• Endo Pharmaceuticals Inc., of Malvern, Pa., said the FDA accepted a complete response submission for Aveed, a long-acting testosterone undecanoate injection, for hypogonadism in men. Read More
• Wockardt Ltd., of Mumbai, India, has changed its leadership and quality control systems following an import alert it received from the FDA. Read More
Mention “vasculature” and “cancer drug” in the same sentence, and most people with think anti-angiogenesis. Which, with blockbusters like Avastin (bevacizumab, Roche AG) on the market and dozens of angiogenesis inhibitors in development, is not surprising. Read More
Not surprisingly, Rigel Pharmaceuticals Inc. has decided not to pursue the oral spleen tyrosine kinase (Syk) inhibitor fostamatinib in rheumatoid arthritis (RA) after Astrazeneca plc, unhappy with trial data, returned the rights to the compound last month. Read More
LONDON – Arsanis Inc. has raised $20 million in Series B funding that will enable the Austro-American company to take its lead monoclonal antibody product, ASN-100, through Phase I/IIa development in the treatment of severe, hospital-acquired Staphylococcus aureus infections. Read More
Macrogenics Inc. joined the roster of biotechs to file for initial public offerings (IPOs) this year, filing an S-1 with aims of raising up to $60 million to support its cancer drug pipeline. Read More
Shares of Agenus Inc., of Lexington, Mass., plummeted 23.5 percent on news that Glaxosmithkline plc’s Phase III DERMA trial testing its MAGE-A3 cancer immunotherapeutic, formulated with Agenus’s QS-21 Stimulon adjuvant, missed its primary endpoint. The trial failed to significantly extend disease-free survival in melanoma patients compared to placebo. Read More
• Mallinckrodt Pharmaceuticals, of St. Louis, reported positive results from a Phase III trial of MNK-795 in acute pain following bunionectomy. Read More
