Biology

Anavex Life Sciences Reports ANAVEX®2-73 (blarcamesine) featured as a Disease-Modifying Small Molecule in Phase 3 Clinical Trials in a New Publication in Medical Journal titled “Future Avenues for Alzheimer’s Disease Detection and Therapy”

Retrieved on: 
Tuesday, March 16, 2021

In addition, the biomarker-driven clinical data is described, thus, enabling targeted therapy and a precision medicine-guided approach.

Key Points: 
  • In addition, the biomarker-driven clinical data is described, thus, enabling targeted therapy and a precision medicine-guided approach.
  • In these same patients ANAVEX2-73 also improved ADCS-ADL, by +4.9 points, a 7% mean improvement from baseline to 57 weeks.
  • In these same patients, ANAVEX2-73 also improved ADCS-ADL, by +6.0 points, an 8% mean improvement from baseline to 70 weeks.
  • Anavex Life Sciences product portfolio includes small molecule drug lead candidate ANAVEX2-73 for the treatment of Alzheimers disease, Parkinsons disease and Rett syndrome.

Regenerative Medicine Market Revenue Worth $39,012 Million by 2030: P&S Intelligence

Retrieved on: 
Tuesday, March 16, 2021

With the mortality rate increasing every year, the global regenerative medicine market revenue is likely to grow to $39,012.0 million by 2030 from $8,186.9 million in 2019, at a 16.3% CAGR between 2020 and 2030.

Key Points: 
  • With the mortality rate increasing every year, the global regenerative medicine market revenue is likely to grow to $39,012.0 million by 2030 from $8,186.9 million in 2019, at a 16.3% CAGR between 2020 and 2030.
  • This is because regenerative medicine is focused on repairing and recreating the tissues and cells destroyed by such diseases.
  • In this regard, the regenerative medicine market is being driven by the rising geriatric population, as the elderly are more prone to chronic diseases than younger people.
  • In the past, the regenerative medicine market was dominated by the cell therapy category, based on type.

Regenerative Medicine Market Revenue Worth $39,012 Million by 2030: P&S Intelligence

Retrieved on: 
Tuesday, March 16, 2021

With the mortality rate increasing every year, the global regenerative medicine market revenue is likely to grow to $39,012.0 million by 2030 from $8,186.9 million in 2019, at a 16.3% CAGR between 2020 and 2030.

Key Points: 
  • With the mortality rate increasing every year, the global regenerative medicine market revenue is likely to grow to $39,012.0 million by 2030 from $8,186.9 million in 2019, at a 16.3% CAGR between 2020 and 2030.
  • This is because regenerative medicine is focused on repairing and recreating the tissues and cells destroyed by such diseases.
  • In this regard, the regenerative medicine market is being driven by the rising geriatric population, as the elderly are more prone to chronic diseases than younger people.
  • In the past, the regenerative medicine market was dominated by the cell therapy category, based on type.

Eisai: Anti-MTBR (Microtubule Binding Region) Tau Antibody E2814 is Selected on Clinical Study for Dominantly Inherited Alzheimer's Disease by Dian-Tu

Retrieved on: 
Tuesday, March 16, 2021

The DIAN-TU tau next-generation program will evaluate three anti-tau drugs in clinical studies and has selected E2814 as the first investigational anti-tau drug.

Key Points: 
  • The DIAN-TU tau next-generation program will evaluate three anti-tau drugs in clinical studies and has selected E2814 as the first investigational anti-tau drug.
  • The clinical study aims to determine whether such drugs affect tau phosphorylation, tau tangles and the damage caused by them, thereby slowing or stopping the progress of AD.
  • An investigational anti-tau antibody, E2814 is being developed as a disease modifying agent for tauopathies including sporadic AD.
  • E2814 is designed to prevent the spreading of tau seeds within the brains of affected individuals.

FDAnews Announces -- Data Integrity for GMP/Postmarket Professionals: Core Requirements, Expectations and Challenges Virtual Workshop March 30, April 1, 2021

Retrieved on: 
Tuesday, March 16, 2021

FALLS CHURCH, Va., March 16, 2021 /PRNewswire-PRWeb/ --Data Integrity for GMP/Postmarket Professionals:

Key Points: 
  • FALLS CHURCH, Va., March 16, 2021 /PRNewswire-PRWeb/ --Data Integrity for GMP/Postmarket Professionals:
    Is the FDA's increasing scrutiny on data integrity producing a data migraine?
  • One must establish internal competency and assessment programs; otherwise, one can expect to receive a Form 483 or warning letter.
  • With FDA data integrity requirements among the most stringent within regulated industries, compliance is challenging for drug and device manufacturers.
  • Data Integrity for GMP/Postmarket Professionals: Core Requirements, Expectations and Challenges will give attendees the tools needed to ensure electronic records are trustworthy and reliable across their entire data lifecycle, from initial data creation through long-term archives.

LogicBio Therapeutics Reports Full Year 2020 Financial Results and Provides Business Update

Retrieved on: 
Monday, March 15, 2021

LEXINGTON, Mass., March 15, 2021 /PRNewswire/ --LogicBio Therapeutics, Inc. (Nasdaq:LOGC) (LogicBio or the Company), a clinical- stage genetic medicine company pioneering gene delivery and gene editing platforms to address rare and serious diseases from infancy through adulthood, today reported financial results for the year ended December 31, 2020 and provided a business update.

