News

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).

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.

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. 

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.

• 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. 

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.