GAITHERSBURG, Md. and CAMBRIDGE, United Kingdom, Jan. 30, 2024 (GLOBE NEWSWIRE) -- Revolo Biotherapeutics (“Revolo” or the “Company”), a company developing therapies that reset the immune system to achieve superior long-term remission for patients with autoimmune and allergic diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to ‘1104, a first-in-class immune-resetting peptide being developed as a potential treatment for eosinophilic esophagitis (EoE). Revolo submitted its original request prior to the initiation of its Phase 2a EoE study (RVLO 121-04) and submitted an amended request following positive results from an additional Phase 2 study.

The FDA grants ODD status to support the development and evaluation of potential new medicines intended for the treatment, diagnosis, or prevention of rare diseases or disorders that affect fewer than 200,000 people in the U.S. Revolo believes that this ODD reflects the potential for ‘1104 to address a critical unmet need for people living with EoE.

ROCKVILLE, Md. and ST. LOUIS, Jan. 30, 2024 (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, and Wugen, Inc., a clinical-stage biotechnology company developing allogeneic, off-the-shelf cell therapies to treat a broad range of hematological and solid tumor malignancies, today announced the signing of a strategic platform license (SPL).

Under the terms of the agreement, Wugen gains non-exclusive clinical and commercial rights to use MaxCyte’s Flow Electroporation^® technology and ExPERT™ platform. In return, MaxCyte will receive annual license fees and program-related revenue.

ROCKVILLE, Md., Jan. 30, 2024 /PRNewswire/ -- NeoImmuneTech, Inc. (NIT), a T cell-focused therapeutics company, today announced that the U.S. Food and Drug Administration (FDA) has granted NT-I7 (efineptakin alfa) (rhIL-7-hyFc) Orphan Drug Designation (ODD) for the treatment of pancreatic cancer.^[3]

Pancreatic cancer is an aggressive tumor-type associated with extremely poor prognosis. It is the third deadliest cancer in the US and European Union with a combined annual mortality of 139,000.^[1],[4] Advanced pancreatic cancer has a five-year relative-survival-rate of 3%. Pancreatic cancer has been labeled as a "silent killer" because it is normally asymptomatic in the early stages which implies that it is often diagnosed at a late stage when tumors are highly resistant to treatment modalities. This underscores the critical need for new and more effective therapeutic approaches.²

By Jelena Ivanjac | January 30, 2024 - The end of 2023 marked the completion of Virginia’s first statewide life sciences initiative, Virginia Bio-Connect, which started in April 2021. This comprehensive industry cluster strengthening project, supported by Virginia Growth and Opportunity Foundation funding and led by the Virginia Biotechnology Association, engaged thousands of life sciences professionals and hundreds of organizations and companies within the sector with the overarching goal of fostering a more connected life sciences ecosystem, providing support for early-stage companies, and driving workforce development throughout the state.

Application deadline is Feb. 15 for the pandemic network edition of “Make Your Medical Device Pitch for Kids!™

WASHINGTON, Jan. 29, 2024 (GLOBE NEWSWIRE) -- The Alliance for Pediatric Device Innovation (APDI) and Pediatric Pandemic Network (PPN) have teamed up to provide a unique opportunity for innovators of pediatric medical devices, diagnostics and digital health solutions. The organizations are inviting submissions for a pitch competition that emphasizes the development of medical countermeasures (MCMs) – innovations designed to address the unique healthcare needs of children during pandemics and other disasters. MCMs play a pivotal role in bolstering readiness and response capabilities to disasters arising from a broad spectrum of threats.

Johns Hopkins University has launched an ambitious endeavor that the school’s leaders say will make Baltimore a hub of the booming artificial intelligence industry.

The new Data Science and Translation Institute, announced several months ago and planned for the western edge of the Homewood Campus, is expected to be “the leading academic hub for data science and artificial intelligence – a resource that will bring world-class experts to the Baltimore region and drive game-changing innovations,” said Rama Chellappa, interim co-director of the planned institute and a Bloomberg Distinguished Professor at the school.

ROCKVILLE, Md., Jan. 29, 2024 /PRNewswire/ -- Rise Therapeutics, a clinical-stage biotechnology company developing novel oral immunotherapeutic medicines, today announced that it has enrolled its first patient in its R-2487 Phase 1 rheumatoid arthritis clinical trial.

"This is an important milestone for the company and patients suffering from rheumatoid arthritis" states Gary Fanger President and Chief Executive Officer of Rise Therapeutics. "This achievement reinforces our commitment to deliver innovative new medicines to the clinical community."

