BARDA

Pre-Sterilized/Ready to Use Pharmaceutical Packaging Market, 2035 - ResearchAndMarkets.com

Retrieved on: 
Tuesday, October 24, 2023
Health, Pharmaceutical, Type, Elastomer, FDA, Biomedical Advanced Research and Development Authority, AptarGroup, Vaccine, Container, SCHOTT, Dätwyler, West Pharmaceutical Services, Glass, BARDA, Development, Growth, COVID-19, RTU, Duran (glass), EMA, Porta Nuova (Milan), Safety, Material, EZ, Investment, Syringe, Value proposition, Patient safety, Sterilization, Medical device, Fine chemical, Borosilicate glass, Stevanato Group

This focus on product safety has given rise to the adoption of pre-sterilized or ready-to-use containers and closures in pharmaceutical packaging.

Key Points: 
  • This focus on product safety has given rise to the adoption of pre-sterilized or ready-to-use containers and closures in pharmaceutical packaging.
  • It's essential to highlight that the growing demand for secure drug delivery systems has fueled the expansion of the global pharmaceutical packaging market.
  • The integration of ready-to-use (RTU) packaging containers in the pharmaceutical sector enables expedited product launches through an optimized value chain.
  • The current landscape of pre-sterilized / ready to use pharmaceutical primary packaging features close to 95 RTU containers and 85 RTU closures.

Pre-Sterilized/Ready to Use Pharmaceutical Packaging Market Size to Expand Lucratively and Reach $14.23 Bn to 2031 - Explained Details | Updated InsightAce Study

Retrieved on: 
Wednesday, October 25, 2023
FDA, Biomedical Advanced Research and Development Authority, AptarGroup, Vaccine, Government, ATMP, SCHOTT, Dätwyler, West Pharmaceutical Services, BARDA, Development, Growth, Schott, COVID-19, RTU, Duran (glass), EMA, Nuova Cometra, SGD, Medication, Investment, Patient safety, Medical device, Beauty salon, Stevanato Group

The main factors responsible for driving the Pre-Sterilized/Ready to Use Pharmaceutical packaging market are increasing preference towards patient safety and rising importance for sterility and integrity of pharmaceutical products.

Key Points: 
  • The main factors responsible for driving the Pre-Sterilized/Ready to Use Pharmaceutical packaging market are increasing preference towards patient safety and rising importance for sterility and integrity of pharmaceutical products.
  • In addition, strict regulatory guidelines set by regulatory agencies such as the FDA and EMA play an essential role in booming the demand for pre-sterilized pharmaceutical packaging.
  • The addition of RTU (ready-to-use) packaging into the pharmaceutical industry ensures that the product is quickly available through the optimized supply chain.
  • Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2023 to 2031 based on Type of Container
    Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2023 to 2031 based on Type of Closure

Pre-Sterilized/Ready to Use Pharmaceutical Packaging Market Size to Expand Lucratively and Reach $14.23 Bn to 2031 - Explained Details | Updated InsightAce Study

Retrieved on: 
Wednesday, October 25, 2023
FDA, Biomedical Advanced Research and Development Authority, AptarGroup, Vaccine, Government, ATMP, SCHOTT, Dätwyler, West Pharmaceutical Services, BARDA, Development, Growth, Schott, COVID-19, RTU, Duran (glass), EMA, Nuova Cometra, SGD, Medication, EZ, Investment, Patient safety, Medical device, Beauty salon, Stevanato Group

The main factors responsible for driving the Pre-Sterilized/Ready to Use Pharmaceutical packaging market are increasing preference towards patient safety and rising importance for sterility and integrity of pharmaceutical products.

