Monday, July 11, 2016
Merrimack Pharmaceuticals has announced that the FDA has granted seribantumab, also known as MM-121, Fast Track designation for development in patients with heregulin-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) whose disease has progressed following immunotherapy. Fast Track is a program designed by the FDA to facilitate and expedite the development and review of drugs that treat serious conditions and fill an unmet medical need.
The largest study ever to investigate how genetic and biological factors contribute to breast cancer risk among black women has launched. This collaborative research project will identify genetic factors that may underlie breast cancer disparities. The effort is funded by the National Cancer Institute (NCI), part of the NIH.
The NIH has announced $55 million in awards in fiscal year 2016 to build the foundational partnerships and infrastructure needed to launch the Cohort Program of President Obama’s Precision Medicine Initiative (PMI). The PMI Cohort Program is a landmark longitudinal research effort that aims to engage 1 million or more U.S. participants to improve our ability to prevent and treat disease based on individual differences in lifestyle, environment and genetics.
In support of the President’s Precision Medicine Initiative, the FDA has issued two draft guidances that, when finalized, will provide a flexible and streamlined approach to the oversight of tests that detect medically important differences in a person’s genomic makeup.
The FDA has approved AbbVie’s Humira (adalimumab) for the treatment of non-infectious intermediate, posterior and panuveitis. Humira is now the first and only FDA-approved non-corticosteroid therapy available for adults with noninfectious intermediate, posterior and panuveitis. This approval marks the 10th approved indication for Humira in the U.S. for immune-mediated diseases.
Veristat, a full service CRO with over 20 years of experience, is continuing its accelerated growth and geographic expansion with the opening of an office in Raleigh-Durham, North Carolina. In addition to this newly planned North Carolina office, Veristat has additional North American-based offices in Southborough, Massachusetts, Cambridge, Massachusetts, San Bruno, California, Montreal, Canada, and its European office in Glasgow, U.K.
The recently launched Genomic Data Commons (GDC) will get a dramatic increase in the power and utility of its resources with the announcement today of the signing of a data sharing agreement between the National Cancer Institute (NCI) and Foundation Medicine (FMI), a molecular information company that has generated genomic profiles of people with cancer.
Agilis Biotherapeutics, a biotechnology company advancing innovative DNA therapeutics for rare genetic diseases that affect the central nervous system (CNS), has announced that the FDA has granted Orphan Drug Designation to Agilis’ gene therapy product candidate, AGIL-AADC, being developed for the treatment of Aromatic L-amino Acid Decarboxylase (AADC) deficiency.
FDA Commissioner Robert Califf, M.D., released a statement announcing the acting director of the FDA Oncology Center of Excellence. He said: