The Gaithersburg biotech has had no product to market in its 35-year history.

The fourth annual HERstory Gala took place on Thursday, April 21, 2022 at the VisArt Studio in Rockville Town Square. This gala is the chapter’s premier event honoring outstanding women in biotech in the Washington DC metro region. Attendees included 85 members and supporters from diverse professional backgrounds, including science, marketing, legal, and entrepreneurship.

Image: https://www.womeninbio.org

Jun 7, 2022

Novavax COVID-19 vaccine receives positive vote from U.S. Food and Drug Administration Vaccines and Related Biological Products Advisory Committee If Emergency Use Authorization is granted by the FDA, the Novavax COVID-19 vaccine would become the first protein-based COVID-19 vaccine available in the U.S. GAITHERSBURG, Md., June 7, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 21 to 0, with one abstention, to recommend that the FDA grant Emergency Use Authorization (EUA) for the Novavax COVID-19 vaccine (NVX-CoV2373) for individuals aged 18 years and over.

"The advisory committee's positive recommendation acknowledges the strength of our data and the importance of a protein-based COVID-19 vaccine developed using an innovative approach to traditional vaccine technology," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "In today's VRBPAC meeting, we heard the overwhelming support for our vaccine from physicians, healthcare organizations, and consumers who are eagerly anticipating a protein-based vaccine option. Consistent with submissions to regulatory authorities worldwide, we have already submitted an amendment with updated manufacturing information for the EUA to the FDA for review. We look forward to collaborating with the FDA as it makes its final decision."

Biotechnology firm United Therapeutics has showcased what it claims to be the “world’s most complex 3D printed object” in partnership with 3D printer manufacturer 3D Systems at the recent LIFE ITSELF conference in San Diego.

The partners have produced a 3D printed human lung scaffold capable of demonstrating gas exchange in animal models, and are now planning to cellularize the scaffold with a patient’s own stem cells to create tolerable, transplantable human lungs.

QIAGEN CEO Thierry Bernard joins Yahoo Finance Live to explain how his company is utilizing technology to track the spread of COVID through wastewater and also discusses how to track the monkeypox outbreak.

Accurately testing wastewater for COVID could help cities and towns prepare for outbreaks, stock up supplies, or put measures in place to prevent further community transmission of COVID-19. And one company recently receiving a nod from the CDC for wastewater testing is German company QIAGEN.

Health and Human Services Secretary Xavier Becerra appointed Adam Russell, Chief Scientist at the University of Maryland’s Applied Research Laboratory for Intelligence and Security (ARLIS), to serve as acting deputy director of the new Advanced Research Project Agency for Health (ARPA-H).

Proposed by President Joseph R. Biden to improve the U.S. government’s ability to speed biomedical and health research, ARPA-H was established by law on March 15 and will operate as an independent entity within the National Institutes of Health.

image: National Institutes of Health in Bethesda, Md.

Rockville, MD - On June 8th, Korea SMEs and Startups Agency (KOSME), its Korean Business Development Center (KBDC) and BioHealth Innovation, Inc. (BHI) will kick-off their second virtual US Market Entry program for Korean companies expanding to the United States.

Last summer, BHI and KOSME conducted a similar pilot program, which included five medical device and diagnostics companies.

This year’s competitively selected 5-member cohort includes medical diagnostics, medical devices, health AI and software companies. Over 25 Korea-based health-tech companies applied to the program.

The program will guide the cohort to adopt cultural business differences and communication methods, outline a go-to-market strategy, connect with strategic partners & key opinion leaders, and suggest product or prototype modifications. BHI’s Entrepreneurs in Residents (EIRs) mentor the cohort to achieve a successful US biohealth market entry.

image: KOSME President Hakdo Kim and BHI President Rich Bendis

Brian Castleberry, Maryland Department of Commerce Regional Manager - Middle East, Africa and India, Office of International Investment and Trade, and & Robin Wiener, President, Get Real Health, Join Rich Bendis on BioTalk to discuss International Collaborations, Maryland Biotech, and Collaborations.

