• Eisai Inc., of Woodcliff Lake, N.J., said the FDA approved Aciphex Sprinkle delayed-release capsules for the treatment of gastroesophageal reflux disease in children, ages 1 to 11, for up to 12 weeks. Read More
• Lightlake Therapeutics Inc., of London, said data from a Phase II trial testing opioid antagonist nasal spray for patients with binge eating disorder showed that patients in the intranasal naloxone group showed a statistically significant 75.2 percent reduction in binge eating. Read More
• MaxCyte Inc., of Gaithersburg, Md., said results published in International Immunopharmacology demonstrated that the use of its cell-loading technology results in fivefold to 20-fold enhancement in potency of dendritic cell vaccines. Read More
• Enanta Pharmaceuticals Inc., of Watertown, Mass., closed its initial public offering of 4.6 million shares priced at $14 apiece, which includes the exercise in full by underwriters of their overallotment option to purchase up to 600,000 shares. Read More
Just days after winning a thumbs-up from the European Committee for Medicinal Products for Human Use, Biogen Idec Inc.'s much-lauded Tecfidera (dimethyl fumarate) was approved by the FDA, and analysts have said the drug has a good shot going up against the two oral multiple sclerosis (MS) therapies already on the market. Read More
While names may not matter to a rose, the naming of biosimilars continues to be a thorny issue for regulators across the globe. And the World Health Organization (WHO) expects it to get a whole lot thornier over the next decade as biosimilar prescriptions begin to outnumber those for the original reference biologics. Read More
By blocking a spectrum of fibroblast growth factor (FGF) signaling pathways, but specifically staying away from others, scientists at Five Prime Therapeutics Inc. have been able to inhibit both tumor and blood vessel growth in animal models of several different cancer types. Read More
ReNeuron plc is planning to move its stem cell therapy ReN001 into a Phase I trial in critical limb ischemia (CLI), just as Aastrom Biosciences Inc., an erstwhile leader in the field, is stepping away from the fray. Read More