Aminolevulinic acid

Orphan designation: Florilglutamic acid (18F) Diagnosis of glioma, 21/03/2016 Withdrawn

Retrieved on: 
tisdag, april 9, 2024
Eurostat, Diagnosis, Civil service commission, Radiation, Personality, Brain, Headache, MRI, 18F, Aminolevulinic acid, Cell, Survival, Disease, Seizure, Magnetic resonance imaging, Patient, Committee, Knowledge, Glioma, PET, Tissue, Regulation, Cancer, FDOPA, EMA, IRIS, Nausea, European, Fluorodeoxyglucose (18F), COMP, Somatic symptom disorder, Sponsor, European Commission, Safety, Vomiting, Marketing, Hepatocellular carcinoma, Molecular imaging, Medicine, Pharmaceutical industry

Orphan designation: Florilglutamic acid (18F) Diagnosis of glioma, 21/03/2016 Withdrawn

Key Points: 


Orphan designation: Florilglutamic acid (18F) Diagnosis of glioma, 21/03/2016 Withdrawn

SonALAsense Presents Preliminary Data From Clinical Study in Patients With Deadly Pediatric Brain Tumor

Retrieved on: 
onsdag, december 13, 2023
Surgery, Medical Devices, Neurology, Clinical Trials, Biotechnology, Radiology, Health, Pharmaceutical, Oncology, SDT, Radiation, Hope, Pakistan Society of Neuro-Oncology, Sonodynamic therapy, Patient, Aminolevulinic acid, Death, Diffusion, Steroid, Incisionless Fritsch otoplasty, Neurosurgery, Hydrogen chloride, Diagnosis, Survival, Diffuse intrinsic pontine glioma, Infrared spectroscopy correlation table, Quality of life, DIPG, SNO, Metastasis, Medical imaging, Pharmaceutical industry, Development

These results were presented at the November 2023 Society for Neuro-Oncology (SNO) Annual Meeting in Vancouver, Canada.

Key Points: 
  • These results were presented at the November 2023 Society for Neuro-Oncology (SNO) Annual Meeting in Vancouver, Canada.
  • The preliminary data from Study SDT-201 shows signals of clinical activity and no safety concerns.
  • Study SDT-201 is a dose escalation and expansion study in patients with DIPG.
  • Six (6) patients have been treated to date and dose escalation is ongoing.

The National Marrow Donor Program® (NMDP)/Be The Match® and Be The Match BioTherapies® Mark Clinical Trials Day With New Resources and Services for Patients, Researchers, and Industry Sponsors

Retrieved on: 
onsdag, maj 17, 2023
Center for International Blood and Marrow Transplant Research, Database, National Marrow Donor Program, Institutional review board, Travel, DSMB, CTSS, Medical college, Survival, Clinical trial, Quality of life, CFR, Support, HCT, Research, Science, Data monitoring committee, Organization, Medical College of Wisconsin, US, Patient, NMDP, Diagnosis, FDA, Aminolevulinic acid, Pharmaceutical industry, Medical imaging, Medical device, Match

The new resources are designed to complement and raise awareness about their breadth of services for patients, researchers, and trial sponsors.

Key Points: 
  • The new resources are designed to complement and raise awareness about their breadth of services for patients, researchers, and trial sponsors.
  • Finally, by supporting expanded clinical trial access, the NMDP/Be The Match, is working to ensure that enrollment in clinical trials reflects the diversity of the whole patient population.
  • The NMDP/Be The Match simplifies access to clinical trials for patients, their families, and care teams through navigational and financial support.
  • The National Marrow Donor Program® (NMDP)/Be The Match® is the leading global partner working to save lives through cellular therapy.

SonALAsense Welcomes Dr. Ely Benaim as Chief Medical Officer and Executive Vice President of Development

Retrieved on: 
tisdag, maj 9, 2023
Science, Neurology, Biotechnology, Research, Pharmaceutical, Oncology, Health, Clinical Trials, Data management, Amgen, Drug development, Diffuse intrinsic pontine glioma, Jude the Apostle, History, Doctor of Philosophy, Glioblastoma, High-intensity focused ultrasound, DIPG, Journal, Patient, ALA, Reactive oxygen species, Takeda Oncology, Journal of Neuro-Oncology, Decompression (diving), Sonodynamic therapy, Aminolevulinic acid, FDA, SDT, Safety, Medical imaging, Nursing, Pharmaceutical industry, Medical device, Development

SonALAsense, a pioneer in the development of non-invasive Sonodynamic Therapy (SDT) using SONALA-001 in combination with Insightec’s MR-guided focused ultrasound (MRgFUS), has appointed Ely Benaim, M.D., as Chief Medical Officer and Executive Vice President of Development.

