Emmes today announced that the U.S. Food and Drug Administration (FDA) has approved a prescription-only medical device used to estimate the weight of infants who are up to 90 days of age.

The Mercy babyTAPE is a tape-measure-like device that permits health care professionals to estimate the body weight of preterm and full-term infants when a scale may not be available or practical to use. Accurately estimating pediatric patient weight is important for drug dosing, resuscitation interventions, and nutritional assessments. This easy-to-produce device could be especially useful in emergency or resource-constrained situations such as remote or rural areas, and in developing countries.

GAITHERSBURG, Md., Jan. 13, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) announced that it has received agreement from the European Medicines Agency (EMA) to pursue its proposed development plan for its chikungunya virus virus-like particle (CHIKV VLP) vaccine candidate. The company has proposed conducting a safety and immunogenicity Phase 3 trial using Serum Neutralizing Antibodies (SNA) as an immune correlate of protection to predict clinical benefit of the vaccine candidate.

“Emergent is encouraged by the concurrence we have received from EMA in paving the path for chikungunya vaccine development based on SNA as the surrogate endpoint,” said Abbey Jenkins, senior vice president and vaccines business unit head at Emergent BioSolutions. “As a leading provider of travel health vaccines, Emergent seeks to address the threat posed by this highly debilitating virus by defining a realistic and optimal path to bring to market a much-needed chikungunya vaccine that could potentially serve patients worldwide. We look forward to continuing to work with regulators, including the U.S. Food and Drug Administration (FDA) with whom we had our End-of-Phase 2 meeting last December, as we plan to initiate a pivotal Phase 3 trial this year and define the approach for a post-approval confirmatory efficacy trial.”

When Robert Lord cofounded Protenus with Nick Culbertson in 2014, it required choosing to put medical school on hold. After six years and plenty of growth at the Fells Point-based healthcare analytics company, Lord is returning to Johns Hopkins this month to complete training to become a physician. With that move, he will transition from a day-to-day leadership role to chairman of the board. The transition has been in the works for several months, and his responsibilities were apportioned across the company in that time.

Image: Protenus cofounder Robert Lord. (Courtesy photo)

Engineered Medical Systems, Longeviti Neuro Solutions and The LaunchPort™ announced today that they have entered into an agreement to place new, low temperature, low toxicity hydrogen peroxide sterilization capacity at The LaunchPort™/EMS facility in Port Covington. The systems are being procured by Longeviti to support the Maryland production of their Low-profile Intracranial Devices (L.I.D.) platform. The Longeviti L.I.D. Platform has led to several innovative FDA cleared products thus far, the ClearFit and InvisiShunt, and more are in development. The systems will be operated by Engineered Medical Systems within EMS’s regulated medical manufacturing facility at LaunchPort™. These new systems are expected to have completed initial validations by the end of Q1 2020.

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Herndon, VA, Jan. 14, 2020 (GLOBE NEWSWIRE) -- The Center for Innovative Technology (CIT) today released the 2019 CIT GAP Funds Impact Report, detailing both return on investment and socio-economic impact made since the fund’s inception in 2005. A family of funds placing equity investments in Virginia’s high-growth based technology, life science, and cleantech companies at the earliest developmental stages, CIT GAP Funds has deployed $28.8 million in capital across 223 investments. CIT GAP Funds investment leadership has attracted national recognition and continues to demonstrate why CIT has been named Virginia’s Most Active Investor for the last five years by CB Insights.CIT GAP Funds has yielded four times their capital invested across Tech Fund “Roadmap” investments in cybersecurity, data analytics, enterprise software and deep tech sectors and helped position the fund for return of all capital deployed. The report highlights several other figures that capture the overall impact CIT GAP Funds has on the Commonwealth, including:

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The seller converted the office space — leased heavily by local biotech companies — to lab suites, then sold the buildings just three years after buying them.

Image: The buildings at West Watkins Mill Road and Clopper Road collectively sold for $53.25 million. COURTESY TRITOWER FINANCIAL

The BioHealth Capital Region (BHCR) experienced significant change in 2019 that has set the table for an intriguing 2020.

