Regulatory affairs

Dr. Chi Li Joins Curevo Vaccine as Chief Regulatory Officer

Retrieved on: 
Monday, April 8, 2024
Shingles, Editas Medicine, Regulatory affairs, Bristol Myers Squibb, Doctor of Philosophy, MBA, Rutgers University, Immunization, Johnson & Johnson, Allergan, RAC, Vaccine, Purdue University, Pharmaceutical industry

SEATTLE, April 08, 2024 (GLOBE NEWSWIRE) -- Curevo Vaccine (Curevo), a privately-held clinical-stage biotechnology company dedicated to developing varicella zoster virus vaccines with improved tolerability and accessibility, today announced Dr. Chi Li is joining as the company’s Chief Regulatory Officer responsible for the global regulatory strategy for amezosvatein.

Key Points: 
  • SEATTLE, April 08, 2024 (GLOBE NEWSWIRE) -- Curevo Vaccine (Curevo), a privately-held clinical-stage biotechnology company dedicated to developing varicella zoster virus vaccines with improved tolerability and accessibility, today announced Dr. Chi Li is joining as the company’s Chief Regulatory Officer responsible for the global regulatory strategy for amezosvatein.
  • “We are thrilled to have Dr. Li join the Curevo team and build upon the regulatory progress made thus far,” stated George Simeon, Curevo’s Chief Executive Officer.” Dr. Li will play a key role in finalizing our global regulatory strategy and harmonizing our approach to key entry markets in Europe, the USA, China, Japan, and other important markets for our shingles and varicella vaccine.”
    Dr. Li’s impressive 20+ year career in regulatory affairs features multiple regulatory successes globally.
  • “I’m genuinely impressed at what the Curevo team has accomplished to date and am excited to join such a dynamic group,” said Dr. Li.
  • Previously, Dr. Li served as Vice President, Regulatory Affairs at both Allergan and Bayer.

AffyImmune Therapeutics Announces Clinical and Regulatory Advisory Board to Support Development of AIC100 in Solid Tumors

Retrieved on: 
Monday, April 8, 2024
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, Clinical Trials, Other Health, Clinical research, Harvard Medical School, Melanoma Research, Translational research, Surgery, Clinical, Associate, George Washington University, Patient, Regulatory affairs, University, Cancer, Doctor of Philosophy, Melanoma, Brown University, Translation, Treatment, Therapy, Drug development, Safety, FACS, University of Southern California, Biomedical Research, Pathology, Research fellow, School, Pharmaceutical industry

The CRAB will provide strategic counsel and expertise as AffyImmune advances its affinity-tuned CAR T therapeutics in clinical development.

Key Points: 
  • The CRAB will provide strategic counsel and expertise as AffyImmune advances its affinity-tuned CAR T therapeutics in clinical development.
  • “This group of distinguished scientists and advisors bring to AffyImmune invaluable CAR T drug development experience from research to commercialization,” said Sonal Gupta, MD, PhD, AffyImmune SVP and Head of Clinical Development.
  • ‘’I am honored to join Affylmmune’s Clinical and Regulatory Advisory Board and look forward to working with the other members to advance the development of novel treatments,” said Carmelo Nucera, MD, PhD.
  • Jorge J. Nieva, MD , Associate Professor of Clinical Medicine, Keck School of Medicine, University of Southern California and Section Head, Solid Tumors, USC/Norris Cancer Center.

LIS Technologies Inc. Announces Oversubscribed $1.3 Million Seed Funding Round Led by Advanced Nuclear Technology Investors to Fund the Rebirth of the Only USA-Origin Patented Laser Uranium Enrichment Technology in the World

Retrieved on: 
Monday, March 25, 2024
Uranium, Nuclear, Isotope, Oak Ridge National Laboratory, Growth, Argonne National Laboratory, Patent, White, Regulatory affairs, Indefinite, Research, University, IDIQ, MBA, Doctor of Philosophy, LIS, Chief Scientific Adviser, HALEU, Government, Fiscal, LEU

This unique laser-based method enhances energy efficiency and can be implemented at highly competitive capital and operational expenses.

Key Points: 
  • This unique laser-based method enhances energy efficiency and can be implemented at highly competitive capital and operational expenses.
  • Ambassador to Russia and distinguished research and development staff member in the Nuclear Security and Isotope Technology Division at Oak Ridge National Laboratory.
  • In late October, the White House requested $2.2 billion for domestic uranium enrichment capabilities.
  • In March, the Fiscal Year 2024 Energy and Water Development Appropriations Act passed , allocated $1.685 billion towards nuclear energy research and development.

National Bank Holdings Corporation Appoints New Board Director

Retrieved on: 
Friday, March 15, 2024
Audit, J. P. Morgan, Risk management, Woman, Regulatory affairs, Executive Committee, Robin, Easter Seals, Dress, Rutgers University, Committee on Finance, Accounting, CPA, Management

DENVER, March 15, 2024 (GLOBE NEWSWIRE) -- National Bank Holdings Corporation (NYSE: NBHC) announced today that its Board of Directors appointed Ms. Robin Doyle as a Director of the Company, effective March 18, 2024.

