News Archive

Symbiomix today announced that the US Food and Drug Administration (FDA) has accepted for filing the Company’s New Drug Application (NDA) for its lead investigational product candidate Solosec™ (secnidazole oral granules), an innovative antibiotic designed to treat bacterial vaginosis (BV). In accordance with the FDA’s priority 6-month review designation, the agency has established a user-fee goal date under the Prescription Drug User Fee Act (PDUFA) of September 17, 2017. Symbiomix submitted the NDA filing in January 2017.

Solosec™ is a potent, next-generation, investigational 5-nitroimidazole antibiotic with enhanced pharmacokinetic properties, which will be the first and only single-dose oral therapy approved for BV if approved by the FDA. The FDA previously designated Solosec™ as a Qualified Infectious Disease Product (QIDP) for the treatment of BV and granted it Fast Track designation, which made Solosec™ eligible for priority review and at least 10 years of market exclusivity.

What’s next for the pharmaceuticals industry, amid digital disruption and rapid technological advances? McKinsey’s Martin Dewhurst sat down for a wide-ranging conversation with David Epstein of venture firm Flagship Pioneering to explore ways the sector could shift in coming years. In this interview, part of our Biopharma Frontiers series on how the pharmaceutical industry is evolving and how leaders can adapt, Epstein discusses the next horizon of innovation, critical elements of an effective business, and the kind of culture he tries to foster. An edited transcript of their conversation follows.

Dear Friends of CONNECTpreneur:

I hope everything is well! This is a “Last Call” for our April 4 Big Idea CONNECTprenuer SPRING FORUM at the Hyatt Regency in Bethesda, MD. We expect over 500 CXOs, founders, entrepreneurs, angel investors, etc., and we will be completely SOLD OUT again. So, please sign up now!

We have unparralled CXO to CXO networking, plus an amazing program:

Fireside chat with DAVID TRONE, Co-Founder and Owner, Total Wine & More

Awesome Entrepreneur “War Stories” Panel (moderated by GLEN HELLMAN (aka Mr. Cranky), angel investor and CEO of Driven Forward) featuring:
· NIGEL JONES, CEO of Koolspan and Managing Director of TWJ Capital
· BETH MALONEY, President of Palladian Partners
· D.P. VENKATESH, VP of Broadsoft and CEO of mPortal

PLUS 9 awesome early stage companies will present their companies.

Host:  UM BioPark & Wexford + Technology

Location:  UM BioPark Life Sciences Conference Center, 801 W. Baltimore Street, Baltimore, Maryland  21201

Date:  March 30, 2017 – 5:00pm to 6:30pm

Please join the BioPark’s Monthly Networking Event along with collegues from the Maryland Proton Treatment Center. Mingle with MPTC leadership and staff, BioPark tenants, and UMB faculty and staff.

The co-founders of a Johns Hopkins-backed startup had personal motivations for developing better health care tracking technology.

The mother of Sathya Elumala, who is CEO of Multisensor Diagnostics, suffers from multiple chronic health conditions and spends time in hospitals almost every month. Gene Fridman, the company’s chief technology officer, lost a sister who had a chronic condition that wasn’t detected soon enough.

Vaccines may be available for pneumococcal infections, but none of them, including the widely used Prevnar 13, can cover all strains. SutroVax is one of the startups trying to solve that problem, and today raised $64 million to test its approach in humans.

New investors Frazier Healthcare Partners and Pivotal bioVenture Partners led the Series B financing round for Foster City, CA-based SutroVax. Also participating in the round were earlier investors Abingworth, Longitude Capital, Roche Venture Fund, and CTI Life Sciences Fund. In addition to the $60 million Series B investment, SutroVax says the earlier investors are also putting another $4 million into the company.

The National Science Foundation’s Small Business Innovation Research (SBIR) program provides small business with equity-free funding to conduct research and development (R&D) work and de-risk technology for commercial success. The NSF SBIR program accepts innovative proposals that show promise of commercial and societal impact in almost all areas of technology.

SBIR Phase I proposals are expected to undertake R&D with the aim of establishing technical feasibility or proof of concept. Successful applicants will receive a grant of up to $225,000 over a period of 6 to 12 months (the period to be decided by the company).

Successful SBIR proposers will receive funding about 6 months after the solicitation deadline. Companies that receive a Phase I award are eligible to apply for a Phase II award (award amount up to $750,000; duration 2 years).

In order for America to maintain its innovative and technological competitive advantage, it is imperative that current policy design favor high growth formation through the catalytic means of institutional financing. The Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs have historically served as crucial financing to help de-risk early-stage technology development and enable validation that encourages follow-on private institution capitalization. With new trends in the Internet of Things, artificial intelligence, advanced materials, genomics, environmental sustainability, renewable energy, national security, and many other areas evolving over the years ahead, national governments bear the responsibility for helping seed the inventive fire that enables economic growth as we move forward.

WEDNESDAY, APRIL 19, 2017, 8:30 AM – 12 PM | WASHINGTON, DC

If you do business with the government, you are a target for cyber-attacks!

If you are a government contractor, join us to learn how to implement a strong and cost effective cybersecurity program that will strengthen your company’s cybersecurity posture and help you meet requirements necessary to do business with the federal government. As an attendee, you can receive two customized assessments to help identify your company’s level of exposure: (1) a mini cyber-risk review from CyberRx that will assess your company’s cyber capabilities within the Cybersecurity Framework; and (2) a threat intelligence assessment from Wapack Labs that can help to identify if your organization has been or will be the victim of an attack. Space is limited. Register today.