BHI Weekly Newsletter Archives Archives - Page 11 of 65

Nov 21 2023

584th Edition, November 21, 2023

Breaking Barriers in Enteral Nutrition: Luminoah’s Innovative MedTech with Neal Piper on BioTalk

Are you ready to explore the transformative world of MedTech and its profound impact on healthcare? Join us in this episode of BioTalk with Rich Bendis as we dive deep into medical technology with an exceptional guest, Neal Piper, Founder & CEO of Luminoah, winner of the 8th Annual BioHealth Capital Region Crab Trap. Neal Piper is the visionary behind Luminoah, a cutting-edge MedTech company dedicated to enhancing the lives of enteral nutrition patients through innovative hardware and software systems. With a background steeped in healthcare, Neal’s journey from Pfizer’s Neuroscience Division to his role as President of the Global Health Fellows Alumni Business Network has uniquely positioned him to drive change in the industry. But what inspired Neal to create Luminoah? In 2019, his family received a cancer diagnosis for their 3-year-old son, leading to a new reality and a pressing need for a better nutritional feeding program. Neal recognized the challenges faced by patients and caregivers, from bulky equipment to limited data sharing with physicians. That’s when Luminoah was born.

Listen now via your favorite podcasting platforms:

Apple: https://apple.co/46hZaE5
Google: https://bit.ly/46hgj0w
Spotify: https://spoti.fi/49MVoFM
Amazon Music: https://amzn.to/47IajPI
TuneIn: https://bit.ly/2M60Wmx

Arcellx and Kite Announce Expansion in Strategic Partnership

— Arcellx to receive $200M equity investment at $61.68 per share and an $85 million upfront cash payment —

— Kite exercises option to Arcellx’s ARC-SparX program ACLX-001 in multiple myeloma —

— The companies expand the scope of their existing collaboration for CART-ddBCMA to include lymphomas —

REDWOOD CITY, Calif. and SANTA MONICA, Calif., Nov. 15, 2023 /PRNewswire/ — Arcellx, Inc. (NASDAQ: ACLX) and Kite, a Gilead Company (NASDAQ: GILD), today announced that the companies have expanded their existing collaboration, which was originally announced in December 2022.

Kite has exercised its option to negotiate a license for Arcellx’s ARC-SparX program, ACLX-001, in multiple myeloma, which is comprised of ARC-T cells and SparX proteins that target BCMA. The companies have also expanded the scope of the collaboration for Arcellx’s CART-ddBCMA to include lymphomas.

“Since entering into this strategic collaboration with Kite almost one year ago, we are thrilled with how the partnership is rapidly progressing and the alignment across our teams,” said Rami Elghandour, Arcellx’s Chairman and Chief Executive Officer. “Helping as many cancer patients as possible serves as the core of our collaboration. With the deep and durable responses demonstrated in our CART-ddBCMA Phase 1 trial in multiple myeloma, we believe that our novel synthetic binder, the D-Domain, underscores the potential to engineer a new class of CAR T therapies. We are excited to deepen our relationship with Kite as they continue to invest in our platform by exercising their rights to our ACLX-001 ARC-SparX program in multiple myeloma and increasing their investment in our company. With this additional investment from Kite, our strengthened cash position is anticipated to extend our runway into 2027, as we advance towards commercializing CART-ddBCMA. Additionally, as our partnership deepens, we continue to identify operational efficiencies and additional opportunities to collaborate which are also reflected in this agreement. Importantly, these efficiencies embody the trust developed with our Kite partners and do not alter the original agreement in principle or economics. We look forward to sharing data from our CART-ddBCMA Phase 1 trial at ASH in December.”

BizJournals – Children’s National Hospital spinout ReveraGen BioPharma gearing up for muscular dystrophy drug launch

Rockville’s ReveraGen BioPharma Inc., a 15-year-old Children’s National Hospital spinout, is preparing for the launch of its neuromuscular disease drug — and sees an opportunity to advance it for other conditions.

ReveraGen scored the Food and Drug Administration’s approval in late October for its treatment for Duchenne muscular dystrophy, or DMD, the most common and severe type of muscular dystrophy that plagues young boys with progressive muscle weakness and atrophy.

The therapy, called vamorolone, has anti-inflammatory properties similar to traditional corticosteroids such as prednisone — but without typical complications such as weakened bones and stunted growth.

For decades, the market has lacked a steroid “that’s able to keep the benefit, but mitigate some of the side effects,” said Eric Hoffman, president and CEO of ReveraGen.

The drug showed in clinical trials to improve muscle strength and stature in DMD patients, and otherwise was comparable in its effects to corticosteroids, the standard of care for DMD. It’ll be sold starting in 2024 under the brand name Agamree by Coral Gables, Florida-based Catalyst Pharma Inc., via a sublicensing deal with Switzerland’s Santhera Pharmaceuticals.

MaxCyte Joins the Alliance for mRNA Medicines (AMM) as a Founding Member

MaxCyte continues supporting the advancement of novel therapeutics and looks to support education and advancement of mRNA medicines

ROCKVILLE, Md., Nov. 16, 2023 (GLOBE NEWSWIRE) — MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT), a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell-based therapeutics and innovative bioprocessing applications, today announced that it has joined the Alliance for mRNA Medicines (AMM), as a founding member. AMM is the leading global organization dedicated to advancing and advocating for mRNA and next-generation encoding RNA therapeutics and vaccines for the benefit of patients, public health and society. AMM’s mission is to propel the future of mRNA medicines, improve patients’ lives, and advance scientific knowledge by convening and empowering mRNA industry leaders, innovators, scientists and other key stakeholders. MaxCyte is one of 31 founding members comprised of biotechnology, biopharma and life sciences companies and educational institutions.

Selecta Biosciences Announces Merger with Cartesian Therapeutics

WATERTOWN, Mass. and GAITHERSBURG, Md., Nov. 13, 2023 (GLOBE NEWSWIRE) — Selecta Biosciences, Inc. (NASDAQ: SELB) (the Company) today announced that it has merged with Cartesian Therapeutics, Inc., a clinical-stage biotechnology company pioneering RNA cell therapies for autoimmune diseases. In connection with the merger, Selecta announced a $60.25 million private financing led by Timothy A. Springer, Ph.D., member of the Selecta Board of Directors.

With the cash from both companies at closing and the proceeds of the concurrent private financing, the combined company is expected to have over $110 million on hand to support the development of the Cartesian pipeline through the Phase 3 study of lead product candidate, Descartes-08, a potential first-in-class RNA-engineered chimeric antigen receptor T-cell therapy (rCAR-T) for the treatment of MG, as well as the advancement of additional RNA cell therapy programs.

Concurrent with the merger, the combined company has been renamed Cartesian Therapeutics, Inc. The Company’s Nasdaq ticker symbol will change to “RNAC” effective prior to the opening of trading tomorrow, November 14, 2023.

President Biden Intends to Appoint Dr. W. Kimryn Rathmell as Director of the National Cancer Institute

Today, President Joe Biden announced his intent to appoint Dr. W. Kimryn Rathmell as the 17^th Director of the National Cancer Institute (NCI), the federal government’s principal agency for cancer research and training and the largest funder of cancer research in the world. Dr. W. Kimryn Rathmell is an accomplished physician-scientist and internationally recognized cancer expert who is well suited to lead the NCI during this critical time to achieve the goals the President set for the Biden Cancer Moonshot as part of his Unity Agenda.

Statement from President Biden: “Dr. Rathmell is the talented and visionary leader the National Cancer Institute needs to drive us toward ending cancer as we know it. Throughout her career, she has been committed to advancing discovery through scientific research, maintaining a steadfast commitment to caring for her patients, and demonstrating leadership in preparing the next generation of researchers. She embodies the promise of the Biden Cancer Moonshot and has spent her career driving toward the goals Jill and I set for the initiative, to improve outcomes and boost support for those facing a cancer diagnosis. The National Cancer Institute is central to the success of the Cancer Moonshot and Dr. Rathmell will lead the agency towards new ways to prevent, detect, and treat cancer and to ensure we reach more Americans with the tools we have to save and extend lives.”

Nov 16 2023

Love0

583rd Edition, November 14, 2023

By admin BHI Weekly Newsletter Archives

Trouble Viewing This Email: Click Here

November 14, 2023

FOUNDING MEMBER OF

BioTalk – Driving Cancer Research Innovation: A Conversation with Michael Weingarten, Director, SBIR Development Center at the National Cancer Institute (NCI)

What are the latest advancements in cancer research and innovation? Join us in this episode of BioTalk with Rich Bendis as we explore the dynamic world of cancer research and technology development with our distinguished guest, Michael Weingarten, Director of the Small Business Innovation Research (SBIR) Development Center at the National Cancer Institute (NCI).

Mr. Weingarten plays a pivotal role in leading a team of Program Directors managing the NCI's SBIR & STTR Programs, overseeing a substantial portfolio of $182 million in grants and contracts annually. These programs are at the forefront of NCI's efforts to drive innovation, fostering the development and commercialization of groundbreaking technologies and products for cancer prevention, diagnosis, and treatment.

Listen now via your favorite podcasting platform:

Explore the intersection of the BioHealth Capital Region and the NCI, understanding how collaboration and partnerships are shaping the future of cancer research and innovation. Michael and Rich delve into the goals for the future, highlighting the NCI's vision and commitment to advancing cancer prevention, diagnosis, and treatment through technology and innovation.

