News Archive

Symbiomix Therapeutics today announced multiple milestones, including the closing of the third and final tranche of a $41 million Series A financing and positive results from a multi-center, randomized Phase 2 trial testing a single oral dose of SYM-1219 for the treatment of bacterial vaginosis (BV). Based on discussions with the U.S. Food and Drug Administration (FDA) at an End-of-Phase 2 meeting, the Company now is planning to submit the Phase 2 trial as one of two pivotal studies for a New Drug Application (NDA) filing in 2016. Simultaneously, the Company announced that the FDA recently designated SYM-1219 as a Qualified Infectious Disease Product (QIDP). SYM-1219 is a novel drug candidate that contains secnidazole, an antibiotic with favorable pharmacokinetics that facilitate administration as a single-dose oral therapy.

University of Maryland (UM) Ventures and Biomecite Diagnostics, LLC announced today the signing of an exclusive option by Biomecite Diagnostics for the rights from University of Maryland, Baltimore (UMB) to develop diagnostics to detect inflammatory bowel diseases (IBD), such as ulcerative colitis (UC) and Crohn’s disease (CD). Drs. Florian Fricke and James White developed the licensed technology while both were with the University of Maryland School of Medicine’s Institute for Genome Sciences (IGS). The technology explores distinctive genomic variances in the populations of bacteria or microbiome found in the human gut to diagnose the closely related but differing gastrointestinal diseases, UC and CD.

Presenter:
Rana Gupta
President, Kwydk, LLC

Moderator:
Gary Robinson, Ph.D.
National Heart, Lung, and Blood Institute

The landscape of potential customers for biomedical products can be complicated, with patients, providers and payers assigning different values to new technologies. Companies must navigate this landscape to find the individuals who will actually make the decision to purchase their products.  In this webinar, entrepreneur and educator Rana Gupta will talk about how customers can not only help biomedical innovators to define the value proposition for their products, but can also guide and fund their product development.

Since it seems that 1776 can’t go a week without making news, they just announced an Innovation Opportunity Program that they are launching with General Assembly. DC’s Mayor Muriel Bowser along with representatives from TDF Foundation, THEARC, Capital One, MedStar Health, and Microsoft were also on hand for the announcement.

Emergent BioSolutions of Gaithersburg has won approval from the U.S. Food and Drug Administration for its hemophilia drug Ixinity.

The treatment, administered intravenously, helps control and prevent bleeding episodes and also is approved for use during surgery in adults and children 12 and older with hemophilia B, according to a company news release. Hemophilia B is a bleeding disorder caused by a mutation on the factor IX gene resulting in a deficiency of clotting factor IX in the blood, which controls bleeding.

On Tuesday, the Senate Health committee held a hearing on the promise of precision medicine. Last week, the House released draft legislation to support biomedical innovation. And following President Obama’s State of the Union in January, the White House unveiled the Precision Medicine Initiative, meant to provide funding to accelerate biomedical research.

What none of these things do directly is to curb the price of speciality drugs—including precision drugs—which cost Americans more than $80 billion in 2013, according to the Campaign for Sustainable Rx Pricing.

The Montgomery County Business Hall of Fame will add four new members later this year, including a former space issues attorney turned health company CEO, a bank chairman, a barbecue expert and the chief executive of a hospital.

The following people have been named to the business hall of fame and are scheduled to be honored at an Oct. 27 event:

Photo Credit: Fortune Live Media – Flickr

Drug testing on humans and animals will be a thing of the past within two decades, United Therapeutics CEO Martine Rothblatt said Monday.

Soon, companies will test pharmaceuticals on silicon versions of the human body, entering drugs as code, she said.

Photo Credit: Fortune Live Media – Flickr

The advent of connected devices and M2M is offering a tremendous opportunity for healthcare professionals. Near-ubiquitous mobile networks are allowing carers to diagnose, monitor, and communicate with patients with unprecedented speed and efficacy.

Every venture firm’s looking for many multiples when it comes to returns – but in reality, they expect things to shake out a little differently. Seth DeGroot, a managing partner at boutique Minneapolis investment firm Brightstone Venture Capital, spoke on what the firm’s expectations in potential investment targets – and how startups can avoid pesky problems like, say, overinflated valuations.