Key Points: 
  • The main factors responsible for driving the Pre-Sterilized/Ready to Use Pharmaceutical packaging market are increasing preference towards patient safety and rising importance for sterility and integrity of pharmaceutical products.
  • In addition, strict regulatory guidelines set by regulatory agencies such as the FDA and EMA play an essential role in booming the demand for pre-sterilized pharmaceutical packaging.
  • The addition of RTU (ready-to-use) packaging into the pharmaceutical industry ensures that the product is quickly available through the optimized supply chain.
  • Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2023 to 2031 based on Type of Container
    Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2023 to 2031 based on Type of Closure

BARDA Expands Partnership With Evidation to Validate and Improve Machine Learning Models for Early Detection of Influenza-like Illness Using Wearables

Retrieved on: 
Tuesday, October 17, 2023
Research, Pharmaceutical, Telemedicine, Virtual Medicine, Medical Devices, Technology, Infectious Diseases, Artificial Intelligence, Health Technology, Science, Biotechnology, Wearables, Mobile Technology, Health, COVID-19, Administration for Strategic Preparedness and Response, Disease, Development, Office of Inspector General, U.S. Department of Health and Human Services, PCR, Human services, Risk, Home, Biomedical Advanced Research and Development Authority, Administration, Sensor, Education, Urinary tract infection, Sleep, RSV, Respiratory syncytial virus, BARDA, Life, HHS, ILI, Heart Protection Study, Ill, Vaccine, Evidence-based policy

The Detect & Protect Studies will support the development of machine learning models to detect respiratory viral infections with data collected from consumer-grade wearable devices.

Key Points: 
  • The Detect & Protect Studies will support the development of machine learning models to detect respiratory viral infections with data collected from consumer-grade wearable devices.
  • This contract will also fund research to expand and better understand the potential impact of Evidation’s FluSmart program to encourage protective health behaviors.
  • This is the third BARDA award issued to Evidation to advance understanding and detection tools for respiratory infections.
  • In 2020, BARDA funded follow-on research to investigate if and how machine learning models and novel data from wearables could be used to detect symptoms of COVID-19 infection .

Basilea reports new data for ceftobiprole (Zevtera®) presented at US IDWeek Congress 2023

Retrieved on: 
Tuesday, October 17, 2023
Efficacy, Staphylococcus, Methicillin-resistant Staphylococcus aureus, Ambrose, Abstract, Treatment, Clinical, Circulatory system, MRSA, Biomedical Advanced Research and Development Authority, BARDA, Enterococcus faecalis, Infection, ASPR, MSSA, IDSA, Isolates, Laboratory, Liolios Xirolivaditis, Staphylococcus aureus, PK/PD models, SAB, ABSSSI, CABP, Bronchopneumonia, Administration for Strategic Preparedness and Response, Streptococcus pneumoniae, Prescription Drug User Fee Act, Duke University School of Medicine, Infectious Diseases Society of America, Randomness, Development, Administration, Safety, Patient, PDUFA, HHS, Pharmaceutical industry, Vaccine, Ceftobiprole, Litherland, Enterococcus, Allschwil, Streptococcus, Bloodstream infections

Dr. Marc Engelhardt, Chief Medical Officer of Basilea, stated: “The data presented at IDWeek provide further evidence for the potent antimicrobial activity of ceftobiprole against MRSA and other clinically relevant pathogens.

Key Points: 
  • Dr. Marc Engelhardt, Chief Medical Officer of Basilea, stated: “The data presented at IDWeek provide further evidence for the potent antimicrobial activity of ceftobiprole against MRSA and other clinically relevant pathogens.
  • It also provides results of pharmacokinetic-pharmacodynamic modeling supporting the dosing regimens to treat severe bacterial infections from the successful clinical phase 3 studies.
  • Abstract #1946 – In Vitro Activity of Ceftobiprole against Staphylococcus aureus Bacteremia Isolates from the United States (2018–2020) – L. Duncan, M. Castanheira, J. I.
  • Smart, M. E. Jones, P. G. Ambrose, K. Litherland
    Abstract #2561 – Population Pharmacokinetic Analyses for Ceftobiprole Using Data from Phase 1 and 3 Studies – A. P. Cammarata, K. Litherland, M. C. Safir, S. M. Bhavnani, M. Saulay, J. I.