Key Points: 
  • DENVER, March 15, 2024 (GLOBE NEWSWIRE) -- National Bank Holdings Corporation (NYSE: NBHC) announced today that its Board of Directors appointed Ms. Robin Doyle as a Director of the Company, effective March 18, 2024.
  • Doyle’s distinguished career in international financial services has spanned over three decades with a focus in finance, regulatory affairs and risk management.
  • She has served as a founding board member of the Global Legal Entity Identifier Foundation, a founding board member for the Rutgers Business School Center for Women in Business, the Rutgers Business School Dean’s Advisory Board, the board of New Jersey Junior Achievement, and the board of Easter Seals of New Jersey.
  • Tim Laney, the Company’s Chairman, President and Chief Executive Officer, said, “We are pleased to welcome Robin to our Board of Directors.

Entrada Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Wednesday, March 13, 2024
Administration, Patient, Regulatory affairs, Research, G&A, EMA, Doctor of Philosophy, DM1, Completeness, Health Canada, Senior, Net operating loss, IND, MHRA, Research and development, Duchenne muscular dystrophy, Clinical trial, Data management, Therapy, Vertex Pharmaceuticals, FDA, DMD, Medication, Pharmaceutical industry

BOSTON, March 13, 2024 (GLOBE NEWSWIRE) -- Entrada Therapeutics, Inc. (Nasdaq: TRDA) is a clinical-stage biopharmaceutical company aiming to transform the lives of patients by establishing a new class of medicines that engage intracellular targets that have long been considered inaccessible. The Company today reported financial results for the fourth quarter and full year ending December 31, 2023, and highlighted recent business updates.

Key Points: 
  • The Company today reported financial results for the fourth quarter and full year ending December 31, 2023, and highlighted recent business updates.
  • “We continue to make significant progress advancing our growing pipeline of intracellular therapeutics,” said Dipal Doshi, Chief Executive Officer of Entrada Therapeutics.
  • Collaboration Revenue: Collaboration revenue was $41.8 million for the fourth quarter of 2023 and $129.0 million for the full year of 2023.
  • The G&A expenses in the fourth quarter of 2023 were lower than the fourth quarter of 2022 primarily due to a decrease in legal and consulting fees.

KBI Biopharma Strengthens Quality and Regulatory Affairs Expertise with Appointment of Chief Quality Officer

Retrieved on: 
Monday, April 1, 2024
Other Manufacturing, Research, Manufacturing, Biotechnology, Other Health, Health, Pharmaceutical, Other Science, Science, CDMO, Novartis, Regulatory affairs, CGMP, Bayer, KBI, Chemical engineering, Multimedia, Amgen, Rensselaer Polytechnic Institute, Engineering

KBI Biopharma, Inc. (KBI), a JSR Life Sciences company and cGMP contract development and manufacturing organization (CDMO), today announced the appointment of Peter Carbone as the new Chief Quality Officer, strengthening KBI’s expertise in Quality and Regulatory Affairs.

Key Points: 
  • KBI Biopharma, Inc. (KBI), a JSR Life Sciences company and cGMP contract development and manufacturing organization (CDMO), today announced the appointment of Peter Carbone as the new Chief Quality Officer, strengthening KBI’s expertise in Quality and Regulatory Affairs.
  • Peter will lead KBI’s Quality and Regulatory Affairs team, spearheading compliance and regulatory initiatives for customers worldwide and positioning KBI to provide the services, expertise, and leadership to partner with health authorities on regulatory policy.
  • "We have made a commitment to establishing KBI Biopharma as a thought leader and catalyst for change in Regulatory Affairs within the biopharma sector,” said J.D.
  • "Peter's addition to our team bolsters our expertise in quality and regulatory compliance and facilitates our continued transformation in support of our current and future customers.

SetPoint Medical Accepted into FDA Total Product Life Cycle Advisory Program for Development of its Neuroimmune Modulation Platform for the Treatment of Multiple Sclerosis

Retrieved on: 
Thursday, March 21, 2024
Research, Medical Devices, Neurology, FDA, Genetics, Clinical Trials, Biotechnology, General Health, Health, Science, Vagus nerve, Device, CDRH, Patient, Regulatory affairs, TAP, Remyelination, Clinical trial, Safety, Set, RRMS, Food, Pharmaceutical industry

SetPoint Medical , a clinical-stage healthcare company dedicated to patients with chronic autoimmune diseases, announced that it has been accepted into the Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot from the U.S. Food and Drug Administration (FDA) for the development of its novel neuroimmune modulation platform for people living with relapsing-remitting multiple sclerosis (RRMS).

