WednesdaySep 18, 2024 10:13 am

BioMedNewsBreaks — Tonix Pharmaceuticals Holding Corp.’s (NASDAQ: TNXP) TNX-801 Positioned as Viable Contender in Global Fight Against Mpox

Tonix Pharmaceuticals Holding (NASDAQ: TNXP) is a biopharmaceutical company with marketed products and a pipeline of development candidates. Tonix’s TNX-801, a live-virus vaccine candidate, could potentially offer a more viable solution to address the growing global mpox crisis. TNX-801 shows promise because it appears to align with the preferred target product profile (“TPP”) recently issued by the World Health Organization (“WHO”). The TPP emphasizes a well-tolerated, single-dose vaccine that can be administered, shipped and stored in Africa and around the world. Jynneos(R) and ACAM2000(R), two FDA-approved vaccines for mpox, do not fully meet WHO’s TPP. Thus, TNX-801 potentially offers a…

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TuesdaySep 17, 2024 9:00 am

BioMedNewsBreaks – NextPlat Corp. (NASDAQ: NXPL) Reports on Voting Held During Annual Meeting of Stockholders

NextPlat (NASDAQ: NXPL), a global e-commerce provider, has released the voting results from its Special Annual Meeting of Stockholders, which was held Sept. 13, 2024. According to the report, shareholder voted on six agenda items, including a proposal to approve and adopt the merger agreement and plan of reorganization making Progressive Care Inc. (OTCQB: RXMD) a wholly owned subsidiary of the company. The proposal was approved, with an anticipated closing date of Oct. 1, 2024. The announcement noted that Progressive Care shareholders also approved the business combination at a special meeting of shareholders held Sept. 13, 2024. Other items approved…

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TuesdaySep 17, 2024 8:55 am

BioMedNewsBreaks – Nutriband Inc. (NASDAQ: NTRB) Reports on Share Repurchase Program

Nutriband (NASDAQ: NTRB), a developer of transdermal pharmaceutical products, has authorized a share repurchase program to buy back up to $1 million of its common stock. According to the announcement, as of Sept. 16, 2024, the company had 11,106,185 shares of common stock outstanding. The company also reported that it is continuing to make progress on the development of AVERSA Fentanyl, with a target date of submitting a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) in the first half of 2025. To view the full press release, visit https://ibn.fm/AfJJt About Nutriband Inc. Nutriband is primarily…

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MondaySep 16, 2024 10:56 am

BioMedNewsBreaks — Clene Inc. (NASDAQ: CLNN) Announces Upcoming In-Person FDA Meeting to Discuss CNM-Au8

Clene (NASDAQ: CLNN), a late clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, will be meeting in-person with the U.S. Food and Drug Administration (“FDA”) before the end of November 2024. The company announced that the meeting, which will focus on discussions about the development of the company’s proprietary CNM-Au8 for the treatment of amyotrophic lateral sclerosis (“ALS”), will include key FDA representatives, including the organization’s director of the Office on New Drugs and director of the Office of Neuroscience, as well as the Division of Neurology 1 (“DN1”) review team and key…

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MondaySep 16, 2024 10:34 am

BioMedNewsBreaks — Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) Reports TNX-801 Aligns with WHO Preferred TPP for Mpox Vaccines

Tonix Pharmaceuticals (NASDAQ: TNXP), a fully integrated biopharmaceutical company with marketed products and a pipeline of development candidates, is reporting that the World Health Organization’s (“WHO”) preferred target product profile (“TPP”) aligns with the characteristics of its proprietary TNX-801 (horsepox, live virus) vaccine; Tonix is developing the vaccine for mpox (formerly known as monkeypox). WHO released the TPP at the Mpox Research and Innovation Scientific Conference, which was held Aug. 29–30, 2024, According to the announcement, key elements of the WHO draft TPP include single-dose, durable protection, administration without special equipment and stability at ambient temperature. “The characteristics of TNX-801…