BioAegis Therapeutics Awarded $20 Million BARDA DRIVe Contract to Advance Gelsolin, an Immune Regulator, as a Treatment for Patients with Acute Respiratory Distress Syndrome (ARDS)

Retrieved on: 
Monday, October 16, 2023
Partnership, Nursing care plan, Development, Inflammation, Office of Inspector General, U.S. Department of Health and Human Services, Human services, Sepsis, Administration for Strategic Preparedness and Response, Mortality, Safety, Administration, NORTH, Therapy, Biomedical Advanced Research and Development Authority, Trauma, Oxygen, Pneumonia, Plasma, ICU, Gelsolin, BARDA, Drive, Patient, Quality of life, Vaccine, Pharmaceutical industry, Research

NORTH BRUNSWICK, N.J., Oct. 16, 2023 (GLOBE NEWSWIRE) -- BioAegis Therapeutics, a pioneering biotech company at the forefront of innovative therapies for inflammatory diseases, is pleased to announce a second partnership with 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. This partnership comes with the award of a $20 million contract from BARDA’s Division of Research, Innovation, and Ventures (DRIVe), to advance gelsolin, a master regulator of the innate immune system, for the treatment of Acute Respiratory Distress Syndrome (ARDS). This significant injection of funding accelerates BioAegis’ ARDS program and the execution of its strategy to transform the treatment of inflammatory diseases.

Key Points: 
  • This partnership comes with the award of a $20 million contract from BARDA’s Division of Research, Innovation, and Ventures (DRIVe), to advance gelsolin, a master regulator of the innate immune system, for the treatment of Acute Respiratory Distress Syndrome (ARDS).
  • This significant injection of funding accelerates BioAegis’ ARDS program and the execution of its strategy to transform the treatment of inflammatory diseases.
  • Acute Respiratory Distress Syndrome (ARDS) is a condition that can develop as a severe complication of pneumonia, sepsis, or trauma resulting in life-threatening lung injury with fluid leakage into the lungs.
  • Breathing becomes difficult and patients require oxygen, mechanical ventilation and extensive critical care resources, placing a significant burden on the healthcare system.

Genevant Sciences LNP Technology Used in samRNA Covid-19 Vaccine Candidate Behind Gritstone bio’s BARDA Award

Retrieved on: 
Thursday, October 12, 2023
COVID-19, Development, LNP, Therapy, Safety, Biomedical Advanced Research and Development Authority, CORAL, Messenger, BARDA, Vaccine, Gritstone

VANCOUVER, British Columbia and BASEL, Switzerland, Oct. 12, 2023 (GLOBE NEWSWIRE) -- Genevant Sciences, a leading nucleic acid delivery company with world-class platforms and a robust and expansive lipid nanoparticle (LNP) patent portfolio, today announced the use of its LNP technology in Gritstone bio’s (Nasdaq: GRTS) self-amplifying mRNA (samRNA) vaccine candidate against COVID-19 in its CORAL program.

Key Points: 
  • VANCOUVER, British Columbia and BASEL, Switzerland, Oct. 12, 2023 (GLOBE NEWSWIRE) -- Genevant Sciences, a leading nucleic acid delivery company with world-class platforms and a robust and expansive lipid nanoparticle (LNP) patent portfolio, today announced the use of its LNP technology in Gritstone bio’s (Nasdaq: GRTS) self-amplifying mRNA (samRNA) vaccine candidate against COVID-19 in its CORAL program.
  • The BARDA award, received by Gritstone following results from multiple Phase 1 studies of its COVID-19 vaccine candidate, is for the conduct of a 10,000 participant, randomized Phase 2b double-blinded study to compare the efficacy, safety, and immunogenicity of Gritstone’s COVID-19 vaccine candidate with an approved COVID-19 vaccine.
  • “We value our longstanding relationship with Gritstone bio and congratulate the Gritstone team on receiving the BARDA award,” said Pete Lutwyche, Ph.D., President and Chief Executive Officer, Genevant Sciences Corporation.
  • “As longtime leaders in the field, we know that delivery is often the difference in the success of nucleic acid-based medicines and we are thrilled with the contribution of our LNP technology to Gritstone’s achievement.”