Listen now via Google https://bit.ly/3xjyLau, Apple https://apple.co/3GU4UIP, Spotify https://spoti.fi/3MrBJ0R, Amazon https://amzn.to/3H0rL5F, and TuneIn https://bit.ly/38Ry0vV

Lung scaffolds developed in partnership with 3D Systems Corporation represent the most complex objects ever printed; reveal took place at the LIFE ITSELF Conference in San Diego

3D-printed lung scaffolds are demonstrating gas exchange in animal models

United Therapeutics expects human clinical trials of 3D-printed, cellularized lungs in the next five years

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C. & ROCK HILL, S.C.--(BUSINESS WIRE)-- United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that in partnership with 3D Systems Corporation (NYSE: DDD) it has produced the world’s most complex 3D-printed object – a human lung scaffold – and demonstrated it at the LIFE ITSELF Conference that occurred May 31 to June 3, 2022 in San Diego. The event was organized and hosted by Dr. Sanjay Gupta and Marc Hodosh and was sponsored by CNN, United Therapeutics, and other prominent corporate leaders in healthcare.

These free 1:1 virtual sessions are an opportunity to discuss your company with experts in diagnostics, therapeutics, digital health and medical devices. If you’re a growth-stage biohealth company looking for unbiased advice on your pitch deck, commercialization strategy, evidence development or entrepreneurial challenges, our EIRs can help.

To sign-up for any of the EIR dates in 2022, please follow this link.

May 31, 2022

Trial will assess safety and antibody responses of NVX-CoV2515 to the Omicron variant of COVID-19 Two-dose primary regimen of NVX-CoV2373 already demonstrated cross-reactive immune responses against Omicron and other variants

Novavax today announced the initiation of its Phase 3 strain change trial to determine if its Omicron variant specific vaccine, NVX-CoV2515 (Omicron BA.1 strain), induces superior antibody responses against the Omicron variant compared to its Wuhan prototype vaccine, NVX-CoV2373, in participants who have received either a primary (two doses) or booster (three doses) series of an mRNA vaccine. The trial will also seek to determine the antibody responses to a bivalent vaccine, containing both NVX-CoV2373 and NVX-CoV2515, administered in participants who have received a booster series of an mRNA vaccine.

The SEED Innovator Support Team helps NIH awardees build a business and explore their life science innovation's potential. Learn about the aspects of product development beyond the science of the awards.

Regulatory & Business Development Consultations

Our business development, intellectual property, regulatory, and reimbursement experts meet with innovators focused on topics including:

Optimizing formulation or manufacturing operations Establishing an advisory board  Layering intellectual property protection Preparing for regulatory interactions Gathering evidence to support reimbursement value Engaging with investors or strategic partners Learn more in this video about innovator consultations

GlaxoSmithKline (GSK) has agreed to acquire Affinivax for up to $3.3 billion, the companies said today, in a deal designed to strengthen the buyer’s vaccine portfolio with jabs based on Affinivax’s technology.

GSK is counting on Affinivax to help it compete better with Pfizer’s blockbuster pneumococcal vaccine franchise, marketed as Prevnar®, and shore up its vaccine offerings as it prepares to spin off its consumer products joint venture with Pfizer.

Image: GlaxoSmithKline (GSK) has agreed to acquire Affinivax for up to $3.3 billion, in a deal designed to strengthen the buyer’s vaccine portfolio with jabs based on Affinivax’s technology. (GlaxoSmithKline)

In recent days, prominent venture capital funds have come out with survival tips for their portfolio companies. While asking startup founders to tighten their belt is sound advice, it’s worth wondering when venture capital titans might be urged by their investors to scale back their own pay, too.

Their compensation has been rising fast. Last year, median cash pay for a partner at a venture capital firm, including base salaries and bonuses, rose 10% to $928,000, reported The Information, citing a survey conducted by Holt Private Equity Consultants.

Richmond medical technology company Tympanogen is a finalist in a national pitch competition from the National Capital Consortium for Pediatric Device Innovation.

The company, which develops nonsurgical treatments for ear, nose and throat issues, earned its place in the “Make Your Medical Device Pitch for Kids!” competition for its gel-patch system for eardrum repair, called Perf-Fix.

These free 1:1 virtual sessions are an opportunity to discuss your company with experts in diagnostics, therapeutics, digital health and medical devices. If you’re a growth-stage biohealth company looking for unbiased advice on your pitch deck, commercialization strategy, evidence development or entrepreneurial challenges, our EIRs can help.

To sign-up for any of the EIR dates in 2022, please follow this link.

Descartes-08, Cartesian Therapeutics’ investigational CAR T-cell therapy, appears generally safe and markedly lessened symptom severity in the first five patients with generalized myasthenia gravis (gMG) enrolled in a Phase 1b/2a clinical trial.

