SARS-CoV-2

ATCC Announces New Award from BARDA to Provide Centralized Storage and Bioprocessing Services for Project NextGen

Retrieved on: 
Thursday, January 4, 2024

ATCC will provide cold-chain and lifecycle management of biological specimens from Project NextGen clinical studies.

Key Points: 
  • ATCC will provide cold-chain and lifecycle management of biological specimens from Project NextGen clinical studies.
  • “Protecting the public’s health against multiple coronavirus variants with effective and longer lasting vaccines, as well as more resilient treatments, is critical.
  • By working together, we can help find innovative solutions to this challenge.”
    Under the Project NextGen initiative, ATCC will provide centralized and standardized services for receipt, processing, storage, protection, retrieval, packaging, shipping, tracking, and distribution of clinical specimens collected from participants across several clinical trials, including Phase IIb efficacy trials.
  • This further expands ATCC’s operation of BARDA’s Medical Countermeasures Clinical Studies Network ( CSN ) Biological Specimen and Investigational Product ( BSIP ) storage facility, which also provides centralized services, storage, and distribution of its clinical samples and investigational products across BARDA-supported studies.

Scinai Immunotherapeutics CEO Issues Letter to Shareholders

Retrieved on: 
Thursday, January 4, 2024

The Company will host a webinar on January 9th to expand on the content of the letter and invites you to submit questions both ahead of and during the webinar.

Key Points: 
  • The Company will host a webinar on January 9th to expand on the content of the letter and invites you to submit questions both ahead of and during the webinar.
  • The CEO letter reads as follows:
    Throughout 2023, I communicated my optimism about Scinai's future growth, including our potential to deliver value to our shareholders, stakeholders and partners.
  • Next, Scinai expects to commence toxicology studies which are required to receive regulatory approval to proceed with a first-in-human clinical trial, which Scinai expects to initiate early next year.
  • We expect Scinai Bioservices to grow and generate revenues in support of our NanoAb pipeline development.

Generate:Biomedicines Fortifies Leadership in Generative AI with Advancing Clinical Pipeline and Expanded Amgen Collaboration, Overviewed at the 42nd Annual J.P. Morgan Healthcare Conference

Retrieved on: 
Thursday, January 4, 2024

Mike Nally, Chief Executive Officer, will overview these updates, as well as share more about the company’s strategy to further strengthen its leadership in generative biology, at the 42nd Annual J.P. Morgan Healthcare Conference, which will be occurring from January 8-11 in San Francisco.

Key Points: 
  • Mike Nally, Chief Executive Officer, will overview these updates, as well as share more about the company’s strategy to further strengthen its leadership in generative biology, at the 42nd Annual J.P. Morgan Healthcare Conference, which will be occurring from January 8-11 in San Francisco.
  • The presentation will take place on January 10 from 10:00-10:25am PST at the Golden Gate (32nd Floor) of The Westin St. Francis.
  • Deploying structure in the learning loop utilizing CryoEM to generate data for iterative learning which has shown faster, improved outcomes.
  • “We look forward to working even more closely together in order to deliver best-in-class therapies that address significant unmet patient needs.”

Emergex Announces Authorisation from Philippines FDA to Initiate Phase I-II Clinical Trial of CoronaTcP™

Retrieved on: 
Wednesday, January 3, 2024

Emergex received authorisation from the Philippines FDA to launch a Phase I-II clinical trial of CoronaTcP, its T cell-priming immune set-point candidate against Betacoronaviruses.

Key Points: 
  • Emergex received authorisation from the Philippines FDA to launch a Phase I-II clinical trial of CoronaTcP, its T cell-priming immune set-point candidate against Betacoronaviruses.
  • Emergex is progressing trial initiation plans, with an anticipated start date in Q2 2024.
  • The naNO-COVID 2 trial (NCT05633446) is a randomized, double-blind, placebo-controlled Phase I-II trial in the Philippines, which will investigate the safety and immunogenicity of CoronaTcP.
  • Professor Thomas Rademacher, Co-Founder and Chief Executive Officer, Emergex, commented: “We thank the Philippines FDA for rapidly approving this trial after a successful Phase I clinical trial in Switzerland.

Molecular Diagnostics Research That Could Transform Healthcare Featured in the January Issue of ADLM's The Journal of Applied Laboratory Medicine

Retrieved on: 
Wednesday, January 3, 2024

This special issue of the Association for Diagnostics & Laboratory Medicine's (formerly AACC's) The Journal of Applied Laboratory Medicine highlights the latest research in this field that could advance care for conditions ranging from infectious diseases to inherited disorders.

