for standard review its new drug application for its investigational anti-thrombotic medicine, vorapaxar for the secondary prevention of cardiovascular events in patients with a history of heart attack and no history of stroke or transient ischemic attack. Read More