Germantown, Maryland, and State College, Pennsylvania, Jan. 25, 2024 (GLOBE NEWSWIRE) -- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced a first-in-kind collaboration with Penn State University in the United States to create a shared research and education facility for the fast-developing microbiome sciences.

The university-industry partnership will serve as a beacon for this field by investigating research opportunities that address challenges and research gaps facing the microbiome, which involves the research into a community of microorganisms that can be found living together in any given environment, including the human body.

Florence, Jan. 26, 2024 – PQE Group, the renowned Life Science consulting powerhouse, concludes the fiscal year 2023 with a 10% growth and an upwardly revised income exceeding 100 million euros in revenues. The Italian headquartered global firm, celebrated as a preferred advisor to pharma manufacturing and medical device corporations and SMEs globally, marks this success as a testament to its resilience, adaptability, and strategic vision amid the complex global landscape.

"At a time when many companies grapple with geopolitical challenges, crises, and inflation rates, PQE Group stands out not only for its resilience but for its ability to thrive in uncertain times, showcasing positive growth across all financial indicators," stated Gilda D'Incerti, CEO & Founder of PQE Group. "This success is rooted in meticulous planning, strategic investments in cutting-edge technologies, and a corporate culture that values agility and innovation."

ROCKVILLE, Md., and SYDNEY, Australia, Jan. 23, 2024 (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, and Imugene, (ASX: IMU), a clinical-stage immuno-oncology and cell therapy company developing a range of new treatments that seek to activate the immune system of cancer patients to identify and eradicate tumors, today announced the signing of a strategic platform license (SPL).

Under the terms of the agreement, Imugene obtains non-exclusive clinical and commercial rights to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform. In return, MaxCyte is entitled to receive platform licensing fees and program-related revenue.

After a period of leadership transition and strategic planning, the organizations behind one of Baltimore’s longest-standing entrepreneurial communities have appointed a new executive director to take it to the next level.

On Tuesday, the Baltimore Development Corporation (BDC) and Maryland Technology Development Corporation (TEDCO) jointly announced the appointment of Arti Santhanam as the new executive director of the Emerging Technology Centers (ETC Baltimore).

Santhanam most recently served as executive director of TEDCO’s Maryland Innovation Initiative (MII), a public-private effort to promote academic research commercialization across the state.

BALTIMORE, Jan. 22, 2024 /PRNewswire/ -- Haystack Oncology, a Quest Diagnostics (NYSE: DGX) company and developer of best-in-class personalized MRD technology (Haystack MRD™), has entered a research collaboration with TriSalus Life Sciences to evaluate therapeutic response and provide molecular insights in connection with the clinical development of TriSalus' SD-101, an investigational class C toll-like receptor-9 (TLR9) agonist. SD-101 is delivered via hepatic arterial infusion or pancreatic retrograde venous infusion in their phase 1 and 1b clinical trials using their proprietary Pressure-Enabled Drug Delivery™ (PEDD™) to overcome the challenges associated with intratumoral pressure for patients diagnosed with hepatocellular carcinoma, intrahepatic cholangiocarcinoma, and pancreatic adenocarcinoma.

Rockville, MD – BioHealth Innovation, Inc. (BHI) is proud to announce that our Founder, President & CEO, Rich Bendis, has been named a finalist for the Community Builder Award in the 2023 BioHealth Capital Region Annual Awards, hosted by BioBuzz.

Rich Bendis’ dedication to fostering innovation and supporting the biohealth ecosystem has been instrumental in driving growth and collaboration within the industry. His visionary leadership at BHI has created a platform for emerging companies, researchers, and entrepreneurs to connect with resources, expertise, and opportunities, significantly contributing to the region’s economic development and public health advancements.

BioBuzz’s recognition of Rich Bendis as a finalist for the Community Builder Award is a testament to his unwavering commitment and impactful work in the BioHealth Capital Region, encompassing Maryland, Washington, DC, and Virginia.

The Covid-19 pandemic triggered an unexpected boom in entrepreneurship, as Americans opted to start businesses at record rates. Just as unexpected has been the boom’s durability. Would-be entrepreneurs have proven to be undaunted by recession fears, labor and supply-chain constraints, the highest inflation rates in a generation, and rapid interest rate hikes. In October 2023, over three and a half years after the pandemic’s onset, Americans were still filing 59% more applications to start new businesses than they were before the pandemic. The resurgence is all the more remarkable given how deeply startup rates and other measures of economic dynamism languished at or near all-time lows throughout the 2010s.