Key Points: 
  • SonALAsense, a pioneer in the development of non-invasive Sonodynamic Therapy (SDT) using SONALA-001 in combination with Insightec’s MR-guided focused ultrasound (MRgFUS), has appointed Ely Benaim, M.D., as Chief Medical Officer and Executive Vice President of Development.
  • Benaim brings decades of clinical and industry experience and incredible insights to SonALAsense,” said Mark de Souza, PhD, Chief Executive Officer at SonALAsense.
  • Later, he moved into drug development, taking high-profile positions at Amgen, Sangamo BioSciences, Millennium Pharmaceuticals, Rexahn Pharmaceuticals and others.
  • Prior to joining SonALAsense, he was Chief Medical Officer for Novocure, where he managed several pivotal clinical trials.

SonALAsense Announces Completion of First Cohort in Phase 2 Study of SONALA-001 Sonodynamic Therapy for Recurrent Glioblastoma

Retrieved on: 
onsdag, mars 8, 2023
Biotechnology, Health, Radiology, Pharmaceutical, Oncology, Health Technology, Medical Devices, Research, Surgery, Science, Clinical Trials, ALA, NYU, Learning, High-intensity focused ultrasound, Brain, Cell death, Light, Patient, Sonodynamic therapy, ABTA, American Brain Tumor Association, Cleveland Clinic, University of California, San Francisco, Mayo Clinic, Clinical trial, Radiation, Monroe Dunaway Anderson, Decompression (diving), Oxidative stress, Quality of life, Barrow Neurological Institute, Glioblastoma, SDT, POC, University, Aminolevulinic acid, Doctor of Philosophy, Cleveland, Safety, Medical imaging, Medical device, MD

SDT-202 is an open-label, dose-escalation trial of SDT in recurrent glioblastoma (rGBM).

Key Points: 
  • SDT-202 is an open-label, dose-escalation trial of SDT in recurrent glioblastoma (rGBM).
  • The first cohort in SDT-202 was enrolled at Cleveland Clinic by principal investigator Matthew Grabowski, MD.
  • “At SonALAsense, we are excited to further develop SONALA-001 SDT as a potential approach to treat this devastating brain cancer.
  • “We look forward to the outcomes of this clinical trial and learning more about the potential benefits of sonodynamic therapy.”

Be The Match BioTherapies® Launches CIBMTR® CRO Services for Cell and Gene Therapy

Retrieved on: 
tisdag, januari 17, 2023
Health, Health Technology, Genetics, Clinical Trials, Research, Science, Biotechnology, Aminolevulinic acid, National Marrow Donor Program, Data monitoring committee, Center for International Blood and Marrow Transplant Research, Patient, Institutional review board, DSMB, Data analysis, Data management, Clinical trial, Physician, CFR, Fine chemical, Dentistry, Medical device, Match

These CRO Services are a collaborative effort between Be The Match BioTherapies and the CIBMTR, resulting in unique expertise and access to unparalleled resources, including research, sites, donors, partnerships, and scientific and operational expertise.

Key Points: 
  • These CRO Services are a collaborative effort between Be The Match BioTherapies and the CIBMTR, resulting in unique expertise and access to unparalleled resources, including research, sites, donors, partnerships, and scientific and operational expertise.
  • “Be The Match BioTherapies and its partners have successfully supported bone marrow transplant and cellular therapy clinical trials for nearly 20 years,” said Erin Leckrone, Senior Director, Clinical Trials, at the CIBMTR.
  • Synergies with National Marrow Donor Program®/Be The Match® (NMDP/Be The Match) and Be The Match Biotherapies for end-to-end clinical trial design, operations, and logistics support.
  • Alternatively, companies can leverage the expertise of CIBMTR CRO Services for select services such as data analysis, surveys, site selection and management, and sample management.

BIOFRONTERA INC. TO PARTICIPATE IN RENMARK’S VIRTUAL NON-DEAL ROADSHOW SERIES ON WEDNESDAY, NOVEMBER 30, MONDAY, DECEMBER 5, FRIDAY, DECEMBER 9, AND MONDAY, DECEMBER 19 2022

Retrieved on: 
måndag, november 28, 2022
Growth, Aminolevulinic acid, Renmark, Health, Sunrise Community, Inc., Google Chrome, FDA, Pharmaceutical industry

Biofrontera is a U.S.-based biopharmaceutical company commercializing a portfolio of pharmaceutical products focused on the fields of photodynamic therapy and topical antibiotics.

Key Points: 
  • Biofrontera is a U.S.-based biopharmaceutical company commercializing a portfolio of pharmaceutical products focused on the fields of photodynamic therapy and topical antibiotics.
  • In collaboration with healthcare providers, we are fully committed to advancing treatment options and patient care.
  • Biofrontera, Inc. was founded in March 2015 to commercialize the FDA-approved flagship drug Ameluz (aminolevulinic acid hydrochloride) gel, 10%, in the United States.
  • In 2019, Biofrontera Inc. expanded its U.S.-product portfolio with the FDA-approved drug Xepi (ozenoxacin) cream, 1%.

