441st Edition, February 2, 2021

The move comes less than three years after the Gaithersburg biotech spun out of MedImmune.

Image: Viela Bio CEO Bing Yao, pictured here on the company’s IPO day at the Nasdaq. LIBBY GREENE

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Manufacturing powerhouse Emergent BioSolutions unveiled its seventh COVID-19 CDMO tie-up Monday, this time to help crank out Humanigen’s late-stage antibody hopeful lenzilumab.

Emergent will hustle along fill-finish work on lenzilumab at its Camden plant in Baltimore, boosting supplies ahead of a possible emergency nod early this year. Humanigen’s monoclonal antibody, designed to treat and prevent the immune hyper-response known as cytokine storm, is currently in a phase 3 trial in hospitalized patients, and the company says it expects to file for an emergency use authorization in 2021’s first quarter.

Image: Emergent recently completed a new filling line at its Camden plant in Baltimore, pictured above. (Emergent BioSolutions)

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The move solidifies the company’s local presence about four months after it secured a temporary occupancy permit in September.

Image: Ben Wu is CEO of the Montgomery County Economic Development Corp. EMAN MOHAMMED

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Novavax electrified investors last night by announcing that its COVID-19 vaccine NVX-CoV2373 showed efficacy of 89.3% in the company’s first analysis of data from a Phase III trial in the U.K., where a variant strain (B.1.1.7) accounted for about half of all positive cases.

However, NVX-CoV2373 achieved only 60% efficacy in a Phase IIb trial in South Africa, where that country’s escape variant of the virus (B.1.351, also known as 20H/501Y.V2) was seen in 90% of cases, Novavax said.

“NVX-CoV2373 is the first vaccine to demonstrate not only high clinical efficacy against COVID-19 but also significant clinical efficacy against both the rapidly emerging U.K. and South Africa variants,” Stanley C. Erck, Novavax’s president and CEO, said in a statement.

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Patient engagement platform GetWellNetwork announced it has acquired patient-messaging company Docent Health for an undisclosed sum.

As part of the deal, GetWellNetwork will be able to offer Docent Health’s tool as a combined offering with its other services. The messaging service uses artificial intelligence to message patients about their care. Additionally, its platform is able to collect patient data and, in turn, triage patients and find them the right place of care to seek.

Image: https://www.mobihealthnews.com

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Oxford, UK – Vaccitech Ltd announces that the European Medicines Agency (EMA) has today recommended the conditional marketing authorisation of the ChAdOx1 nCoV-19 coronavirus vaccine developed by the University of Oxford with its partner AstraZeneca. Distribution will begin across all 27 member states once the decision is ratified by the European Commission. The vaccine was co-invented by Vaccitech and The University of Oxford’s Jenner Institute.

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THE BIDEN administration announced Monday that it is investing $230 million in Ellume, an Australian company, for millions of its at-home coronavirus testing kits.

The deal, struck by the Department of Health and Human Services and the Department of Defense, ensures 100,000 over-the-counter test kits will arrive in the U.S. starting this month through July, acting Centers of Medicare and Medicaid Services Administrator Andy Slavitt said Monday during a White House briefing.

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Medical device engineering firm, Engenious Design, partners with Innara Health to design the 2nd generation of their ground-breaking technology designed to improve feeding outcomes in premature infants. Prairie Village, KS: Engenious Design, a 39-person creative product development firm specializing in electronic medical device design, has partnered with Kansas City-based start-up Innara Health to develop Innara’s next-generation NTrainer System ®, designed to improve access to more patients by reducing the size and cost of the system, enabling Innara to expand into new markets and provide better access to life-changing therapy and assessment tools for infants.

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The Children’s National Research & Innovation Campus (RIC), the first-of-its-kind pediatric research and innovation hub located in Washington, D.C., now has its first occupant – the Rare Disease Institute (RDI).

The institute, which includes the largest clinical group of pediatric geneticists in the nation, focuses on developing the clinical care field of the more than 8,000 rare diseases currently recognized and advancing the best possible treatments for children with these diseases.

Image: https://innovationdistrict.childrensnational.org/

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Two young pharmaceutical companies are teaming up to bring a sizable new facility and nearly 200 new jobs to Petersburg.

Gov. Ralph Northam announced Thursday that Civica Inc., a Utah-based drug manufacturing nonprofit, will build a $124.5 million pharmaceutical plant along North Normandy Drive in Petersburg.

Image: The proposed $125 million pharmaceutical plant in Petersburg will total 120,000 square feet. (Courtesy of Phlow)

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Baltimore-based LifeBridge Health is partnering with Healthworx, the innovation and investment arm of CareFirst BlueCross BlueShield, to launch a new incubator for startup companies developing healthcare technologies and innovations.

The incubator, dubbed 1501 Health, will provide companies participating in the program up to $100,000 in investment as well as access to mentorship and support from payer and provider experts, according to a Jan. 26 news release emailed to Becker’s Hospital Review.

