The FDA approved Affymax Inc.'s anemia drug Omontys (peginesatide) for adult dialysis patients with chronic kidney disease. It is the first new erythropoiesis-stimulating agent (ESA) approved since 2001.
Successful commercialized products have become one of the hottest new survival strategies for biotech pipelines in the new and continuously cautious venture capital environment. Dara Biosciences Inc., of Raleigh, N.C., is securing its future with the acquisition of a solid commercial oncology product through a licensing agreement with Innocutis Holdings LLC.
In the midst of enrolling for a second pivotal Phase III trial of its lead product, dalbavancin, for skin infections, Durata Therapeutics Inc. has filed a registration statement with the SEC for an initial public offering of common stock.
Relief may be on the way for cardiac patients who can't tolerate aspirin. Pozen Inc., of Chapel Hill, N.C., reported positive results from two Phase III pivotal trials showing that treatment with PA32540, a formulation of aspirin combined with the proton pump inhibitor omeprazole, led to a significant reduction in gastric ulcers compared to enteric-coated aspirin.
The FDA's oncologic drugs advisory committee (ODAC) voted 13 to 1 against the approval of Taltorvic (ridaforolimus) by Ariad Pharmaceuticals Inc., partnered with Merck & Co. Inc., for soft-tissue and bone sarcoma.
An abrupt termination by Merck & Co. Inc. of development of oral vernakalant caught Cardiome Pharma Corp., of Vancouver, British Columbia, flatfooted as it prepared to release a financial update Monday.
Tarsa Therapeutics Inc.'s $28 million financing will push Ostora, its once-daily oral calcitonin tablet, through a new drug application (NDA) filing and a European marketing authorization application, as well as fund other pre-commercialization activities.
Merck and Co. Inc. helped to launch a new nonprofit translational institute based in San Diego, the California Institute for Biomedical Research (Calibr), to accelerate translation of basic biomedical research into commercialized medicines.
Kala Pharmaceuticals Inc., of Waltham, Mass., raised $6.2 million in equity financing from its existing investors. The new round completes its seed financing of $11.2 million to support its pipeline in diseases affecting mucosal tissues, including cystic fibrosis.
A Phase III trial of a product in development to prevent complications during delicate intraocular lens replacement surgery met its primary and secondary endpoints, Omeros Corp. reported Tuesday.