BioHealth Innovation, Inc. Welcomes Dr. Eric S. Edwards of Phlow Corporation to the Board of Directors and Appoints Donna J. Edmonds of BRAINBox Solutions, Inc. as Vice Chair

ROCKVILLE, MARYLAND, November 13, 2023 – BioHealth Innovation, Inc. (BHI), a leading organization dedicated to supporting and advancing the BioHealth industry, is pleased to announce the appointment of Dr. Eric S. Edwards, Co-founder and CEO of Phlow Corporation, to its Board of Directors. In addition, Donna J. Edmonds, CEO of BRAINBox Solutions, Inc., has been appointed as the new Vice Chair of the Board.

“We are incredibly excited to welcome Dr. Eric S. Edwards to our Board of Directors and to appoint Donna J. Edmonds as our new Vice Chair,” said Richard Bendis, BHI President and CEO. “Dr. Edwards' remarkable achievements in pharmaceutical innovation and his dedication to improving healthcare delivery are perfectly aligned with our mission at BHI. Similarly, Donna's extensive experience and proven leadership in the healthcare sector will be invaluable as we continue to drive forward our vision. Their appointments signify BHI's continued journey towards fostering a robust and dynamic BioHealth ecosystem in our region.”

Dr. Eric S. Edwards, currently the Co-founder and CEO of Phlow Corporation, brings a wealth of experience and innovation to BioHealth Innovation, Inc. (BHI). With a remarkable career spanning pharmaceuticals and healthcare, Dr. Edwards is at the forefront of securing the supply chain for critical essential medicines in America. His visionary leadership extends beyond Phlow, as he co-founded Kaléo, Inc., a pharmaceutical company dedicated to novel treatments for chronic and acute-care diseases.

Selecta Biosciences Announces Merger with Cartesian Therapeutics

VLP Therapeutics group announces 3rd closing of funding to develop cancer, infectious disease vaccines; establish investigational vaccine manufacturing facility

US-based biotech company VLP Therapeutics, Inc. (VLPT) and its Tokyo-based group company VLP Therapeutics Japan, Inc. (VLPT Japan) together announced on November 8 the third closing of its financing round, which secured investments from Sumitomo Mitsui Trust Bank, Limited, a new investor headquartered in Tokyo, and Mr. Robert G. Hisaoka, an existing investor in the US.

With this funding the VLPT group plans to: 1) bolster its vaccine research and development underway in the US for cancer treatment and infectious disease prevention, such as malaria and dengue; and 2) establish a manufacturing facility, which is expected to begin operation in 2024–2025 and will enable VLPT Japan to produce investigational vaccines in-house in Fukuoka, Japan.

Emergent BioSolutions Submits Supplemental Biologics License Application Seeking U.S. FDA Approval of ACAM2000®, (Smallpox (Vaccinia) Vaccine, Live) for Immunization Against Mpox

GAITHERSBURG, Md., November 7, 2023 – Emergent (NYSE: EBS) has recently submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking approval for the expansion of the indication for ACAM2000®, Smallpox (Vaccinia) Vaccine, Live to include immunization against mpox virus. The sBLA includes data from a well-controlled animal study in which ACAM2000® vaccine has been shown to be effective in protecting against mpox virus exposure.

“Community transmission of mpox continues to be a public health challenge in the U.S.,” said Paul Williams, SVP and Products Business Head, Emergent BioSolutions. “Our sBLA submission for ACAM2000® reflects Emergent’s commitment to expanding our product capabilities and continuously support the U.S. government as we address emerging infectious diseases and strengthen future preparedness.”

Mpox, formerly called monkeypox, is a rare disease caused by infection with the mpox virus. Mpox virus is part of the same family of viruses as variola virus, the virus that causes smallpox. Mpox symptoms are similar to smallpox symptoms, but milder, and mpox is rarely fatal.¹ Since the start of last year, there have been more than 31,000 mpox cases in the U.S. and 55 deaths, according to the CDC, with more than 91,000 cases and 166 confirmed deaths globally.

Endpoints News Exclusive: With backing of Ravens owner, Blackbird launches with $100M to boost Baltimore’s biotech scene

A life sciences accelerator called Blackbird Laboratories has $100 million to spend to turn Baltimore into a biotech hub.A life sciences accelerator called Blackbird Laboratories has $100 million to spend to turn Baltimore into a biotech hub.

Blackbird was founded at the start of this year with the backing of Baltimore Ravens owner Steve Bisciotti’s family foundation. So far, Blackbird has looked at about 80 to 100 proposals and funded five programs, Blackbird CEO Matt Tremblay told Endpoints News.

Baltimore has had a few notable biotech success stories, such as Thrive Earlier Detection (acquired by Exact Sciences in 2020) and Personal Genome Diagnostics (acquired by Labcrop in 20222), but Tremlay said he hopes to support a "Kendall Square-like phenomena." He's looking to back research ideas that ultimately become biotech startups based in Baltimore.

Click here to read more (subscription required)

Irazú Oncology and University of Maryland, Baltimore Mark Anniversary of Exclusive License for Development of Colorectal Cancer Vaccine

BALTIMORE, MD, November 7, 2023 –Irazú Oncology, LLC, a biotechnology research company working to develop the next generation of cancer vaccines, and University of Maryland, Baltimore (UMB) are marking the one-year anniversary of their exclusive, worldwide license agreement and continuing partnership for the development of UMB’s novel immunotherapeutic vaccine technology. The Company, founded and led by Marco Chacón, PhD, is a UMB startup pursuing its plans to commercialize UMB’s technology as part of its oncology vaccine platform.

Irazú Oncology’s Membrane Vesicle Platform (MVP) technology utilizes nanosized outer membrane vesicles (OMVs) derived from attenuated bacteria to display and deliver tumor antigens to sites of immune response. The OMV vaccines are designed to stimulate the body’s own immune system to attack and destroy tumor cells. The Company’s lead vaccine candidate, IRZ-CRC-1, is a bivalent colorectal cancer vaccine that has shown excellent efficacy in colorectal cancer preclinical models.

The NHLBI is accepting applications for the I-Corps at NIH™ Program

The NHLBI is accepting applications for the I-Corps at NIH™ Program, which provides funding, mentoring, and networking opportunities to current Phase I SBIR/STTR awardees and Fast-Track awardees in the first phase of their award to help commercialize your promising biomedical technology. 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.  

Program benefits include:  

Funding up to $55,000 to cover total program costs  
Training from biotech sector experts  
Expanding your professional network 
Building the confidence and skills to create a comprehensive business model  
Gaining years of entrepreneurial skills in a matter of week

All applications must be submitted through PAR-22-073 no later than November 15, 2023. Please note that the updated due dates for the FY2024 I-Corps at NIH™ cohorts may be found at NOT-OD-23-188. This cohort begins in March 2024. The sessions will be held virtually except for the in-person kickoff in Houston, TX, and the in-person closeout session in Bethesda, MD.

For more information, contact Stephanie Davis, Small Business Program Coordinator (nhlbi_sbir@mail.nih.gov) or visit the I-Corps at NIH™ program website.

Nov 16 2023

Love0

582nd Edition, November 7, 2023

By admin BHI Weekly Newsletter Archives

Unlocking the Future of Stem Cell Research with MSCRF: A Conversation with Ruchika Nijhara, PhD, Executive Director of Maryland Stem Cell Research Fund (MSCRF)

Are you curious about the world of transformative regenerative medicine and stem cell research? Are you eager to understand how Maryland champions researchers and companies in the field of stem cell and regenerative medicine? Do you want to learn more about the Maryland Stem Cell Research Fund (MSCRF)? Listen to the latest episode of BioTalk with Rich Bendis as he welcomes MSCRF Executive Director, Ruchika Nijhara, PhD.

In this enlightening episode, Dr. Nijhara, a forward-thinking leader driven by her passion for advancing scientific innovation, delves into the funding mechanisms that Maryland employs to support research and development at all stages and fosters collaboration and innovation.

QIAGEN and Element Biosciences partner to offer complete next-generation sequencing workflows for the AVITI System

Partnership combines QIAGEN’s QIAseq panels, CLC LightSpeed, and QCI Interpret software to support Element’s AVITI System users in genomic analysis
Collaboration to accelerate discovery, enhance cost efficiencies, and improve turnaround times for genomic applications in the scientific community
QIAGEN to present performance data for universal QIAseq library preparation panels running on other sequencing platforms at ASHG Annual Meeting 2023 in Washington, DC

Venlo, the Netherlands, and San Diego, California, Nov. 02, 2023 (GLOBE NEWSWIRE) — QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) and Element Biosciences, Inc. today announced a strategic partnership to offer comprehensive next-generation sequencing (NGS) workflows for the Element AVITI™ System, an innovative sequencing platform.

Element’s AVITI System is a versatile benchtop sequencer offering a combination of performance, cost, and flexibility for a wide range of NGS applications. For customers using the AVITI System, QIAGEN provides Sample to Insight NGS workflows with validated QIAseq panels and integrated bioinformatic solutions, including CLC LightSpeed and QCI Interpret software.

“The collaboration between QIAGEN and Element Biosciences delivers unprecedented insights across various genomic applications to our customers worldwide. Researchers are increasingly searching for complete solutions and workflows from sample to insight, and we are committed to advancing the field together by providing innovative technology and applications that help researchers accelerate discovery,” said Nitin Sood, Senior Vice President, Head of Life Sciences Business Area at QIAGEN.