Medexus Announces Strongest Quarter in Company History with Fiscal Q2 2023 Revenue of US$27.7 Million, a 55% Increase Over Fiscal Q2 2022

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tisdag, november 8, 2022
GLOBE, Rheumatoid arthritis, Meningioma, Aminolevulinic acid, Marketing, Investment, CDH, Calendar, Treosulfan, World Health Organization, Acceleration, MAT, Customer service, Webcast, Research, PAP, Glioma, Health Canada, Hematology, Mission statement, IQVIA, Hematopoietic stem cell transplantation, Safety, Allergy, EBITDA, Clinical trial, Patent, Patient, Growth, TSX, SEDAR, NDA, Blood, FDA, Pharmaceutical industry, Video game, Cryptocurrency, Risk management, Rupal State, Collaboration, Methotrexate

TORONTO and CHICAGO, Nov. 08, 2022 (GLOBE NEWSWIRE) --  Medexus Pharmaceuticals (Medexus) (TSX: MDP) (OTCQX: MEDXF) today announced its operating and financial results and provided a business update for the company’s second fiscal quarter ended September 30, 2022. All dollar amounts in this press release are in United States dollars unless specified otherwise.

Key Points: 
  • Record total revenue of $27.7 million, a year-over-year increase of 55%, and a quarter-over-quarter increase of 20%.
  • This represents the strongest fiscal quarter in Medexuss history.
  • The primary drivers for this substantial year-over-year improvement were increases in revenues, a reduction in research & development costs, and an increase in gross margin.
  • Marcel Konrad, Chief Financial Officer of Medexus, further noted, During the second quarter we delivered an increase in our cash position versus previous quarter and generated positive operating cash flow this quarter.

Biofrontera Inc. to Sponsor the 2022 Fall Clinical Dermatology Conference

Retrieved on: 
tisdag, oktober 18, 2022
Dermatology, SEC, Skin, Conference, Literature, AK, XL, Nasdaq, Private Securities Litigation Reform Act, Knowledge, BFRI, Company, Marketing, Industry, Â, Impetigo, Face, GLOBE, Advisory board, PDT, Scalp, COVID-19, Aminolevulinic acid, Pharmaceutical industry, Cosmetics, Medical device, Collagen induction therapy

WOBURN, Mass., Oct. 18, 2022 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company specializing in the commercialization of dermatological products, announces its sponsorship of the Fall Clinical Dermatology Conference, being held October 20-23 in Las Vegas. As a Gold Industry Sponsor, Biofrontera will host an exhibit booth showcasing commercial and upcoming products, an Advisory Board meeting featuring leading dermatologists and four posters on investigator-initiated and Company-sponsored research with Ameluz®.

Key Points: 
  • WOBURN, Mass., Oct. 18, 2022 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI), a biopharmaceutical company specializing in the commercialization of dermatological products, announces its sponsorship of the Fall Clinical Dermatology Conference, being held October 20-23 in Las Vegas.
  • As a Gold Industry Sponsor, Biofrontera will host an exhibit booth showcasing commercial and upcoming products, an Advisory Board meeting featuring leading dermatologists and four posters on investigator-initiated and Company-sponsored research with Ameluz.
  • Additionally, Biofrontera is sponsoring an Advisory Board meeting on Friday, October 21st.
  • Title: Field Therapy for Actinic Keratosis: Structured Review of the Literature on Efficacy, Cost, and Adherence
    This study was investigator-initiated and funded by Biofrontera Inc.

Biofrontera Inc.’s Marketing Campaign and Website for Ameluz Won 2022 PM360 Trailblazer Awards

Retrieved on: 
måndag, september 26, 2022
Online, BF, Skin, COVID-19, Silver, Publication, Trailblazer, PDT, Creativity, Company, Premier's Multicultural Communications Awards, Achievement, Industry, Gold, Aks, Patient, Decision-making, CEO, Acosta Sales & Marketing, Nasdaq, Leadership, Private Securities Litigation Reform Act, Impetigo, BFRI, Associate, GLOBE, Overalls, Marketing, SEC, Awareness, Shark, Communication, AK, PR, Pharmaceutical industry, Public relations, Aminolevulinic acid, Dermatology

These awards were announced at the 14th Annual Trailblazer Awards held September 22, 2022 in New York, where they also recognized the previously announced Trailblazer Brand Champion in Dermatology, Leslie Hopkins, Associate Director of Marketing at Biofrontera Inc.

Key Points: 
  • These awards were announced at the 14th Annual Trailblazer Awards held September 22, 2022 in New York, where they also recognized the previously announced Trailblazer Brand Champion in Dermatology, Leslie Hopkins, Associate Director of Marketing at Biofrontera Inc.
  • Biofronteras Ameluz marketing campaign, developed in collaboration with the healthcare-focused branding agency Elevate Healthcare Marketing, was a creative call to action emphasizing the threat of actinic keratoses (AK).
  • The launch of the Ameluz website was a strategic step in a broader initiative to enhance medical support and build brand awareness.
  • Since 2009, the PM360 Trailblazer Awards have recognized outstanding achievement and innovation in healthcare marketing.