How 2020 plays out across the region is unknown.

However, if you’ve followed BioBuzz throughout the past year, it is abundantly clear that workforce development strategy, investment, and support will be a critical issue for the next decade in the BHCR. In addition to change and growth across more traditional life science sectors, the ascension of personalized medicine within the region, which includes a host of new and growing regenerative medicine, cell therapy, and gene therapy companies, has transformed the region’s workforce needs.

A Baltimore business incubator has been named among the best in the world.

Emerging Technology Centers in Baltimore has been recognized by UBI Global as one of the 10 best public business incubators in the world.

The ranking was created based on a world benchmark study that included a total of 1,580 programs worldwide assessed on 21 key performance indicators including economy enhancement, talent retention, access to funds, post-graduation performance of companies and more to create lists of the top university, public and private incubators.

Image: The ETC is located at the King Cork & Seal building in Highlandtown. CONTROL TEC INC, & METRO DEVELOPMENT LLC

LOS ANGELES, Jan. 15, 2020 /PRNewswire/ -- USA News Group – A new study published in the journal Molecular Therapy reports that researchers found a drug used in the treatment of HIV that may also suppress Zika virus infection. Zika virus disease is caused by a virus transmitted primarily by Aedes mosquitoes, which bite during the day.

Research and developments with multidisciplinary approaches are proving vital to the treatment and defense against viral and infection diseases as they become more aggressive and deadly. Companies preparing to offer new treatments to deal with the onslaught may become some of valuable over the next decade. Leaders in this space are anticipating strong revenue from collaborations including NGM Biopharmaceuticals Inc. (NASDAQ: NGM), Emergent BioSolutions Inc. (NYSE: EBS), and SIGA Technologies, Inc. (NASDAQ: SIGA)

SAN FRANCISCO—Roche has inked a 15-year partnership with Illumina in oncology, which will include collaborating on new companion diagnostic indications for the DNA sequencing giant’s pan-cancer assay.

Announced during the J.P. Morgan Healthcare Conference, the nonexclusive pact will also enable Roche to develop and distribute in vitro diagnostic tests for Illumina’s current and future hardware lines—such as the NextSeq 550Dx and the upcoming NovaSeqDx system. The deal’s financial terms were not disclosed. 

Image: Roche and Illumina, as well as Roche's Foundation Medicine division, will work to secure regulatory approvals for Illumina’s TruSight Oncology 500 assay as a pan-cancer companion diagnostic for different targeted therapies. (Illumina)

GERMANTOWN, Md., Jan. 6, 2020 /PRNewswire/ — Precigen, Inc., a biopharmaceutical company specializing in the development of innovative gene and cellular therapies to improve the lives of patients, today announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to PRGN-3006, a first-in-class investigational therapy using Precigen’s non-viral UltraCAR-T™ therapeutic platform for patients with relapsed or refractory acute myeloid leukemia (AML) (clinical trial identifier: NCT03927261). Precigen announced in Q3 2019 that it had completed enrollment for the first cohort of this clinical trial and expects an initial data readout in the second half of 2020.

The National Institute of Standards and Technology is seeking public feedback on its plan to revamp the Interagency Edison (iEdison) System, an online portal where companies that receive federal government funding report their inventions.

The project is part of NIST’s increased focus on federal technology transfer as part of the Lab-to-Market Cross-Agency Priority Goal under the President’s Management Agenda. Every year the federal government invests more than $100 billion in research and development, and in return grantees report the inventions that come out of this funding to the government through iEdison.

The Maryland Department of Commerce has created a new role focused on the state's startup ecosystem and tapped a former investment banker and angel investor to head up the effort.

Allyson Redpath, who previously worked at Citigroup and Goldman Sachs, started as the department's entrepreneurship director on Dec. 18, Secretary Kelly Schulz announced Thursday. In her new role, Redpath will work to attract and retain early-stage companies in Maryland. She will also help facilitate connections between these businesses and available resources, such as access to capital, company counseling and other small business workshops and events.

