The injectable aesthetics market has a new player following the FDA's late Tuesday approval of laViv (azficel-T) from Exton, Pa.-based Fibrocell Science Inc., but don't expect the autologous cell therapy to go head-to-head – or face-to-face – with the market-leading injectable Botox (onabotulinumtoxin A). Read More
With one oral multiple sclerosis (MS) drug already approved and several more finishing Phase III programs, Merck Serono opted to bail on its oral MS candidate cladribine rather than embark on a new clinical program as the FDA had requested. Read More
In breast cancer, both having high levels of the proinflammatory signaling molecule CCL2 and having macrophages, a type of immune cell, infiltrate the tumor bodes poorly for the patients. A new study showed the link between those two observations, and suggested that targeting CCL2 signaling might be a way to treat metastatic breast cancer. Read More
Achillion Pharmaceuticals Inc. stock soared nearly 21 percent by close Wednesday following the company's pricing of an underwritten public offering of 9.6 million shares at $5.90 a share, a 1.8 percent discount. The New Haven, Conn.-based company expects net proceeds of about $52.9 million, and could add about $7 million more through an underwriters' overallotment option for as many as 1.44 million shares. Read More
P2D Biosciences, of Cincinnati, received a $1.5 million grant from the National Institutes of Health to develop its lead dopamine transport inhibitor PD2007, for treatment of central nervous system diseases, through investigational new drug application safety and toxicology studies for future use in humans. Read More
Threshold Pharmaceuticals Inc., of Redwood City, Calif., completed patient enrollment in its Phase II study of TH-302, a small-molecule tumor-selective hypoxia-activated prodrug, in pancreatic cancer. The company expanded the enrollment target from 165 patients to at least 200, which increases the statistical power of the study to greater than 80 percent. The trial is testing TH-302 in combination with gemcitabine in patients with first-line disease, and the primary endpoint is progression-free survival. Read More