Vaccine

Smart Blood Analytics Swiss Achieves EU-MDR Certification for VIRUS vs. BACTERIA Model

Retrieved on: 
Lunedì, Aprile 29, 2024
Public, WHO, Risk, World Health Organization, Safety, Certification, Blood, Infection, AMR, Research, Patient, Physician, Diagnosis, Death, Vaccine

ZÜRICH, April 29, 2024 /PRNewswire/ -- In a significant stride towards preventing antimicrobial resistance, Smart Blood Analytics Swiss proudly announces the attainment of EU-MDR (European Medical Device Regulation)1 certification for their VIRUS vs. BACTERIA Clinical Decision Support Software. This innovative medical device sets a new benchmark in accurately distinguishing between viral and bacterial infections, thus aiding physicians in delivering targeted and effective treatment to patients.

Key Points: 
  • ZÜRICH, April 29, 2024 /PRNewswire/ -- In a significant stride towards preventing antimicrobial resistance, Smart Blood Analytics Swiss proudly announces the attainment of EU-MDR (European Medical Device Regulation)1 certification for their VIRUS vs. BACTERIA Clinical Decision Support Software.
  • The VIRUS vs. BACTERIA model has also recently been showcased in an article published in Heliyon, highlighting its effectiveness and great accuracy ( https://doi.org/10.1016/j.heliyon.2024.e29372 ).
  • Dr. Marko Notar, CEO of Smart Blood Analytics Swiss, shared his excitement about the EU-MDR certification, stating, "This achievement shows our commitment to advancing healthcare through innovation.
  • Smart Blood Analytics Swiss is committed to maintaining the highest standards of safety, performance, and compliance, and this EU-MDR certification reaffirms its ongoing dedication to excellence in the healthcare industry.

Streamlining the mRNA Manufacturing Supply Chain: Challenges and Solutions Provided by CDMOs, Upcoming Webinar Hosted by Xtalks

Retrieved on: 
Lunedì, Aprile 29, 2024
CDMO, Messenger, DNA, LNP, Plasmid, Therapy, Business development, RNA, Patient, Risk, Quality control, Vaccine

TORONTO, April 29, 2024 /PRNewswire-PRWeb/ -- Discover an informative webinar on the benefits of uniting with a contract development and manufacturing organization (CDMO) for nucleic acid-based therapeutics production.

Key Points: 
  • TORONTO, April 29, 2024 /PRNewswire-PRWeb/ -- Discover an informative webinar on the benefits of uniting with a contract development and manufacturing organization (CDMO) for nucleic acid-based therapeutics production.
  • Attendees of this event will gain insights into overcoming current program challenges while maximizing efficiency and product quality.
  • However, navigating the intricate landscape of their manufacturing processes poses significant challenges, often requiring coordination among multiple vendors.
  • Key topics include leveraging a CDMO's expertise, facilities and technology to optimize regulatory submissions, mitigate supply chain risks and enhance commercial manufacturing readiness.

Repertoire® Immune Medicines and Bristol Myers Squibb Announce Multi-Year Strategic Collaboration to Develop Tolerizing Vaccines for Autoimmune Diseases

Retrieved on: 
Lunedì, Aprile 29, 2024
Doctor of Philosophy, Flagship Pioneering, BMY, Epitope, Research, Vaccine, Repertoire, Disease, Autoimmune disease, Patient, Immunology, BMS, Immune system, Bristol Myers Squibb, TCR, Biotechnology, Pharmaceutical industry

CAMBRIDGE, Mass., April 29, 2024 /PRNewswire/ -- Repertoire® Immune Medicines, a biotechnology company pioneering the discovery and development of programmable T cell targeted immune medicines, announced today that it has entered a multi-year strategic collaboration with Bristol Myers Squibb (NYSE: BMY) to develop tolerizing vaccines for up to three autoimmune diseases. The collaboration aims to develop efficacious, selective, and durable treatments for patients suffering from autoimmune disease by resetting the immune system.

Key Points: 
  • CAMBRIDGE, Mass., April 29, 2024 /PRNewswire/ -- Repertoire® Immune Medicines, a biotechnology company pioneering the discovery and development of programmable T cell targeted immune medicines, announced today that it has entered a multi-year strategic collaboration with Bristol Myers Squibb (NYSE: BMY) to develop tolerizing vaccines for up to three autoimmune diseases.
  • The collaboration aims to develop efficacious, selective, and durable treatments for patients suffering from autoimmune disease by resetting the immune system.
  • "We are excited to collaborate with Bristol Myers Squibb to combine their leadership in immunology with our unique ability to discover key disease-associated epitopes in patients with autoimmune diseases.
  • This collaboration enables us to serve patients suffering from autoimmune diseases by translating our DECODE discoveries into potentially transformative medicines that address the underlying cause of their disease."

