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.

3D Model of ATP Synthase - molecular motor (enzyme) that powers cells, generating chemical energy in the form of ATP molecules.

The 1997 Nobel prize in Chemistry was awarded to John Walker and Paul Boyer for solving the structure and mechanism of the enzyme ATP synthase which is involved in the synthesis of adenosine triphosphate (ATP). ATP is a molecule that provides energy to drive many processes in living cells.

Join Venable’s Ari J. Markenson, Ilisa Halpern Paul, and Joshua Raymond in a discussion of the implications for national healthcare and life sciences policy following the results of the midterm congressional election.  Ari will moderate the discussion with Ilisa and Joshua as they provide insights into and analysis of what investors, lenders, providers, manufacturers, and stakeholders might expect in the next 18 to 24 months with respect to federal health policy. The discussion will cover a wide range of topics, such as the anticipated House and Senate policy agendas, regulatory priorities for the Biden-Harris administration, and potential areas of bipartisan agreement. There will be time for questions from the audience following the panel.

Maryland Manufacturing Extension Partnership joins City/County consortium to expand third Biotech Bootcamp in Frederick

FREDERICK, MD. (PRWEB) DECEMBER 01, 2022

Following the completion of two successful sessions, Frederick Community College, Frederick County Workforce Services, The City of Frederick Department of Economic Development, and the Frederick County Office of Economic Development are pleased to announce the next "Biotech Bootcamp" will be held in Frederick in January 2023. Maryland Manufacturing Extension Partnership (Maryland MEP) has joined the Frederick consortium to provide additional programming support aimed at expanding the program’s footprint in the future.

A year marked mostly by biopharma mergers and acquisitions (M&A) in the hundreds of millions of dollars could end with a blockbuster, depending how far Horizon Therapeutics (HZNP) gets, and how quickly its talks with a trio of potential suitors, all of them being corporate giants.

Horizon shares jumped 27% from $78.76 to $100.29 on Wednesday, the first trading day after the company announced that it was in M&A talks with Amgen (AMGN), Johnson & Johnson (JNJ)’s Janssen Global Services, and Sanofi (SAN, SNY), confirming a report in The Wall Street Journal.

Over the past four fiscal years, there have been 1,977 initial public offerings (IPOs) completed by companies headquartered in the U.S., according to PitchBook, yielding more than $549 billion in capital invested. These companies are located in 45 states, D.C., and Puerto Rico. Almost 20% of those companies are no longer publicly held, having been returned to private ownership, been acquired, merged or gone out of business.

Across the four years, data shows a spike of IPO size and count in 2021, with a total IPO count of 956 and total IPO size of $315.7 billion for the year.

Image: https://ssti.org

After creating the satellite-radio industry and developing a drug for her daughter's serious disease, Martine Rothblatt is leading her biotech to test another boundary of what's possible.

The 68-year-old entrepreneur's newest mission is to create an endless supply of organs. Her company, the $12 billion Maryland-based biotech United Therapeutics, has already put gene-edited pig hearts, lungs, and kidneys into humans in clinical studies. Rothblatt now hopes to start making organs with 3D printing to solve the organ-supply crisis, with over 100,000 Americans on waiting lists for transplants.

Image: Martine Rothblatt, CEO of United Therapeutics, previously founded the satellite-radio pioneer SiriusXM. Elijah Nouvelage/REUTERS

Cancer continues to be a leading cause of mortality worldwide, accounting for nearly 10 million deaths in 2020. Alongside growing incidence rates each year, knowledge of molecular and tumor biology has also increased and notably affected cancer treatment paradigms. Until recently, cancer therapeutics focused on four main types of treatment: surgery, chemotherapy, radiotherapy, and targeted therapy. However, over the past ten years, immunotherapy has emerged as a novel and revolutionary approach to cancer treatment.

There is a new revolution of technology emerging based on the understanding of sub-atomic physics: quantum. This revolution leverages advanced scientific understanding and engineering capabilities at the sub-atomic level to create new solutions across critical domains such as computing, sensing, cryptography, materials, and communications. Through particle-level precision controls, technologies may provide uniquely powerful, fast, and precise capabilities that will benefit society.

You’ve Created the Technology. Put It to Work with I-Corps.

I-Corps at NIH is an entrepreneurship training program specifically designed for companies that received Small Business Innovation Research or Small Business Technology Transfer funding from NIH and the Centers for Disease Control and Prevention (CDC). During this 8-week, hands-on program, you’ll learn how to focus your business plan and get the tools to bring your treatment to the patients who need it most.

I-Corps Program Benefits

• Get funding up to $55,000 to cover program costs.
• Receive training from biotech sector experts.
• Expand your professional network.
• Build the confidence and skills to create a comprehensive business model.
• Gain years of entrepreneurial skills in only weeks.

Questions about the program should be directed to the agency contact at your awarding NIH/CDC institute or to one of the contacts in the table below.

Expedited Bill 31-22 will alter eligibility requirements of the Small Business Innovation Research and Small Business Technology Transfer Matching Grant Program

ROCKVILLE, Md., Nov. 29, 2022—Today the Montgomery County Council unanimously passed legislation that will fuel economic development by providing the County Executive with greater flexibility regarding the administration of the County's program to match federal Small Business Innovation Research and Small Business Technology Transfer grants. The legislation is sponsored by Planning, Housing and Economic Development (PHED) Committee Chair Hans Riemer and Councilmembers Will Jawando and Andrew Friedson, who sit on the PHED Committee.

Illumina Accelerator alum Polaris Genomics is investigating how genomics can help diagnose post-traumatic stress disorder (PTSD) and other mental health issues. The Maryland-based company is developing genomic panels that could more objectively screen people for PTSD and help them get the care they need.

“Our mission is to make these invisible wounds visible using the power of genomics,” says Polaris Co-Founder and CEO Charles Cathlin. “We believe genomics is a driving force to connect mental illness to its biological underpinnings. By doing that, we can decrease the stigma, suffering, silence, and suicide.”

Image: Polaris Chief Medical Officer Dr. Anne Naclerio and Polaris Co-Founder and CEO Charles Cathlin | Photo: Noah Willman

SANTA MONICA, Calif. & AMSTERDAM--(BUSINESS WIRE)--Neogene Therapeutics, Inc. (Neogene), a global clinical-stage biotechnology company pioneering the discovery, development and manufacturing of next-generation T-cell receptor therapies (TCR-Ts), today announced it has entered into a definitive agreement to be acquired by AstraZeneca.

With a shared goal of bringing cell therapies to patients with solid tumors, Neogene’s expertise in TCR-T discovery, development and manufacturing will strengthen AstraZeneca’s ambition to transform outcomes for patients.

The NIH Technology Transfer Program has won the Licensing Executive Society’s Deals of Distinction award for 2022. The Deals of Distinction Award is given to an outstanding licensing deal from the past year. Steve Ferguson, Special Advisor at the NIH Office of Technology Transfer, recently attended the LES award ceremony to accept the award on NIH’s behalf. Continue reading to learn about this award-winning license agreement from Steve himself.

For this LES “Deals of Distinction” Award the National Institutes of Health (NIH) licensed COVID-19 technologies arising from our intramural research to the Medicines Patent Pool (MPP) for access through the World Health Organization’s (WHO) COVID-19 Technology Access Pool (C-TAP). These licenses for COVID-19 technologies will enable global manufacturers to develop COVID-19 vaccines, treatments, and diagnostics for low- and middle-income countries (LMICs), where access to COVID-19 countermeasures is severely lacking.