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."

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

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.

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.”

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.

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.

On Friday December 16, Merck (NYSE: MRK) today announced the launch of their first biopharmaceutical cohort through the Merck Digital Sciences Studio (MDSS), a collaboration between Merck, Microsoft for Startups, and the New Jersey Innovation Institute, a New Jersey Institute of Technology (NJIT) subsidiary. The 10-month startup accelerator program with direct investments from Merck Global Health Innovation Fund, Northpond Ventures, and McKesson Ventures will empower members and enable the generation of innovative digital technologies for drug discovery and development through hands-on mentorship, connection opportunities with industry leading partners, and training in an active entrepreneurial setting. The program includes workshops, mentorship, coaching, subsidized office space, and access to Microsoft's Founders Hub resources, including Azure Cloud computing credits.

Great minds, innovators, bold thinkers and visionaries come to Montgomery County, MD to create something revolutionary. There’s a reason why. We have everything you need to succeed – top talent, diverse thinkers, incredible incentives and funding, proximity to D.C., and much more.

Image: From Video

Maryland Department of Commerce 2022 Annual Report

When I walked out of my last final at the University of Maryland, College Park two decades ago, I remember saying to myself, "That was the last test I'll ever take".” Yet, I am now in my second and final year of the University of Maryland, Baltimore School of Pharmacy’s Master of Science in Medical Cannabis Science and Therapeutics program offered at the Universities at Shady Grove (USG).

Johan Kördel can trace his decision to co-found Sound Bioventures to a conversation back in 2018. After spending the better part of a decade as senior partner at a venture capital fund, leading investments and serving on many companies’ boards of directors, Kördel felt an increasing need to do something different. He was telling a business associate about how he wanted more independence and direct influence on decisions and the funding processes. “I was having this conversation with my colleague,” Kördel recalls, “and they said, ‘Why don’t you start your own fund?’ And funny enough, I actually hadn’t thought about that before.”

Image: https://soundbioventures.com

Emmes is dedicating a center to enhance the company’s legacy and depth in cell and gene therapy research.

The company, a global, full-service clinical research organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, noted in a news release that the center will focus on supporting the clinical trials of our clients who are developing cell and gene therapies around the world and across multiple therapeutic areas, including ophthalmology and rare diseases.

The BioHealth Capital Region (BHCR) and its life science ecosystem have a rich and deep history of pioneering scientific innovation, research, development, and commercialization. The region’s history has been written by life science anchor companies, scientific research universities, government research organizations, rich startup culture, and serial entrepreneurs, all of whom have played critical roles in transforming the BHCR into one of the most innovative and productive biocluster in the world.

Image: https://biobuzz.io

Sykesville, MD, and Fairfax, VA, December 21, 2020 – Noble Life Sciences (NLS), a preclinical contract research organization located in Sykesville, MD, has signed a Collaboration Agreement with George Mason University (Mason) to access the National Center for Biodefense and Infectious Diseases (NCBID) BSL-3 facility located within their Biomedical Research Laboratory at Mason’s Science and Technology Campus in Manassas. The Agreement enables NLS to perform federal and non-federally funded BSL-3 animal model projects to support the development of new antiviral and antibacterial agents against infectious and resistant pathogens.

Image: https://noblelifesci.com

Linshom Medical CEO, Ric Hughen, joins Rich Bendis on BioTalk to discuss his career, their respiratory monitor, and growing a company in the BioHealth Capital Region.

Listen now via Apple https://apple.co/3GkByoi,  Google https://bit.ly/3C4TUY9, Spotify https://spoti.fi/3Gk6Ewh, Amazon Podcasts https://amzn.to/3WphyXb, and TuneIn https://bit.ly/3WOnWHB

Richard Hughen’s thirty years of medical device experience spans three Fortune 500 and three start-up companies with two successful exits to date. He is currently CEO of Linshom Medical, a start-up that is first to deliver continuous predictive respiratory monitoring (CPRM) to the patient bedside and home.

Since 2000, global investment in research and development (R&D) has tripled to $2.4 trillion.

R&D spend is also casting a wider global net. In 1960, the U.S. made up nearly 70% of global R&D spending, and by 2020 this had fallen to 30%. From job creation and public health to national security and industrial competitiveness, R&D plays a vital role in a country’s economic growth and innovation, impacting nearly every corner of society—either directly or indirectly.

Image: https://www.visualcapitalist.com

TUCSON, AZ and COLLEGE PARK, MD / ACCESSWIRE / December 15, 2022 / Research parks, innovation districts and related entities across the United States should prepare and strategize now to compete for federal funding from the recently enacted CHIPS and Science Act of 2022, according to a new white paper from AURP, the leading nonprofit organization representing research parks and innovation districts.

The white paper, prepared by Brian Darmody, AURP Chief Strategy Officer, showcases a dynamic range of ways organizations and institutions - such as research parks, innovation districts, businesses, universities, federal labs, states, regions and local communities - engaged in science and technology-based economic development can leverage the unprecedented amount of federal grant funding authorized in the CHIPS and Science Act.

