Forest Laboratories Inc., of New York, said it submitted a new drug application seeking FDA approval for a fixed-dose combination of nebivolol and valsartan for the treatment of hypertension. Read More
Sucampo Pharmaceuticals Inc., of Bethesda, Md., reported net income for the fourth quarter of 2013 of $2.4 million compared to $13.5 million in the same period in 2012. Read More
Basilea Pharmaceutica Ltd., of Basel, Switzerland, said the FDA designated isavuconazole as a qualified infectious disease product for the treatment of invasive mucormycosis, a life-threatening invasive fungal infection caused by certain emerging molds. Read More
Scholar Rock Inc. CEO Nagesh Mahanthappa’s previous biopharma experiences include stints at RNAi powerhouse Alnylam Pharmaceuticals Inc. and privately held Avila Therapeutics Inc., which was snapped up by Celgene Corp. in a potential $935 million deal in 2012, and he is the first to admit that “those are high standards.” Read More
With the Internet and globalization making counterfeit drugs an enticing opportunity for international organized crime and a way to fund terrorism, the U.S. needs to step up the certainty and the severity of punishment for dealing in counterfeit and unapproved drugs. Read More
Radius Health Inc. expanded the circle of biotech initial public offerings (IPOs), filing to raise up to $86.25 million. In its preliminary prospectus, the Cambridge, Mass.-based company took a different angle than most recent biotech IPOs, becoming one of the first – perhaps the only – since the passage of the Jumpstart Our Business Startups Act of 2012 that did not file as an emerging growth company. Read More
Eisai Inc., of Woodcliff Lake, N.J., said it started a phase III trial to compare the efficacy, safety and tolerability of eribulin mesylate to standard weekly paclitaxel as first- or second-line treatment for HER2-negative locally recurrent or metastatic breast cancer. Read More