Indo US Bridging Rare Summit Heralds a New Era of Cooperation for Rare Diseases Orphan Drugs Development

The FDA’s Commissioner, Dr. Robert M. Califf, recently visited India and shared his opinion on India’s Unique Opportunity and Important Responsibility as the Pharmacy to the World. The Inaugural 2-day Indo US Bridging RARE Summit was held on Oct 29 and 30, 2023 at George Mason University in Arlington, VA. The organizing committee led by Dr. Harsha Karur Rajasimha at the Indo US Organization for Rare Diseases (IndoUSrare), a US-based nonprofit committed to combating rare diseases, are aiming to catalyze this potential cooperation and harmonization between the FDA and Indian regulators to create a pathway for biopharmaceutical sponsors to start commercially launching orphan therapies in India. The effect can be far reaching, saving or impacting millions of lives. Dr. Peter Marks, Director of Center for Biologics Evaluation Research (CBER), FDA, keynote speaker at the Summit, announced the Creation of Operation Warp Speed for Rare Diseases, a pilot program called Support for Clinical Trials Advancing Rare Disease Therapeutics (START).

(HERNDON, Va.) October 24, 2023: The launch of Operation Warp Speed in 2020 to develop COVID-19 vaccines was a resounding success, developing and making available the vaccines to the general public in record time and saving an estimated 3.2 million lives and $1.15 trillion in the U.S. alone.1 As a result of that achievement, the U.S. Food and Drug Administration (FDA) is launching a pilot program — Support for Clinical Trials Advancing Rare disease Therapeutics (START) — this year to accelerate the pace of development of therapeutics for very small populations with very high medical need. 1 Globally, rare diseases are defined by The World Health Organization (WHO) as a disorder which affects less than 6.5 to 10 people out of 10,000.2 According to a report by RARE-X, there are over 10,897 known rare diseases affecting over 400 million people worldwide. Since the Orphan Drug Act of 1983, the FDA has approved about 1100 orphan drugs to treat about 5-7% of rare diseases. Hence, a majority of rare diseases remain without treatment options. At the recently concluded Indo US Bridging RARE Summit 2023, Dr. Peter Marks, director at the FDA’s Center for Biologics Evaluation and Research (CBER), spoke about the START program, the India opportunity, and stated, “We have fifteen FDA approved gene therapies till date. We are very committed to working with the rare disease communities for gene therapies and with our colleagues globally. India is an incredible opportunity in terms of capacity and capability. By leveraging them and working together, we can achieve some wonderful things for people with rare diseases.”

United Therapeutics to Acquire Miromatrix Medical

October 30, 2023 06:00 AM Eastern Daylight Time – SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C. & EDEN PRAIRIE, Minn.–(BUSINESS WIRE)–United Therapeutics Corporation (Nasdaq: UTHR) and Miromatrix Medical Inc. (Nasdaq: MIRO) announced today a definitive agreement for United Therapeutics to acquire Miromatrix.

Miromatrix is a life sciences company focused on the development of bioengineered organs composed of human cells. United Therapeutics is a biotechnology company with six FDA-approved therapies to address rare, life-threatening conditions, and a pipeline that includes four ongoing registration-phase studies. The acquisition of Miromatrix will expand United Therapeutics’ existing complementary platform of organ manufacturing programs, which include ex-vivo lung perfusion, xenotransplantation, 3-D bioprinting, and regenerative medicine approaches with the objective of creating an unlimited supply of tolerable, transplantable organs.

ATCC and USP Launch First Set of Products to Advance Quality and Reduce Risk in the Development of Biological Therapeutics and Vaccines

Six new products that can be used to detect residual host cell genomic DNA (gDNA)

MANASSAS, Va. and ROCKVILLE, Md., Oct. 30, 2023 /PRNewswire/ — Today, ATCC and U.S. Pharmacopeia (USP), two premier materials management and standards organizations, announced the launch of their first set of joint products to advance the quality control and reduce the risk in the manufacturing of biological therapies and vaccines. This initial set of six products consists of highly characterized and pure genomic DNA (gDNA) from cell lines used in bioproduction that can be used to measure residual host cell DNA in various biotherapeutic products, as required by regulatory authorities. The presence of gDNA is a predominant concern in the development of biological therapies as it can pose a safety risk if it is not removed from the product.

“Developing cutting-edge medicines in the biologics space requires trusted reference materials and standards to ensure quality, consistency and safety,” said Amanda Cowley, General Counsel and SVP Legal, Strategy and People of USP. “With increased demands around the globe for new biological medicines on accelerated timelines, it’s essential that there are products and solutions that can be used to address and advance quality assessment and bring confidence to the development process. By focusing on the detection of gDNA, this first set of ATCC and USP products is significant for the future of biological development as it addresses a common concern when it comes to quality and mitigating risk.”

Vaccitech Renames as Barinthus Biotherapeutics to Highlight Strategic Evolution into a T Cell Immunotherapy Company Targeting Chronic Infectious Diseases, Autoimmunity, and Cancer

OXFORD, United Kingdom, Nov. 06, 2023 (GLOBE NEWSWIRE) — Barinthus Biotherapeutics plc (NASDAQ: BRNS), formerly Vaccitech plc (NASDAQ: VACC), a clinical-stage biopharmaceutical company developing novel T cell immunotherapeutic candidates designed to guide the immune system to overcome chronic infectious diseases, autoimmunity and cancer will present data from its Phase 2 Hepatitis B trials of VTP-300 at The American Association for the Study of Liver Diseases (AASLD) – The Liver Meeting® 2023, November 10-14 in Boston, MA.

The company also announced today that it has changed its name to Barinthus Biotherapeutics plc to represent the evolution and expansion of its focus beyond vaccines. The company expects to begin trading under its new name and ticker (Nasdaq: BRNS) effective as of November 7, 2023. As part of the rebranding, the company has also updated its website — learn more at www.barinthusbio.com.

Johnson & Johnson Innovation Names Awardees in the Advancing Oncology InnoVAtion QuickFire Challenge

October 25th, 2023 – Johnson & Johnson Innovation, in collaboration with Carilion Clinic Innovation, Verge Alliance (with support from City of Roanoke), and Virginia Tech Corporate Research Center (VTCRC), announced today at the Harnessing the Potential of Antibody Drug Conjugates (ADC) in Oncology event at JLABS @ Washington D.C. that Bacchus Therapeutics, Luminary Therapeutics, and QurCan Therapeutics Inc., have been selected as the awardees in the Advancing Oncology InnoVAtion QuickFire Challenge.

The challenge invited innovators from across the globe with an active interest in the Virginia innovation ecosystem to submit potential solutions aiming to transform patient outcomes in oncology in adult populations with potential applications in pediatric oncology. The awardees hope to nurture Virginia’s outstanding innovation ecosystem and spearhead innovative solutions to enhance the quality of life for cancer patients across the globe.

BioBuzz: Addimmune Prepares to go Public, Initiate Phase Ib HIV Trial

By Alex Keown | October 31, 2023 –

Addimmune, currently American Gene Technologies HIV-focused research, is expected to become a publicly traded company in early 2024 following a merger with 10X Capital Venture Acquisition Corp. III, a special purpose acquisition company (SPAC).

Following the merger with the SPAC company, Addimmune will use the raised funds to support its planned Phase Ib clinical trial assessing the company’s Gag-specific AGT103-T, a genetically modified cell product, CEO Jeff Galvin told BioBuzz. The merger announcement comes months after plans to separate the HIV business were shared by AGT.

Addimmune launched with the goal of building on the success of a Phase I study assessing AGT103-T as a potential therapeutic for HIV that could offer a functional cure of the disease. Trial data revealed that 100% of participants showed active immune responses to HIV after participants ceased taking their antiretroviral therapy. The data showed that several of the seven trial participants achieved significant viral suppression, which signals the possibility that AGT103-T has the potential to deliver a functional cure to HIV patients. The Phase I data was published in November 2022 in Frontiers in Medicine, a peer-reviewed scientific journal focused on medical advancement.

Oct 31 2023

Love0

581st Edition, October 31, 2023

By admin BHI Weekly Newsletter Archives

BioHealth Innovation Inc. (BHI) Announces the Addition of New Technical Writer and Program Manager, Jon Nelson

ROCKVILLE, MARYLAND, October 30, 2023 – BioHealth Innovation Inc. (BHI) proudly welcomes Jon Nelson to its innovative team. Jon joins BHI as a Technical Writer and Program Manager, bringing an impressive nine years of research experience within the biological sciences, further enhancing BHI’s commitment to advancing healthcare technologies.

Jon’s journey in biological sciences began with the pursuit of his master’s degree in biology at the University of North Carolina at Greensboro. During this time, he worked with bioinformatics to predict epigenetic drug efficacy and leverage cutting-edge technology for groundbreaking solutions.

“We are excited to have Jon Nelson join our team. His extensive research experience and innovative mindset align perfectly with BHI’s mission to drive innovation and transformative healthcare solutions,” said Monique Bennett, BHI Life Science Business Strategist.

BRAINBox Solutions Announces Initial Series B Investments to Support U.S. Regulatory Clearance, Initial Commercialization of BRAINBox TBI Concussion Diagnostic/Prognostic Test

RICHMOND, Va., Oct. 30, 2023 /PRNewswire/ — BRAINBox Solutions today announced initial investments into the company’s Series B financing to support U.S. regulatory clearance and initial commercialization of its BRAINBox TBI concussion diagnostic/prognostic test in adults and completion of a clinical study in pediatric patients. Genoa Ventures is leading the financing, which includes other current and new investors.