Thus, one of the most intriguing questions facing the U.S. economy right now is whether the pandemic has durably shaken the country out of its entrepreneurial slump. The answer to this question matters inordinately to the health and direction of the economy in the years ahead, affecting everything from job growth to productivity. And answering it requires digging into three things: what’s driving the boom, how economically significant it may be, and what policymakers can do to sustain it.

ROCKVILLE, Md., Jan. 16, 2024 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced positive interim data from the Phase II AAVIATE^® trial of ABBV-RGX-314 for the treatment of wet age-related macular degeneration (wet AMD) using suprachoroidal delivery. Wet AMD is a chronic, life-long disease with available anti-VEGF treatment options that may reduce the risk of blindness, but require frequent injections. Investigational ABBV-RGX-314 using suprachoroidal delivery is designed to be a one-time, in office treatment that has the potential to sustain constant anti-VEGF therapy and stabilize or improve vision long-term for wet AMD patients. The new data presented at the Hawaiian Eye and Retina meeting in Maui, HI by John Pitcher, M.D., Eye Associates of New Mexico, includes 6-month results from two additional dose level 3 cohorts (Cohorts 5 and 6). ABBV-RGX-314, being developed in collaboration with AbbVie, is also being investigated as a potential one-time gene therapy for the treatment of diabetic retinopathy and other chronic retinal conditions.            

ROCKVILLE, MARYLAND, January 16, 2024– BioHealth Innovation, Inc. (BHI), a leading public-private non-profit organization dedicated to advancing healthcare innovation in the BioHealth Capital Region, is pleased to announce the appointment of Peter Ronco to its Board of Directors.

Peter Ronco is an accomplished drug developer and innovative senior pharmaceutical executive, currently serving as the Chief Executive Officer of Emmes, a full-service Contract Research Organization (CRO) operating in 30+ countries and across multiple disease areas, including ophthalmology, vaccines, rare diseases, cell & gene therapy, and neuroscience. With extensive global experience spanning therapeutic areas such as oncology, immunology, neuroscience, vaccines, anti-infectives, cardiovascular, and retinal gene therapy, Peter brings a wealth of knowledge and expertise to the BHI Board.

As CEO of Emmes, Peter is responsible for setting the strategic direction and the organization’s day-to-day operations, which collaborates with over 210 sponsors, including pharmaceutical and biotech companies, government agencies, academic institutions, and non-profit foundations.

WASHINGTON, D.C., Jan. 16, 2024 (GLOBE NEWSWIRE) -- Artificial intelligence (AI) has the potential to detect rheumatic heart disease (RHD) with the same accuracy as a cardiologist, according to new research demonstrating how sophisticated deep learning technology can be applied to this disease of inequity. The work could prevent hundreds of thousands of unnecessary deaths around the world annually. 

Developed at Children’s National Hospital and detailed in the latest edition of the Journal of the American Heart Association, the new AI system combines the power of novel ultrasound probes with portable electronic devices installed with algorithms capable of diagnosing RHD on echocardiogram. Distributing these devices could allow healthcare workers, without specialized medical degrees, to carry technology that could detect RHD in regions where it remains endemic. 

BioHealth Innovation (BHI) was prominently represented at the 2024 J.P. Morgan Healthcare Conference, with several Entrepreneurs-in-Residence (EIRs) in attendance. The insights gathered by these experienced professionals provide a comprehensive view of the current trends, challenges, and opportunities in the biohealth industry. Here's a summary of their observations and thoughts.

GERMANTOWN, Md., Jan. 16, 2024 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced that the European Commission (EC) has granted Orphan Drug Designation for the Company's first-in-class investigational medicine PRGN-2012 for the treatment of recurrent respiratory papillomatosis (RRP). RRP is a rare, difficult-to-treat and sometimes fatal neoplastic disease of the upper and lower respiratory tracts caused by human papillomavirus type 6 (HPV 6) or HPV type 11 (HPV 11). PRGN-2012 received Orphan Drug Designation from the United States Food and Drug Administration (FDA) and Precigen was the first company to receive Breakthrough Therapy Designation and an accelerated approval pathway from the FDA for an RRP treatment.

January 16, 2024  -  By This email address is being protected from spambots. You need JavaScript enabled to view it. - Principal Investigator Robert K. Ernst, PhD, the Dr. Paul and Mrs. Jean Corcoran Endowed Professor and chair of the Department of Microbial Pathogenesis at the University of Maryland School of Dentistry (UMSOD) and Distinguished University Professor, has been awarded a five-year, $9.4 million contract from the National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) to continue work developing and testing novel adjuvants for the improvement of vaccines. Ernst was awarded $6.4 million in funding through the same NIAID program in 2018, bringing his total funding for adjuvant development to over $16 million.

