The falter by Forest Laboratories Inc. and Spanish partner Almirall SA in submitting a new drug application (NDA), originally planned for the first quarter of this year, pushes the duo back somewhat in the race by pharma and biotech firms to win approval of the magic potion, long-acting muscarinic antagonist with a long-acting beta agonist for chronic obstructive pulmonary disease. Read More
Interleukin-15 (IL-15) is considered to be a critical factor in development, proliferation and activation of the cellular immune response, and as such a promising cancer immunotherapeutic agent that is being tested in clinical studies by the National Cancer Institute and the National Institutes of Health. However, IL-15 is limited by a very short half-life in the body. Read More
An attempt to lift California's 6-year-old ban on compensating women for donating human eggs for medical research ended this week with a veto by Gov. Jerry Brown. Read More
SHANGHAI – Multinational drug companies may have to deal with much greater oversight of their pricing policies in China as regulators sharpen their focus and work to bring down costs for patients. Read More
Scientists have reported "a detailed molecular circuit of how asthma is initiated and maintained," David Corry told BioWorld Today. "And that in turn helps us think in fundamentally different ways about new therapeutic approaches" to allergic asthma, which accounts for more than half of all asthma and affects nearly 5 percent of the population. Read More
• Axogen Inc., of Alachua, Fla., said it closed an underwritten offering of 6 million shares of its common stock at $3 per share and plans to use the net proceeds to expand product commercialization and marketing efforts for its portfolio of peripheral nerve repair products. Read More
• Hyperion Therapeutics Inc., of South San Francisco, reported net revenue of $7.3 million following the first full quarter of sales of its newly approved compound, Ravicti (glycerol phenylbutyrate) oral liquid, and one month of sales of Buphenyl (sodium phenylbutyrate) tablets and powder following the company's acquisition of that product. Read More
• Opko Health Inc., of Miami, surpassed 50 percent enrollment in the second Phase III trial of Rayaldy, an oral vitamin D pro-hormone treatment for patients with secondary hyperparathyroidism, Stage III or IV chronic kidney disease and vitamin D insufficiency. Identical to the initial Phase III, the randomized, double-blind, placebo-controlled, multisite study is designed to establish the safety and efficacy of Rayaldy. Read More
• Allosource, of Centennial, Colo., launched a new allograft, the Allomend Acellular Dermal Matrix, for use in a range of soft-tissue surgical procedures such as ventral hernia repair and post-mastectomy reconstruction. Read More
• Silvergate Pharmaceuticals Inc., of Denver, said the FDA approved Epaned (enalapril maleate powder for oral solution) to treat hypertension in pediatric patients 1 month and older. Read More
• Boehringer Ingelheim GmbH, of Ingelheim, Germany, said enrollment of more than 950 treatment-naïve genotype-1b patients in the pivotal Phase III interferon-free HCVerso 1 and 2 trials is complete. Read More
