Hoping to gain some ground in an all-out war against superbugs, the FDA is taking the first steps toward creating an approval shortcut for new antimicrobials with a public hearing Feb. 4. Read More
NewLink Genetics Corp.'s HyperAcute technology will get a boost from a public offering of 4 million shares of common stock in the company priced at $11.40 per share, or net proceeds of $42.5 million. Read More
Autophagy, Beth Levine told BioWorld Today, "can very simply be understood as a cellular housekeeping mechanism." But that simplicity is deceptive. Autophagy's housekeeping, it turns out, sits at a crossroads that gives it a role in many diseases. Read More
After Tuesday's market close, Vertex Pharmaceuticals Inc. reported 2012 revenues of $1.53 billion, including net product revenues of $1.16 billion from Incivek (telaprevir) and $171.6 million from Kalydeco (ivacaftor), launched in the U.S. in February 2012. Read More
• Pluristem Therapeutics Inc., of Haifa, Israel, said it is moving into its new GMP facility, which allows for the production of mass quantities of PLacental eXpanded cells that possess the advantages of being grown using Pluristem's 3D bioreactor technology. Read More
• Boehringer Ingelheim GmbH, of Ingelheim, Germany, said the FDA's Pulmonary-Allergy Drugs Advisory Committee recommended that clinical data included in a new drug application provide substantial and convincing evidence to support the approval of olodaterol as a once-daily maintenance bronchodilator treatment for airflow obstruction. Read More
• Alnylam Pharmaceuticals Inc., of Cambridge, Mass., and collaborators published results from a Phase I trial with ALN-VSP, a systemically delivered RNAi therapeutic for treating solid tumors with liver involvement. Read More