ROCKVILLE, Md., Jan. 15, 2024 /PRNewswire/ -- NeoImmuneTech, Inc. (NIT or "NeoImmuneTech"), a clinical-stage T cell-focused biopharmaceutical company, today announces the appointment of Luke Oh, Ph.D., as President, effective immediately.

Dr. Oh is an expert in regulatory policies and drug development, encompassing both biologics and small molecules. He brings over six years of regulatory experience at the U.S. FDA. His recent tenure at Samsung Bioepis as Vice-President in charge of Regulatory Development was marked by the successful preparation and submission of seven biosimilar applications to regulatory agencies in the US, EU, UK, and Canada. Prior to this position, he has worked as Senior Staff Fellow at the U.S. FDA Division of Clinical Pharmacology III and Division of Inflammation and Immune Pharmacology, and he has held various roles in research and development for leading organizations such as Mallinckrodt Pharmaceuticals, Human Genome Sciences, and Vertex Pharmaceuticals. Dr. Oh has a Ph.D. in Neuroimmunology from the McGill University (Montreal, Canada).

GAITHERSBURG, Md., Jan. 11, 2024 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has secured an indefinite-delivery, indefinite-quantity (IDIQ) procurement contract with a maximum value up to $235.8 million to supply BioThrax^® (Anthrax Vaccine Adsorbed) for use by all branches of the U.S. military as Pre-Exposure Prophylaxis (PrEP) for anthrax disease. The new contract with the U.S. Department of Defense (DoD) and led by the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, is comprised of a five-year base agreement ending on September 30, 2028, and an additional five-year option that would extend the contract to September 30, 2033. 

CHARLOTTESVILLE, VA – January 11, 2024 – Luminoah Inc., a medical technology company dedicated to improving the standard of care for patients requiring enteral nutrition, has been awarded a $463,000 grant from Virginia Catalyst. This funding propels Luminoah’s innovative enteral feeding system one step closer to commercialization, poised to grant millions of users the freedom to feed themselves anytime, anywhere, while empowering healthcare providers to support their patients remotely. 

The Virginia Catalyst, also known as the Virginia Biosciences Health Research Corporation (VBHRC), announced that it has awarded $2.2 million in grants to four life and bioscience projects in the Commonwealth of Virginia. These grants, which will be met with significant matching funds from partner companies, were awarded through Grant Round 15 of Virginia Catalyst’s ongoing mission to stimulate economic development by promoting collaborative projects that address large, unmet needs for improving human health, and that can create high-paying jobs in the Commonwealth.

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• New Business Unit Veridix AI Launched to Embed Technology and AI in Day-to-Day Clinical Operations
• Dr. Rama Kondru to Join the Emmes Group as CEO, Veridix AI
• Industry Leader Matthew Holt to Join Board of Directors

SAN FRANCISCO, Jan. 9, 2024 /PRNewswire/ -- Emmes today announced the creation of the Emmes Group, with Sastry Chilukuri serving as its executive chairman and chief executive officer. The company also announced a new board member, Matthew Holt.

The Emmes Group will have two business units: Emmes, its Clinical Research Organization (CRO) led by Peter Ronco, and Veridix AI, the newly launched technology and artificial intelligence (AI) group, led by recently appointed executive Dr. Rama Kondru.

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The Virginia Catalyst, also known as the Virginia Biosciences Health Research Corporation (VBHRC), today announced that it has awarded $2.2 million in grants to four life and bioscience projects in the Commonwealth of Virginia. These four collaborative projects, involving Virginia research universities and industry partners, were awarded through Virginia Catalyst Grant Round 15 to address major unmet healthcare needs and drive job creation and capital formation in Virginia.

Through this 15^th round of funding, Virginia Catalyst has awarded 61 grants totaling $29.7 million, resulting in over $47 million in matching funds and an additional $821 million in follow-on funding to date.

January 9, 2024 / By Clary Estes - National wastewater viral activity levels for COVID-19 have been  very high since December. (It wasn’t your imagination that everyone seemed sick over the holidays.) Currently, wastewater data is the best way to track COVID infections as most people are testing at home and not reporting their status. And currently, wastewater levels indicate that about 2 million Americans are getting infected each day.

This means that we are now in the second-highest COVID surge, after Omicron. As we hover around the fourth year of living with COVID, it is clear COVID could be endemic. With surges such as we are seeing now, personal safety measures are still very much needed—including (and especially) staying up to date on COVID vaccines.