Key Points: 
  • This special issue of the Association for Diagnostics & Laboratory Medicine's (formerly AACC's) The Journal of Applied Laboratory Medicine highlights the latest research in this field that could advance care for conditions ranging from infectious diseases to inherited disorders.
  • The COVID-19 pandemic is the most striking recent example of the central role of molecular diagnostics in global health.
  • And pandemic management isn't the only area of infectious disease testing that molecular diagnostic technology is revolutionizing.
  • Broadening access to personalized medicine is another goal of modern healthcare that wouldn't be possible without molecular diagnostics.

Enable Biosciences Inc. Reveals Key Findings on COVID-19 Transmission from Mothers to Newborns

Retrieved on: 
Wednesday, January 3, 2024

This research is crucial in understanding how maternal antibodies against SARS-CoV-2 are transferred to and persist in newborns.

Key Points: 
  • This research is crucial in understanding how maternal antibodies against SARS-CoV-2 are transferred to and persist in newborns.
  • The study involved analyzing dried blood spots from newborns for the presence of these antibodies.
  • With 15.7% of newborns testing positive, the study provides new insights into the prevalence and longevity of maternal antibodies, highlighting a significant maternal transmission rate.
  • Dr. Jason Tsai, CTO of Enable Biosciences, commented, "This study is a landmark in neonatal research, offering unprecedented insights into maternal-to-neonatal antibody transfer.

Eden Park to Launch MobileShield222 at CES: Introducing Continuous Disinfection for Personal and Crowded Spaces

Retrieved on: 
Wednesday, January 3, 2024

Eden Park, an industry-leading manufacturer of Far UV-C technology, is excited to introduce MobileShield222, the most advanced mobile handheld continuous disinfection device available to consumers.

Key Points: 
  • Eden Park, an industry-leading manufacturer of Far UV-C technology, is excited to introduce MobileShield222, the most advanced mobile handheld continuous disinfection device available to consumers.
  • No matter where you use it, MobileShield222 provides continuous disinfection of air, surfaces, and personal devices to help halt the spread of harmful pathogens.
  • “Everyone has the right to indoor spaces free of pathogens and viruses,” said John Yerger, CEO of Eden Park.
  • Yerger continued, “Made in the USA, MobileShield222 has virtually limitless applications in enclosed and crowded spaces.

Invivyd Submits Request for Emergency Use Authorization (EUA) to U.S. FDA for VYD222 for the Pre-exposure Prevention of COVID-19 in Immunocompromised Adults and Adolescents

Retrieved on: 
Wednesday, January 3, 2024

Many immunocompromised people do not achieve full benefit from COVID-19 vaccines as their immune systems are unable to provide sufficient defense against SARS-CoV-2.

Key Points: 
  • Many immunocompromised people do not achieve full benefit from COVID-19 vaccines as their immune systems are unable to provide sufficient defense against SARS-CoV-2.
  • On December 18, 2023, Invivyd announced positive initial results from the ongoing CANOPY pivotal clinical trial.
  • VYD222 produced high serum virus neutralizing antibody (sVNA) titer levels against XBB.1.5 in the immunocompromised cohort.
  • If authorized, Invivyd aims to have VYD222 commercially available rapidly thereafter.

Human medicines European public assessment report (EPAR): Veklury, remdesivir, Date of authorisation: 03/07/2020, Revision: 23, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024

Human medicines European public assessment report (EPAR): Veklury, remdesivir, Date of authorisation: 03/07/2020, Revision: 23, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Veklury, remdesivir, Date of authorisation: 03/07/2020, Revision: 23, Status: Authorised

Human medicines European public assessment report (EPAR): VidPrevtyn Beta, COVID-19 Vaccine (recombinant, adjuvanted), Date of authorisation: 10/11/2022, Revision: 2, Status: Authorised

Retrieved on: 
Tuesday, January 2, 2024

Human medicines European public assessment report (EPAR): VidPrevtyn Beta, COVID-19 Vaccine (recombinant, adjuvanted), Date of authorisation: 10/11/2022, Revision: 2, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): VidPrevtyn Beta, COVID-19 Vaccine (recombinant, adjuvanted), Date of authorisation: 10/11/2022, Revision: 2, Status: Authorised