“I am very encouraged by the interim analysis findings,” as the therapy “appears safe and well tolerated, and the extent of clinical improvement seen in our early participants is remarkable,” Volkan Granit, MD, the trial’s principal investigator at the University of Miami, said in a press release.

Image: https://myastheniagravisnews.com

Health and Human Services Secretary Xavier Becerra today announced the formal establishment of the Advanced Research Project Agency for Health (ARPA-H) as an independent entity within the National Institutes of Health and the appointment of Adam H. Russell, D.Phil., as acting deputy director. Currently, Dr. Russell is the Chief Scientist at University of Maryland's Applied Research Laboratory for Intelligence and Security (ARLIS). He spent more than a decade as a Program Manager, first at the Intelligence Advanced Research Projects Activity (IARPA) and then at the Defense Advanced Research Projects Agency (DARPA). Dr. Russell will begin his new role in June.

COLUMBIA, Md. (May 25, 2022)—TEDCO, Maryland’s economic engine for technology companies, announced today it will receive up to $50 million from Governor Hogan’s small business relief plan that was approved for funding from the United States Treasury Department’s State Small Business Credit Initiative (SSBCI). TEDCO will allocate the funds into four existing programs targeting technology-based Maryland businesses and entrepreneurs.

“We want to express our thanks to our colleagues at DHCD for their leadership on getting us to this point,” said TEDCO CEO Troy LeMaile-Stovall. “And this point is about investing in individuals and communities that are underrepresented in our innovation ecosystem, while also creating additional funds for TEDCO to invest in firms that will start and scale in Maryland – generating a more equitable future.”

1:45 PM - 2:45 PM (PDT), Wednesday, June 15, 2022 ・ Upper Level, Session Room 6D

Longevity tech is one of the fastest-growing yet relatively underserved markets worldwide. Forty percent of today’s older adults self-identify as early adopters of new technology, making the field ripe for innovation. To meet the needs of older consumers, we must understand their needs and behaviors, develop strategies designed to target them, and provide capital to seed technological innovations. Non-profit foundations and accelerators, such as AARP and its Innovation Labs, play a critical role helping entrepreneurs understand, optimize, and test longevity innovations

Quantum World Congress is the first-ever gathering of its kind – connecting the world’s quantum ecosystem, including the brightest researchers, innovators, technology developers, legislators, and industry experts – to accelerate the value of the growing quantum industry.

First, there was Delta. Then Omicron. Now, it’s the Omicron subvariant BA.2.12.1. And, public health officials are keeping a close watch on the BA.4 and BA.5 subvariants. These waves of cases, caused by infections with new variants, have characterized the COVID-19 pandemic. But how can public health officials know which variants are likely to cause large numbers of cases and which will not take hold in the population?

COLUMBIA, Md. (May 25, 2022)—TEDCO, Maryland’s economic engine for technology companies, announced today it will receive up to $50 million from Governor Hogan’s small business relief plan that was approved for funding from the United States Treasury Department’s State Small Business Credit Initiative (SSBCI). TEDCO will allocate the funds into four existing programs targeting technology-based Maryland businesses and entrepreneurs.

First approval of a dry powder inhaler for treatment of PAH and PH-ILD

DPI device represents a convenient option for administration of treprostinil therapy

Commercial launch activities underway; patient availability expected in June 2022

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)-- United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, announced today that the U.S. Food and Drug Administration (FDA) has approved Tyvaso DPI™ (treprostinil) inhalation powder for the treatment of pulmonary arterial hypertension (PAH; WHO Group 1) and pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3) to improve exercise ability. Tyvaso DPI represents a new formulation and inhalation device for inhaled treprostinil and is the only dry powder inhaler approved by the FDA for use in PAH and PH-ILD.

Legal & General Capital and U.S.-based real estate developer Ancora establish landmark 50:50 partnership as LGC internationalizes its platform to drive shareholder value

London, England, UK and Durham, NC | May 25, 2022 08:00 AM Eastern Daylight Time

Legal & General Capital (LGC) today announced that it has formed a 50:50 partnership with U.S.-based real estate developer Ancora to create a real estate platform dedicated to driving life science, research and technology growth across the U.S. The deal will see Legal & General Capital investing an initial $500 million of seed capital to form a new company, Ancora L&G, LLC. Operating under the name Ancora, the business’ geographic focus will sit predominantly within emerging regional markets in the U.S. where early mover advantages are available.