“We have made significant clinical and pre-commercial progress in developing the BRAINBox TBI test,” said Donna Edmonds, BRAINBox Solutions’ CEO. “We are working with selected platform partners as we determine the fastest path to market for use in both point-of-care and emergency department settings.” She noted that in addition to the adult population, the company is developing BRAINBox TBI tests for pediatric patients, and, through a National Institutes of Health grant, for geriatric patients.

United Therapeutics to Acquire Miromatrix Medical

FDA approves muscular dystrophy drug built on Children’s National research

WASHINGTON, D.C., Oct. 27, 2023 (GLOBE NEWSWIRE) — Boys with Duchenne muscular dystrophy (DMD) have a clinically proven, new treatment option with the Food and Drug Administration’s approval Thursday of vamorolone, a steroidal-type, anti-inflammatory drug developed based on research performed at Children’s National Hospital.

Created by ReveraGen BioPharma Inc., vamorolone has a molecular structure similar to traditional corticosteroids, which are currently used to treat DMD. Yet its structure was found to be chemically different enough to reduce unwanted side effects, including brittle bones and reduced stature. Nearly two decades ago, ReveraGen leaders – President and CEO Eric Hoffman, Ph.D., and Vice President for Research Kanneboyina Nagaraju, D.V.M., Ph.D. – launched research efforts into the drug when they led the Center for Genetic Medicine Research at Children’s National. They worked with then-Chief Academic Officer Mark Batshaw, M.D., on the new clinical option.

Gaithersburg’s Georgiamune and Verily Announce Strategic Partnership to Advance Novel Cancer Treatment

GAITHERSBURG, Md. & SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Georgiamune, a privately held, clinical stage biotechnology company, and Verily, an Alphabet precision health technology company, today announced a strategic partnership to advance novel therapeutics for patients with cancer.

The partnership will focus on deploying Verily’s advanced molecular and real-world evidence solutions with the intention to support the development of Georgiamune’s therapeutic candidates through the discovery of predictive and outcome biomarkers. The two companies will also focus on driving more efficient clinical development by incorporating clinical trial data and longitudinal real-world data sources. The collaboration innovates how clinical trials are currently conducted by bringing together different data modalities to identify the patient populations most likely to benefit from Georgiamune’s novel therapy and by providing a more holistic analysis of how participants are responding to the therapy over time.

Altimmune Granted Fast Track Designation by FDA for Pemvidutide for the Treatment of Non-Alcoholic Steatohepatitis (NASH)

GAITHERSBURG, Md., Oct. 26, 2023 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to its clinical program investigating pemvidutide for the treatment of NASH.

NASH is a serious, potentially life-threatening condition that is a leading cause of liver failure and liver transplantation globally. NASH is a growing public health concern, and there are currently no approved treatments. The Fast Track designation is designed to facilitate the development and expedite the review of new drugs intended to treat serious conditions and address unmet medical needs.

“The FDA’s decision was informed by the results of Altimmune’s studies including its Phase 1b randomized, placebo-controlled study of pemvidutide in subjects with non-alcoholic fatty liver disease (NAFLD), which showed class-leading relative reductions in liver fat and non-invasive markers of hepatic inflammation and a favorable safety and tolerability profile,” said Vipin K. Garg, Ph.D., President and CEO of Altimmune. “The Fast Track designation reflects Altimmune’s commitment to patients with NASH and efforts to find safe and effective treatments for this condition.”

Centers for Medicare & Medicaid Services Awards MITRE New Five-Year Contract to Continue Operating Health R&D Center

MCLEAN, Va. & BEDFORD, Mass.–(BUSINESS WIRE)–MITRE announced a new five-year contract with the Centers for Medicare & Medicaid Services (CMS) to operate the CMS Alliance to Modernize Healthcare, a federally funded research and development center, more commonly known as the Health FFRDC.

Established in 2012, the Health FFRDC serves the public interest by tackling complex, cross-cutting challenges affecting health and well-being. As the Health FFRDC operator, MITRE serves as an objective advisor to CMS, the Centers for Disease Control and Prevention, Food and Drug Administration, National Institutes of Health, Health Resources and Services Administration, Administration for Children and Families, and all the operating divisions across HHS, as well as other governmental organizations with health missions.

Unveiling the Future of Viral Safety: The 2024 PDA Virus Conference in Amsterdam

Dive into the world of viral safety with the upcoming 2024 PDA Virus Conference. Set against the picturesque backdrop of Amsterdam, this event promises to be a melting pot of knowledge, innovation, and networking.

? Dates to Remember:

Conference: Jun 26 – Jun 27, 2024
Abstract Submission Deadline: November 30, 2023

? Location: Amsterdam Marriott Hotel, Stadhouderskade 12, Amsterdam, The Netherlands. Nestled amidst iconic attractions, the hotel offers a blend of luxury and convenience.

? Theme: “Viral Safety Reloaded – the Finalized ICH Q5A (R2)”

? Highlights:

A unique opportunity to attend two conferences in a week, with the Advanced Therapy Medicinal Product Conference preceding this event.
Engage with a diverse Scientific Program Planning Committee, featuring stalwarts from ViruSure, Eli Lilly, Merck KGaA, U.S. FDA, and more.
Submit your abstracts! Remember, they should be non-commercial and focus on breakthroughs in Virus Safety.

Oct 24 2023

Love0

580th edition, October 24, 2023

By admin BHI Weekly Newsletter Archives

Biden-Harris Administration Designates 31 Tech Hubs Across America Including Maryland & Virginia

As part of the President’s Investing in America agenda, the U.S. Department of Commerce identified regional centers primed for technological innovation and job creation.

WASHINGTON, DC — The Biden-Harris administration, through the U.S. Department of Commerce’s Economic Development Administration (EDA), today announced the designation of 31 Tech Hubs in regions across the country. This is the first phase of the new Tech Hubs program, which is an economic development initiative designed to drive regional innovation and job creation by strengthening a region’s capacity to manufacture, commercialize, and deploy technology that will advance American competitiveness. The program invests directly in burgeoning, high-potential U.S. regions and aims to transform them into globally competitive innovation centers.

TEDCO Announces Investment into Sisu Global Health (A BHI Portfolio Company)

Maryland-based, woman-owned biotech company providing hospitals with an autotransfusion device to address the global blood shortage

COLUMBIA, Md. (October 23, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced a recent Inclusion Fund investment of $100,000 into Sisu Global Health, a company that is providing hospitals with an autotransfusion device to replace or augment donor blood in emergency situations.

Sisu Global Health, based in Baltimore, Md., has created an autotransfusion device, Hemafuse; the device provides surgical patients access to fresh, whole blood by capturing it from internal bleeding and giving it back to them immediately in the same surgery. The patented Hemafuse System can operate anywhere there is a surgeon (regardless of infrastructure), making it well suited for military and emerging markets, with applications in the U.S., Sisu Global is bringing Hemafuse to the global market after clinical success in Ghana, Kenya, Tanzania and Ukraine.

Baltimore’s MyMD Announces Preclinical Study Results Showing Novel Cannabidiol Analog, Supera-CBD™, Reduced Acute Inflammatory Pain

– Supera-CBD eased heat-related pain due to inflammation quickly and provided long-lasting pain relief lasting up to five hours

– Results suggest Supera-CBD may target specific pain pathways, lessening the potential for side effects

– MyMD was issued Japanese Patent No. 7293561 B2, covering Supera-CBD as a new molecular entity, in pharmaceutical formulations, and for use in therapeutic treatments

October 19, 2023 09:00 AM Eastern Daylight Time

BALTIMORE–(BUSINESS WIRE)–MyMD Pharmaceuticals, Inc.® (Nasdaq: MYMD) (“MyMD” or “the Company”), a clinical stage biopharmaceutical company developing groundbreaking therapies for the treatment of serious and debilitating autoimmune and inflammatory diseases, today announced results from a preclinical study of its investigational cannabinoid Supera-CBD™, a novel, synthetic, non-toxic cannabidiol (CBD) analog. In the study, Supera-CBD targeted and quickly reduced inflammatory pain within 60 minutes, providing pain relief for up to five hours. Comparatively, traditional CBD had no effect on this type of pain in the same study.

BioTalk – Revolutionizing Autoimmune Medicine: MyMD Pharmaceuticals Innovative Therapies

Are you interested in exploring cutting-edge autoimmune medicines? In this episode of BioTalk with Rich Bendis, we’re delving deep into the world of transformative therapies with two remarkable guests, Dr. Chris Chapman and Dr. Adam Kaplin, from MyMD Pharmaceuticals. MyMD Pharmaceuticals is on a mission to make that a reality. Their lead clinical candidate, MYMD-1®, has the potential to reshape the entire field. But how does MYMD-1 work, and what sets it apart from current treatments? Join us as we unravel the science behind this revolutionary therapy and explore the potential indications and patient populations it could benefit. And that’s not all. We also spotlight Supera-CBD, a novel synthetic cannabidiol with incredible potency and anti-inflammatory effects. How could this innovation change the landscape of chronic pain and anxiety management? Don’t miss this episode of BioTalk with Rich Bendis as we embark on a journey into the future of autoimmune medicine with MyMD Pharmaceuticals. Tune in now and be part of the conversation.

