Cubist Pharmaceuticals Inc., of Lexington, Mass., reported fourth quarter 2013 revenues of $299.7 million, an increase of 22 percent over the same quarter in 2012 ($245.9 million). Read More
The FDA will do well if the House and Senate approve a fiscal 2014 spending bill hashed out by congressional appropriators. Unveiled late Monday, the legislation would give the agency $2.55 billion in discretionary funding, $91 million more than enacted in fiscal 2013. Read More
Galena Biopharma Inc., of Portland, Ore., and Dr. Reddy’s Laboratories Ltd., of Hyderabad, India, formed a strategic development and commercialization partnership for Neuvax (nelipepimut-S) in India. Read More
Biomarin Pharmaceutical Inc., of San Rafael, Calif., dosed the first child in the Phase II trial with BMN 111, an analog of c-type natriuretic peptide, for the treatment of children with achondroplasia. Read More
Pieris AG, of Freising, Germany, has achieved the third milestone for its lead Anticalin program with Daiichi Sankyo Co. Ltd., of Tokyo, triggering an undisclosed payment. Read More
Concert Pharmaceuticals Inc., of Lexington, Mass., filed for an initial public offering to raise $74.75 million. The number of shares to be offered and the price range were not disclosed. Read More
LONDON – Sequencing the genomes of cells from patients with childhood leukemia has allowed scientists to pinpoint the sequence and type of mutations that lead to this disease. Read More
Once again, the Cardiovascular and Renal Drug Advisory Committee (CRDAC) shot down many of the red flags the FDA raised about Chelsea Therapeutics International Ltd.’s droxidopa (Northera). Read More
SAN FRANCISCO – Privately held Aduro Biotech Inc. reported that the Phase II trial of cancer immunotherapy candidates, CRS-207 and Gvax Pancreas, used in combination in metastatic pancreatic cancer was halted early on the recommendation of the data safety monitoring board and approval by the FDA after the study met the primary efficacy endpoint at a pre-planned interim analysis. Read More
SAN FRANCISCO – Gilead Sciences Inc.’s breakthrough hepatitis C virus (HCV) drug Sovaldi (sofosbuvir), which gained approval in the U.S. in December and got off to a strong start despite typical slowdown of the holidays, is expected to be approved in Europe later this month, likely with favorable pricing. Read More
Back in October 2013, Merck & Co. Inc. chairman and CEO Kenneth C. Frazier announced a major strategic restructuring to create “greater efficiencies” for the company. The goal: to put its R&D operations in order and pare its annual operating expenses by approximately $2.5 billion by the end of 2015. Read More
SAN FRANCISCO – As California’s year-long drought continued, Regeneron Pharmaceuticals Inc. refreshed investors at the 32nd Annual J.P. Morgan Healthcare Conference (JPM) with news of a new deal for a combination therapy in wet age-related macular degeneration (AMD). Read More
