USAN

BioVie Presents Data Showing Potential for Bezisterim (NE3107) to Reduce Inflammation and Restore Homeostasis in a Manner Correlated with Alzheimer’s Disease and Biomarker Endpoints

Retrieved on: 
Jeudi, avril 25, 2024
Political moderate, Inflammation, International, M1, WHO, Notifiable disease, USAN, Liver disease, Homeostasis, Chronic obstructive pulmonary disease, World Health Organization, Randomness, Monocyte, CVD, Drug development, Sepsis, DNA methylation, Microglia, Doctor of Philosophy, Dementia, Respiratory disease, Disease, IBD, INN, DNA, CKD, Exercise, Data, Inflammatory bowel disease, Diet, Patient, Macrophage, Metabolism, Cardiovascular disease, Jools' Annual Hootenanny, PD, Cancer, Chronic kidney disease, Gene, COPD, Vaccine

The DNA methylation dataset assessed the extent of DNA methylation on roughly 965,000 individual sites where methyl groups can be attached to the patients’ DNA.

Key Points: 
  • The DNA methylation dataset assessed the extent of DNA methylation on roughly 965,000 individual sites where methyl groups can be attached to the patients’ DNA.
  • But these data provide evidence that bezisterim may have the potential to help keep people healthier for a longer time as we age,” said Cuong Do, BioVie’s President and CEO.
  • “BioVie believes that DNA methylation may not need to constantly increase as we age, and thus the progression of age-related disease may not be uni-directional.
  • This suggests that bezisterim disrupted the negative consequences of DNA methylation that promotes inflammation and restored homeostasis.

BioVie to Present Data Showing How NE3107 Potentially Restores Homeostasis via Specific Genes Associated with Dementia, Metabolism, and Inflammation

Retrieved on: 
Jeudi, avril 18, 2024
International, WHO, EDT, USAN, World Health Organization, Randomness, Drug development, Poster, DNA methylation, INN, DNA, Vaccine

Additionally, the United States Adopted Names (USAN) Council, and the World Health Organization (WHO) International Nonproprietary Names (INN) expert committee has approved “bezisterim” as the non-proprietary (generic) name for NE3107, an orally active partial NF-κB inhibitor product candidate being studied in Parkinson’s Disease and Alzheimer’s Disease.

Key Points: 
  • Additionally, the United States Adopted Names (USAN) Council, and the World Health Organization (WHO) International Nonproprietary Names (INN) expert committee has approved “bezisterim” as the non-proprietary (generic) name for NE3107, an orally active partial NF-κB inhibitor product candidate being studied in Parkinson’s Disease and Alzheimer’s Disease.
  • The oral presentation titled “Clinical Outcomes and Biomarker Findings from a Randomized, Placebo-Controlled Trial of NE3107 in Subjects with Mild to Moderate Probably Alzheimer’s Disease” will be presented by Christopher L. Reading, BioVie’s Senior Vice President, Alzheimer’s Disease Program, on Wednesday, April 24 at 2:30 p.m. EDT.
  • The poster with the same title will be presented at 6:45 p.m. on the same day.
  • Details of the presented data and conclusions will be announced once the presentations are made public at the conference.

Marker Therapeutics Reports Year-End 2023 Corporate and Financial Results

Retrieved on: 
Lundi, mars 25, 2024
ODD, Research, Food and Drug Administration, U.S. FDA, Drug discovery, AML, International, Patient, Committee, SBIR, Female, Acute myeloid leukemia, Sale, INN, Marker, EMA, OTS, NIH, IND, Myelodysplastic syndrome, European Medicines Agency, Counsel, Therapy, MRD, Bone marrow, USAN, MDS, APOLLO, FDA, DLBCL, Press release, CD19, Pharmaceutical industry

Marker also executed a comprehensive non-dilutive agreement with Cell Ready which included a sale of select cell manufacturing assets from Marker for approximately $19 million in cash.

Key Points: 
  • Marker also executed a comprehensive non-dilutive agreement with Cell Ready which included a sale of select cell manufacturing assets from Marker for approximately $19 million in cash.
  • Granted ODD from the Committee for Orphan Medicinal Products of the EMA for the treatment of patients with AML in 2023.
  • On June 26, 2023, Marker completed a non-dilutive transaction with Cell Ready, under which Cell Ready purchased certain cell manufacturing assets from Marker for approximately $19 million in cash.
  • Cash Position and Guidance: At December 31, 2023, Marker had cash and cash equivalents of $15.1 million.