Listen now via your favorite podcasting platform:

Click here to read the transcript.

Immunomic Therapeutics Reports Positive Results from Its Phase 1 Clinical Trial

Immunomic Therapeutics Reports Positive Results from Its Phase 1 Clinical Trial of ITI-3000 in Patients Diagnosed with Merkel Cell Carcinoma

ROCKVILLE, Md.–(BUSINESS WIRE)–Immunomic Therapeutics, Inc. (ITI), a privately-held clinical-stage biotechnology company pioneering the development of LAMP-mediated nucleic acid-based immunotherapy, today announced safety and tolerability results from its phase 1 clinical trial evaluating ITI-3000, a plasmid DNA (pDNA) vaccine, targeting patients with Merkel cell carcinoma (MCC), a rare but aggressive form of skin cancer that is typically caused by the Merkel cell polyomavirus (MCPyV). ITI-3000 was granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) in November 2022.

FDA Clears Rise Therapeutics’ IND Application to Initiate a Phase 1 Clinical Study

FDA Clears Rise Therapeutics’ IND Application to Initiate a Phase 1 Clinical Study of Its Novel Oral Immunotherapy for the Treatment of Rheumatoid Arthritis

ROCKVILLE, Md., Oct. 19, 2023 /PRNewswire/ — Rise Therapeutics a biotechnology company engaged in developing novel oral immunotherapeutics, today announced that the U.S. Food and Drug Administration (FDA) has accepted its investigational new drug (IND) application to proceed with a rheumatoid arthritis Phase 1 clinical trial for its program candidate, R-2487. This is Rise Therapeutics’ second clinical program developed using synthetic biology and its proprietary oral biologics delivery platform.

FDA Clears Rise Therapeutics’ IND Application to Initiate a Phase 1 Clinical Study

RICHMOND, Va.–(BUSINESS WIRE)– Qnovia, Inc., a pharma company developing inhaled therapeutics across a variety of indication areas, today announced it has entered into a drug development collaboration with the University of Virginia (UVA) to advance novel inhaled-drug candidates for treating bacterial infections in the lungs. Qnovia will work with UVA School of Medicine investigators Dr. Molly Hughes and Dr. Matthew Crawford to combine Qnovia’s RespiRx^TM inhaled drug delivery platform and UVA’s proprietary portfolio of antimicrobial peptides to kill antibiotic-resistant and biodefense bacteria that can cause life-threatening infections. As a result of this agreement, Qnovia will add two new assets to its development pipeline: QN-05 for the treatment of pneumonia and QN-06 for the treatment of pulmonary infection for individuals exposed to the biodefense agent B. anthracis, the causative agent of anthrax.

IndoUSrare Announces Bridging RARE Summit to Combat Rare Diseases by Fostering Cross-Border Collaborations, Data Sharing, and Clinical Trials – Register Now

With an increasing number of U.S. biopharmaceutical firms feeling the financial constraints imposed by the Inflation Reduction Act (IRA) and subsequently shutting down or suspending their research programs in the rare disease domain, hundreds of millions of patients in both the U.S. and India face the grim prospect of not receiving a breakthrough treatment for their condition within their lifetimes. IndoUSrare, a US-based nonprofit committed to stanching rare diseases, launches the inaugural Bridging RARE conference to forge a path for affordable clinical innovation via strengthened Indo-US collaborations and more inclusive clinical trials for minimizing the devastating health consequences arising from this policy shift.

(HERNDON, Va.) October 10, 2023: Rare diseases, as defined by the World Health Organization (WHO), refer to some 10,867 medically significant conditions, each with a prevalence of one or less per 1,000 individuals. With only about 8% of them being treatable,¹ rare diseases include congenital malformations, autoimmune disorders, lysosomal storage disorders, thalassemia, muscular dystrophies, and infrequent forms of cancer and infections. Despite substantial progress during the 40 years since the enactment of the Orphan Drug Act of 1983, which incentivized the U.S. private sector to develop 1,100 FDA-approved orphan treatments,² the global thrust against rare diseases is on the verge of losing steam.

Oct 17 2023

Love0

579th Edition, October 17, 2023

By admin BHI Weekly Newsletter Archives

BioTalk – Revolutionizing Autoimmune Medicine: MyMD Pharmaceuticals Innovative Therapies

Listen now via your favorite podcasting platform:

IndoUSrare Announces Bridging RARE Summit to Combat Rare Diseases by Fostering Cross-Border Collaborations, Data Sharing, and Clinical Trials – Register Now

Maryland based United Therapeutics is leading a medical revolution

magine a world where unhealthy organs are replaced with transplants constructed with a 3D printer using the patient’s own cells. No more agonizing waits and desperate searches for a suitable donor organ, and, because the printed organs use cells from the patients themselves, no more fear of organ rejection. It might sound like science fiction set in the far off future, but thanks to the pioneering work of United Therapeutics , it may become a reality a lot sooner than you think, and it’s happening here in Maryland.

Co-headquartered in Silver Spring, United Therapeutics was founded in 1996 by Dr. Martine Rothblatt, a mom who wanted to save her 7 year-old daughter Jenesis who’d been diagnosed with a rare and serious disease called pulmonary arterial hypertension. Twenty seven years later, Jenesis has defied the odds and works at the company her mother founded to save her life.

Ascentage Pharma and AstraZeneca Enter into Clinical Collaboration

Ascentage Pharma and AstraZeneca Enter into Clinical Collaboration on the Registrational Phase III Study of Bcl-2 Inhibitor Lisaftoclax in Combination with BTK Inhibitor Acalabrutinib in Treatment-Naïve Patients with First-Line CLL/SLL

SUZHOU, China, and ROCKVILLE, Md., Oct. 15, 2023 /PRNewswire/ — Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancer, chronic hepatitis B (CHB), and age-related diseases, announced today that it has entered into a clinical collaboration with AstraZeneca Investment (China) Co., Ltd. (or “AstraZeneca”). The two companies will jointly conduct a registrational Phase III study of the Bcl-2 inhibitor, APG-2575 (lisaftoclax), in combination with AstraZeneca’s Bruton’s tyrosine kinase (BTK) inhibitor, CALQUENCE® (acalabrutinib), in treatment-naive patients with first-line chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).

Governor Moore Spotlights Biotechnology and Economic Development During Visit to University of Maryland BioPark

ANNAPOLIS, MD — Governor Wes Moore today visited the University of Maryland BioPark for a discussion and tour focused on biotechnology, innovation and economic development. Governor Moore was joined by University of Maryland Baltimore President Bruce E. Jarrell, M.D., F.A.C.S.; Biotechnology Innovation Organization Chief Executive Officer Rachel King; and numerous biotech and life sciences industry leaders to discuss opportunities for collaboration and promoting the innovation economy in Maryland.

“BioPark isn’t just a hub for discovering new, breakthrough treatments and cures–it’s also a key piece of our state’s economic engine,” said Gov. Moore. “The biotech industry contributes $20 billion to our state’s economy each year, and average annual life sciences incomes are significantly higher than other industries in Maryland. The biotech sector is going to create jobs, drive growth, and build an economy fit for the 21st century.”

Maryland Industrial Partnerships (MIPS) Program Provides Matching Grants for 17 Technology Development Projects Teaming Maryland Companies, USM Faculty

The Maryland Industrial Partnerships (MIPS) program announced that it is providing matching grants for 17 technology product development projects in Maryland.

Each project pairs University System of Maryland faculty members with Maryland-based companies to develop new technology products or processes. Projects are jointly funded by both MIPS and participating companies. All funding goes to the university research.

Oct 17 2023

Love0

578th Edition, October 10, 2023

By admin BHI Weekly Newsletter Archives

BioHealth Innovation, Inc. Announces Strategic Agreement to Provide ARPA-H with Entrepreneurs-in-Residence

ROCKVILLE, MARYLAND, October 5, 2023 – BioHealth Innovation, Inc. (BHI) is proud to announce a pivotal agreement with the Advanced Research Projects Agency for Health (ARPA-H) to provide Entrepreneurs-in-Residence (EIRs) in support of ARPA-H’s mission. This collaboration aims to bolster the development and commercialization of transformative health solutions.

Under the agreement, BHI’s EIRs will offer strategic guidance to ARPA-H Program Managers (PMs) in areas including technology development, intellectual property, and small business needs. They will assist in the development and execution of programs, evaluate partnership opportunities with government biomedical and health research agencies, and leverage industry associations to support funded performers.

Amgen Completes Acquisition of Horizon Therapeutics PLC

Advances Amgen’s Mission to Serve Patients With First-in-Class Rare Disease Medicines

THOUSAND OAKS, Calif., Oct. 6, 2023 /PRNewswire/ — Amgen (NASDAQ: AMGN) today announced that it has completed its acquisition of Horizon Therapeutics plc for $116.50 per share in cash, representing a transaction equity value of approximately $27.8 billion.

“Today marks an exciting milestone as we welcome Horizon employees to Amgen and begin working together to serve even more patients around the world suffering from serious illnesses,” said Robert A. Bradway, Amgen’s chairman and chief executive officer. “We have strong momentum in our core business and the addition of Horizon will further position Amgen as a leader across a broader range of diseases.”

