Trial master file

Northwest Biotherapeutics Announces That A Marketing Authorization Application Has Been Submitted To The UK MHRA For DCVax®-L For Glioblastoma

Retrieved on: 
Thursday, December 21, 2023
Neoplasm, Survival, B cell, Northwest Biotherapeutics, Biotechnology, Research, Marketing, TCR, MAA, Medication, Sponsor, Recurrence, MHRA, GMP, Glioblastoma, ChromeOS, OTCQB, Cancer, Central nervous system, Patient, Peptide, Trial master file, PNAS, Medical imaging

BETHESDA, Md., Dec. 21, 2023 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today that a Marketing Authorization Application (MAA) was submitted yesterday to the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK for DCVax®-L for glioblastoma brain cancer.

Key Points: 
  • The MAA seeks approval for commercialization of DCVax-L for both newly diagnosed and recurrent glioblastoma (GBM).
  • We believe DCVax-L can offer a much needed new treatment option for GBM patients, both alone and in combination with other treatment agents.
  • We look forward to bringing the treatment to as many patients as possible, including in community settings where most patients are treated."
  • The Company looks forward to resuming its clinical development of DCVax-Direct for a wide range of inoperable solid tumors.

Northwest Biotherapeutics Announces That A Marketing Authorization Application Has Been Submitted To The UK MHRA For DCVax®-L For Glioblastoma

Retrieved on: 
Thursday, December 21, 2023
Neoplasm, Survival, B cell, Northwest Biotherapeutics, Biotechnology, Research, Marketing, TCR, MAA, Medication, Sponsor, Recurrence, MHRA, GMP, Glioblastoma, ChromeOS, OTCQB, Cancer, Central nervous system, Patient, Peptide, Trial master file, PNAS, Medical imaging

BETHESDA, Md., Dec. 21, 2023 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today that a Marketing Authorization Application (MAA) was submitted yesterday to the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK for DCVax®-L for glioblastoma brain cancer.

Key Points: 
  • The MAA seeks approval for commercialization of DCVax-L for both newly diagnosed and recurrent glioblastoma (GBM).
  • We believe DCVax-L can offer a much needed new treatment option for GBM patients, both alone and in combination with other treatment agents.
  • We look forward to bringing the treatment to as many patients as possible, including in community settings where most patients are treated."
  • The Company looks forward to resuming its clinical development of DCVax-Direct for a wide range of inoperable solid tumors.

Egnyte Launches eTMF Quality Control Feature

Retrieved on: 
Tuesday, November 28, 2023
Data Management, Security, Apps, Applications, Technology, Other Technology, Mobile, Wireless, Software, Trial master file, DevOps, Clinical trial, Quality control, Data management, TMF, Organization, Mobile phone, Video game, Egnyte

Egnyte announced today a new Quality Control feature for its electronic Trial Master File (eTMF) application.

Key Points: 
  • Egnyte announced today a new Quality Control feature for its electronic Trial Master File (eTMF) application.
  • This feature allows users to conduct review and approval workflows on documents in the eTMF application before formally filing sensitive trial content into their TMF, removing the complexities associated with operating across multiple systems.
  • “Egnyte’s new eTMF Quality Control feature joins a suite of eTMF-focused features in the Egnyte platform and is a reflection of our commitment to creating industry-leading solutions that improve workflows and data management for biotechs,” said Abhay Kini, director of Life Sciences at Egnyte.
  • To learn more about Egnyte’s latest eTMF Quality Control feature and other upcoming platform enhancements, register for Egnyte’s virtual Global Summit on December 6, 2023.

Surrozen Chooses TransPerfect’s Trial Interactive eClinical Platform for Comprehensive TMF Management

Retrieved on: 
Tuesday, February 21, 2023
Health, Technology, Health Technology, Software, Clinical Trials, Pharmaceutical, Biotechnology, Clinical trial, QMS, TMF, CTMS, Partnership, Risk, Interactivity, DevOps, Patient, Soft tissue injury, Therapy, Trial master file, Clinical data management, TransPerfect, Quality control, Regeneration, Pharmaceutical industry

TransPerfect Life Sciences, a leading provider of services and technologies to support global clinical trials and product development for the biopharmaceutical industry, today announced that Surrozen has selected its Trial Interactive eClinical platform, including electronic Trial Master File (eTMF) and TMF solutions to create a centralized, quality-focused approach to TMF management.

