BHI News Section

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.”

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.

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