541st Edition, January 10, 2023

This free 1:1 virtual session is 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 request a feedback session, please send a non-confidential pitch deck, and a short description of the input you’re seeking from the EIRs, to Sarah Miller   smiller@biohealthinnovation.org  

The requested information should be received by our office at least 2 weeks in advance, so that we can schedule the appropriate experts. Thank you!

On September 30, 2022, the SBIR and STTR Extension Act of 2022 (the Act) was enacted, reauthorizing the SBIR and STTR programs until September 30, 2025. The Act makes several significant changes related to national security risks and foreign influence in the programs. The changes include agency implementation of due diligence procedures, new offeror disclosure and ongoing contractor reporting requirements, and new award eligibility requirements, with an offeror’s or contractor’s omissions or misstatements resulting in repayment of the entire award amount, among other changes to the programs.

Jan 9 (Reuters) – Life sciences firm Qiagen said on Monday it has acquired DNA-biometrics firm Verogen in a $150-million cash deal, strengthening its forensics portfolio.

The deal builds on the companies’ existing partnership from 2021, under which Qiagen has the rights to distribute some of Verogen’s products such as its next-generation gene sequencing panels and genetic code analyzing technology GEDmatch.

GAITHERSBURG, Md., Jan. 05, 2023 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has signed an indefinite-delivery, indefinite-quantity procurement contract with a maximum value up to $379.6 million to supply RSDL® (Reactive Skin Decontamination Lotion Kit) for use by all branches of the U.S. military. Emergent’s Canadian Subsidiary will serve as the sole subcontractor to deploy RSDL® to the U.S. Department of Defense (DoD) through a new contract award to the Canadian Commercial Corporation (CCC). The new contract has a base year, which began in December 2022, and four single year option renewals.

“Emergent has a 25-year history of developing and supplying medical countermeasures (MCM) for the U.S. and other governments around the world,” said Paul Williams, senior vice president, government MCM at Emergent. “RSDL® has been a routine part of the U.S. warfighters armamentarium for 13 years. This new contract award demonstrates the unique capabilities of our core MCM business to continue to meet the needs and deliver on the requirements for chemical and biological preparedness of public and military forces, which is an important part of our mission to help protect and enhance life.”

Today we announced an agreement to acquire CinCor Pharma, Inc., a US-based clinical-stage biopharmaceutical company, focused on developing novel treatments for resistant and uncontrolled hypertension.

The acquisition will strengthen our cardiorenal pipeline, where there is a high unmet medical need.

This acquisition is expected to close in first quarter of 2023, subject to regulatory approvals and other customary closing conditions. Additional important information can be found here: https://know.az/3IvkzkQ

SHANGHAI, Jan. 4, 2023 /PRNewswire/ — WuXi Biologics (“WuXi Bio”) (2269. HK), a leading global Contract Research, Development, and Manufacturing Organization (CRDMO), today announced a license agreement with GSK plc (LSE/NYSE: GSK) under which GSK will have exclusive licenses for up to four bi- & multi-specific TCE antibodies developed using WuXi Biologics’ proprietary technology platforms.

Under the terms of the agreement, GSK will be granted an exclusive global license for the research, development, manufacturing, and commercialization of a pre-clinical bispecific antibody that crosslinks tumor cells and T cells by targeting a tumor-associated antigen (TAA) on tumor cells and CD3 expression on T cells and up to three additional pre-clinical TCE antibodies currently at an earlier discovery stage. WuXi Biologics will receive a $40 million upfront payment and up to $1.46 billion in additional payments for research, development, regulatory and commercial milestones across the four TCE antibodies. WuXi Biologics is also eligible to receive tiered royalties on net sales.

ROCKVILLE, Md., Jan. 4, 2023 /PRNewswire/ — Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that Matt Honan has joined the company as vice president and global head of corporate development.

In this newly created position, Honan will lead the company in identifying and executing acquisitions that complement Emmes’ existing strong federal government client base, expand its biopharma portfolio, enhance its technology offerings, and broaden its global reach.

For the second year in a row, we offer readers a look at the 100 men and women who are shaping our businesses, governments, nonprofits, law firms and other key institutions.

Thomas Baden Jr.

The Power 100 List for 2022-23 focuses on the people who play an outsized role in the culture, lifestyle, civic conversation and economic fortunes of Maryland.

Image: https://thedailyrecord.com – Thomas Baden Jr.

The transition will take place in late January.

Image: Stanley Erck is retiring as CEO of Gaithersburg vaccine maker Novavax. EMAN MOHAMMED

ROCKVILLE, Md., Jan. 3, 2023 /PRNewswire/ — NeoImmuneTech, Inc. (NIT or “NeoImmuneTech”), a clinical-stage T cell-focused biopharmaceutical company, today announced an agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (NIH), to develop NeoImmuneTech’s main asset NT-I7 (efineptakin alfa) (rhIL-7-hyFc), for the treatment of Acute Radiation Syndrome (ARS).

ARS is an acute illness caused by irradiation of most of the body by a high dose of penetrating radiation in a short period of time. These kinds of exposures can cause profound suppression of hematopoiesis and T cell depletion, significantly increasing susceptibility to infections. Currently, there is no therapeutic option for accelerating recovery of the T cell compartment following radiation exposure. NT–I7, a novel long-acting human interleukin-7 (IL-7), is expected to quickly restore lymphocyte levels and reduce vulnerability to infectious disease after radiation exposure. In the clinical setting, NT–I7 has been shown to increase T cell counts significantly and persistently while being safe and well tolerated.

Maryland, with its six million plus residents, may not be the biggest state, but even before the creation of the United States, the colony’s location in the mid-Atlantic was key to its economic prosperity.

While the state’s central location on the Eastern seaboard is still vital for companies like Amazon and its massive Baltimore-area shipping enterprise, the proximity to another center, the federal capital, provides Maryland with its most important source of large employers.

Image: https://www.heraldmailmedia.com

Cast your mind back to 2020, if you can bear it. As the year progressed, so did the impact of covid-19. We were warned that wearing face coverings, disinfecting everything we touched, and keeping away from other people were some of the only ways we could protect ourselves from the potentially fatal disease.

Thankfully, a more effective form of protection was in the works. Scientists were developing all-new vaccines at rapid speed. The virus behind covid-19 was sequenced in January, and clinical trials of vaccines using messenger RNA started in March. By the end of the year, the US Food and Drug Administration issued emergency-use authorization for these vaccines, and vaccination efforts took off.

Image: STEPHANIE ARNETT/MITTR; ENVATO

Looking forward to the trends that will define the new year, and predictions for 2023, a group of leading life sciences industry analysts predicted a much more cautious approach to investment, a reflection of larger macroeconomic challenges, yet continued long-term investment in an asset class that continues to grow in importance.

“We’ve entered a really slow, kind of cautious period,” JLL Head of Americas Work Dynamics and Industry Research Amber Schiada said. “We’ve also seen valuations come back down to earth, too.”

Scientists and researchers have made remarkable breakthroughs in basic science to better understand the complex pathology of many diseases today. Some of that progress is through utilizing technology to uncover new insights, and some of the progress is through the incalculable capacity of the human mind to analyze problems and find solutions. With all that knowledge and all the effort put in, however, human biology and disease pathology continue to be surprising. Every day researchers continue to make profound discoveries in basic science that create new possibilities in fighting disease.