Key Points: 
  • TransPerfect Life Sciences, a leading provider of services and technologies to support global clinical trials and product development for the biopharmaceutical industry, today announced that Surrozen has selected its Trial Interactive eClinical platform, including electronic Trial Master File (eTMF) and TMF solutions to create a centralized, quality-focused approach to TMF management.
  • Surrozen is a US-based biotechnology company pioneering a new class of therapeutics to treat serious diseases characterized by tissue injury.
  • In order to streamline and own their TMF operations, Surrozen sought a technology and service solution that would provide an extensible eTMF paired with TMF services for independent quality control.
  • Trial Interactive’s TMF expertise was essential to our decision.”
    TransPerfect President and CEO Phil Shawe commented, “Surrozen’s work in tissue regeneration is innovative and important, and we are proud that Trial Interactive has been chosen to support Surrozen’s TMF management processes.”

Surrozen Chooses TransPerfect's Trial Interactive eClinical Platform for Comprehensive TMF Management

Retrieved on: 
Tuesday, February 21, 2023
TransPerfect, Therapy, Clinical data management, Patient, Clinical trial, CTMS, Interactivity, Soft tissue injury, Risk, QMS, Quality control, Trial master file, TMF, Partnership, Regeneration, DevOps, Pharmaceutical industry

NEW YORK, Feb. 21, 2023 /PRNewswire/ -- TransPerfect Life Sciences, a leading provider of services and technologies to support global clinical trials and product development for the biopharmaceutical industry, today announced that Surrozen has selected its Trial Interactive eClinical platform, including electronic Trial Master File (eTMF) and TMF solutions to create a centralized, quality-focused approach to TMF management.

Key Points: 
  • NEW YORK, Feb. 21, 2023 /PRNewswire/ -- TransPerfect Life Sciences, a leading provider of services and technologies to support global clinical trials and product development for the biopharmaceutical industry, today announced that Surrozen has selected its Trial Interactive eClinical platform, including electronic Trial Master File (eTMF) and TMF solutions to create a centralized, quality-focused approach to TMF management.
  • Surrozen is a US-based biotechnology company pioneering a new class of therapeutics to treat serious diseases characterized by tissue injury.
  • In order to streamline and own their TMF operations, Surrozen sought a technology and service solution that would provide an extensible eTMF paired with TMF services for independent quality control.
  • TransPerfect President and CEO Phil Shawe commented, "Surrozen's work in tissue regeneration is innovative and important, and we are proud that Trial Interactive has been chosen to support Surrozen's TMF management processes."

Disc Medicine Announces $62.5 Million Financing led by Bain Capital Life Sciences to Advance Portfolio of Novel Hematology Programs

Retrieved on: 
Tuesday, February 14, 2023
Diamond, Erythropoiesis, AURORA, DBA, Diamond–Blackfan anemia, Erythropoietic protoporphyria, Science, IRON, CKD, Patient, Clinical trial, Polycythemia, Form, Inflammation, Anemia, Trial master file, Sodium- and chloride-dependent glycine transporter 1, OrbiMed, IND, S-3, Dialysis, FDA, Chronic kidney disease, HJV, EPP, Ruxolitinib, Doctor of Philosophy, Pharmaceutical industry, Security (finance), Disc

The financing was led by Bain Capital Life Sciences, who contributed $50 million, with participation from existing investors, Access Biotechnology and OrbiMed.

Key Points: 
  • The financing was led by Bain Capital Life Sciences, who contributed $50 million, with participation from existing investors, Access Biotechnology and OrbiMed.
  • The offering is expected to close on or about February 15, 2023, subject to customary closing conditions.
  • The shares of common stock and pre-funded warrants were offered pursuant to a shelf registration statement on Form S-3 (File No.
  • “We are delighted to welcome Bain Capital Life Sciences as an investor during a transformational time for Disc.

Positive CHMP opinion for darolutamide in combination with docetaxel for the treatment of metastatic hormone-sensitive prostate cancer

Retrieved on: 
Friday, January 27, 2023
Marketing, Royal commission, Disease, European Directive on Traditional Herbal Medicinal Products, Prostate cancer, Docetaxel, ADT, European Commission, Risk, European Medicines Agency, Trial master file, Phase, Ari, Patient, Union, Co-promotion, Orion, Committee, EMA, Death, Committee for Medicinal Products for Human Use, AES, Darolutamide, Pharmaceutical industry, EU, CHMP, Bayer

Darolutamide is already approved under the brand name Nubeqa® for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease.

Key Points: 
  • Darolutamide is already approved under the brand name Nubeqa® for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease.
  • The final decision from the European Commission on the marketing authorisation is expected in the coming months.
  • This includes the ARANOTE Phase III trial evaluating darolutamide plus androgen deprivation therapy (ADT) versus ADT alone for mHSPC.
  • Bayer is responsible for global commercialisation, with co-promotion from Bayer and Orion in certain European markets, e.g.