Image: Joanne S. Lawton

Rockville, Maryland-based Hememics Biotechnologies Inc. has secured a $2.5 million investment from AMVI Partners, an international investment firm with offices in McLean, Virginia.

The startup is working on developing a handheld device equipped with a multiplex panel chip that is able to rapidly test a blood sample to detect bacteria or proteins in less than a minute. The initial device in development, named HEMEMICS, is a point-of-care panel to test for sexually transmitted diseases.

IBT Vaccines, a wholly owned subsidiary of Integrated Biotherapeutics Inc., announces it has received $3.9 million to advance the development of the IBT-V02 vaccine for Staphylococcus aureus induced recurrent skin and skin structure infections (SSSI). The funding is part of a $48 mil. investment in 8 companies by Novo Holding’s REPAIR Impact Fund, established in 1999 to support the discovery and early development of therapies targeting drug resistant microorganisms. IBT-V02, which is currently in late pre-clinical development, is a unique and potentially first-to-market multivalent toxoid vaccine with broad coverage. S. aureus produces a remarkably large number of toxins that modulate host immune response. The goal is to harness the growing knowledge about its complex relationship with the host to develop effective prophylaxis and immunotherapy for S. aureus/MRSA disease.

When Daria Mochly-Rosen discovered a compound in her lab that promised to lessen the effects of heart attacks, she set out to convince pharmaceutical companies to develop it.

She couldn’t.

So the professor of chemistry and systems biology at Stanford University’s School of Medicine took a leave of absence and started her own company to further test and potentially commercialize the drug.

It seemed the obvious next step. After all, universities often speak of their success in turning research into products that make life better, with the added bonus of contributing to the economy. There are seemingly countless examples, including Gatorade, invented at the University of Florida; Google, which began at Stanford; web browsers and plasma screens, both created at the University of Illinois; and the drug that became the allergy medicine Allegra, developed at Georgetown University.

The big deal about the just-completed J.P. Morgan (JPM) 38th Healthcare Conference had little to do with big M&A deals, because there weren’t any. This time last year, the $74-billion Bristol-Myers Squibb acquisition of Celgene was announced, as was Eli Lilly’s takeover of Loxo Oncology for $8 billion.

There were no such blockbusters this year, though there was an interesting potentially up-to-$2 billion-plus collaboration: MorphoSys outlicensed ex-U.S. commercialization rights to its anti-CD19 Fc-engineered antibody tafasitamab to Incyte, with the companies agreeing to co-commercialize the B cell malignancy candidate Stateside.

Image: A dearth of deals, Illumina’s double launches, and the usual crowds marked the 38th J.P. Morgan 38th Conference. - https://www.genengnews.com

When was the last time you analyzed how much you should pay your board members? How do you know if you are paying too much or not enough? In this article we examine the results of our most recent research that highlights how much board members should receive in compensation.

Business size, industry, structure, complexity, the number of yearly meetings are just a number of variables you have to consider when setting your board remuneration programs. Private companies tend to struggle with board compensation because it is difficult to find accurate benchmarks for director pay.

SAN FRANCISCO, Jan. 17, 2020 /PRNewswire/ -- AMPEL BioSolutions' Co-Founder and COO/CSO Dr. Amrie Grammer today at the Biotech Showcase at JP Morgan Healthcare announces the kickoff of a Series A $12.5M raise to commercialize LuGENETM, a gene-based diagnostic.  AMPEL's initial focus is Lupus, but the test can be used for many autoimmune or inflammatory diseases.  AMPEL'S goal is to have its test available for routine use by physicians within the next few years.

Why me?

I have spent the last 20 years as a serial CEO of multiple healthcare startups, as well as spending the last 3 years as a corporate/strategic venture capitalist. I have made many mistakes and gotten lucky on more than a few occasions. What I hope to accomplish in this blog is simple: educate and, on a good day, entertain. There are many that are much, much more successful than me (nearly everyone in Silicon Valley!). There are some that are worse (also in Silicon Valley...e.g. Elizabeth Holmes re: Theranos). I am not from Silicon Valley. If you have questions, comments, or suggestions (future topics), please feel free to reach out to me.