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Wilmington’s Amalgam Rx, a digital medicine and patient support company, has acquired Baltimore-based Avhana Health.

With the acquisition, which closed this month, Avhana’s seven employees will join Amalgam’s 100-member team, which already has a presence in Baltimore. The acquisition is Amalgam Rx’s first. Terms were not disclosed.

Image: (Image via linkedin.com/company/amalgamrx)

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A new “blank check” company created through a partnership between Baltimore venture capital firm Catalio Capital Management and New York investment firm HealthCor Management launched a $180 million IPO Wednesday.

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One of the questions I get asked the most is when I think the world will get back to normal. I understand why. We all want to return to the way things were before COVID-19. But there’s one area where I hope we never go back: our complacency about pandemics.

The unfortunate reality is that COVID-19 might not be the last pandemic. We don’t know when the next one will strike, or whether it will be a flu, a coronavirus, or some new disease we’ve never seen before. But what we do know is that we can’t afford to be caught flat-footed again. The threat of the next pandemic will always be hanging over our heads—unless the world takes steps to prevent it.

Image: https://www.linkedin.com/pulse/its-too-soon-start-thinking-next-pandemic-bill-gates/

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The Johnson & Johnson one-shot coronavirus vaccine is expected to be a game-changer in fighting COVID-19 — and it will be made in Baltimore.

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2020 was an interesting year for the biotech industry and the BioHealth Capital Region as we adjusted to continue moving forward during the COVID-19 Pandemic. While the biggest stories in terms of dollars were related to the Coronavirus and funding to create a vaccine in record time, that didn’t stop other biotech companies from working hard to develop their research, science, and/or devices.

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WASHINGTON, D.C., January 29, 2021 – Connected DMV’s COVID-19 Strategic Renewal Task Force held its seventh meeting on Thursday, adopting a recommendation to proactively address climate change through the establishment of a regional Hydrogen Center that affirms Greater Washington as a leader in the hydrogen economy. Task Force members agreed that collaboration across borders and disciplines to tackle climate change, using hydrogen energy, is a national and regional imperative, and by utilizing the significant assets of the DMV region, an achievable goal.

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The COVID-19 pandemic is a stark wake-up call for the United States to take biological threats seriously. The virus is on track to take the lives of more than 400,000 Americans and cost our economy trillions of dollars. The risks of future pandemics increase as technological progress eases barriers to modifying pathogens, raising the specter of novel biological agents causing diseases much worse than humanity has ever faced. Meanwhile, U.S. vulnerabilities to biological attacks have never been clearer to our adversaries.

However, there is a path forward. The Apollo Program for Biodefense would provide the United States the opportunity to mobilize the nation and lead the world to meet these challenges: a world where we detect and continually trace any new pathogen from the source; where we can distribute rapid point-of-person tests to every household in the country within days of that detection; where effective treatments are already in-hand; where vaccine development and rollout occur in weeks rather than years; and where pandemics will never again threaten the lives and livelihoods of Americans and people around the world.

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Georgetown-based Halcyon Incubator has announced the 14th cohort for its incubator for early-stage social impact entrepreneurs. The 18-month fellowship welcomes nine ventures, majority of which are minority-owned, to scale their business models.

Image: Halcyon House in Georgetown. (Photo via Halcyon on Facebook)

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In the race to vaccinate people for Covid-19, everyone agrees front-line health workers, the elderly and those with pre-existing conditions should get priority. But one vital group is being overlooked. Even worse, some are criticizing efforts to vaccinate them as some sort of effort to “cut the line.”

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Recently a colleague asked me to predict the future of pediatric #medicine in 30 years. To help develop my list, I tapped many of the smartest people I know: Leaders from Children’s National Hospital. Here are some of the fascinating predictions.

1) Healing children and keeping them healthy will be an international priority, which is reflected in increased attention and funding for pediatric medicine and #research.

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The lack of reliable access to broadband internet service for many in Baltimore, particularly the poor, has profound economic and social consequences. The COVID-19 pandemic has made this painfully clear with its abrupt shifts to online learning, remote work, and telemedicine. A new analysis from Johns Hopkins University’s 21st Century Cities Initiative says the city could move towards digital equity, with a roadmap of recommendations built on existing knowledge of Baltimore’s digital assets and the experiences of other cities.

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Newswise — Healthworx, the innovation and investment arm of CareFirst BlueCross BlueShieldis partnering with LifeBridge Health to launch 1501 Health, an incubator for healthcare startups. 1501 Health will provide investment and resources to help early-stage companies, located regionally or nationally, develop their healthcare solutions.

Companies participating in the program will receive up to $100,000 in investment and have access to unique mentorship and support from payer and provider experts, along with networking and educational events with other startups, investors and stakeholders.

Image: Healthworx 1501 Health in Baltimore, MD

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Earlier this month we posited the idea that 2021 could be the year of quantum computing-led drug discovery and predicted that partnerships like those of Google and European pharma giant Boehringer Ingelheim would be more common with more quantum hardware makers tying the knot with drug manufacturers.

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