WASHINGTON – As more and more drugs fall off patent, Congress may need to reset the scales to maintain the proper balance of lower drug prices through access to generics and an environment that encourages innovation. Read More
The course of HIV is driven by the virus' infection of immune system cells. But the virus also infects other cell types, including two kinds of kidney cells. The viruses' infection of kidney cells leads to fibrosis and, ultimately, kidney failure. Read More
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. Read More
• InterMune Inc., of Brisbane, Calif., said Germany's reimbursement body granted the additional benefit of Esbriet (pirfenidone) in adults for mild to moderate idiopathic pulmonary fibrosis, classifying the drug's additional benefit as Stage IV, or not quantifiable. That designation "takes the worst-case scenario off the table," noted Wells Fargo analyst Brian Abrahams, and positions the firm "reasonably for upcoming pricing negotiations." Esbriet won European approval a year ago. The company is conducting another pivotal trial for FDA approval. Read More
• Cytomedix Inc., of Gaithersburg, Md., said data from a randomized Phase I trial of ALD-201 in ischemic heart failure were published in the online edition of the American Heart Journal. The study enrolled 20 heart failure patients with no treatment options, evaluating safety as the primary endpoint. Read More
• Celldex Therapeutics Inc., of Needham, Mass., said underwriters of its public offering of common stock exercised in full their overallotment option to purchase an additional 1,575 million shares at $3.85 each. Read More
• Watson Pharmaceuticals Inc., Parsippany, N.J., said its subsidiary filed an abbreviated new drug application for Nebivolol hydrochloride tablets, a generic version of New York-based Forest Laboratories Inc.'s Bystolic, a beta-adrenergic blocking agent for use in hypertension. Read More