Unveiling Key Insights with Pete Briskman: A Comprehensive Update on the BioHealth Capital Region

In the 9th Annual BioHealth Capital Region Forum, Pete Briskman, Executive Managing Director and Co-Lead for the Mid-Atlantic Life Sciences Practice, offered a thorough update on the BioHealth Capital Region (BHCR) and its significant strides in the life sciences sector.

BHCR’s Noteworthy Achievements:

Securing the #3 rank among Life Science Clusters.
Leading the nation in the number of biotechnology patents.
Holding a prominent third position in total NIH grant funding.
Establishing itself robustly as the third-largest science cluster.

Navigating 2023’s BioPharma Clusters with Alex Philippidis

Alex Philippidis, Senior Business Editor of Genetic Engineering and Biotechnology News, for the 4^th consecutive year, attended the 9th Annual BioHealth Capital Region Forum, presenting his expert insights into the “Top 10 U.S. BioPharma Clusters, 2023,” providing a detailed analysis and overview of the current state and future prospects of the BioPharma industry.

Revisiting Rich Bendis’s Welcome at the 9th Annual BioHealth Capital Region Forum

In a year that underscored “Global Breakthroughs for a Healthier Future,” Rich Bendis, President and CEO of BioHealth Innovation Inc (BHI), extended a heartfelt welcome to attendees, marking the 9th consecutive year of the Annual BioHealth Capital Region Forum.

Take a moment to reflect on Rich’s thorough review of the region’s transformative journey from its inception to its present-day stature, proudly holding a #3 ranking in the GEN Top 10 BioPharma Clusters in the United States. This achievement is a testament to its prowess in NIH Funding, Venture Capital Funding, Patents, Lab Space, and Jobs.

Rich highlighted the global impact of the term “BioHealth,” which has become more woven into the fabric of health discussions and innovations over nearly a decade.

Emmes Acquires VaxTRIALS

VaxTRIALS Adds a New Latin America Base and Greater Vaccine Research Depth

Rockville, MD, October 5, 2023 – Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced the acquisition of VaxTRIALS. Headquartered in Panama City, Panama, VaxTRIALS’ 160+ staff members manage and monitor vaccine clinical trial activities throughout Latin America.

“Today’s clinical trials are both more complex and more global in nature than ever before,” said Emmes Executive Chairman Sastry Chilukuri. “Combining VaxTRIALS’ depth of expertise in Latin America and Emmes’ strengths, particularly in technology, biostatistics and data management, will give clients an unmatched partnership experience in conducting their clinical trials.”

Maryland based United Therapeutics is leading a medical revolution

Imagine a world where unhealthy organs are replaced with transplants constructed with a 3D printer using the patient’s own cells. No more agonizing waits and desperate searches for a suitable donor organ, and, because the printed organs use cells from the patients themselves, no more fear of organ rejection. It might sound like science fiction set in the far off future, but thanks to the pioneering work of United Therapeutics , it may become a reality a lot sooner than you think, and it’s happening here in Maryland.

Novavax 2023-2024 COVID-19 Vaccine Now Authorized and Recommended for Use in the U.S.

GAITHERSBURG, Md., Oct. 3, 2023 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its novel Matrix-M^™ adjuvant, today announced that the Novavax COVID-19 Vaccine, Adjuvanted (2023-2024 Formula) (NVX-CoV2601) has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for active immunization to prevent COVID-19 in individuals aged 12 and older. Immediately upon authorization, Novavax’s vaccine has also been included in the recommendations issued by the U.S. Centers for Disease Control and Prevention (CDC) on September 12, 2023.

Doses will be available nationwide at thousands of locations, including national and local retail pharmacies and physicians’ offices, following the Center for Biologics Evaluation and Research release of vaccine batches, expected in the coming days.

IndoUSrare Announces Bridging RARE Summit to Combat Rare Diseases by Fostering Cross-Border Collaborations, Data Sharing, and Clinical Trials

Gain Therapeutics Announces Dosing of First Two Subjects in Phase 1 Clinical Trial of GT-02287, a Novel GCase-targeting Small Molecule Therapy for GBA1 Parkinson’s Disease

First small molecule allosteric binder discovered with Gain’s computational drug discovery platform enters clinical development

BETHESDA, Md., Oct. 04, 2023 (GLOBE NEWSWIRE) — Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today announced dosing of the first two subjects in a Phase 1 clinical trial of GT-02287, Gain’s lead drug candidate for the treatment of GBA1 Parkinson’s disease. The Company expects to complete this trial in the first half of 2024.

“Initiating first-in-human dosing with GT-02287 is an important milestone for Gain as we enter a new era as a clinical-stage company,” said Matthias Alder, Chief Executive Officer of Gain Therapeutics. “I am very proud of the work accomplished by the entire Gain team to get us to this stage today, and we are eager to advance our understanding of the safety, tolerability and effect of GT-02287 in humans. This represents another major step forward toward providing a treatment for Parkinson’s patients and their families impacted by this devastating disease.”

Welldoc Expands Chronic Care Digital Health Platform to Include Weight Management

Welldoc’s industry-leading holistic platform now incorporates AI-driven digital coaching and features specifically designed to support individuals throughout the complex journey of weight management

COLUMBIA, Md., October 4, 2023 — Welldoc^®, a digital health leader revolutionizing chronic care, today announced the expansion of its platform to support weight management. Welldoc’s comprehensive chronic care platform now provides multi-condition support across prediabetes, diabetes, hypertension, heart failure and weight management, along with integrated mental wellbeing and sleep apnea support. Welldoc’s weight management solution is currently available to all customers and will be launching in early 2024 with two of the leading health care companies in the U.S.

Nearly two-thirds of U.S. adults are overweight or obese, which increases their risk of developing chronic comorbid conditions like type 2 diabetes, hypertension, heart failure, and sleep apnea.  As part of Welldoc’s total health approach to chronic care, AI-driven, personalized digital coaching is available 24/7 to help individuals navigate weight management whether they are just beginning their weight management journey with lifestyle changes or are prescribed a GLP-1 medication. Welldoc enables individuals to understand and connect with their health data in a meaningful way, making the achievement of weight and overall health goals more attainable. Welldoc also provides clinical escalations and decision support for the care team when needed.

Luminoah Wins 8th Annual Crab Trap Competition at BioHealth Capital Region Forum

Luminoah Wins 8th Annual Crab Trap Competition at BioHealth Capital Region Forum

Rockville, MD, September 22, 2023 — Luminoah, a MedTech startup located in Charlottesville, VA, dedicated to improving the lives of people requiring enteral feeding, emerged as the top company at the 8^th Annual Crab Trap Competition, held as part of this year’s BioHealth Capital Region Forum. The event, which took place on September 20th, showcased Luminoah’s innovative wearable system, designed to optimize compliance and clinical outcomes through the integration of durable medical equipment, consumable nutrition pouches, and remote patient monitoring.

Neal Piper, Founder & CEO of Luminoah, delivered an outstanding presentation highlighting the company’s groundbreaking technology. Luminoah’s wearable system represents a significant advancement in the field of enteral feeding, offering an innovative solution to enhance patient care.

Oct 03 2023

Love0

577th Edition, October 03, 2023

By admin BHI Weekly Newsletter Archives

Navigating the Future of Autoimmune Medicine: A Conversation with Dr. Theresa Podrebarac, Senior Vice President, Clinical Development at Horizon Therapeutics

How can patients help shape the future of scientific innovation? What’s the vital role of the patient’s voice in developing life-changing medicines? In this captivating episode, fresh off her thought-provoking appearance at the 9th Annual BioHealth Capital Region Forum, Dr. Theresa Podrebarac takes us on a journey through the dynamic landscape of autoimmune medicine.

Dr. Podrebarac is a renowned physician scientist with a wealth of expertise in the biotech industry. As the Senior Vice President of Clinical Development at Horizon Therapeutics, she’s at the forefront of bringing hope to patients with rare, autoimmune, and severe inflammatory diseases. Join us as we explore pivotal questions:

What is Horizon Therapeutics’ mission, and what are Dr. Podrebarac’s primary responsibilities in this quest for life-changing medicines?
How has Dr. Podrebarac’s background as a rheumatologist influenced her belief in the importance of the patient’s perspective in drug development?
Discover Horizon’s impressive journey in clinical development, with a sharp focus on autoimmune diseases.
Dive into Horizon’s global presence and the crucial role of its Maryland operations.
What are the clinical goals that will shape the future of autoimmune medicine?

Innara Health Acknowledges BioHealth Innovation, Inc. (BHI) and Ethel Rubin for Their Role in Joining Cardinal Health

Innara Health has extended their recognition to BioHealth Innovation, Inc. (BHI) and Ethel Rubin for our significant contributions to Innara Health’s journey. BHI is acknowledged for our confidence and insight in introducing Innara Health to the BioHealth Capital Region, while Ethel Rubin is thanked for her expert counsel, candor, and influential role on the Board, along with her valuable network. Our support has played a crucial part in Innara Health’s mission to improve the lives of premature newborns and infants.

Israeli BioHealth Companies Shine at BioHealth Capital Region Events

The BioHealth Capital Region recently played host to a series of significant events that drew attention from the global biopharma community. Notably, several Israeli BioHealth companies, some traveling directly from Israel, participated in these events, underscoring the region’s growing prominence, especially after being recognized by GEN as a Top 3 BioPharma Cluster in the United States. This remarkable participation was made possible with the dedicated efforts of Aisha Espey, Director of Commerce, Head of Science and Technology from the Embassy of Israel in Washington DC, and Andrea Yonah, Director of Business Development for the U.S. East Coast/Midwest at the U.S. Israel Binational Industrial R&D (BIRD) Foundation.