Hemafuse is the Solution

There is an urgent need for blood in Ukraine. With donor blood in short supply, Hemafuse can meet this need. It is a simple, handheld device that enables surgeons to capture and reuse a trauma patient's own blood. Hemafuse is completely mechanical and can be used regardless of infrastructure. For more information visit Sisu Global's website.

Image: https://fundrazr.com

Female-founded companies account for less than one-fourth of venture funding recipients in every U.S. state with a startup scene. But they’re a lot closer to the top of the spectrum in some states, and much nearer to the bottom in others.

That was the finding from a state-by-state analysis of funding over the past three years to companies with at least one female founder. We focused on 25 states that collectively account for  over 95 percent of total U.S. funding rounds.

Image: https://news.crunchbase.com

After making striking advancements in HIV and COVID-19 research, Virongy, a biotechnology company in Prince William County, Virginia, has set its sight on tackling even more viruses. With millions of people being afflicted by viral illnesses worldwide each year, Virongy’s objective addresses an ever-increasing market need.

“Our goal is to create advanced diagnostics so that doctors can promptly prescribe treatments to patients,” said Brian Hetrick, chief scientific officer of Virongy.

After making striking advancements in HIV and COVID-19 research, Virongy, a biotechnology company in Prince William County, Virginia, has set its sight on tackling even more viruses. With millions of people being afflicted by viral illnesses worldwide each year, Virongy’s objective addresses an ever-increasing market need.

“Our goal is to create advanced diagnostics so that doctors can promptly prescribe treatments to patients,” said Brian Hetrick, chief scientific officer of Virongy.

Image: Photo by Amy Adams/Institute for Biohealth Innovation

The U.S. Department of the Treasury awarded the first batch of funding awards for the State Small Business Credit Initiative (SSBCI), a program designed to increase access to capital for traditionally underserved small businesses and entrepreneurs.

The new, expanded SSBCI provides nearly $10 billion to states, the District of Columbia, territories, and Tribal governments to promote entrepreneurship, especially in traditionally underserved communities. SSBCI funding is expected to catalyze up to $10 of private investment for every $1 of SSBCI capital funding. State governments filed plans with the Treasury on using their SSBCI allocation to provide funding to small businesses.

United Therapeutics announced on Tuesday that it received U.S. Food and Drug Administration approval for its therapeutic Tyvaso DPI.

Tyvaso DPI marks the first approval of a dry powder inhaler for the treatment of pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD).

TEDCO’s strategic plan, The Time, Talent, and Treasure Imperative for Maryland’s Ecosystem (T3IME), seizes this moment to build upon past successes and move forward differently than we have in the past. Specifically, we must scale significantly, and expand the type of resources over the next ten years (FY23-FY33). We must ensure that in this growth, we expand and include those that have been historically excluded.  We will achieve this not only with market-based fiscal returns but also by curating, investing, and growing to scale enterprises that drive societal change for our citizens and the world.

Image: https://www.tedcomd.com

The GW TCO SBIR Matching Fund will help startups collaborate with GW researchers to develop innovations licensed from GW.

The first awards will be available in summer 2022. Applications from startups will be considered on a rolling basis and may now be submitted.

The GW TCO SBIR Matching Fund will provide up to $100K per award for internal GW research. It will match 2:1 the amount of research the applicant company has sponsored at GW in the last 2 years. Also included in the match are amounts the company is providing to GW as a subaward on a Phase I SBIR or STTR, which started in the last 2 years. The maximum award is $100,000. The scope of work is to further develop a technology licensed from GW TCO. Up to 2 GW TCO SBIR Matching Funds will be provided per fiscal year.

Image: https://commercialization.gwu.edu

Y Combinator, one of the biggest startup incubator in the world, has issued an unprecedented stark warning to their startup founders.

“No one can predict how bad the economy will get, but things don’t look good,” it said, before ordering entrepreneurs to tighten their belt, lean up, and try to just survive for the next two years without any further funds.

Image: Y Combinator's Paul Graham addressing startup founders, 2020

These free 1:1 virtual sessions are an opportunity to discuss your company with experts in diagnostics, therapeutics, digital health and medical devices. If you’re a growth-stage biohealth company looking for unbiased advice on your pitch deck, commercialization strategy, evidence development or entrepreneurial challenges, our EIRs can help.

To sign-up for any of the EIR dates in 2022, please follow this link.