USAN

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: 
Wednesday, February 21, 2024

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: 
Thursday, March 7, 2024

“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: 
Wednesday, February 14, 2024

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: 
Monday, January 22, 2024

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: 
Wednesday, January 17, 2024

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: 
Monday, January 8, 2024

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.

Sage Therapeutics to Provide Business Updates at 42nd Annual J.P. Morgan Healthcare Conference

Retrieved on: 
Monday, January 8, 2024

Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, today announced that Chief Executive Officer Barry Greene will discuss the Company’s key business drivers for 2024 at the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco, California.

Key Points: 
  • Sage Therapeutics, Inc. (Nasdaq: SAGE), a biopharmaceutical company leading the way to create a world with better brain health, today announced that Chief Executive Officer Barry Greene will discuss the Company’s key business drivers for 2024 at the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco, California.
  • Sage and Biogen field sales teams are engaging in promotional dialogues with health care professionals (HCPs) who actively identify and treat women with PPD.
  • Sage is advancing a portfolio of early-stage and clinical programs featuring internally discovered novel chemical entities targeting the GABAA and NMDA receptor systems.
  • A replay of the webcast will be available following the completion of the event and will be archived for up to 30 days.

Novartis expands production of Pluvicto™ with addition of its largest and most advanced radioligand therapy manufacturing facility in Indianapolis

Retrieved on: 
Friday, January 5, 2024

The 70,000-square foot site, the company’s second US location, is designed specifically for RLT manufacturing and is now the largest and most advanced Novartis facility of its kind in the world.

Key Points: 
  • The 70,000-square foot site, the company’s second US location, is designed specifically for RLT manufacturing and is now the largest and most advanced Novartis facility of its kind in the world.
  • The Indianapolis site represents the next phase of RLT manufacturing growth as this new addition brings substantial supply increases for the foreseeable future.
  • “The intricate process of providing RLTs to patients within hours of production requires precision manufacturing expertise to bring these medicines to individuals who critically need them,” said Steffen Lang, President, Operations, Novartis.
  • Novartis is committed to expanding the radioligand therapy platform to shape the future of RLT as a treatment class.

Larimar Therapeutics Reports Third Quarter 2023 Operating and Financial Results

Retrieved on: 
Tuesday, November 14, 2023

“For the OLE trial, initiation remains on track for the first quarter of 2024, and we expect to report interim data later that year in the fourth quarter.

Key Points: 
  • “For the OLE trial, initiation remains on track for the first quarter of 2024, and we expect to report interim data later that year in the fourth quarter.
  • Research and development expenses for the third quarter of 2023 were $6.6 million compared to $5.6 million for the third quarter of 2022.
  • General and administrative expenses for the third quarter of 2023 were $3.8 million compared to $2.9 million for the third quarter of 2022.
  • Other income (expense), net was $1.3 million of income in the third quarter of 2023 compared to $0.2 million in the third quarter of 2022.

Amazon Connect Introduces Generative AI Capabilities to Help Organizations Boost Worker Productivity, Save Costs, and Improve Customer Service Experiences

Retrieved on: 
Tuesday, November 28, 2023

Lastly, Amazon Connect Customer Profiles—an Amazon Connect feature that enables agents to deliver faster, more personalized customer service—now creates unified customer profiles from disparate software-as-a-service applications and databases.

Key Points: 
  • Lastly, Amazon Connect Customer Profiles—an Amazon Connect feature that enables agents to deliver faster, more personalized customer service—now creates unified customer profiles from disparate software-as-a-service applications and databases.
  • The new generative AI capabilities of Amazon Connect include:
    Amazon Q in Connect: generative AI to assist agents with recommended responses and actions for faster customer support.
  • Amazon Lex in Amazon Connect: generative AI to simplify bot building and create improved self-service experiences.
  • These new omnichannel communications—as well as the generative AI enhancements to Amazon Lex, Amazon Q in Connect, and Amazon Connect Customer profiles—are generally available.