Roka Bioscience Raises $20 Million

Roka Bioscience revealed that it has completed a Series C round of equity financing, raising $20M. The investor syndicate included participation from all existing investors including OrbiMed Advisors, New Enterprise Associates, Inc., TPG Biotech and Gen-Probe Inc. (NASDAQ: GPRO).  Established in September...

FDA Needs To Replace Flawed 510(k) Medical Device Clearance Process

According to a report released by the Institute of Medicine (IOM) Friday, the U.S. Food and Drug Administration needs to develop a new regulatory framework to replace the 35-year-old 510(k) clearance process for medical devices.  The 510(k) process lacks the legal basis to be a reliable premarket screen of...

InSite Vision Is Developing Treatment For Common Eye Disease Blepharitis, For Which There Is Currently No Approved Treatment

InSite Vision Inc. (OTCBB:INSV) has reached an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for the design of a Phase 3 clinical trial of AzaSite Plus and DexaSite in patients with blepharitis. Blepharitis, also known as lid margin disease, is a very...

Ampio Pharmaceuticals Shows Promising Results In Treating The Most Common Male Sexual Dysfunction

Premature ejaculation is a distressing male sexual dysfunction that is more common than erectile dysfunction (ED) and has a major impact on the quality of life for men and their sexual partners. Ampio Pharmaceuticals, Inc., a company focused on new uses for previously approved drugs and new molecular...

Icagen and Pfizer Form Three Way Collaboration with Yale To Explore Chronic Pain Remedies

Chronic pain and epilepsy are debilitating disorders that affect millions of individuals in the US and throughout the world. Icagen, Inc., a biopharmaceutical company focused on the discovery, development and commercialization of novel orally-administered small molecule drugs that modulate ion channel...

Cynvenio Biosystems Selected as 2011 FiReStarter Company

Individualized therapy has been a window to cancer, effectively increasing response rates and prolonging survival. Cynvenio Biosystems, which has been selected and invited to present at OneMedforum NY 2011, is developing technology that delivers on the promise of personalized medicine and has the capability...