GLP

Proving that Quality Comes First: Lab-monitoring-as-a-service Provider XiltriX Becomes ISO 9001 Certified

Tuesday, October 26, 2021 - 10:45am

Pioneering Clinical Laboratory Services Company Obtains ISO 9001 Certification for Quality Management Systems.

Key Points: 
  • Pioneering Clinical Laboratory Services Company Obtains ISO 9001 Certification for Quality Management Systems.
  • "We are very proud to have achieved ISO certification," said XiltriX CEO, Moises Eilemberg.
  • XiltriX's ISO 9001:2015 certificate was issued by American Systems Registrar, LLC, a provider of third-party system registration and accredited by the ANSI National Accreditation Board.
  • "For many businesses, 'quality' can be a marketing term or otherwise 'fuzzy'," said XiltriX President, Stephen Tierney.

 Titan Medical Announces Completion of Pre-Clinical GLP Studies

Monday, October 25, 2021 - 12:30pm

GLP is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies that are intended to support marketing permits for products regulated by government agencies.

Key Points: 
  • GLP is a set of principles intended to assure the quality and integrity of non-clinical laboratory studies that are intended to support marketing permits for products regulated by government agencies.
  • The COVID-19 pandemic has impacted the processing time at laboratories, resulting in a longer than expected turnaround time for results.
  • With the completion of these studies, surgeons have now performed over 70 pre-clinical procedures representing multiple subspecialties with Titans Enos system.
  • We are pleased to report that the studies were completed on time, adding to the cadre of data supporting the Enos systems use in pre-clinical studies.

Athira Pharma Announces Completion of Enrollment in Phase 2 ACT-AD Trial Evaluating ATH-1017 for Mild-to-Moderate Alzheimer’s Disease

Friday, October 22, 2021 - 1:22pm

BOTHELL, Wash., Oct. 22, 2021 (GLOBE NEWSWIRE) -- Athira Pharma, Inc. (NASDAQ: ATHA), a late clinical-stage biopharmaceutical company focused on developing small molecules to restore neuronal health and stop neurodegeneration, announced today that it has completed enrollment in ACT-AD, a Phase 2 randomized, placebo-controlled study of ATH-1017 in patients with mild-to-moderate Alzheimer’s disease. ATH-1017 is a small molecule designed to enhance the activity of Hepatocyte Growth Factor (HGF) at its receptor, MET, which are expressed in the central nervous system to promote brain health and function. Athira expects to report topline results from the trial in the first half of 2022.

Key Points: 
  • We look forward to building on this momentum and sharing topline results from this Phase 2 trial in the first half of 2022.
  • The completion of enrollment in ACT-AD is an important clinical milestone for Athira.
  • By focusing on neuronal network recovery, ATH-1017s novel mechanism of action is agnostic to the underlying disease pathology of Alzheimers and other dementias.
  • Athira is currently advancing its lead therapeutic candidate, ATH-1017, a novel small molecule for Alzheimers and Parkinsons disease dementia.

ProMIS Neurosciences Announces Update to Senior Management Team

Friday, October 22, 2021 - 12:00pm

TORONTO and CAMBRIDGE, Mass., Oct. 22, 2021 (GLOBE NEWSWIRE) -- ProMIS Neurosciences, Inc. (TSX: PMN); (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics selectively targeting toxic oligomers implicated in the development of neurodegenerative diseases, today announced several updates to its senior management team.

Key Points: 
  • TORONTO and CAMBRIDGE, Mass., Oct. 22, 2021 (GLOBE NEWSWIRE) -- ProMIS Neurosciences, Inc. (TSX: PMN); (OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics selectively targeting toxic oligomers implicated in the development of neurodegenerative diseases, today announced several updates to its senior management team.
  • Gavin T. Malenfant, experienced drug development executive, joins the ProMIS senior management team as Chief Operating Officer.
  • Gavin brings over 30 years of biopharmaceutical experience to the ProMIS team, with special focus on providing expert management and oversight of drug development programs.
  • Gavin will be working with the CEO and leadership of the PMN310 project team, whose key members include:
    Michael Grundman, MD, MPH, Senior Medical Adviser.

Athira Pharma Announces Leadership Changes; Mark Litton, Ph.D., M.B.A. Named President and Chief Executive Officer; Rachel Lenington, M.B.A. Named Chief Operating Officer

Thursday, October 21, 2021 - 9:05pm

Since 2018, ATH-1017has been assessed in multiple preclinical and clinical studies by Athira and by its third-party contractors.

Key Points: 
  • Since 2018, ATH-1017has been assessed in multiple preclinical and clinical studies by Athira and by its third-party contractors.
  • Athira is currently advancing its lead therapeutic candidate, ATH-1017, a novel small molecule for Alzheimers and Parkinsons dementia.
  • These forward-looking statements speak only as of the date hereof and Athira undertakes no obligation to update forward-looking statements.
  • Athira may not actually achieve the plans, intentions, or expectations disclosed in its forward-looking statements, and you should not place undue reliance on the forward-looking statements.

Lovelace Biomedical Presents a New Webinar on Rare Diseases and Gene Therapy Preclinical Research

Thursday, October 21, 2021 - 7:19pm

ALBUQUERQUE, N.M., Oct. 21, 2021 /PRNewswire/ --Lovelace Biomedical, a contract research organization, who has a vast and storied, 70 plus year history and expertise in studying respiratory diseases and developing therapeutics at the preclinical stage, will present a webinar in gene therapies for diseases, and will use Cystic Fibrosis results as a case study.

