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.

Updated 11/29

BioHealth Innovation, Inc. (BHI) and Montgomery County are pleased to announce the selection of Luis Gutierrez as a part-time “Executive in Residence”—a position dedicated to providing 1:1 technical assistance to Montgomery County-based biotech and medtech startups.

We’re excited to announce this year’s finalists for the third annual 2022 BioBuzz Awards. These awards celebrate the people and companies across our regional community and their efforts and accomplishments to impact human health and build a stronger biotech community.

The annual BioBuzz awards celebrate the people, companies and communities across the BioHealth Capital Region and, starting this year, Greater Philadelphia. These awards laud and recognize their efforts and to impact human health and build stronger, more vibrant biotech communities.

There are so many people and organizations doing great work in these regions, selecting finalists was not an easy task. We’re very excited to announce this year’s BioBuzz Awards finalists for 2022.

Johns Hopkins Medicine researchers have revamped an anti-cancer drug to better target cancer cells and leave healthy tissues unharmed. Scientists have dubbed this type of targeted approach a “prodrug” — a medicine designed to release its payload in a particular area of the body and in no other areas. The Johns Hopkins-discovered prodrug, called DRP-104 (sirpiglenastat), is in early-stage clinical trials in people with advanced solid tumors. The newly published studies in mice show that the augmented drug preferentially eliminates cancer cells but does not harm healthy cells.

Biotechnology firm Haystack Oncology Inc. has signed a lease in the City Garage Science & Technology Center at the recently rebranded Baltimore Peninsula mixed-use development.

Haystack, which describes itself as developing personalized cancer diagnostics with the potential of leading to proactive clinical interventions, said it's moving into a 20K SF lab space in City Garage at 101 West Dickman St. by this coming summer.

Image: Google Maps - City Garage in south Baltimore is a former makers' hub turned life sciences laboratory space.

HILDEN, Germany & GERMANTOWN, Maryland--(BUSINESS WIRE)--QIAGEN N.V. (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the launch of the monkeypox (MPXV) test for its NeuMoDx automated PCR platform to strengthen surveillance and research into the current outbreak in non-endemic regions that has infected tens of thousands of people all over the world since first being identified in May 2022.

“NeuMoDx MPXV enables researchers the fast and reliable qualitative detection and differentiation of both monkeypox clades, a huge help for those trying to understand and contain this virus”

ROCKVILLE, MD, Nov. 17, 2022 (GLOBE NEWSWIRE) --

MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on developing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today reported that the U.S. Food and Drug Administration announced the approval of the Biologics License Application (BLA) for teplizumab, an anti-CD3 monoclonal antibody that was previously developed by MacroGenics.  Teplizumab was acquired by Provention Bio, Inc. in May 2018 pursuant to an asset purchase agreement.

"We are very pleased to see the culmination of years of effort by Provention, MacroGenics, and tireless champions in academia and government, with the achievement of the approval of teplizumab," said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "We applaud this outcome, which represents an advancement for individuals and their families dealing with the risks and consequences of type 1 diabetes."

In Montgomery County, lab space has long been a prized get for biotechs, because there was so little of it. Shockingly little, actually, given the county is home to both the National Institutes of Health and the Food and Drug Administration.

That’s changing, and fast. There’s about 2 million square feet of the specialized space in the county’s pipeline, much of it taking the place of obsolete office buildings that are either being converted to labs, or demolished in favor of gleaming, state-of-the-art new construction.

NEW YORK, Nov. 15, 2022 /PRNewswire/ -- The Princeton Review® and Entrepreneur® today announced the results of The Princeton Review's 17th annual ranking of undergraduate and graduate schools for entrepreneurship studies.

Based on a summer 2022 survey The Princeton Review conducted of nearly 300 schools with entrepreneurship offerings, the rankings reported today took into account more than 40 data points about the school programs, faculties, students, and alumni.

The Princeton Review and Entrepreneur published the project's ranking lists on their respective websites at https://www.princetonreview.com/entrepreneur and https://www.entrepreneur.com/topcolleges.

Pixelligent, a nanotechnology firm that produces materials used in augmented reality displays and sensors, recently raised $38 million in IP-backed financing from a funding vehicle by MVolution Partners LLC. These funds brings the total raised this round of funding to $45 million, with the other $7 million coming from existing investors.

Image: Inside Pixelligent's manufacturing facility. (Courtesy photo)

According to a recent report from CBRE, Chicago ranks No. 6 for job growth out of the Top 25 life sciences markets in the U.S. To establish itself as a prominent hub on par with the coastal life sciences clusters in Boston and San Francisco, Chicago needs to enhance its offering in the areas of funding, talent, real estate and infrastructure. While the city has made many positive strides toward becoming a life sciences destination, there are four key steps city and state leaders can take to accelerate this process.

Image: https://www.pexels.com/photo/architectural-photography-of-tunnel-2088233/