Enterprise Connect 2024 Brought the Enterprise Communications and Customer Experience Community Together to Improve Business Communications/CX

Retrieved on: 
Jeudi, mars 28, 2024
Software, Networks, Other Communications, Public Relations, Investor Relations, Data Management, Communications, Technology, Other Technology, Diamond, Theta, Jabra, AVAYA, AT&T, Labs, Learning, Unified communications management, CX, TransUnion, Enterprise, CallMiner, Goto, Zoom, Spotlight Awards, USAN, Telefónica, Emulator, Lunch, Cisco Webex, TD SYNNEX, Microsoft, Intrado, Cyber, BICS, Communication, ZOOM, IRIS, Medtronic, RingCentral, AWS, Uniphore, Woman, ViewSonic, Cargill, Exhibition, Singlewire Software, Gold, RSI, HP, Continuant, Organization, XTEN, Poly, AI, Cisco, Amazon Web Services, ASC, Security, Light-year, Syniverse, Consultant, Silver, Verizon Business, UC, AudioCodes, Motus, Electronics, Charter Communications, Ecosystem, Platinum, Delta Air Lines, Management

Enterprise Connect , the leading conference and exhibition for enterprise communications and customer experience (CX), brought IT decision-makers together to improve business communications and CX.

Key Points: 
  • Enterprise Connect , the leading conference and exhibition for enterprise communications and customer experience (CX), brought IT decision-makers together to improve business communications and CX.
  • “We had an extraordinary week bringing the industry together in person in Orlando and digitally,” said Eric Krapf, General Manager, Enterprise Connect.
  • “For more than 30 years, Enterprise Connect has brought corporate IT decision makers together with industry vendors, analysts, consultants, and channel partners to focus on the issues central to enterprise communications.
  • The Best of Enterprise Connect awards program recognized excellence and innovation in the enterprise communications and customer experience industry.

Acumen Pharmaceuticals to Present Sabirnetug (ACU193) Fluid Biomarker and Target Engagement Analyses from Phase 1 INTERCEPT-AD Study in Early Alzheimer’s at the AD/PD™ 2024 Annual Meeting

Retrieved on: 
Mercredi, février 21, 2024
ABOS, Immunotherapy, Pathology, Neurogranin, USAN, Conference, Safety, Biomarker, DSM-IV codes, Pharmaceutical industry

CHARLOTTESVILLE, Va., Feb. 21, 2024 (GLOBE NEWSWIRE) -- Acumen Pharmaceuticals, Inc. (NASDAQ: ABOS), a clinical-stage biopharmaceutical company developing a novel therapeutic that targets soluble amyloid beta oligomers (AβOs) for the treatment of Alzheimer’s disease (AD), today announced that it will be presenting biomarker data and target engagement methods in an oral and poster presentation, respectively, at the upcoming International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders (AD/PD), taking place March 5-9, 2024, in Lisbon, Portugal, and online.

Key Points: 
  • Acumen’s sabirnetug (ACU193) is the first humanized monoclonal antibody to demonstrate selective target engagement of AβOs, a soluble and highly toxic form of Aβ that accumulates early in AD and triggers synaptic dysfunction and neurodegeneration.
  • Positive topline results from 62 participants in the Phase 1 INTERCEPT-AD trial (NCT04931459) showed sabirnetug to be well-tolerated with a favorable overall safety profile.
  • Effects of sabirnetug on both neurogranin and pTau181 levels in CSF in this Phase 1 study are consistent with downstream pharmacologic effects of the drug.
  • Presentation details as follows:
    Sabirnetug is the nonproprietary name for ACU193 accepted by USAN and INN.

TriSalus Life Sciences Receives Approval from the World Health Organization and the American Medical Association’s Adopted Name Council for “Nelitolimod” as the Nonproprietary Drug Name for SD-101

Retrieved on: 
Jeudi, mars 7, 2024
Research, Medical Devices, Clinical Trials, Health Technology, Biotechnology, Health, Pharmaceutical, Science, Oncology, Liver, International, Neoplasm, Immunotherapy, Hepatocellular carcinoma, USAN, INN, Organization, World Health Organization, Tumor microenvironment, Patient, HCPCS, Cholangiocarcinoma, Publication, WHO, Cancer, Liver disease, Uveal melanoma

“The WHO INN and USAN approval of nelitolimod is an important milestone in the continued progress we are making with our nelitolimod program,” said Mary Szela, Chief Executive Officer and President of TriSalus.

Key Points: 
  • “The WHO INN and USAN approval of nelitolimod is an important milestone in the continued progress we are making with our nelitolimod program,” said Mary Szela, Chief Executive Officer and President of TriSalus.
  • This approach has the potential to enable more durable responses by patients to other immunotherapeutics, thereby facilitating better patient outcomes.
  • Information on nelitolimod will be posted on the USAN website ( www.ama-assn.org/go/usan ) and will be published in the Chemical Abstracts Service and in the U.S. Pharmacopeia.
  • Going forward, TriSalus will use the name in publications and public statements, at conferences and other forums, and in corporate-related materials.