KeifeRx is currently advancing programs investigating KFRX03, KFRX04, KFXR05 and KFX06 in neurodegenerative, neuroinflammatory, and mast cell-associated diseases

WASHINGTON, Jan. 8, 2024 /PRNewswire/ -- KeifeRx, an emerging clinical-stage biopharmaceutical company specializing in the discovery and development of new treatment options for neurodegenerative and immune diseases, announced today entry into an amended exclusive licensing agreement with Georgetown University to advance the development of novel tyrosine kinase inhibitor (TKI) chemical entities (NCE) for the treatment of multiple disease indications. The amendment provides an extension of the exclusively licensed rights to these four novel chemical entities for the treatment of new disease conditions including inflammatory, mast-cell associated diseases, and oncology, in addition to existing rights in neurodegenerative diseases. KeifeRx is currently conducting optimizing and IND-enabling studies involving four separate formulations of the TKI (renamed KFRX03, KFRX04, KFRX05, and KFRX06) with patent life through 2037.

ROCKVILLE, Md., Jan. 8, 2024 /PRNewswire/ -- Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH) ("Shuttle Pharma") today announced they have received the 'Safe to Proceed' letter from the U.S. Food and Drug Administration (FDA) for the Company's investigational new drug (IND) application for its Phase II study of Ropidoxuridine (IPdR) as a radiation sensitizing agent during radiotherapy in patients with newly diagnosed IDH-wildtype glioblastoma with unmethylated MGMT promoter. Receipt of the letter allows Shuttle to commence the Phase II study.

Shuttle Pharma is currently finalizing site enrollment with 'first patient, first dose' expected in the coming months. Ropidoxuridine is Shuttle Pharma's lead radiation sensitizer candidate for use in combination with radiation therapy (RT) to treat glioblastoma, a deadly malignancy of the brain with no known cure.

The Advanced Research Projects Agency for Health (ARPA-H) is soliciting proposals from small business concerns that possess the research and development (R&D) expertise to conduct innovative research that will contribute toward ARPA-H mission needs and Small Business Innovation Research (SBIR) program objectives.

SOLICITATION 75N91024R00006 is anticipated to be made available on or about January 23, 2024 through SAM.gov.  This solicitation is anticipated to have a closing date of February 22, 2024 for receipt of proposals.

The purposes of the SBIR program are to: (a) stimulate technological innovation; (b) strengthen the role of small business in meeting Federal research/research & development (R/R&D) needs; (c) foster and encourage participation by socially and economically disadvantaged small business concerns and women-owned business concerns; and (d) increase private sector commercialization of innovations derived from Federal R/R&D, thereby increasing competition, productivity and economic growth. 

Are you prepared to discover a transformative shift in orthopedic innovation? Join us in this episode of BioTalk with Rich Bendis as step into the world of Nanochon with CEO Ben Holmes.

The overall deal flow in biopharma tapered off in 2023 but the big companies sure know what they want (what they really, really want), according to a new report from J.P. Morgan.

And that’s antibody-drug conjugates, which drove a fourth-quarter spike in licensing deal proceeds and provided a glimmer of hope to an industry battered by outside forces and grim financing prospects.

2023 was tough, but clinical biotechs still had a lot of opportunities to wheel and deal, according to J.P. Morgan. While licensing deals, venture investments, M&A and IPOs were down overall in the fourth quarter, deal values stayed fairly high thanks to a flurry of late-stage tie ups.

• NeuMoDx CT/NG Assay designed to improve accessibility, affordability and timeliness in sexually transmitted infection (STI) testing in the U.S.

• U.S. regulatory clearance of new assay for use on both NeuMoDx 96 and 288 versions of integrated PCR-based clinical molecular testing system

• Global presence anchored by 16 EU-certified in-vitro diagnostics (CE-IVD) tests, positioning NeuMoDx as having one of the broadest test menus available to customers

Germantown, Maryland, and Venlo, the Netherlands, Jan. 08, 2024 (GLOBE NEWSWIRE) -- QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) today announced the U.S. Food and Drug Administration (FDA) clearance for the NeuMoDx CT/NG Assay 2.0, growing its test menu for its integrated PCR-based clinical molecular testing systems NeuMoDx 96 and 288 in the United States.

This assay is designed for direct detection of asymptomatic and symptomatic bacterial infections involving Chlamydia trachomatis (CT) and / or Neisseria gonorrhoeae (NG) – the most common type of bacterial infection among sexually transmitted infections (STIs), according to the U.S. National Institutes of Health. The majority of these infections are asymptomatic and generally curable with existing single-dose regimens of antibiotics. However, the time it takes for results to be received is often long, impeding follow-up care.