On March 12, 2013, Acadia Pharmaceuticals (ACAD) reported financial results for the fourth quarter and full year 2012. Total revenues in the quarter were $0.4 million, essentially in-line with our estimate of $0.3 million. Revenues consisted of collaborative payments from Allergan, Inc. (AGN) and other collaboration partners. For the full year 2012, total revenues were $4.9 million.
Metastasized breast cancer now has a new therapy on the market, though it remains to be seen whether noticeably dangerous side effects may prevent widespread use. Trastuzumab emtansine (T-DM1) or Kadcyla, produced by Immunogen [Nasdaq: IMGN], is a treatment that targets the HER2 protein.
The Healthcare ecosystem in the United States is changing dramatically due to significant regulations and legislation. Though Obamacare gets the most attention for its impact on patient care and healthcare coverage, legislation such as the Meaningful Use Regulations passed in 2009, followed by the passage of the Affordable Care Act in 2010, and the most recent Sequestration may have a profound impact on the opportunities for developing medical devices and medical device investors.
GlySure Limited, developer of in-hospital continuous blood glucose monitoring systems, today announced that it has achieved ISO 13485 certification, the global standard for the requirements of a quality management system for the design, manufacture and distribution of medical devices. By establishing a quality management system that meets international regulatory and customer requirements, GlySure has set the foundation for its European clinical trials.
WHAT IF there were a way to give cancer a ‘fever’ to enhance the results of chemotherapy and radiation? There is, says Actium BioSystems…
The BIO CEO Investor Conference remains one of the most important events for companies, investors and industry executives to explore partnerships, raise capital, network or simply gain some useful, fresh insight from industry experts. Monday’s opening Plenary Session, Word on the Street–Buy Side View for 2013, was informative and featured some of the industry’s most respected names.
ALLERGY is a burgeoning disease, and food allergies represent the segment where life can be directly threatened. In the U.S., more than three million people are allergic to peanut. Indeed, peanut allergy causes about 100 to 150 deaths each year in the U.S.—but no treatment is currently available. Until now, avoidance of the culprit food has been the primary solution.
Aftab Jamil of BDO spoke with OneMedTV during the 6th Annual OneMedForum in January to discuss the state of life sciences investment, and how companies can formulate new strategies to attract a sustainable class of investors. At the core of these new strategies are the initiatives being implemented to increase access to non-venture capital in the earlier rounds, which may incubate a company long enough to grow a pipeline, attract tenable/diverse revenue opportunity, and eventually reach market.
Last month, Santarus, Inc’s Uceris for ulcerative colitis received FDA approval, and the company has announced a planned launch in March 2013. Santaurs has already begun adding 85 new positions to its sales staff in anticipation of Uceris’ future. The Uceris approval hopes to promise strong returns for a company with a checkered past, but a promising future.
Aside from re-defined financing structures, the most important issue facing life sciences EGCs is the need to increase clinical trial efficiency and productivity so that development budgets are used prudently to support products that have the best chance of market success. Speaking to OneMedTV during OneMedForum this past January, Donnelly discussed current changes that will impact the future of product development and the central role that innovative trial design will play in this.
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