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MondaySep 16, 2024 9:35 am

BioMedNewsBreaks – Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) Schedules Virtual Panel Discussion on Plaque Psoriasis, Its Promising Novel Solution

Scinai Immunotherapeutics (NASDAQ: SCNI), a biopharmaceutical company focused on developing inflammation and immunology (“I&I”) biological products and providing CDMO services through its Scinai Bioservices business unit, today announced plans to host a scientific webinar to discuss the plaque psoriasis landscape, current treatment methods, and existing unmet needs in treating mild to moderate plaque psoriasis. The virtual panel discussion will also explore intralesional injections of the company’s novel anti-IL-17A/F VHH single domain VHH antibodies as a promising solution. Other topics will include an introduction to single domain VHH antibodies and the company’s pipeline, with panelists also reviewing the biological drug development…

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WednesdaySep 11, 2024 11:00 am

BioMedNewsBreaks – Astiva Health Notes ‘Outstanding Expansion’ in 2024, Projects ‘Substantial’ Growth for 2025

Astiva Health, a fast-growing Medicare Advantage Prescription Drug (“MAPD”) health plan dedicated to reshaping personalized and comprehensive healthcare, is forecasting membership growth for 2025. This year the company has seen “outstanding expansion,” and based on that growth, Astiva Health anticipates have an additional 7,000 members join its unique, personalized plan membership in the upcoming year. According to the announcement, those numbers would represent a substantial 70% increase over its current membership base. “We are thrilled to continue building on the momentum we've achieved this year,” said Astiva Health cofounder and CEO Dr. Tri T. Nguyen in the press release. “Our…

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TuesdaySep 10, 2024 11:27 am

BioMedNewsBreaks — Tonix Pharmaceuticals Holding Corp. (NASDAQ: TNXP) Names Seasoned Veteran as New EVP of Commercial Operations

Tonix Pharmaceuticals (NASDAQ: TNXP), a biopharmaceutical company with marketed products and a pipeline of development candidates, has appointed a new executive vice president of commercial operations, effective immediately. According to the announcement, the company named Thomas (Tom) Englese as its new executive, noting that he has more than two decades of commercial and operations experience in the biopharmaceutical industry. The company also noted that it is on track to submit an NDA for TNX-102 SL for fibromyalgia in October 2024. “Tom brings extraordinary biopharmaceutical expertise as an industry leader with more than 20 years of commercial experience and a proven…

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TuesdaySep 10, 2024 11:10 am

BioMedNewsBreaks – HeartBeam Inc. (NASDAQ: BEAT) Appoints Industry Expert as New CFO

HeartBeam (NASDAQ: BEAT), a medical technology company focused on transforming cardiac care through the power of personalized insights, has named a seasoned medtech leader as its new chief financial officer. According to the announcement, Timothy Cruickshank has accepted the role of chief financial officer, effective immediately; he succeeds Richard Brounstein, who announced his retirement. Cruickshank has a proven track record of strategic planning, financial stewardship and commercial success with a focus on growing businesses with disruptive technologies through authentic leadership, strategic focus, data-driven decisions, and strong risk management and governance. “Tim has an outstanding record of delivering results and creating…

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MondaySep 09, 2024 1:09 pm

BioMedNewsBreaks – Scinai Immunotherapeutics Ltd. (NASDAQ: SCNI) CEO Featured Guest on Latest Episode of BioMedWire Podcast

Scinai Immunotherapeutics (NASDAQ: SCNI), a biopharmaceutical company focused on developing inflammation and immunology (“I&I”) biological products and on providing contract development and manufacturing organization (“CDMO”) services through its Scinai Bioservices business unit, is spotlighted in this week’s episode of The BioMedWire Podcast. During the episode, Scinai Immunotherapeutics CEO Amir Reichman talks with host Carmel Fisher about SCNI’s business model as well as entities and experts the company works closely with. The BioMedWire Podcast features fast-paced interviews with experts guiding the next wave of pharmaceutical and biotech innovation. “In the end, we went for a derisking strategy where our molecular targets are molecular…

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