Northwest Biotherapeutics Announces Positive Votes At Annual Meeting; Reviews 2022 Progress and Looks Forward to Strong 2023

Retrieved on: 
Friday, January 6, 2023
Linda, Trial master file, OTCQB, Biotechnology, Annual general meeting, PIP, Northwest Biotherapeutics, Certificate, R, The Meeting, Annual Meetings of the International Monetary Fund and the World Bank Group, Patient, Q & A, Consultant, JAMA Oncology, The, New Year, Documentation, Q&A, Holding company, Pharmaceutical industry, Financial adviser, Video game console, Sawston

BETHESDA, Md., Jan. 6, 2023 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, reported positive results of voting at the Annual Shareholders Meeting on December 30, 2022, and discussion at the Meeting (which was publicly available) about achievements in 2022 and anticipated activities in 2023.

Key Points: 
  • There was a strong vote turnout at the Annual Meeting, with votes cast for 78% of all common and preferred shares that were outstanding as of the record date (841,223,911 votes cast).
  • Building upon the achievements and progress in 2022, the Company believes that 2023 can be another very strong year.
  • Linda Powers, the Company's CEO, commented:  "2022 has been a year of major accomplishments, and we look forward to an even stronger 2023.
  • We are very grateful for the ongoing strong support from our shareholders, as reflected in the exceptional voting results of the Annual Meeting."

Northwest Biotherapeutics Announces Positive Votes At Annual Meeting; Reviews 2022 Progress and Looks Forward to Strong 2023

Retrieved on: 
Friday, January 6, 2023
Linda, Trial master file, OTCQB, Biotechnology, Annual general meeting, PIP, Northwest Biotherapeutics, Certificate, R, The Meeting, Annual Meetings of the International Monetary Fund and the World Bank Group, Patient, Q & A, Consultant, JAMA Oncology, The, New Year, Documentation, Q&A, Holding company, Pharmaceutical industry, Financial adviser, Video game console, Sawston

BETHESDA, Md., Jan. 6, 2023 /PRNewswire/ -- Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, reported positive results of voting at the Annual Shareholders Meeting on December 30, 2022, and discussion at the Meeting (which was publicly available) about achievements in 2022 and anticipated activities in 2023.

Key Points: 
  • There was a strong vote turnout at the Annual Meeting, with votes cast for 78% of all common and preferred shares that were outstanding as of the record date (841,223,911 votes cast).
  • Building upon the achievements and progress in 2022, the Company believes that 2023 can be another very strong year.
  • Linda Powers, the Company's CEO, commented:  "2022 has been a year of major accomplishments, and we look forward to an even stronger 2023.
  • We are very grateful for the ongoing strong support from our shareholders, as reflected in the exceptional voting results of the Annual Meeting."

John Kent Kidwell, Esq., is recognized by Continental Who's Who

Retrieved on: 
Wednesday, October 12, 2022
Ownership, Financial planner, Book, American Bar Association Model Rules of Professional Conduct, Private law, Nation, Sale, American Bar Association, Law, Professional, Wills, Estate, Private practice, The arts, Kidwell, Antonin Scalia Law School, American Institute, Association, Virginia State Bar, Uniform Combined State Law Exam, Continental, University of Mary Washington, Law of the United Kingdom, Trial master file, Supreme court, Property management, Practice of law, MD

FAIRFAX, Va., Oct. 12, 2022 /PRNewswire/ -- John Kent Kidwell, Esq., is being recognized by Continental Who's Who as a Distinguished Attorney and Financial Planner in the Legal Services field, acknowledging his private practice achievements with The Law Offices of Kidwell & Kent.

Key Points: 
  • FAIRFAX, Va., Oct. 12, 2022 /PRNewswire/ -- John Kent Kidwell, Esq., is being recognized by Continental Who's Who as a Distinguished Attorney and Financial Planner in the Legal Services field, acknowledging his private practice achievements with The Law Offices of Kidwell & Kent.
  • With 17 years of experience in practicing law, Mr. Kidwell is the Owner and Managing Partner of The Law Offices of Kidwell & Kent, with offices in Fairfax, VA, and Rockville, MD.
  • He also owns and operates an in-firm commercial and residential real estate title company, Old Dominion Title Services, Inc.
  • In 2018, the American Institute of Family Lawyers named The Law Offices of Kidwell & Kent as one of the 10 Best Law Firms in Virginia.