RNA

QuidelOrtho Receives 510(K) Clearance for Savanna® Multiplex Molecular Platform and Savanna® HSV 1+2/VZV PCR Assay

Retrieved on: 
Wednesday, December 20, 2023
Health, FDA, Medical Devices, Infectious Diseases, Hospitals, Genetics, Biotechnology, RNA, Dicarboxylic acid, Food, Virus, Hospital, DNA, PCR, VZV, Laboratory, Transfusion medicine, Infection, Growth, Patient, Diagnosis, QuidelOrtho, Medical device

The clearance allows QuidelOrtho to market and sell the Savanna multiplex molecular platform and the Savanna HSV 1+2/VZV assay to laboratories performing moderate or high complexity diagnostic testing in the United States.

Key Points: 
  • The clearance allows QuidelOrtho to market and sell the Savanna multiplex molecular platform and the Savanna HSV 1+2/VZV assay to laboratories performing moderate or high complexity diagnostic testing in the United States.
  • “Our relentless pursuit of revolutionizing testing across the healthcare continuum has resulted in the achievement of another major milestone – the clearance of our Savanna platform and the Savanna HSV 1+2/VZV assay,” said Douglas Bryant, President and Chief Executive Officer of QuidelOrtho.
  • Savanna is a fully integrated, sample-to-result, automated in vitro diagnostic platform that performs real-time polymerization chain reaction (“PCR”) tests by using the Savanna instrument and Savanna assay cartridges.
  • The Savanna HSV 1+2/VZV test panel is intended to aid in the differential diagnosis of infections with these viruses.

Vesigen Receives National Institutes of Health Award in Targeted Genome Editor Delivery Challenge

Retrieved on: 
Tuesday, December 19, 2023
Biotechnology, Genetics, Health, SCGE, RNA, Gene editing, Cell, Therapy, Tropism, Genome, Bangladesh Technical Education Board, NIH, Vaccine

Vesigen Therapeutics, Inc., a biotechnology company developing a novel non-viral delivery platform for gene editors, RNA, and protein-based therapeutics, was selected as a Phase 1 winner of the National Institutes of Health TARGETED (Targeted Genome Editor Delivery) Challenge .

Key Points: 
  • Vesigen Therapeutics, Inc., a biotechnology company developing a novel non-viral delivery platform for gene editors, RNA, and protein-based therapeutics, was selected as a Phase 1 winner of the National Institutes of Health TARGETED (Targeted Genome Editor Delivery) Challenge .
  • The Company’s proposal, “Engineered ARMMs: Promising Human-Derived Vectors for Cell Type-Specific Delivery of Genome Editors”, builds on recent data demonstrating directed tropism of the Company’s non-viral ARMM (ARrestin-domain 1 Mediated Microvesicles) delivery platform and was among five proposals selected as “Winning Solutions” for programmable delivery systems for gene editing.
  • We look forward to advancing our platform toward the clinic and unlocking the full potential of genetic medicines.”
    The NIH launched the TARGETED Challenge to advance genome editing technology by sourcing innovative solutions for delivering genome editing components safely and effectively.
  • The three-phase challenge supports the NIH's Somatic Cell Genome Editing (SCGE) commitment to developing targeted delivery systems for delivering genome editors to somatic cells in the body.

CSL and Arcturus Therapeutics' ARCT-154 Demonstrates Non-Inferiority to Original Strain and Superior Immunogenicity to Omicron BA.4/5 Variant Compared to First-Generation mRNA Vaccine Booster

Retrieved on: 
Thursday, December 21, 2023
SRR, RNA, Senior, ASX, Partnership, Messenger, Vaccine, Arcturus Therapeutics, SAN, Therapy, Vaccination, GMT, Omicron, CSL, COVID-19, Doctor of Philosophy, Upendra J. Chivukula, Patient, Arcturus, Safety