Sage Therapeutics Announces Fourth Quarter and Full Year 2023 Financial Results and Highlights Pipeline and Business Progress

Retrieved on: 
Mercredi, février 14, 2024
Mental Health, Health, Neurology, Clinical Trials, Pharmaceutical, Biotechnology, PD, Research, Sale, Tremor, Health care, NMDA, Innovation, Webcast, Plasma, Incidence, GABAA, CIV, Standard of care, Deficit spending, Therapy, European Medicines Agency, Food and Drug Administration, MCI, NEST, HCP, Woman, Schedule, USAN, Postpartum depression, ODD, Safety, Prescription, Insurance, EMA, FDA, Food, Passport, DEA, PAM, DSM-IV codes, Risk, PPD, Patient, MHRA, Cognition, Essential tremor, Pharmaceutical industry

Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, today reported business highlights and financial results for the fourth quarter and full year ended December 31, 2023.

Key Points: 
  • Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, today reported business highlights and financial results for the fourth quarter and full year ended December 31, 2023.
  • Revenue: Collaboration revenue from sales of ZURZUVAE was $0.8 million in the fourth quarter of 2023, the first quarter of sales.
  • Net Loss: Net loss was $32.7 million for the fourth quarter of 2023 compared to $147.1 million for the same period in 2022.
  • ET to review its fourth quarter and full year 2023 financial results and discuss recent corporate updates.

Marker Therapeutics Receives Approval from United States Adopted Name (USAN) Council and International Nonproprietary Names (INN) Expert Committee for “Neldaleucel” as Nonproprietary Name for MT-601

Retrieved on: 
Lundi, janvier 22, 2024
USAN, World Health Organization, Patient, Therapy, Advertising, International, Lymphoma, Press release, WHO, United States Adopted Name, INN, Bone marrow

Nonproprietary names are intended for use in pharmacopoeias, labelling, product information, advertising and other promotional material, drug regulation and scientific literature, and as a basis for product names, e.g.

Key Points: 
  • Nonproprietary names are intended for use in pharmacopoeias, labelling, product information, advertising and other promotional material, drug regulation and scientific literature, and as a basis for product names, e.g.
  • The adoption of the name neldaleucel is a step forward for continued advancements of multiTAA therapies Marker is developing.
  • “The assignment of the nonproprietary name to MT-601 represents a significant milestone as we advance this potential treatment for patients with lymphoma,” said Juan Vera, M.D., President and CEO of Marker Therapeutics.
  • “The INN and USAN naming process meticulously evaluates proposed drug names for adherence to nomenclature guidelines and potential conflicts, followed by expert consensus and public review.

USAN Unveils Realm: Revolutionizing Contact Centers on Amazon Connect

Retrieved on: 
Mercredi, janvier 17, 2024
Speech, USAN, Amazon Web Services, Amazon, Customer experience, Software as a service, WhatsApp, CX, Realm, CRM, Organization, Friction, Sales

PEACHTREE CORNERS, Ga., Jan. 17, 2024 /PRNewswire/ -- USAN, a leader in customer engagement solutions, is proud to announce the launch of USAN Realm™, a groundbreaking SaaS platform designed to transform contact center operations and Customer Experience (CX) on Amazon Connect. Realm empowers contact centers to create, deliver, and manage Amazon Connect deployments with unmatched speed, reducing deployment time by 40%.

Key Points: 
  • PEACHTREE CORNERS, Ga., Jan. 17, 2024 /PRNewswire/ -- USAN, a leader in customer engagement solutions, is proud to announce the launch of USAN Realm ™, a groundbreaking SaaS platform designed to transform contact center operations and Customer Experience (CX) on Amazon Connect.
  • Realm empowers contact centers to create, deliver, and manage Amazon Connect deployments with unmatched speed, reducing deployment time by 40%.
  • Announcing USAN Realm™, a SaaS platform designed to transform contact center operations and CX on Amazon Connect.
  • Additionally, Realm facilitates the secure deployment of Amazon Connect in minutes, leveraging its no-code approach and pre-packaged applications for omnichannel environments.

USAN Approves Generic Name “Ruxoprubart” for NM8074, an Antibody Therapy focused on Complement-Mediated Diseases

Retrieved on: 
Lundi, janvier 8, 2024
Clinical trial, Marketing, Anemia, PNH, USAN, Alternative complement pathway, Name, United States Adopted Name, Paroxysmal nocturnal hemoglobinuria, Patient, Safety, Publication, Clinical research associate, PRBC, AP, Vaccine

Phase I Clinical Trial results in healthy subjects demonstrated the safety and well-tolerance of NM8074.

Key Points: 
  • Phase I Clinical Trial results in healthy subjects demonstrated the safety and well-tolerance of NM8074.
  • Across all cohorts, total Alternative Pathway (AP) inhibition was achieved, with the duration of AP inhibition showing a dose-dependent response.
  • The USAN Council has approved the nonproprietary name "Ruxoprubart" (pronounced Ruk” soe proo’ bart) for NM8074, designating it as a first-in-class Alternative Pathway selective investigational monoclonal antibody.
  • Ruxoprubart, a potent and highly selective investigational drug candidate, targets the complement protein Bb, playing a crucial role in benefiting several complement-mediated diseases.