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BioSciCon, Inc., a woman-owned small business based in Rockville, Maryland focused on providing a low-cost and accessible diagnostic system for the detection of cervical cancer announced today that it is seeking a partner to make its proprietary MarkPap® platform available to women in low- and middle-income countries.

According to BioSciCon Director and President of the Global Academy for Women’s Health Dr. Olivera Markovic, “In low- and middle-income countries (LMICs), thousands of women still are dying needlessly every year from cervical cancer due to the astonishingly low screening in LMICs for this highly preventable disease. Our kit and screening model, if applied as designed, could prevent the deaths of about 300,000 women annually, through improved and expanded screening and early detection of cervical cancer.”

The idea for BioSciCon was conceived by Drs. Olivera and Nenad Markovic upon discovery of a new bioactive protein residing only in specimens obtained from abnormal cervical tissues. Continued success of their team of scientists led to the development of a proprietary technology for visualization of this protein by simple laboratory pathology means known as the CAP-PAP Test. The MarkPap® System has been tested in more than 2000 women and proven to result in faster, less expensive and more accurate diagnosis of cervical cancer than the conventional Pap and liquid-based Pap test.  These improved outcomes have been documented in more than 60 publications in peer-reviewed  journals and in the reference guide “What Every Woman Should Know about Cervical Cancer”).  To further the company’s mission to save women’s lives through early intervention in LMICs, BioSciCon is seeking a partner to distribute MarkPap kits to underprivileged women in low resource settings.

Click here for more information.

AstraZeneca today announced the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for FARXIGA® (dapagliflozin) to reduce the risk of cardiovascular (CV) death or the worsening of heart failure (HF) in adults with heart failure with reduced ejection fraction (HFrEF) with and without type 2 diabetes (T2D).

The Prescription Drug User Fee Act date, the FDA action date for this supplemental application, is scheduled for the second quarter of 2020.

Hi, I am Harsha Rajasimha, Founder and Chairman of IndoUSrare, an independent non-profit organization focused on helping patients with rare diseases of Indian origin in the USA, India and globally with a vision to build collaborative bridges between the east and the west to accelerate research and development of diagnostics and therapies through education, advocacy, research & grants.

WASHINGTON – The National Capital Consortium for Pediatric Device Innovation (NCC-PDI), in collaboration with MedTech Innovator, is now accepting applications for its showcase pitch event on March 23, 2020, in College Park, Maryland. The competition is focused on pediatric devices in three areas of critical need: cardiovascular, orthopedic and spine, and neonatal intensive care unit (NICU).

Up to ten companies selected from this event will move on to the “Make Your Medical Device Pitch for Kids!” on Oct. 4, 2020 in Toronto, Canada, to compete for up to $250,000 in grant awards. These companies also receive a spot in the MedTech Innovator 2020 Accelerator – Pediatric Track, which provides a customized curriculum and in-depth mentorship.

BioMarker Strategies, LLC, today announced that the National Cancer Institute (NCI) has awarded the Company a Phase II Small Business Innovation Research (SBIR) contract to continue development of its PathMAP® Immunotherapy test to predict clinical response to PD-1/PD-L1 targeted immune checkpoint inhibitors, both alone and in combination with chemotherapies, for individual patients with non-small cell lung cancer (NSCLC). The contract totals $1.5 million over two years.

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A company developing treatments for drug-resistant bacterial infections is getting a boost from the Department of Defense.

Gaithersburg, Maryland-based Adaptive Phage Therapeutics, also known as APT, said Tuesday that it the DoD had awarded it $10.2 million to fund a clinical trial to develop its personalized bacteriophage therapeutic, PhageBank.

CHICAGO/TEL AVIV-YAFO (January 7, 2020) – LionBird has a new partner: Robert Lord. Lord is the co-founder of Protenus, a healthcare compliance analytics company from LionBird’s second fund. Lord joins LionBird to provide strategic insight as the company prepares to hone its digital health focus for its upcoming fund, LionBird III. In addition to his role at LionBird, Lord is the Chairman of the Board of Protenus, providing support to the Protenus team while also completing his medical degree at Johns Hopkins University School of Medicine.