KING OF PRUSSIA, Pa. and SAN DIEGO, Dec. 21, 2023 /PRNewswire/ -- Global biotechnology leader CSL (ASX:CSL; USOTC:CSLLY) and Arcturus Therapeutics (Nasdaq: ARCT) today announced the publication in Lancet Infectious Diseases of a Phase 3 study showing that a booster dose of ARCT-154, a novel, self-amplifying messenger RNA (sa-mRNA) vaccine, elicited a numerically higher immune response (meeting the non-inferiority criteria) against the original Wuhan-Hu-1 virus strain,  and a superior immune response against Omicron BA.4/5 subvariant of SARS-CoV-2 virus compared to a booster dose of the conventional mRNA vaccine Comirnaty®. ARCT-154 results were achieved with one-sixth the dose of Comirnaty® (5 μg vs 30 μg).

Key Points: 
  • Both vaccines were well-tolerated, with no causally associated severe or serious adverse events.
  • The study was conducted in partnership with Meiji Seika Pharma, a global health company based in Japan.
  • "This study represents the first phase of CSL and Arcturus' plans to launch this innovative vaccine platform globally."
  • Key secondary objectives included the assessment of immunological non-inferiority and superiority against the Omicron BA.4/5 subvariant and vaccine tolerability assessed using participant-completed electronic diaries.

WRQ Sciences and Superfluid Dx., Inc. Announce Completion of Oversubscribed Series A Financing in Breakthrough Alzheimer's Disease Diagnostic Company Superfluid Dx

Retrieved on: 
Wednesday, December 20, 2023
RNA, APOE, Drug development, Messenger, Scripps Institute, Research, FDA, Data analysis, Stanford University, Biochemistry, Dual-energy X-ray absorptiometry, PALO, Medicare, Pathology, Patient, Diagnosis, Dementia, UCSF, Superfluidity, Medical imaging

PALO ALTO, Calif., Dec. 20, 2023 /PRNewswire/ -- WRQ Sciences and Superfluid Dx, Inc., announced today the completion of an oversubscribed Series A financing led by WRQ Sciences. With this transaction, WRQ Sciences has acquired majority ownership in the Alzheimer's Disease (AD) diagnostics company, Molecular Stethoscope, Inc., which is now renamed Superfluid Diagnostics, Inc. The Alzheimer's Drug Discovery Foundation's (ADDF) Diagnostics Accelerator (DxA) participated in the Series A financing.

Key Points: 
  • PALO ALTO, Calif., Dec. 20, 2023 /PRNewswire/ -- WRQ Sciences and Superfluid Dx, Inc., announced today the completion of an oversubscribed Series A financing led by WRQ Sciences.
  • With this transaction, WRQ Sciences has acquired majority ownership in the Alzheimer's Disease (AD) diagnostics company, Molecular Stethoscope, Inc., which is now renamed Superfluid Diagnostics, Inc.
  • "One million Americans per year develop Alzheimer's Disease and the need for a fast and accurate diagnostic test is acute and expanding," said Gajus Worthington, Superfluid Diagnostics' CEO and Managing Director of WRQ Sciences.
  • The breakthrough work at Superfluid Diagnostics will transform the Alzheimer's Disease diagnostic landscape."

Breaking Barriers: Fluent BioSciences and Element Biosciences Collaborate to Enhance scRNA-seq Access

Retrieved on: 
Tuesday, December 19, 2023
Fluency, RNA, B cell, Tissue, Laboratory, ABC, Element, Library, Particle

WATERTOWN, Mass., Dec. 19, 2023 /PRNewswire/ -- Fluent BioSciences, a leader in breakthrough single-cell analysis technology, and Element Biosciences, a pioneer in novel sequencing solutions, are excited to announce their collaboration to enhance the accessibility and scalability of single-cell RNA sequencing (scRNA-seq).

