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PHLOW & USP

Phlow Corp., U.S. Pharmacopia open Richmond labs to develop new pharma techniques

By News

PHLOW & USPThe 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

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Precigen Announces Positive Phase 1 Dose Escalation Data for Autologous PRGN-3006 UltraCAR-T® Manufactured Overnight for Next Day Infusion in Relapsed or Refractory Acute Myeloid Leukemia Patients

By News

Precigen Logo–   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.

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188 2022 BioBuzz The John Holaday BioHealth Leadership Award YouTube

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

By News

188 2022 BioBuzz The John Holaday BioHealth Leadership Award YouTubeIn 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.

Cursor and 187 2022 BioBuzz Media Award YouTube

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

By News

Cursor and 187 2022 BioBuzz Media Award YouTubeThis 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.

187 2022 BioBuzz Breakthrough Company of the Year Award YouTube

The Breakthrough Life Science Company of the Year Award: Vaccitech

By News

187 2022 BioBuzz Breakthrough Company of the Year Award YouTubeThis 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.

BioTalk Execs In Rez Gif

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

By News

BioTalk Execs In Rez GifNew 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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BioTalk Execs In Rez Gif

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

By BioTalk with Rich Bendis Podcast

BioTalk Execs In Rez GifNew 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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USP Logo

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

By News

USP LogoUSP 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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Webmail gzty

Amgen Agrees to Deal to Buy Horizon Therapeutics – WSJ

By News

Webmail gztyThe 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-Logo

Emmes launches cell and gene therapy centre

By News

Emmes-LogoEmmes, 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.

 

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