BioSpace is proud to present its NextGen Bio “Class of 2020,” a list of up-and-coming life sciences companies in North America that launched* no earlier than mid-2018.

To come up with this list, BioSpace sorted companies into that age grouping, and they were then weighted by a number of different categories and finally ranked in a cumulative fashion, based on the points awarded for each category. These categories were: Finance, Collaborations, Pipeline and Innovation (view methodology below).

Image: https://www.biospace.com

Here we are… 2020. As we approach this new decade with a fresh lens of excitement and rejuvenated ambition for impact, there are a few fundamentals that we should review. Elements we all know are important in our commercial strategy, yet can be abandoned in the hustle of launching a new product, service, or company to market. We should take a moment to reflect on the past decade’s success and challenges specific to the life science industry. Many questions still remain as we progress into the new year—will painful blood draws finally be a thing of the past thanks to Velano Vascular’s needless vascular access device? Or, could cutting edge digital health companies, such as Livongo or Virta Health, eliminate chronic conditions like Type 2 diabetes? Further, many often wonder, will traditional pharmaceutical drugs be replaced by Prescription Digital Therapies (PDT) altogether? 

Oncology, neurology, and fatty liver disease are among the areas where one can expect to see significant activity this year, according to forecasts from investment bank analysts.

Anticipated highlights for 2020 include potentially the first regulatory approval of a drug to treat the liver disease nonalcoholic steatohepatitis, or NASH; the launches of two new drugs for sickle cell disease; and late-stage data for a drug to treat amyotrophic lateral sclerosis, among others. Several company executives also shared their insights in a story published over the weekend.

Competition for startups aims to increase the pace of development and commercialization of critically needed pediatric medical devices. In the world of innovation, devices used for pediatric medical care, particularly the very young, are lagging behind those created for adult purposes. A contest is now open, inviting innovators to do something about it. Top contenders will be awarded with support from an innovation accelerator to further develop their device and an opportunity to win up to $250,000 in grant money.

A new initiative spearheaded by Johns Hopkins is setting out to organize and grow the digital health community in the region, with an aim of fueling successful startups.

The Chesapeake Digital Health Exchange (Chesapeake DHX) wants to create more connectivity between the stakeholders in digital health, such as companies, investors and healthcare providers. The regional effort aims to include Maryland, D.C. and Northern Virginia.

COLUMBIA, Md., Jan. 8, 2020 /PRNewswire/ -- TEDCO, Maryland's economic engine for technology companies, announced its recent round of funding for select projects through the Maryland Innovation Initiative (MII). This round of funding includes project grants for technology assessment and investments in the spin-out companies, from its five partner universities for a total of $2.63M.

Established in 2012, the MII program was created as a partnership between the State of Maryland and five Maryland academic research institutions: University of Maryland, College Park; University of Maryland, Baltimore County; University of Maryland, Baltimore; Johns Hopkins University; and Morgan State University. The program's mission is to accelerate promising technologies with significant commercial potential to market while leveraging each partner University's strengths.

The Center for Innovative Technology (CIT) today announced that CIT GAP Funds has invested in Herndon, Va.-based Jeeva Informatics Solutions Inc. (Jeeva), a precision medicine data science company focused on significantly accelerating clinical trial operations by taking trials to patients’ homes. Using AI and digital health technologies, Jeeva fast tracks patient recruitment, improves adherence to trial protocols, and reduces patient burden and dropout rates, solving some of the pressing challenges in bringing innovative medicines to market effectively. Jeeva plans to use the GAP Funds investment to advance customer pilot projects and use cases for further validation.

NexImmune, a clinical-stage biopharmaceutical company developing novel immune-therapeutics based on a proprietary Artificial Immune Modulation (AIM) nanotechnology platform, announced that industry veterans Han Myint, MD has been appointed as the Company’s Chief Medical Officer. Additionally, John Trainer, MBA has been appointed as the Chief Financial Officer.

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