Key Points: 
  • WATERTOWN, Mass., Dec. 19, 2023 /PRNewswire/ -- Fluent BioSciences, a leader in breakthrough single-cell analysis technology, and Element Biosciences, a pioneer in novel sequencing solutions, are excited to announce their collaboration to enhance the accessibility and scalability of single-cell RNA sequencing (scRNA-seq).
  • Fluent BioSciences addresses these challenges with its Particle-templated Instant Partitions sequencing (PIPseq) technology, providing a low barrier to entry without the need for complex instrumentation or expensive consumables.
  • A recent application note highlights the successful collaboration between Fluent BioSciences and Element Biosciences, showcasing the compatibility of PIPseq libraries with the AVITI System.
  • Fluent BioSciences and Element Biosciences are committed to empowering researchers with cutting-edge technologies that advance the understanding of cellular and molecular diversity.

AQTUAL NAMES GREGG C. FERGUS TO ITS BOARD OF DIRECTORS

Retrieved on: 
Tuesday, December 19, 2023
RNA, Manta ray, Nucleic acid thermodynamics, Medicine, Baird (investment bank), Research, Ion semiconductor sequencing, Life Technologies, Conditional sentence, Hyperfine structure, DNA, Therapy, Rheumatoid arthritis, Clinical trial, AI, Affymetrix, Gene expression, Thermo Fisher Scientific, Cancer, Doctor of Philosophy, American College, Patient, Organization, Butterfly network

HAYWARD, Calif., Dec. 19, 2023 /PRNewswire/ -- Aqtual, a precision medicine company with a novel cfDNA platform to aid in treatment decisions for chronic diseases and cancers through a simple blood test, announced today that Gregg C. Fergus has joined as a member of its board of directors.

Key Points: 
  • Gregg brings over 30 years of corporate, entrepreneurial, and venture capital experience working with category-defining companies in life sciences.
  • Gregg was CEO of 4Catalyzer, where he launched groundbreaking companies, including Butterfly Network, Hyperfine, Quantum-Si, and AI Therapeutics.
  • Prior to 4Catalyzer, Gregg was president and COO of Ion Torrent, which sold to Life Technologies and is now a division of Thermo Scientific.
  • Gregg currently serves as executive chairman of the board at Ascertain.

ChemDiv Helps Advance Viriom's Influenza Treatment to Successful Phase I Clinical Trials Completion

Retrieved on: 
Tuesday, December 19, 2023
RNA, Safety, Chemical Diversity, SAN, Virus, Vaccine

SAN DIEGO, Dec. 19, 2023 /PRNewswire/ -- ChemDiv Inc., dedicated to partnering in discovery and development of breakthrough therapies based on its unique chem-bio platforms, announces successful completion of Phase I clinical trials for AV5124, an innovative influenza virus replication inhibitor being developed by Viriom Inc. (Viriom).

Key Points: 
  • SAN DIEGO, Dec. 19, 2023 /PRNewswire/ -- ChemDiv Inc., dedicated to partnering in discovery and development of breakthrough therapies based on its unique chem-bio platforms, announces successful completion of Phase I clinical trials for AV5124, an innovative influenza virus replication inhibitor being developed by Viriom Inc. (Viriom).
  • AV5124 is an extremely effective inhibitor of influenza virus RNA processing that is potent against all tested influenza types including viruses resistant to neuraminidase inhibitors (Tamiflu®) or cap-dependent endonuclease inhibitors (Xofluza®).
  • Together, Viriom and ChemDiv showcase AV5124's potent suppression of diverse Influenza A and Influenza B viruses, including drug-resistant variants and highly pathogenic avian influenza strains.
  • The completion of Phase I clinical trials stands as a testament to AV5124's remarkable safety and tolerability.

