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537th Edition, December 13, 2022





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December 13, 2022

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BHI’s New BHI Executives-In-Residence Featured on BioTalk

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.

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Amgen Agrees to Deal to Buy Horizon Therapeutics – WSJ

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

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Arcellx and Kite Announce Strategic Collaboration to Co-Develop and Co-Commercialize Late-Stage Clinical CART-ddBCMA in Multiple Myeloma

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.

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Emmes Launches Cell and Gene Therapy Center

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.

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USP Launches R&D Analytical Solutions To Advance Continuous Manufacturing Technologies

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.”

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Updated: Gilead, Arcellx team up on anti-BCMA CAR-T as biotech touts a 100% response rate at #ASH22 – Endpoints News

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

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The ‘John Holaday’ BioHealth Leadership Award: Dr. Kurt Newman, President & CEO, Children’s National Hospital

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.

Click here to watch the video on YouTube.

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The BioBuzz Media Award: American Gene Technologies® “The Cure Chronicles” Video Series

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.

Click here to watch on YouTube.

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The Breakthrough Life Science Company of the Year Award: Vaccitech

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.

Click here to watch the video.

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