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.

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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

REDWOOD CITY, Calif., and SANTA MONICA, Calif., Dec. 9, 2022 /PRNewswire/ -- Arcellx, Inc. (NASDAQ: ACLX) and Kite, a Gilead Company (NASDAQ: GILD), today announced a global strategic collaboration to co-develop and co-commercialize Arcellx's lead late-stage product candidate, CART-ddBCMA, for the treatment of patients with relapsed or refractory multiple myeloma.  Multiple myeloma is an incurable disease for most patients and the need remains for effective, safe, and broadly accessible therapies.

The Johns Hopkins University researchers behind two of Baltimore's most successful biotech firms have founded a new company that has now raised $56 million to create a new diagnostic tool for cancer.

The University of Maryland is partnering with Montgomery County to develop a new biotech campus near the North Bethesda Metro Station that will open in 2023.

The new facility will be yet another biotech stakeholder in the county, which is one of the richest biotech hubs in the nation. The university’s campus will join federal research laboratories, including the National Institutes of Health and the Food and Drug Administration, and significant private sector companies such as GSK plc and AstraZeneca.

The new campus, named the University of Maryland 3 — Institute for Health Computing, will focus on life sciences research.

The institute is scheduled to open at a temporary location in the first half of 2023 before moving to a permanent location by 2028 near the North Bethesda Metro Station, according to Tom Lewis, who is leading the project.

While the exact specifications are being finalized, Lewis expects the campus to be between 20,000 and 25,000 square feet. The campus will begin with about 20 employees before scaling up to almost 100 employees in 18 months.

Click here to read more via the Diamondback

Decades of Experience and Emerging Opportunities Led to its Creation

ROCKVILLE, Md., Dec. 8, 2022 /PRNewswire/ -- Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced the creation of a dedicated center to enhance Emmes' legacy and depth in cell and gene therapy research.

The new 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 hematology, oncology, cardiology and ophthalmology, as well as rare diseases. The center will combine a team of 100 researchers to capitalize on the company's 35 years of cell and gene therapy experience.

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C., December 08, 2022--(BUSINESS WIRE)--United Therapeutics (Nasdaq: UTHR), a public benefit corporation, today announced that the company has been named on Newsweek’s list of America’s Most Responsible Companies 2023. This award is presented by Newsweek and Statista Inc., the world-leading statistics portal and industry ranking provider. The list of awards was announced on December 7, 2022, is available on Newsweek’s website, and recognizes the top 500 most responsible companies in the United States, spanning 14 industries.

• Emergent’s supplemental new drug application is the first prescription-to-over-the-counter switch application in history to be granted Priority Review by the FDA.
• NARCAN® (naloxone HCI) Nasal Spray 4 mg, the first intranasal form of naloxone approved by the FDA in 2015, is designed for community use for the treatment of known or suspected opioid overdose.

GAITHERSBURG, Md., Dec. 06, 2022 (GLOBE NEWSWIRE) -- Today, Emergent BioSolutions Inc. (NYSE:EBS) announced that the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental New Drug Application (sNDA) for NARCAN® (naloxone HCI) Nasal Spray, as an over-the-counter (OTC) emergency treatment for known or suspected opioid overdose. The application has been granted Priority Review by the FDA and, if approved, would be the first 4 mg naloxone nasal spray available OTC in the U.S. The Prescription Drug User Fee Act goal date is March 29, 2023.

The opioid epidemic is an ongoing national public health issue and has been exacerbated by the escalating use of synthetic opioids, namely fentanyl. According to the Centers for Disease Control and Prevention, deaths related to synthetic opioids increased nearly 60 percent from 2019 to 2020,¹ and in 2021 alone, more than 71,000 people died from opioids containing fentanyl.²

University of Maryland College Park (UMCP) graduates are some of the most sought-after graduates in the country – Maryland is the No. 1 state for technology and science workforce and second in graduate or professional degree attainment. The state is also the second-largest recipient of federal funding in Maryland and 10th in the nation among public universities, according to Ken Porter, director of UM Ventures for UMCP.

UMCP is one of five universities working in partnership with TEDCO as part of our Maryland Innovation Initiative (MII), established in 2012 as a technology transfer program with the goal to grow and accelerate promising technologies through venture creation. Porter is a member of the MII board.

WASHINGTON, Dec. 2, 2022 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today reported results in a Phase II clinical study of VQW-765, a novel small molecule alpha 7 nicotinic acetylcholine receptor (α7-nAChR) partial agonist, in the treatment of acute performance anxiety in social situations, such as public speaking.

In clinical study VP-VQW-765-2201 (Study 2201), 230 volunteers with prior history of performance anxiety were randomized to receive a single dose of VQW-765 or placebo and were challenged with the standardized Trier Social Stress Test (TSST). The TSST creates an acute stress by requiring participants to make an interview-style presentation in front of a panel who provides no feedback or encouragement. Participants who received VQW-765 showed numerically lower stress levels compared to those who received placebo.