Smart Blood Analytics Swiss Achieves EU-MDR Certification for VIRUS vs. BACTERIA Model

Retrieved on: 
Lunedì, Aprile 29, 2024
Public, WHO, Risk, World Health Organization, Safety, Certification, Blood, Infection, AMR, Research, Patient, Physician, Diagnosis, Death, Vaccine

ZÜRICH, April 29, 2024 /PRNewswire/ -- In a significant stride towards preventing antimicrobial resistance, Smart Blood Analytics Swiss proudly announces the attainment of EU-MDR (European Medical Device Regulation)1 certification for their VIRUS vs. BACTERIA Clinical Decision Support Software. This innovative medical device sets a new benchmark in accurately distinguishing between viral and bacterial infections, thus aiding physicians in delivering targeted and effective treatment to patients.

Key Points: 
  • ZÜRICH, April 29, 2024 /PRNewswire/ -- In a significant stride towards preventing antimicrobial resistance, Smart Blood Analytics Swiss proudly announces the attainment of EU-MDR (European Medical Device Regulation)1 certification for their VIRUS vs. BACTERIA Clinical Decision Support Software.
  • The VIRUS vs. BACTERIA model has also recently been showcased in an article published in Heliyon, highlighting its effectiveness and great accuracy ( https://doi.org/10.1016/j.heliyon.2024.e29372 ).
  • Dr. Marko Notar, CEO of Smart Blood Analytics Swiss, shared his excitement about the EU-MDR certification, stating, "This achievement shows our commitment to advancing healthcare through innovation.
  • Smart Blood Analytics Swiss is committed to maintaining the highest standards of safety, performance, and compliance, and this EU-MDR certification reaffirms its ongoing dedication to excellence in the healthcare industry.

INTREPID Alliance Landscape of Promising Antivirals in Clinical Development Reveals Gaps in Global Defense Against Potential Future Pandemics

Retrieved on: 
Lunedì, Aprile 29, 2024
Public, Ecosystem, Pandemic, Risk, Safety, Triage, Disease, Human, Global Health, Virus, Drug development, COVID-19, Medication, Vaccine

CAMBRIDGE, Mass., April 29, 2024 /PRNewswire/ -- Building on its commitment to identify strengths and gaps in the R&D pipeline for antivirals, the INTREPID Alliance, a consortium of innovative biopharmaceutical companies dedicated to accelerating antiviral treatments to help protect the world ahead of future pandemics, today published the second edition of its Antiviral Clinical Development Landscape. This ongoing scientific review and triage of a global R&D database of clinical antivirals reveals concerning gaps in the development of promising clinical compounds targeting 12 viral families1 of greatest pandemic potential.

Key Points: 
  • This ongoing scientific review and triage of a global R&D database of clinical antivirals reveals concerning gaps in the development of promising clinical compounds targeting 12 viral families1 of greatest pandemic potential.
  • Globalization, urban expansion, and exploitation of natural habitats increase the chances of facing new and known pathogens with the potential to cause pandemics.
  • In addition, of the 60 distinct antiviral clinical compounds, 41 are considered novel compounds in various phases of clinical development.
  • See criteria listed in the report "Antiviral Clinical Development Landscape and Promising Clinical Compounds."

INTREPID Alliance Landscape of Promising Antivirals in Clinical Development Reveals Gaps in Global Defense Against Potential Future Pandemics

Retrieved on: 
Lunedì, Aprile 29, 2024
Public, Ecosystem, Pandemic, Risk, Safety, Triage, Disease, Human, Global Health, Virus, Drug development, COVID-19, Medication, Vaccine

CAMBRIDGE, Mass., April 29, 2024 /PRNewswire/ -- Building on its commitment to identify strengths and gaps in the R&D pipeline for antivirals, the INTREPID Alliance, a consortium of innovative biopharmaceutical companies dedicated to accelerating antiviral treatments to help protect the world ahead of future pandemics, today published the second edition of its Antiviral Clinical Development Landscape. This ongoing scientific review and triage of a global R&D database of clinical antivirals reveals concerning gaps in the development of promising clinical compounds targeting 12 viral families1 of greatest pandemic potential.

Key Points: 
  • This ongoing scientific review and triage of a global R&D database of clinical antivirals reveals concerning gaps in the development of promising clinical compounds targeting 12 viral families1 of greatest pandemic potential.
  • Globalization, urban expansion, and exploitation of natural habitats increase the chances of facing new and known pathogens with the potential to cause pandemics.
  • In addition, of the 60 distinct antiviral clinical compounds, 41 are considered novel compounds in various phases of clinical development.
  • See criteria listed in the report "Antiviral Clinical Development Landscape and Promising Clinical Compounds."

FDA Roundup: April 26, 2024

Retrieved on: 
Venerdì, Aprile 26, 2024
FDA, Lutetium (177Lu) oxodotreotide, Sale, Answer, Public, Report, Cosmetics, Syringe, Dietary supplement, News, Safety, DCM, Food, Research, Human services, GFI, Animal, Dilated cardiomyopathy, Cardinal Health, Commitment, Diabetes, Furosemide, Glomus tumor, Vaccine, Development, VFD, Osteoporosis, Novartis, BRAF, Inflammatory bowel disease, Tablet, Patient, Rheumatoid arthritis, Psoriasis, Heated tobacco product, Macular degeneration, Multimedia, Dog, Cancer, LGG, Food and Drug Administration, BRAF V600, Heart, Pharmaceutical industry

On Thursday, the FDA announced it has approved the first generic pimobendan for the management of congestive heart failure in dogs.