Revive Therapeutics Provides Update of Novel Bucillamine Formulation Development

Retrieved on: 
Wednesday, October 11, 2023
Infection, ASPR, Inflammation, Injury, Development, Office of Inspector General, U.S. Department of Health and Human Services, Defence Research and Development Canada, University, Organization, Therapy, Administration, Organ transplantation, FDA, Biomedical Advanced Research and Development Authority, RVV, CSE, Acute respiratory distress syndrome, Disorder, DRDC, BARDA, Administration for Strategic Preparedness and Response, HHS, Research, Pharmaceutical industry, Bucillamine

TORONTO, Oct. 11, 2023 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, provides an update on the development of a next generation lyophilized formulation of Bucillamine.

Key Points: 
  • TORONTO, Oct. 11, 2023 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (OTCQB: RVVTF) (CSE: RVV) (FRANKFURT:31R), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, provides an update on the development of a next generation lyophilized formulation of Bucillamine.
  • Under an agreement with the University of Waterloo, formulation development is ongoing and aims to be completed by the end of December 2023.
  • The Company expects to have its novel lyophilized formulation of Bucillamine ready for clinical evaluation in 2024.
  • The Company intends to explore the novel Bucillamine formulation as a potential treatment for public health medical emergencies including, pandemic influenza, emerging infectious diseases, and medical countermeasure incidents and attacks.

Ocugen Mucosal Vaccine Candidate OCU500 Selected by NIH/NIAID Project NextGen for Inclusion in Clinical Trials

Retrieved on: 
Tuesday, October 10, 2023
COVID-19, NIAID, Nextgen, Vaccine, Public, ChAdOx1, Therapy, Project, Inhalation, Infection, National Institute of Allergy and Infectious Diseases, Vaccination, Bangladesh Technical Education Board, BARDA, Pharmaceutical industry

Ocugen is developing a novel anti-viral mucosal vaccine platform initially targeting COVID-19 and influenza (flu).

Key Points: 
  • Ocugen is developing a novel anti-viral mucosal vaccine platform initially targeting COVID-19 and influenza (flu).
  • NIAID, with funding from Project NextGen, will cover the full cost of the clinical trials, including operations and related analysis.
  • Ocugen will be responsible for providing clinical trial materials and upon completion will have full right of reference to the findings, which Ocugen believes will provide clinical evidence to support the further development of the Company’s lead mucosal vaccine candidate.
  • Ocugen looks forward to this important next step in the development of its novel mucosal vaccine platform and further supporting the Company’s commitment to advancing public health.

BioTools Innovator Names Limula 2023 Winner

Retrieved on: 
Friday, October 13, 2023
Biotechnology, Health Technology, Health, Medical Devices, Black Snow, Development, Sigma-Aldrich, AstraZeneca, Research Corporation, NIIMBL, Research, Standard BioTools, Eppendorf, Biomedical Advanced Research and Development Authority, RCT, Drug discovery, BARDA, Danaher, Prize, Patient, Feedback, Management, Pharmaceutical industry, Agilent Technologies, Genentech, Tolna limula

BioTools Innovator , the first-ever accelerator focused on life science tools companies, announced today that Limula (Lausanne, Switzerland) is the grand prize winner of the BioTools Innovator 2023 Final competition.

Key Points: 
  • BioTools Innovator , the first-ever accelerator focused on life science tools companies, announced today that Limula (Lausanne, Switzerland) is the grand prize winner of the BioTools Innovator 2023 Final competition.
  • The winning company was determined by a live audience vote Oct. 12 at the BioTools Innovator Capstone Event in Carlsbad, Calif.
    Limula, the winner of the $250,000 non-dilutive Grand Prize and the title of 2023 BioTools Innovator, offers an automated tool for scalable cell therapy manufacturing.
  • Nineteen companies were then selected to participate in the BioTools Innovator Accelerator, which prominently features best-in-class life science startups from around the world.
  • “Congratulations to Limula and all of the BioTools Innovator 2023 cohort companies.