The BioHealth Capital Region Forum serves as the region’s premier gathering for the biopharma sector, fostering collaborations and discussions that advance public health and economic outcomes. The Crab Trap, now in its 8th year, is a competition spotlighting entrepreneurs with transformative health solutions. The Investment Conference is a platform for companies and investors to create partnerships, featuring brief presentations highlighting BioHealth opportunities and innovations.

Deka Biosciences Closes USD $20 Million Series B2 Financing Led by MPM BioImpact

GERMANTOWN, Md., Sept. 28, 2023 /PRNewswire/ — Maryland-based biotech company Deka Biosciences (“Deka”) today announced that it has successfully closed a USD $20 Million Series B2 financing with a syndicate of life science investors led by MPM BioImpact, and joined by additional investors including Leaps by Bayer, Lumira Ventures, O-Bio (Echo Investment Capital), Viva BioInnovator, Alexandria Venture Investments, Amana Investments, Plains Ventures, ATEM Capital and CEO John Mumm. The proceeds of the financing will support the advancement of Deka’s pipeline and drug product manufacturing as they continue clinical trials following the receipt of a notice to proceed letter from the FDA for their investigational new drug (IND) application to evaluate DK2¹⁰ (EGFR). Additionally, Detlev Biniszkiewicz, Ph.D. of MPM-BioImpact, will join the Deka board.

Maryland Department of Commerce: Maryland, together with D.C and Virginia, now a “Top 3” biopharma cluster

The latest rankings from Genetic Engineering & Biotechnology News (or GEN) included some long-awaited good news for Maryland: the Biohealth Capital Region (BHCR) had moved up to No. 3 on the publication’s list of the top ten biopharma clusters in the United States.

Leaders in Maryland’s biohealth industry have been working to make the BHCR a “Top 3 by 2023” since back in 2016. In recent years, the region (comprising Maryland, Virginia and Washington, D.C.) has ranked No. 4.

“It’s been an incredible journey working with so many dedicated individuals and organizations in the region over the years to meet this goal,” Rich Bendis, president and CEO of BioHealth Innovation, Inc., said in a statement . “The spirit of collaboration and innovation that defines the BioHealth Capital Region has been the driving force behind this success, and I’m proud to be part of this remarkable community.”

Click here to read the entire article.

Emmes Introduces Telehealth Capabilities into Advantage eClinical

The latest upgrade is part of wider goals to create the industry’s first unified digital data platform for decentralized and hybrid trials

ROCKVILLE, Md., Sept. 27, 2023 /PRNewswire/ — Emmes, a global, full-service Contract Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, announces the addition of telehealth capabilities within Advantage eClinical. The new application means any scheduled visit can become virtual with video calls augmented directly through the platform and patients signing in through their existing participant portal. Advantage eClinical is designed to enable a simple, intuitive experience that fits seamlessly into the everyday lives of study participants and sites.

Maryland Department of Commerce Webinar Event: Reach Your Raise: Attract Investors with Maryland’s Biotech Tax Credit

If your Maryland-based life sciences company is doing R&D in biotechnology and preparing to raise equity funding, your investors may be eligible to benefit from tax credits from the State of Maryland through the Biotechnology Investment Incentive Tax Credit (BIITC) program. Join the Maryland Department of Commerce on October 2nd to learn about the program benefits and how you can work with your investors to enhance their returns by investing in you.

Click here to learn more and register.

Anzu Partners Closes Third Venture Fund Focused on Companies Enabling Next-Gen Solutions in Clean Tech, Industrial, and Life Sciences Technologies

Fund III cohort accelerates the energy transition, facilitates discovery of better therapeutics and advances critical industries

ATLANTA & BOSTON & SAN DIEGO & TAMPA, Fla. & WASHINGTON–(BUSINESS WIRE)–Anzu Partners, an investment firm delivering capital and strategic support to early-stage breakthrough technology companies, today announced it has raised more than $200 million at the close of its third venture capital fund.

Fund III was established to invest in companies developing next-generation solutions in clean technology, industrial innovations, and life sciences. Investors in Fund III include new and returning public and private institutions, single and multifamily offices, and accredited investors across the U.S. and overseas.

TEDCO invests in AGED Diagnostics

COLUMBIA, Md. (September 28, 2023) –TEDCO, Maryland’s economic engine for technology companies, announced a recent $200,000 Seed Funds investment into AGED Diagnostics, a biotechnology company. Previously, AGED Diagnostics received a $250,000 investment from TEDCO’s Builder Fund, a funding opportunity that is under the umbrella of our Social Impact Funds.

“1 in 3 Americans have liver disease, but many remain unaware of it until the disease progresses to a stage when it is no longer curable, patient outcomes are poor and/or healthcare costs are burdensome,” said Rachel Zayas, CEO of AGED Diagnostics. “Thanks to TEDCO’s investment we are able to continue our research and development, working towards a future where liver disease can have early detection.”

The BioHealth Capital Region Successfully Hosted Its Annual Forum, Crab Trap, and Investment Conference

The BioHealth Capital Region continued its tradition of fostering innovation, collaboration, and growth in the life sciences sector with its series of events in 2023. The highlights included the 9th Annual BioHealth Capital Region Forum, the 8th Annual BioHealth Capital Region Crab Trap, and the 6th Annual BioHealth Capital Region Investment Conference, bringing together industry, academic, government, entrepreneurs, and investors.

WBJ: Dr. Kurt Newman’s journey from surgeon to CEO

The Greater Washington area has a long history of influential business leaders powering the growth of our region and the strength of their communities. On Dec. 5, the Washington Business Hall of Fame will welcome five such leaders to receive our region’s signature lifetime business achievement award. The Hall of Fame brings these visionaries (the best in business) to the table with the next generation of leaders (the next in business), through an experience that connects and inspires us all.

The 2023 Hall of Fame Laureates are no strangers to media coverage. If you live in the Washington region, chances are you’ve seen their names in headlines for years. What you may not have witnessed is these trailblazers telling their stories in their own words. That’s what this series brings you – the look back, lessons and life advice that these Laureates have to offer based on a lifetime of success.

Luminoah Wins 8th Annual Crab Trap Competition at BioHealth Capital Region Forum

Luminoah Wins 8th Annual Crab Trap Competition at BioHealth Capital Region Forum

Oct 03 2023

Love0

576th Edition, September 26, 2023

By admin BHI Weekly Newsletter Archives

The BioHealth Capital Region Successfully Hosted Its Annual Forum, Crab Trap, and Investment Conference

Luminoah Wins 8th Annual Crab Trap Competition at BioHealth Capital Region Forum

Luminoah Wins 8th Annual Crab Trap Competition at BioHealth Capital Region Forum

Immediate Opening for a Technical Grant Writer and Project Manager with BioHealth Innovation, Inc.

Opening – Technical Writer and Project Manager

BioHealth Innovation (BHI) is an innovation intermediary that facilitates commercialization of emerging technologies in the BioHealth Capital Region (Maryland, DC and Virginia).

BHI is seeking a Technical Writer and Project Manager to join its team remotely. This position provides the opportunity to leverage scientific knowledge to evaluate the commercial potential of emerging technologies and provide recommendations on go-to-market strategies. This is a customer facing role with a focus on supporting clients in the development of commercial analyses and federal grant proposals. This position is geared toward an early-career scientist with extensive writing experience and a history of funded grant proposals.

This position could be either employee or part time contractor depending on applicants experience and availability. Compensation will be competitive but dependent based on experience.

FDA awards nearly $7.5 million to pediatric device consortium led by Children’s National Hospital

Federal funding fosters development and commercialization of medical devices designed for children

WASHINGTON, D.C., Sept. 19, 2023 (GLOBE NEWSWIRE) — To foster the development and commercialization of medical devices designed for children, the Food and Drug Administration (FDA) has awarded a nearly $7.5 million grant to the Alliance for Pediatric Device Innovation (APDI), a consortium led by Children’s National Hospital. The nonprofit group, which is one of five in the FDA’s Pediatric Device Consortia (PDC) program, will utilize the five-year grant to provide a platform of services, expertise and funding that supports pediatric innovators in bringing medical devices to the market that specifically address the needs of children. New in this cycle, APDI will provide expertise on evidence generation, including the use of real-world evidence (RWE), for pediatric device development.

BizJournals – D.C. startup Nanochon raising money to fund trials of 3D-printed knee cartilage implant

D.C.’s Nanochon LLC is raising $3.5 million to make it through the final leg of its journey to bring a 3D-printed knee cartilage implant to market.

The company has already raised $1.8 million toward the round, according to a Securities and Exchange Commission filing. The company said it plans to use the funds to begin human trials and ultimately get Food and Drug Administration approval for its 3D-printed implant.

Nanochon has raised $5 million since its founding in 2016 to fund the clinical trials needed to bring its medical device to market.

Emmes Appoints Peter Ronco as Chief Executive Officer

Ronco’s Global Pharmaceutical Experience Will Support the Next Chapter of Emmes’ Growth and Technology Enablement

Rockville, MD, September 20, 2023 – Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that Peter Ronco has been named Chief Executive Officer, effective immediately.

Mr. Ronco succeeds Dr. Christine Dingivan, who will serve as a senior advisor to Executive Chairman Sastry Chilukuri, and Emmes’ Board of Directors.