Key Points: 
  • On Thursday, the FDA announced it has approved the first generic pimobendan for the management of congestive heart failure in dogs.
  • The FDA expects this firm to fully address the violations described in the warning letter.
  • This represents the first FDA approval of a radioactive drug, or radiopharmaceutical, for pediatric patients 12 years of age and older with SSTR-positive GEP-NETs.
  • This represents the first FDA approval of a systemic therapy for the treatment of patients with pediatric LGG with BRAF rearrangements, including fusions.

EQS-News: CureVac Announces Financial Results for the Fourth Quarter and Full-Year 2023 and Provides Business Update

Retrieved on: 
Venerdì, Maggio 3, 2024
University, Part, CMO, Federal republic, Research, Cancer, Federal Patent Court (Germany), Vaccine, Business, Webcast, BioNTech, District court, Whole genome sequencing, Vaccination, Public, WHO, Hearing loss, Cardiology, Animal, EP 1, Omicron, GSK, Systems biology, Workforce, Infection, Messenger, Federal court, Therapy, Data monitoring committee, Safety, Monroe Dunaway Anderson, CVAC, Justice, RNA, Astrocytoma, Motion, Human, CureVac, Pandemic, GMP, Sąd rejonowy, SARS-CoV-2, Business development, Epitope, MD, Acuitas Therapeutics, DSMB, Ageing, Patent, Patient, Neurology, Operating cost, H5N1, MD Anderson Cancer Center, PPA, Interim, MBA, Antigen, COVID-19, Amgen

ET / 3 p.m. CET

Key Points: 
  • ET / 3 p.m. CET
    TÜBINGEN, Germany/BOSTON, USA – April 24, 2024 – 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 fourth quarter and full-year 2023 and provided a business update.
  • “We closed out 2023 on a sturdy footing and are poised to advance strongly through 2024 with strategic initiatives to make CureVac fit-for-purpose.
  • Thaminda Ramanayake was appointed to the CureVac Management Team as Chief Business Officer effective June 1, 2024.
  • Mr. Ramanayake joins CureVac from Affini-T Therapeutics, where he served as Chief Business Officer and was responsible for creating the company’s business development organization.

EQS-News: CureVac and MD Anderson Enter Strategic Collaboration to Develop Novel Cancer Vaccines

Retrieved on: 
Venerdì, Maggio 3, 2024
University, Cell, Monroe Dunaway Anderson, CVAC, Malignancy, MD, RNA, Vaccine, IND, CureVac, Patient, Collaboration, MD Anderson Cancer Center, Assistant, Messenger, Antigen, Evolution, Drug discovery, Therapy, Whole genome sequencing, Investigational New Drug

Collaboration aims to develop novel, off-the-shelf, mRNA-based cancer vaccines in selected hematological and solid cancers with high unmet medical need

Key Points: 
  • Collaboration aims to develop novel, off-the-shelf, mRNA-based cancer vaccines in selected hematological and solid cancers with high unmet medical need
    MD Anderson responsible for leading initial Phase 1/2 studies; CureVac retains worldwide exclusive rights to late-stage development, commercialization, or partnering of cancer vaccine candidates
    TÜBINGEN, Germany/HOUSTON, Texas, USA – April 16, 2024 – CureVac N.V. (Nasdaq: CVAC) (“CureVac”), a global biopharmaceutical company developing a new class of transformative medicines based on messenger ribonucleic acid (“mRNA”), and The University of Texas MD Anderson Cancer Center today announced a co-development and licensing agreement to develop novel mRNA-based cancer vaccines.
  • The collaboration creates strong synergies between CureVac’s unique end-to-end capabilities for cancer antigen discovery, mRNA design, and manufacturing and MD Anderson’s expertise in cancer antigen discovery and validation, translational drug development, and clinical research.
  • The collaboration will focus on the development of differentiated cancer vaccine candidates in selected hematological and solid tumor indications with high unmet medical need.
  • “We are excited for cancer vaccines to potentially emerge as an essential therapeutic tool in the future,” Shukla said.

EQS-News: CureVac Announces Start of Combined Phase 1/2 Study in Avian Influenza (H5N1); Development in Collaboration with GSK

Retrieved on: 
Venerdì, Maggio 3, 2024
Ageing, Infection, H5N1, Messenger, Human, CureVac, CVAC, Influenza, GSK, Safety, Virus, Vaccine

The H5N1 avian influenza virus is considered a potential future pandemic threat, known to sporadically cross species from its original bird host to other animal hosts and humans.

Key Points: 
  • The H5N1 avian influenza virus is considered a potential future pandemic threat, known to sporadically cross species from its original bird host to other animal hosts and humans.
  • The monovalent vaccine candidate is based on CureVac’s proprietary second-generation mRNA backbone and encodes an influenza A H5-antigen.
  • In the initial Phase 1 dose-escalation part of the study, up to five dose levels will be assessed compared to a placebo control.
  • It focuses on applying CureVac’s mRNA-technology to the development of new products for infectious disease targets.