Download the White Paper by Clicking Here

Novo Holdings and experienced venture capitalists on both sides of the Atlantic have come together to create a new fund focused on rare diseases. Led by VCs who spent years at Lundbeckfonden Ventures and NEA, Sound Bioventures will use its initial 110 million euros ($124 million) to back biotechs that are either in or on the cusp of the clinic.

Image: Novo Holdings framed its interest in Sound Bioventures as about more than just generating a return on investment. ((Pixabay))

The founders of Fermi Energy have an idea which, if it pans out, could revolutionize the auto industry.

That industry is already seeing the rise of electric vehicles, but electric vehicles are hampered by one thing: Their batteries require nickel and cobalt, two elements that must be imported. Fermi founders Feng Lin and Zhengrui Xu believe they can use other elements (they won’t say which ones for proprietary reasons) to achieve the same energy output, reduce the charging time – and cut costs by 20%.

Image: Here's the lab space under construction at the Virginia Tech Corporate Research Center. Photo by Dwayne Yancey.

New COO Adds International Experience and Clinical Operations Depth to Emmes' Portfolio

ROCKVILLE, Md., Dec. 15, 2022 /PRNewswire/ -- Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that Wendy Buckland will join the company as its chief operating officer, leading global operations.

Prior to her new position at Emmes, Buckland headed PPD's neuroscience therapeutic unit where she was responsible for strategy, client satisfaction, operational delivery, profitability and talent development, as well as oversight for all clinical development programs in neuroscience and ophthalmology.

The Gaithersburg biotech, which also detailed changes to a U.K. sales agreement for its Covid vaccine, saw its share price drop in after-hours trading.

Vaccine exclusively delivered with the PharmaJet Stratis® Needle-free Injection System

December 13, 2022 11:00 AM Eastern Standard Time

GOLDEN, Colo.–(BUSINESS WIRE)–PharmaJet®, a company that engineers precision delivery systems that overcome the challenges of vaccine and pharmaceutical companies, today announced that their partner Immunomic Therapeutics received FDA fast track designation (FTD) for the clinical study of their plasmid DNA vaccine ITI-3000 in patients with Merkel cell carcinoma (MCC), a rare but aggressive form of skin cancer. Enrollment is in progress for the phase 1 study that exclusively uses the PharmaJet Stratis Needle-free Injection System (NFIS).

ROCKVILLE, Md., Dec. 14, 2022 /PRNewswire/ -- Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that Ching Tian has joined the company as chief innovation officer.

Emmes Chief Executive Officer Dr. Christine Dingivan said, "Ching brings a wealth of data and digital experience, which will be immediately useful as we accelerate our transition to decentralized trials. Her role is to work across the company to integrate technology and processes that strengthen the way we'll address clinical trials of the future."

The Richmond area partnership that’s been working to revolutionize U.S. drug making has reached another milestone with the opening of a new lab space in the city.

Two groups – Phlow Corp. and U.S. Pharmacopeia – announced the opening of new laboratories that are co-located at the Advanced Pharmaceutical Development Center at the Virginia Biotechnology Park in Richmond.

Two new labs are aiming to research and develop new manufacturing technologies in the pharmaceutical industry. Those technologies are expected to benefit other pharma and biotechnology companies.

Research and development at the labs is focused on using new advanced manufacturing techniques to make “small molecule” active pharmaceutical ingredients (APIs), and key starting materials (KSMs). It is hoped that those processes can be used to make essential drugs more efficiently and in a more cost effective manner.

Click here to read more via Richmond.com

–   Single infusion of UltraCAR-T cells with or without lymphodepletion demonstrated robust expansion and persistence in blood and bone marrow –

–   PRGN-3006 infusion with lymphodepletion resulted in a decrease in bone marrow blasts in 60% of heavily pre-treated patients –

–   Single infusion of autologous PRGN-3006 cells resulted in 27% objective response rate (ORR) in heavily pre-treated relapsed or refractory (r/r) acute myeloid leukemia (AML) patients infused following lymphodepletion –

–  PRGN-3006 was well-tolerated with no dose-limiting toxicities (DLTs) reported to date –

GERMANTOWN, Md., Dec. 12, 2022 /PRNewswire/ -- Precigen, Inc., a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today presented positive Phase 1 dose escalation data from the ongoing Phase 1/1b clinical study of PRGN-3006 UltraCAR-T® in patients with r/r AML and higher risk myelodysplastic syndromes (MDS) (clinical trial identifier: NCT03927261) at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition (Abstract# 4633). The presentation was delivered by David A. Sallman, MD, Assistant Member in the Department of Malignant Hematology at the H. Lee Moffitt Cancer Center & Research Institute (Moffitt) and a lead investigator for the PRGN-3006 clinical trial.

In honor of the late John Holaday, Ph.D., renowned scientist, CEO, philanthropist, mentor, and community leader, this award recognizes a regional biohealth leader who embodies Holaday’s personal credo — “do well by doing good”, and exemplifies a similar unwavering devotion to excellence. With this award we want you to nominate a servant leader who is carrying on John’s legacy and lives each day with a passionate pursuit of excellence and innovation in their own work to make a difference in the lives of others. As CEO and Founder EntreMed, and MaxCyte, Holaday had an important role in building the foundation for the biohealth industry that exists here today, and we want to honor that legacy through this award.

