BIO is surveying members and non-members on their interactions with the FDA during the various stages of drug development prior to submitting an NDA/BLA. The survey can be accessed here.
Why is it important for you to share your feedback? In an increasingly competitive and fiscally-constrained environment, it is more important than ever for all stakeholders to work together to promote effective R&D for innovative medicines.
Next Due Date June 19, 2015; Submit Your Letter of Intent by May 19, 2015 Informational Webinar Coming Soon – Stay Tuned!
NHLBI’s Phase IIB Bridge Award provides up to $3M to support the continued development of your innovative technology requiring regulatory oversight. Applicants are expected to leverage NHLBI funding to attract matching third-party financing. For NHLBI-related technologies focused on rare diseases or pediatric populations, the Phase IIB Small Market Award (RFA-HL-14-012) provides up to $3M, with an expectation of partial matching funds from third-party investors. The next due date for RFA-HL-14-012 is June 19, 2015. Both Phase IIB programs are open to Phase II SBIR or STTR awardees from any agency.
Baltimore health IT startup Emocha Mobile Health Inc. is taking its medication-tracking mobile app to one of the largest counties in the country — Harris County, Texas. Emocha on Friday announced a year-long, $65,000 contract with the Houston-area county to help health workers make sure tuberculosis patients are taking their medication. The contract can be extended for up to a total of five years.
emocha Mobile Health launched its video-based directly observed therapy application, miDOT, in Harris County, Texas. miDOT will be used to bridge the distance between healthcare workers and the tuberculosis (TB) patients that are dispersed across the nearly 1,800 square miles surrounding Houston, which has one of the nation’s highest Tuberculosis rates. The roll-out began in early February after emocha won a competitive bidding process based on a head-to-head pilot with competing technologies.
Johns Hopkins University officials have been talking about putting more energy into fostering more entrepreneurship among the Baltimore institution’s vast research megalith. This week, they put a plan in writing.
On Wednesday, Hopkins President Ronald J. Daniels released a 20-page report that lays out plans for $40 million in new investment over five years. Officials want the new money to fuel the growth of an “innovation ecosystem.”
The interest in adopting digital health tools such as clinical wearables and smartphone diagnostics has been hindered in some ways by the rapid growth in the number of these devices and relatively little clinical validation. GE Ventures and Stanford Health Care have partnered to launch a company called Evidation Health to validate and optimize digital health tools, according to a company statement.
Aura Biosciences, a biotech company developing highly tumor-targeted breakthrough therapies for rare cancers, has secured a $21M Series B round of funding. The financing was led by Advent Life Sciences, with participation from new investors, Chiesi Ventures, Ysios Capital, and Alexandria Venture Investments. Existing investors, including LI-COR Biosciences and Henri Termeer, former Chief Executive Officer of Genzyme, also participated in the financing. The financing will be used to advance Aura’s unique and novel therapies into clinical trials for the treatment of rare cancers of the eye, and to further develop for additional cancer indications its first-in-class technology that was discovered and developed in partnership with Dr. John Schiller at the National Cancer Institute (NCI).
Italian drugmakers Alfa Wasserman and Sigma-Tau said on Thursday they had agreed to merge pharmaceutical activities to create a domestic champion with sales of more than 900 million euros ($992 million).
In October sources told Reuters the two companies were in advanced talks to combine their Italian operations.
For the second year, The Johns Hopkins University and Johns Hopkins Medicine are co-sponsoring an opportunity that prepares health information technology startups to present their innovative ideas to the world. DreamIt Health Baltimore is a four-month intensive boot camp program for entrepreneurs, designed to accelerate new product development for health IT startup companies. The program provides six new startups with access to top-tier legal and accounting services, along with opportunities to meet and pitch to angel investors and venture capitalists. Each startup also receives additional seed capital of up to $50,000.
Google has been making major waves in healthcare lately, with a significant change in how it displays health search results in a collaboration with the Mayo Clinic that may include a change to its algorithms.
And efforts to make Google Glass more applicable to healthcare seem to be increasing. But that’s far from the only area it intends on disrupting. The folks at HIT Consultant put together this handy infographic that details the potential dominance, or at least influence, ranging from genomics to diagnosis to wearables.
