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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.

• 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.

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.

Thomas (Tommy) Luginbill has accepted the position of executive director of the Pinkney Innovation Complex for Science and Technology at Montgomery College (PIC MC). PIC MC is part of Montgomery College’s efforts to grow a hub of education, business, and entrepreneurship, where industry partners co-locate and actively interact with faculty and students to achieve both educational and economic success. In this capacity, Luginbill will continue to advance the development of this innovative science and technology hub in collaboration with academic, corporate and government partners. 

“I am honored to follow in the footsteps of those who have paved the way before me at PIC MC. Their dedication and hard work have laid the foundation for our mission,” Luginbill said. “We are committed to building upon this legacy, creating a vibrant hub for education, business, and innovation that will continue to thrive and benefit the Montgomery County community. Together with our partners, we are ready to embrace this challenge and honor the past while shaping the future.”

Board appointees represent expertise of Maryland’s academic research institutions

COLUMBIA, Md., Jan. 4, 2024 /PRNewswire/ — TEDCO, Maryland’s economic engine for technology companies, announced the recent appointment of Christina DeMur, director of technology development at Johns Hopkins Technology Ventures, to the Maryland Innovation Initiative Board of Directors.

The Maryland Innovation Initiative (MII) was created as a collaboration between the State of Maryland and five Maryland academic research institutions: Johns Hopkins University (JHU); Morgan State University (MSU); University of Maryland, College Park (UMCP); University of Maryland, Baltimore (UMB); University of Maryland, Baltimore County (UMBC).

Recently this collaboration has expanded to include two more comprehensive universities – Frostburg State University and Bowie State University. This expansion will allow MII to further its reach and help bring more innovative research to the market.

ROCKVILLE, Md., Jan. 4, 2024 /PRNewswire/ — MaximBio, a leading Maryland-based manufacturer specializing in lateral flow and diagnostic devices, is announcing the receipt of a $49.5 million award from the U.S. Department of Health and Human Services (HHS) through the Administration for Strategic Preparedness and Response (ASPR). This funding is designated to fortify the domestic manufacturing capabilities for diagnostic tests and enhance preparedness for potential future pandemics. The award is part of a broader initiative awarding $600 million to 12 domestic COVID-19 test manufacturers.

Project NextGen is a $5 billion initiative to develop next-generation medical countermeasures, including vaccines and therapeutics, to enhance preparedness for future COVID-19 strains and variants.

MANASSAS, Va.–(BUSINESS WIRE)–ATCC, the world’s premier biological materials management and standards organization, today announced a five-year, $87 million award from the Biomedical Advanced Research and Development Authority (BARDA), part of the Administration for Strategic Preparedness and Response within the U.S. Department of Health and Human Services, to support the development of next-generation medical countermeasures (MCMs) to protect Americans from public health security threats such as coronaviruses.