This award honors a media campaign that most aligns with our mission; ‘to create exceptional experiences that better connect people and employers and foster a stronger regional ecosystem.’ At its core, it recognizes the media campaigns or platforms that have successfully engaged, informed, and connected people and reflect favorably on the BHCR. Eligible nominations may include social media, podcasts, video series, blog series, event or webinar series, and other advertising, marketing, and public relations campaigns. Nominees should be selected based on the strategic approach, quality, and results achieved.

This award recognizes the companies who have pursued their mission with dedication and perseverance and built momentum towards commercialization with a substantial breakthrough this past year. Nominees should be selected of companies who have achieved important milestones such as advancing to a clinical-stage company, achieving successful pivotal trials, or getting FDA approval to commercialize their technology to bring it to the patients who need it.

A long list of companies had breakthroughs this year and achieved great milestones for their technology, so it was a challenging task to narrow down finalists. These finalists were chosen from that list because their technology addresses an essential advancement in the field of medicine for their patient population or the medical field as a whole. Congratulations to all of the finalists who are on their way to changing the world by saving and improving lives.

New BHI Executives-In-Residence, Jennifer Butler and Luis Gutierrez, join VP Economic Development Sarah Miller on BioTalk with Rich Bendis to discuss the recent launch of this program and cultivating the local life sciences ecosystem by working with start-up and growth-stage companies in diagnostics, medical devices, digital health, bioinformatics, AI/machine learning and therapeutics within Montgomery County, Maryland.

Listen now via Apple https://apple.co/3uJ1NhD, Google https://bit.ly/3W8RZcv, Spotify https://spoti.fi/3Hv93FA, Amazon Podcasts https://amzn.to/3hgMeL4, or TuneIn https://bit.ly/3WbCRem.

USP Advanced Manufacturing Technology Lab Opens in Richmond, Virginia

Rockville, MD, December 12, 2022 – The U.S. Pharmacopeia (USP) today announced the opening of the USP Advanced Manufacturing Technology Lab in Richmond, Virginia as part of its launch of a suite of R&D analytical solutions. These analytical lab services will support the efforts of drug manufacturers seeking to adopt advanced manufacturing technologies including pharmaceutical continuous manufacturing (PCM) as one way to help increase geographic diversity in pharmaceutical manufacturing and support medicines supply chain resilience.

“While presenting potential advantages, adopting new technologies comes with challenges. When it comes to PCM, not all companies have access to the expertise, resources, or capacity to develop and qualify new in-line, at-line, and off-line analytical methods required for the new manufacturing processes,” said Dennis Hall, USP Vice President, Advanced Manufacturing Technologies. “USP’s analytical lab service offerings can help fill the gap, and assist manufacturers to further drive innovation, contain production costs, and optimize efficiencies in staffing and resources while facilitating market access to quality medicines made with PCM. Our facility in Richmond provides capacity to support these vital services.”

The U.S. biotechnology company will pay $116.50 for each Horizon share

Amgen Inc. has agreed to acquire Horizon Therapeutics PLC in an all-cash deal valued at $27.8 billion, marking the largest healthcare merger of the year.

Under the terms of the deal, which was first reported by The Wall Street Journal, Amgen will pay $116.50 for each Horizon share owned. The offer was equal to a premium of 19.7% over the stock’s closing price Friday at $97.29.

“The acquisition of Horizon is a compelling opportunity for Amgen and one that is consistent with our strategy of delivering long-term growth by providing innovative medicines that address the needs of patients who suffer from serious diseases,” Amgen Chief Executive Robert Bradway said.

Amgen will finance the deal via a bridge loan for $28.5 billion with Citibank N.A. acting as administrative agent, and Citibank, Bank of America N.A. as lead arrangers and bookrunners.

The deal is expected to generate robust cash flow, with the companies drumming up about $10 billion in combined cash flow over the 12 months through the third quarter of 2022. Amgen expects the regulatory approvals and other conditions under the Irish business code—it is based in Dublin—to be achieved by the first half of 2023.

Click here to read more via the WSJ

Emmes, a global, full-service clinical research organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, has announced the creation of a dedicated centre to enhance Emmes’ legacy and depth in cell and gene therapy research.

The new centre will focus on supporting the clinical trials of our clients who are developing cell and gene therapies around the world and across multiple therapeutic areas, including haematology, oncology, cardiology and ophthalmology, as well as rare diseases. The centre will combine a team of 100 researchers to capitalize on the company’s 35 years of cell and gene therapy experience.

Gilead and Kite are plunking down big cash to get into the anti-BCMA CAR-T game.

The pair will shell out $225 million in cash upfront and $100 million in equity to Arcellx, Kite announced Friday morning, to develop the biotech’s lead CAR-T program together. Kite will handle commercialization and co-development with Arcellx, and profits in the US will be split 50-50.

Image: https://endpts.com