Key Points: 
  • ALBUQUERQUE, N.M., Oct. 21, 2021 /PRNewswire/ --Lovelace Biomedical, a contract research organization, who has a vast and storied, 70 plus year history and expertise in studying respiratory diseases and developing therapeutics at the preclinical stage, will present a webinar in gene therapies for diseases, and will use Cystic Fibrosis results as a case study.
  • Dr. McDonald will present on the framework for the use of rare disease models and regulatory considerations for safety.
  • Lovelace Biomedical is a contract research organization that conducts research to advance pharmaceutical and biotechnology companies in their complex drug development studies from the preclinical stage, and on to clinical trials.
  • For over 70 years, the organization has leveraged its multidisciplinary expertise in toxicology, gene therapy, neurological disorders, infectious disease, and medical countermeasures.

Homology Medicines Announces Presentations Across Gene Therapy and Gene Editing Programs, including GTx-mAb, at European Society of Gene & Cell Therapy Meeting

Thursday, October 21, 2021 - 12:00pm

BEDFORD, Mass., Oct. 21, 2021 (GLOBE NEWSWIRE) --  Homology Medicines, Inc. (Nasdaq: FIXX), a genetic medicines company, announced today four presentations of preclinical data spanning its clinical-stage gene therapy program for mucopolysaccharidosis type II (MPS II, or Hunter syndrome), clinical-stage gene editing program for phenylketonuria (PKU), GTx-mAb program for paroxysmal nocturnal hemoglobinuria (PNH) and assays to evaluate levels of pre-existing antibodies to the Company’s adeno-associated viral vectors (AAVHSCs) during the 2021 European Society for Gene & Cell Therapy Virtual Conference (ESGCT).

Key Points: 
  • gene therapy candidate for MPS II, and showcased gene editing data in the PKU and humanized murine models, including on- and off-target assessment confirming the precision of our nuclease-free in vivo gene editing.
  • Encouraging data from our GTx-mAb platform showed a single dose resulted in sustained and robust expression of full-length antibodies from the liver consistent with anti-C5 therapeutics.
  • Further, we presented details of the methods of our neutralizing antibody assays used in our clinical trial screening.
  • Both methods are used in the screening phase of Homologys HMI-102 gene therapy pheNIX clinical trial to determine patient eligibility based on pre-existing Nabs.

Charles River Laboratories Plans to Increase CRADL Capacity in Cambridge

Wednesday, October 20, 2021 - 1:00pm

Charles River Laboratories International, Inc. (NYSE: CRL) today announced the expansion of its Charles River Accelerator and Development Lab (CRADL) on Binney Street in Cambridge, Massachusetts, and the addition of a second Cambridge location on Bent Street.

Key Points: 
  • Charles River Laboratories International, Inc. (NYSE: CRL) today announced the expansion of its Charles River Accelerator and Development Lab (CRADL) on Binney Street in Cambridge, Massachusetts, and the addition of a second Cambridge location on Bent Street.
  • Additionally, Charles River has begun the process of opening a second CRADL location on Bent Street in Cambridge, adding an additional 18,000 square feet of capacity for clients, with the first phase planned to open in late 2021.
  • This growth, combined with the added CRADL capacity, complements Charles Rivers portfolio of drug discovery and development capabilities locally.
  • Julie Freebersyser, DVM, DACLAM, Director of CRADL Operations at Charles River
    For over 70 years, Charles River has supplied the research community with industry-leading products and services.

Krystal Biotech Announces Virtual Presentation of Pre-clinical Data on KB407 for the Treatment of Cystic Fibrosis

Tuesday, October 19, 2021 - 9:05pm

The data include more detailed results from the IND-enabling good laboratory practice (GLP) toxicology study of KB407 from which top line results were previously announced .

Key Points: 
  • The data include more detailed results from the IND-enabling good laboratory practice (GLP) toxicology study of KB407 from which top line results were previously announced .
  • Cystic fibrosis is the most common fatal inherited disease in the United States, affecting more than 80,000 patients worldwide.
  • Lack of functional CFTR in secretory airway epithelial cells causes dehydrated mucus buildup in the lungs, pancreas and other organs.
  • According to the US Cystic Fibrosis Foundation (CFF), the median age at death for patients with CF in the United States was 30.8 years in 2018.

Fifth Wall's "Choose Earth" Mural Campaign Launches in Los Angeles

Thursday, October 14, 2021 - 2:00pm

"While the long-term possibility of multiplanetary civilization is adventurous and inspiring, the near-term priority is clear -- we must choose Earth. Investing in climate technology is absolutely critical to decarbonizing real estate, among other industries," said Brendan Wallace, Co-Founder and Managing Partner at Fifth Wall. "Fifth Wall's Climate Tech Fund presents an opportunity for sustainability-focused real estate firms committed to reducing carbon emissions to do so through investments in climate technology that addresses decarbonization across all stages and asset classes within the global real estate industry -- the single largest contributor to the climate crisis." 

Key Points: 
  • The Fifth Wall mural campaign will continue later this month in Glasgow, Scotland, leading up to COP26, the UN Climate Change conference.
  • Unfortunately, most real estate firms are not investing nearly enough into this critical climate technology and this is what Fifth Wall's mural campaign seeks to highlight.
  • A video produced by the firm provides a behind-the-scenes look at the creation of the mural in Los Angeles' Venice neighborhood and shares the inspiration behind the campaign.
  • The Los Angeles installation was created in collaboration with BBMG , a branding and social impact agency and muralist, Kent Yoshimura.