Key Points: 
  • SetPoint Medical , a clinical-stage healthcare company dedicated to patients with chronic autoimmune diseases, announced that it has been accepted into the Total Product Life Cycle (TPLC) Advisory Program (TAP) Pilot from the U.S. Food and Drug Administration (FDA) for the development of its novel neuroimmune modulation platform for people living with relapsing-remitting multiple sclerosis (RRMS).
  • The FDA’s Center for Devices and Radiological Health (CDRH) launched the TAP Pilot to help expedite development and patient access to safe and effective high-quality medical devices upon FDA approval.
  • In October 2023, the FDA expanded the program to include neurological and physical medicine devices.
  • SetPoint's integrated neurostimulation device uses precise vagus nerve stimulation to activate innate anti-inflammatory and immune-restorative pathways to treat autoimmune conditions.

ELIQUENT Life Sciences Announces Appointment of Former FDA Senior Officials

Retrieved on: 
Thursday, March 21, 2024
Public Policy, Government, Biotechnology, Pharmaceutical, Health, FDA, Other Policy Issues, Medical Devices, College, Principal, Federation, Enzyme, Commissioner, Georgetown University, Regulatory affairs, BIO, National Cancer Institute, OBP, Biotechnology Innovation Organization, Laboratory, Quality, Divisional patent application, Biosimilar, Pennsylvania State University, Cell, Multimedia, Food, Pharmaceutical industry

ELIQUENT Life Sciences, a global regulatory consulting firm for the life sciences industry, today announced the appointment of John Taylor as head of the firm’s Quality & Compliance Practice and Michele Dougherty as head of the firm’s Regulatory Affairs Practice.

Key Points: 
  • ELIQUENT Life Sciences, a global regulatory consulting firm for the life sciences industry, today announced the appointment of John Taylor as head of the firm’s Quality & Compliance Practice and Michele Dougherty as head of the firm’s Regulatory Affairs Practice.
  • View the full release here: https://www.businesswire.com/news/home/20240321127987/en/
    John Taylor, Head of Quality & Compliance Practice, ELIQUENT Life Sciences (Photo: Business Wire)
    ELIQUENT’s integrated suite of services deliver the answers and solutions that global life sciences innovators need to gain and maintain market authorization for their products.
  • Most recently, John served for 10-years as President and Principal of Compliance & Regulatory Affairs at Greenleaf Health, a legacy brand of ELIQUENT Life Sciences.
  • A 10-year veteran of FDA, Michele’s career includes more than 15-years of regulatory experience across the product quality lifecycle, including her most recent role as President of DataRevive, a legacy brand of ELIQUENT Life Sciences.

Coya Therapeutics Provides a Corporate Update and Reports Fiscal 2023 Financial Results

Retrieved on: 
Tuesday, March 19, 2024
Mental Health, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, Research, Pharmacology, LD, Survival, Serum, ALS, Science, PD, Houston Methodist Hospital, Patient, Regulatory affairs, Granulocyte-macrophage colony-stimulating factor, FD, GM-CSF, Nebraska Medicine, COYA, University, IPO, Senior, Society, IND, Commerce, Viral disease, Therapy, Frontotemporal dementia, FDA, FTD, Pharmaceutical industry

Coya Therapeutics, Inc. (Nasdaq: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance regulatory T cell (Treg) function, provides a corporate update and announces its financial results for the year ended December 31, 2023.

Key Points: 
  • Coya Therapeutics, Inc. (Nasdaq: COYA) (“Coya” or the “Company”), a clinical-stage biotechnology company developing biologics intended to enhance regulatory T cell (Treg) function, provides a corporate update and announces its financial results for the year ended December 31, 2023.
  • COYA 302 is Coya’s combination of its proprietary LD IL-2 formulation with the immunomodulatory drug CTLA4-Ig.
  • “We believe that we have under-promised and over-delivered in executing on numerous deliverables in 2023 that have brought value to Coya,” commented Howard Berman, Ph.D., Chief Executive Officer of Coya.
  • Net loss was $8.0 million for the year ended December 31, 2023, compared to net loss of $12.2 million for the year ended December 31, 2022.

Medical Device Software Course: Complying with the EU MDR, EU IVDR & FDA Regulations (4 Day Online Event) - ResearchAndMarkets.com

Retrieved on: 
Tuesday, March 12, 2024
Education, Software, Technology, Training, Regulatory affairs, FDA, Documentation, MDR, Risk management, Cloud computing, Artificial intelligence, Medical device

The "Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations" conference has been added to ResearchAndMarkets.com's offering.

Key Points: 
  • The "Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations" conference has been added to ResearchAndMarkets.com's offering.
  • This intensive four-day course provides a comprehensive appraisal of the regulations and requirements that apply to medical device software worldwide.
  • There will be in-depth coverage on how to prepare compliant technical file documentation for medical device software products and a review of software specification, risk management, architectures, usability and resulting design documentation.
  • There will be sessions on the practical implication of risk management and usability and an analysis of the differences between FDA guidance and MDR guidance on medical device software.