Ionis announces European licensing agreement with Otsuka for donidalorsen in hereditary angioedema

Retrieved on: 
Monday, December 18, 2023
RNA, Hereditary angioedema, Ionis Pharmaceuticals, Orphan, ADPKD, HAE, Patient, IONS, OLE, Pharmaceutical industry

Ionis plans to independently bring donidalorsen to U.S. patients if approved

Key Points: 
  • Ionis plans to independently bring donidalorsen to U.S. patients if approved
    CARLSBAD, Calif., Dec. 18, 2023 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced that it has entered into a license agreement with Otsuka Pharmaceutical Co., Ltd. (Otsuka) under which Otsuka obtains exclusive rights in Europe to commercialize donidalorsen, an investigational prophylactic treatment for hereditary angioedema (HAE).
  • Ionis will maintain responsibility for the non-clinical and clinical development of donidalorsen, and Otsuka will be responsible for European regulatory filings and commercialization.
  • Ionis plans to independently launch donidalorsen in the U.S. if approved, as part of the company's strategy to deliver a steady flow of wholly owned medicines to patients.
  • The company plans to report Phase 3 results with donidalorsen for prophylactic treatment of HAE in the first half of 2024.

EQS-News: CureVac Announces Financial Results for the Third Quarter and First Nine Months of 2023 and Provides Business Update

Retrieved on: 
Tuesday, December 26, 2023
Survival, Research and development, BioNTech, CureVac, Workforce, Operating cost, GSK, Epitope, Webcast, Safety, Business development, RNA, CVAC, Conference, Sąd rejonowy, Astrocytoma, Neoplasm, Pfizer–BioNTech COVID-19 vaccine, Development, Vaccine, Commercial, LNP, Phase II, Acquisition, Immortalised cell line, Animal, GMP, Interim, Palatine Higher Regional Court, Patent, SARS-CoV-2, Tumor microenvironment, Toxicity, Glioblastoma, Antigen, Therapy, Research, Messenger, Mouse, COVID-19, Infection, Clinical trial, District court, Cancer, Patient, CMO, CD8

ET / 3 p.m. CET

Key Points: 
  • ET / 3 p.m. CET
    TÜBINGEN, Germany/BOSTON, USA – November 14, 2023 – CureVac N.V. (Nasdaq: CVAC) (“CureVac”), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), today announced financial results for the third quarter and first nine months of 2023 and provided a business update.
  • Positive preliminary data reported in early 2023 in COVID-19 and flu provided strong validation of CureVac’s mRNA technology platform.
  • All jointly tested candidates are based on CureVac’s proprietary second-generation mRNA backbone, targeting improved intracellular mRNA translation for early and strong immune responses.
  • The first nine months of 2022 were positively impacted by €36.8 million related to the reversal of an outstanding CRO provision.

Altamira Therapeutics Announces Partial Spin-Off of Bentrio® Business

Retrieved on: 
Friday, November 17, 2023
Sale, Therapy, International, FDA, Allergic rhinitis, Growth, CHF, OTC, International Financial Reporting Standards, RNA, Medica

Hamilton, Bermuda, Nov. 17, 2023 (GLOBE NEWSWIRE) -- Altamira Therapeutics Ltd. ("Altamira") (Nasdaq: CYTO), a company dedicated to developing therapeutics that address important unmet medical needs, today announced that it has entered into a binding agreement for the sale of a 51% stake in its subsidiary Altamira Medica AG (“Medica”) to a Swiss private equity investor as part of its strategic repositioning around its RNA delivery technology. Medica’s key asset is Bentrio®, a drug-free OTC nasal spray utilized for the treatment of allergic rhinitis, which has been cleared by the FDA and is being commercialized in a growing number of countries.

Key Points: 
  • Altamira has agreed to sell the 51% stake in Medica for a cash consideration of CHF 2,040,000 (about $2.3 million) and will retain 49% of the company’s share capital.
  • Further, Altamira will be entitled to receive 25% of Medica’s future licensing income.
  • Medica will continue its operations under its current name and with current staff in collaboration with Altamira.
  • “This marks an important first step in our strategic repositioning of the Company,” commented Thomas Meyer, Altamira Therapeutics’ founder, Chairman and CEO.