United Therapeutics Announces Recent Milestones for its Heart and Kidney Xenotransplantation Programs

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.–(BUSINESS WIRE)– United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced the achievement of two milestones for its xenotransplantation programs in September: the second transplant of a UHeart™ xenoheart into a living person, and a 61-day study of the UThymoKidney™ xenokidney and thymus in a human pre-clinical model.

United Therapeutics’ organ manufacturing efforts consist of seven investigational programs: xenoheart, xenokidney, xenothymokidney, regenerative lungs, 3D-printed lungs, 3D-printed livers, and 3D-printed kidneys. These groundbreaking programs are intended to address the ongoing shortage of transplantable organs for patients with end stage organ disease.

TEDCO Invests in Natáur

COLUMBIA, Md. (September 25, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced a recent $200,000 investment into Natáur. This recent investment came from TEDCO’s Social Impact Funds.

“Natáur is creating bio-based taurine—an essential nutrient for brain development, healthy aging, heart health, and microbiome balance,” said Kathleen Turano, Natáur CEO. “Taurine occurs naturally in animal products but it is missing in plants. With shifts towards more plant-based diets, taurine will need to be added as an ingredient or taken as a supplement to maintain healthy taurine levels. With TEDCO’s investment, we move closer to launching our bio-based taurine.”

Seraxis Announces Closing of Second VC Tranche and Successful Completion of Preclinical Studies of Pancreatic Organoids From Seraxis’ Novel Pancreas-Derived Stem Cells

Leadership team expanded with addition of Chief Corporate Development Officer, Ted Hibben, a 25-year venture-stage business development biotherapeutic industry veteran Total venture funding tops $50M to date

GERMANTOWN, MD / ACCESSWIRE / September 21, 2023 / Seraxis Inc., a cell therapy company developing a pancreatic organoid cure to transform the lives of patients with Type 1 and insulin-requiring Type 2 diabetes, today announced the closing of the second tranche of its inaugural VC round to bring total equity investment in the company to over $50 million. Frazier Life Sciences, Polaris Partners, Eli Lilly and the JDRF T1D Fund participated in the step-up triggered by Seraxis’ achieving the completion of preclinical milestones of Seraxis’ novel pancreatic organoids, SR-02.

Washington DC’s VerImmune Announces Over $3M Additional Funding

WASHINGTON, Sept. 20, 2023 /PRNewswire/ — VerImmune Inc. (“VerImmune”), an early-stage biotechnology company specializing in the development of innovative products based on a novel Virus-inspired Particle (ViP™) technology platform, announced today the securing of an additional $3.125 million from follow-on Seed financing and a partnership milestone payment.

The follow-on financing was led by previous investor, Proxima VC, a specialist seed-to-growth healthcare venture capital firm with participation from other previous investors such as Gaingels, Mana Ventures and others. In addition to this financing, a milestone payment from Fosun Pharma USA was triggered by the successful completion of a process development milestone.

Maryland Stem Cell Research Fund’s Ruchika Nijhara, PhD, selected as one of The Daily Record’s 2023 Influential Marylanders

Impactful leader of the Maryland Stem Cell Research Fund recognized

COLUMBIA, Md. (September 21, 2023) – TEDCO, Maryland’s economic engine for technology companies, announced that Maryland Stem Cell Research Fund (MSCRF) executive director, Ruchika Nijhara, PhD, was named one of The Daily Record’s 2023 Influential Marylanders.

“Although a new addition to 1TEDCO, it’s already evident why Ruchika was chosen to be an Influential Marylander,” said Troy LeMaile-Stovall, TEDCO CEO. “Her dedication to supporting researchers is unwavering; she actively works to improve processes, support others and so much more. We are proud to be working with someone as talented and influential as Ruchika.”

Women Building Bio 2023

Virginia Bio’s Women Building Bio Conference celebrates the contribution of women to the life sciences in the Commonwealth and beyond. The 8th annual conference theme, Building Better, will prompt us to explore how life sciences contribute to building a better future and highlight the increasingly significant role of women in it.

Sep 18 2023

Love0

575th Edition, September 19, 2023

By admin BHI Weekly Newsletter Archives

5 Excellent Finalists Chosen for the 8th Annual BHCR Crab Trap

Rockville, Maryland – September 13, 2023 – BioHealth Innovation, Inc. (BHI), a leading regional innovation intermediary, is thrilled to announce the five outstanding finalists for the 8th Annual BioHealth Capital Region Crab Trap competition. The Crab Trap is a competition designed to identify and showcase promising life sciences and biotechnology startups from around the world. These finalists have demonstrated exceptional innovation, vision, and potential to significantly impact the healthcare industry.

Last Chance to Register for the BioHealth Capital Region Forum 2023!

We’re just ONE DAY away from the FREE 9th Annual BioHealth Capital Region Forum, and there’s still time to register! Don’t miss out on this incredible opportunity to join nearly 500 other registrants on September 19th and 20th. ?️

? Location: US Pharmacopeia (USP), 12601 Twinbrook Pkwy, Rockville, MD 20850
? Attire: Business/Business Casual
? Parking: Paid-parking garage across the street or metered-street parking
? Metro: Twinbrook Metro stop on the Red Line (8-minute walk)

? Why Attend?

Network with esteemed government officials, academic leaders, and industry executives.
Explore new avenues for growth within the BioHealth Capital Region.
Engage in thought-provoking discussions and knowledge sharing.
Discover investment and partnership opportunities in the vibrant biohealth industry.

? The BioHealth Capital Region is a thriving hub of innovation and opportunity, boasting over 2,300 life science companies, 78 federal labs, and renowned academic institutions.

? Register now to be a part of this prestigious event and help shape the future of the BioHealth Capital Region!

Visit https://bit.ly/BHCRForum2023 to register now.

Federal Trade Commission allows Amgen’s $27.8 billion acquisition of Horizon Therapeutics

THOUSAND OAKS, Calif. and DUBLIN, Sept. 1, 2023 /PRNewswire/ — Amgen (NASDAQ:AMGN) and Horizon Therapeutics plc (NASDAQ:HZNP) today announced the entry into a consent order agreement with the Federal Trade Commission (FTC) that resolves the pending FTC administrative lawsuit. This clears the path to take the final steps to close Amgen’s acquisition of Horizon.

As a result of the consent order agreement, Amgen and Horizon expect that the parties will jointly file stipulated proposed orders to dismiss the preliminary injunction motion and dissolve the temporary restraining order (TRO) in the U.S. District Court for the Northern District of Illinois, and that Amgen and Horizon will quickly seek the final approvals required under Irish law to close the acquisition.

Accelerate Investor Conference Returns to Showcase Leading Early-Stage Companies to National Investors

ARLINGTON, Va.–(BUSINESS WIRE)–The Accelerate Investor Conference is back for its third year at George Mason University’s Arlington Campus, November 1-2, 2023. Spurring the region’s innovation and entrepreneurship engagement to a new level, the conference will showcase the Virginia, Maryland, and metropolitan DC region as a destination for business development, venture investment, and job creation.

Top venture firms from across North America participate to attend top keynotes and industry panels and watch 40+ high growth tech and life science companies pitch for their next round of capital. These cutting-edge startups compete for top prizes and are joined by 25 regional student teams presenting business concepts.

Gain Therapeutics Receives Approval to Commence Phase 1 Clinical Study of GT-02287 from the Human Research Ethics Committee (HREC) in Australia

BETHESDA, Md., Sept. 12, 2023 (GLOBE NEWSWIRE) — Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today announced that the Company has received approval from the Bellberry Human Research Ethics Committee (HREC) in Australia to initiate a Phase 1 clinical study of its lead drug candidate GT-02287 in development for GBA1-Parkinson’s disease (GBA1-PD). Dosing in healthy volunteers to assess the safety and pharmacokinetics of GT-02287 is expected to begin in the near term.

Altimmune Announces Completion of Dosing in the Phase 2 MOMENTUM Trial of Pemvidutide in Subjects with Obesity or Overweight

GAITHERSBURG, Md., Sept. 12, 2023 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced the completion of dosing (last subject last dose) in its 48-week Phase 2 MOMENTUM trial evaluating the efficacy and safety of pemvidutide in subjects with obesity or overweight. Pemvidutide is a novel, investigational GLP-1/glucagon dual receptor agonist under development for the treatment of obesity and non-alcoholic steatohepatitis (NASH).

PQE Group Opens Office in Montreal, Quebec, Canada

PQE Group is excited to announce the opening of its newest office in Montreal, Quebec, Canada, marking a significant expansion for the company. The expansion aims to provide enhanced services to both existing and potential clients across various regions in Canada. The Greater Montreal area, located along North America’s east coast, is renowned for its vibrant life sciences community, featuring prestigious universities, leading hospitals, and innovative life sciences companies. Notably, Quebec serves as a hub for the development and acceleration of artificial intelligence (AI), reflecting its forward-thinking approach to shaping the future. Canada’s expertise in AI, characterized by its high-quality research, skilled workforce, and contributions to AI innovation on a global scale, has been a key source of inspiration for PQE Group.

BHI Weekly Newsletter Archives

MaxCyte continues supporting the advancement of novel therapeutics and looks to support education and advancement of mRNA medicines

About BioHealth Innovation

Contact

Connect

BHI Weekly Newsletter Archives

About BioHealth Innovation

Contact

Connect

Search