Researchers from Massachusetts General Hospital, the Broad Institute and the Howard Hughes Medical Institute have reported what may be a simplified method for understanding the function of disease-associated genetic variants, and used their method to gain new insight into a form of diabetes. Read More
The current initial public offering (IPO) window has not proven particularly welcoming for specialty pharmaceutical firms, but that didn't stop Supernus Pharmaceuticals Inc. from joining the queue with a $100 million filing. Read More
King Pharmaceuticals Inc., of Bristol, Tenn., resubmitted its new drug application for Remoxy, a twice-daily formulation of oxycodone, to the FDA, following a review 2008 letter from the FDA. Read More
Intellect Neurosciences Inc., of New York, reported that a draft pharmacokinetic report from its completed Phase Ib trial for its lead Alzheimer's candidate, OX1, indicated that the drug is rapidly absorbed and distributed in the body after oral administration, the company said, adding that the terminal elimination half-life increased from approximately six to eight hours on the first day of the trial to eight to nine hours on the 14th day. Read More
Shares in Atlanta-based Alimera Sciences Inc. and partner pSivida Corp., of Watertown, Mass., sank Monday in the aftermath of an FDA complete response letter asking for analyses of the safety and efficacy data through month 36 of a Phase III trial of Iluvien (fluocinolone acetonide intravitreal insert), a sustained drug delivery system for treatment of diabetic macular edema (DME). Read More
Cephalon Inc. will not pursue approval of its sleep disorder drug Nuvigil (armodafinil) for jet lag following a second complete response letter from the FDA. Read More
