• Clovis Oncology Inc., of Boulder, Colo., set terms for its proposed initial public offering. The company plans to sell 9.3 million shares priced between $13 and $15 apiece, the midpoint of which would raise $130.2 million. An additional 1.4 million shares will be available to underwriters J.P. Morgan, Credit Suisse and Leerink Swann to cover overallotments. The majority of proceeds will support its pipeline of cancer drugs. Clovis applied to list its common stock on the NASDAQ Global Market under the symbol "CLVS." (See BioWorld Today, June 24, 2011.) Read More
• Auxilium Pharmaceuticals Inc., of Malvern, Pa., reported third-quarter revenues of $66.7 million, in line with analyst estimates of $66.8 million. Testim (testosterone gel) for hypogonadism generated $53.6 million and Xiaflex (collagenase clostridium histolyticum) for Dupuytren's contracture generated $13.1 million. Although U.S. Xiaflex revenues were $10.3 million, up 124 percent over the third quarter last year, analysts had expected $11.3 million, and some voiced concerns about Auxilium's ability to meet guidance for the year. Read More
• Stem Cell Therapeutics Corp., of Calgary, Alberta, said it received U.S. Patent No. 7,994,131, titled "Stimulation of Proliferation of Pluripotent Stem Cells through Administration of Pregnancy Associated Compounds." It relates to the use of human chorionic gonadotropin to treat patients presenting with damaged or diseased heart cells.• Trophos SA, of Marseille, France, was granted U.S. Patent No. Read More
• Alios BioPharma Inc., of South San Francisco, and Versitech Ltd., of Hong Kong, signed an exclusive worldwide licensing agreement for technology to advance the research, development, manufacture and commercialization of medicines to treat influenza virus. The companies inked two additional influenza-related, nonexclusive license agreements and a sponsored research agreement. Read More
• Circadian Technologies Ltd., of Melbourne, Australia, said the FDA approved the investigational new drug application filed by its wholly owned subsidiary, Vegenics Pty Ltd., to initiate clinical trials of VGX-100, a human antibody that acts against the human VEGF-C protein. The Phase I study will evaluate VGX-100 in a variety of late-stage cancers. Read More
DUSSELDORF, Germany – Golden autumn sunlight breaking over the mighty Rhine was the pleasing sight for delegates taking a breather from the many sessions at the BIO-Europe Fall 2011 meeting, which opened at the Congress Center Dusseldorf Monday.But there was little time to savor the view. Read More
WASHINGTON – In trying to identify the culprit for the drug shortage crisis facing the nation, the Department of Health & Human Services (HHS) had only to look to the marketplace. But finding a solution isn't as easy.Patent expirations, a rush to generic drugs, manufacturing capacity limitations, pricing issues and expanding use of oncology drugs have combined to create a record number of shortages in off-patent sterile injectables, according to a new report from the Office of the Assistant Secretary for Planning and Evaluation at HHS. Read More
Most people don't think of Arctic ground squirrels and Burmese pythons as having much in common. But Leslie Leinwand does.In a nutshell, both animals go to physiological extremes in their lifestyles. Read More
Privately held AgonOx LLC, which could afford to be picky with its hot T-cell technology, selected MedImmune LLC, a unit of AstraZeneca plc, over more than two dozen other potential suitors for an exclusive global agreement to develop agonists and other immune system activators for cancer therapy using AgonOx's OX40 platform.OX40 is a protein transiently expressed on the surface of effector T-cells, but only after activating the T-cells with immune-stimulating antigens, including tumor antigens. Read More
Just nine months ago, shares of NPS Pharmaceuticals Inc. jumped 32 percent on positive Phase III data for Gattex (teduglutide) in short bowel syndrome. But on Monday those gains were erased – and then some – in the wake of concerns about three cancer cases in the Phase III follow-on trial.NPS' stock (NASDAQ:NPSP) fell $2.59, or 33.4 percent, to close Monday at $5.17.The concerns stemmed from data presented at the American College of Gastroenterology annual meeting, particularly an interim analysis of the open-label, follow-on STEPS 2 trial. Read More