Key Points: 
  • LEXINGTON, Mass., March 15, 2021 /PRNewswire/ --LogicBio Therapeutics, Inc. (Nasdaq:LOGC) (LogicBio or the Company), a clinical- stage genetic medicine company pioneering gene delivery and gene editing platforms to address rare and serious diseases from infancy through adulthood, today reported financial results for the year ended December 31, 2020 and provided a business update.
  • "The fourth quarter of 2020 marked a continuation of strong momentum for LogicBio which has also extended into 2021," said Frederic Chereau, President and CEO.
  • LogicBio Therapeutics is a clinical-stage genetic medicine company pioneering gene delivery and gene editing platforms to address rare and serious diseases from infancy through adulthood.
  • Except as required by law, the Company assumes no obligation to update these forward-looking statements publicly, even if new information becomes available in the future.

Global Cell and Gene Therapy Manufacturing QC Market Report 2021Opportunities in Drug Approvals and Strong Pipeline of Cell and Gene Therapies & Multiple Investments in Expansion of cGMP Units

Retrieved on: 
Monday, March 15, 2021

The market is driven by certain factors, which include increasing prevalence of cancer and chronic diseases, rising number of clinical trials for cell and gene therapy, steady investment and consolidation in the cell and gene therapy market, and favorable regulatory environment are fueling the growth of the global cell and gene therapy manufacturing QC market.

Key Points: 
  • The market is driven by certain factors, which include increasing prevalence of cancer and chronic diseases, rising number of clinical trials for cell and gene therapy, steady investment and consolidation in the cell and gene therapy market, and favorable regulatory environment are fueling the growth of the global cell and gene therapy manufacturing QC market.
  • Quality control is a critical aspect of manufacturing, particularly considering advanced therapies such as cell and gene therapies.
  • Key Questions Answered in this Report:
    What are the major market drivers, challenges, and opportunities and their respective impacts in the global cell and gene therapy manufacturing QC market?
  • What is the current market demand along with future expected demand for the global cell and gene therapy manufacturing QC market?

Tevogen Bio Announces Partnership With BioCentriq, New Jersey Innovation Institute’s Pioneering Cell and Gene Therapy Center, to Enhance Tevogen’s Development Capacity of Its Proprietary Targeted T Cell Therapy For COVID-19

Retrieved on: 
Monday, March 15, 2021

Tevogen Bio announces partnership with BioCentriq, a New Jersey based cell and gene therapy development and manufacturing center, to support clinical manufacturing of Tevogens investigational COVID-19 treatment.

Key Points: 
  • Tevogen Bio announces partnership with BioCentriq, a New Jersey based cell and gene therapy development and manufacturing center, to support clinical manufacturing of Tevogens investigational COVID-19 treatment.
  • Under the partnership, experts from both entities will collaborate at BioCentriqs state-of-the art GMP facilities to produce Tevogens proprietary COVID-19 targeted T cells.
  • The teams will utilize the processes and technology required to ensure that all quality standards are met in the large scale manufacturing of Tevogens clinical grade, allogeneic T-cell therapy.
  • Tevogens Investigational New Drug (IND) application for its proprietary antigen specific T cell therapy is currently under review by the U.S. Food and Drug Administration (FDA).

Gamida Cell Presents Efficacy and Safety Results of Phase 3 Study of Omidubicel in Patients with Hematologic Malignancies at the 47th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT)

Retrieved on: 
Monday, March 15, 2021

In the study, treatment with omidubicel showed faster hematopoietic recovery, fewer bacterial and viral infections and fewer days in hospital.

Key Points: 
  • In the study, treatment with omidubicel showed faster hematopoietic recovery, fewer bacterial and viral infections and fewer days in hospital.
  • Gamida Cell is an advanced cell therapy company committed to cures for patients with blood cancers and serious blood diseases.
  • 1 Gamida Cell press release, Gamida Cell Announces Positive Topline Data from Phase 3 Clinical Study of Omidubicel in Patients with High-Risk Hematologic Malignancies, issued May 12, 2020.
  • Phase I/II study of stem-cell transplantation using a single cord blood unit expanded ex vivo with nicotinamide.

Embark Veterinary Grows Its Senior Leadership Team, Fetching Strategic New Hires Amid Continued Growth

Retrieved on: 
Monday, March 15, 2021

"It's exciting to welcome this group of great talent that we're confident will help us exceed our short and long-term goals."

Key Points: 
  • "It's exciting to welcome this group of great talent that we're confident will help us exceed our short and long-term goals."
  • Medros joins Embark from edX where he was President and co-CEO overseeing day-to-day management of operations including product, marketing, engineering, content, sales, finance, and HR.
  • Plante was promoted to CMO in December 2020 after previously leading the Growth Marketing team as the VP of marketing.
  • Embark Veterinary, Inc., a leader in dog genetics, launched in 2015 with a mission to improve the life and longevity of all dogs.