United States Adopted Name

Anebulo Pharmaceuticals Reports Second Quarter Fiscal Year 2024 Financial Results and Recent Updates

Retrieved on: 
Tuesday, February 13, 2024
Biotechnology, Pharmaceutical, Health, Clinical Trials, Anxiety, Paranoia, Coma, Somatic symptom disorder, Substance abuse, ACI, FDA, United States Adopted Name, Psychosis, CNS, Patient, Medication, Cannabis, Seizure, Depression, Pharmaceutical industry

Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB), a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication (ACI) and substance abuse (the “Company” or “Anebulo”), today announced financial results for the three months ended December 31, 2023, and recent updates.

Key Points: 
  • Anebulo Pharmaceuticals, Inc. (Nasdaq: ANEB), a clinical-stage biopharmaceutical company developing novel solutions for people suffering from acute cannabinoid intoxication (ACI) and substance abuse (the “Company” or “Anebulo”), today announced financial results for the three months ended December 31, 2023, and recent updates.
  • Second Quarter Fiscal Year 2024 and Subsequent Highlights:
    “Anebulo continues to make progress towards our goal of becoming the first company to have an approved treatment for acute cannabinoid intoxication.
  • “We are pleased to report that the USAN Council has adopted selonabant as the generic name for ANEB-001.
  • Net loss in the second quarter of fiscal 2024 was $2.7 million, or $(0.11) per share, compared with a net loss of $3.8 million, or $(0.15) per share, in the second quarter of fiscal 2023.

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

Retrieved on: 
Monday, January 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.

Opthea Announces “Sozinibercept” as the Nonproprietary Drug Name for OPT-302

Retrieved on: 
Wednesday, July 26, 2023
American Medical Association, Communication, USAN, Marketing, AMD, Zi, Retina, Shore, Publication, Journal of the American Pharmacists Association, INN, United States Adopted Name, Ranibizumab, FDA, Visual acuity, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, ClinicalTrials.gov, American Pharmacists Association, Food, World Health Organization, Pharmaceutical industry

Sozinibercept is proprietary to Opthea with issued patents running to at least 2034 and currently pending patents that are expected to extend coverage.

Key Points: 
  • Sozinibercept is proprietary to Opthea with issued patents running to at least 2034 and currently pending patents that are expected to extend coverage.
  • Obtaining regulatory approval of these adopted drug names is a necessary step for marketing authorization.
  • The primary endpoint for both studies is superiority in visual acuity gains at 12 months for the combination therapy compared with standard-of-care monotherapy.
  • For more information regarding the Phase 3 ShORe (Clinicaltrials.gov identifier: NCT04757610) and COAST (Clinicaltrials.gov identifier: NCT04757636) trials, please visit www.opthea.com and https://clinicaltrials.gov .

Verastem Oncology Reports Third Quarter 2022 Financial Results and Highlights Recent Company Progress

Retrieved on: 
Thursday, November 3, 2022
Biotechnology, Other Health, Health, Pharmaceutical, Oncology, International, Verastem Oncology, Executive, FDA, Pancreatic Cancer Action Network, KRAS, Geron Corporation, Large-cell lung carcinoma, Table, Research, U.S. Securities and Exchange Commission, Mirati, Partnership, SEC, Program, Company, GAAP, Food, MEK, Intellectual property, CEO, Mission statement, Security (finance), Patient, Cancer, INN, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Government, USAN, Part, Review, Breakthrough therapy, RAS, Pancreatic cancer, Strategic management, CRAF, RAF, United States Adopted Name, Investment, International nonproprietary name, RAMP, Patent, Safety, NSCLC, FAK, ARAF, Everolimus, Amgen, Oncology, BRAF, Pharmaceutical industry, Medical imaging, Video game, Bank

Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today reported financial results for the three months ended September 30, 2022, and highlighted recent progress.

Key Points: 
  • Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today reported financial results for the three months ended September 30, 2022, and highlighted recent progress.
  • Verastem Oncology ended the three months ended September 30, 2022 (2022 Quarter) with cash, cash equivalents and investments of $104.0 million.
  • Research and development expenses for the 2022 Quarter were $11.3 million, compared to $9.3 million for the 2021 Quarter.
  • Selling, general and administrative expenses for the 2022 Quarter were $6.4 million, compared to $5.5 million for the 2021 Quarter.

DGAP-News: Abivax presents first-half 2022 financial results and operations update

Retrieved on: 
Thursday, September 15, 2022
Natural killer T cell, Safety, ARD, Research, Nivolumab, File, Patient, Clinical trial, HCC, RA, Methotrexate, Inflammation, IQVIA, ACR20, Volunteering, ISIN, Company, Degenerative disease, JAK, Toxic leukoencephalopathy, EMA, USAN, Trial of the century, Director, FDA, MD, COVID-19, ASCO, Association, INN, Population, Cancer, Progression-free survival, G&A, Board of directors, WHO, Board, Marketing, IRB, Congress, Operating cost, Hepatocellular carcinoma, Twitter, United States Adopted Name, MTX, Maintenance, EULAR, Ulcerative colitis, CRO, R, Scripps, Bristol Myers Squibb, Film, Fine chemical, Medical device, Pharmaceutical industry, EUR, Rheumatology, UC, Abivax, Euronext

2022 Research Tax Credit revenue amounts to EUR +2.2M as of June 30, 2022, compared with EUR+1.6M as of June 30, 2021.

Key Points: 
  • 2022 Research Tax Credit revenue amounts to EUR +2.2M as of June 30, 2022, compared with EUR+1.6M as of June 30, 2021.
  • Net loss is amounting at EUR -29.6M as of June 30, 2022 (EUR -13.0M compared to EUR -16.5M as of June30, 2021).
  • Cash at the end of June 2022 was EUR +26.6M, compared to EUR +60.7M at the end of 2021.
  • Following the induction study results, in March 2022, Abivax reported its phase 2a maintenance results in RA after the first year of treatment.

Brand Institute President of Nonproprietary Naming Division Advises Clients on Guidance Set Forth by INN Regarding COVID-19 Variant Vaccines

Retrieved on: 
Wednesday, August 3, 2022
United States Adopted Name, COVID-19, Brand Institute, Indian Medical Association, American Medical Association, AMA, DSI, EMA, WHO, Variant, Safety, FDA, USAN, Program, Health Canada, Inn, International nonproprietary name, Pharmaceutical industry, Generic drug

"Vaccine variants have minimal changes in their structure compared to the structure of an existing INN.

Key Points: 
  • "Vaccine variants have minimal changes in their structure compared to the structure of an existing INN.
  • The name for the variant is linked to the original INN by a random two- or three-letter prefix.
  • Ms. Fuerst has spent her career in nonproprietary naming, first as United States Adopted Name (USAN) Secretariat and afterward opening the Nonproprietary Naming Division within Brand Institute's Drug Safety Institute.
  • Drug Safety Institute (DSI) is a wholly owned subsidiary of Brand Institute that provides Brand Institute's healthcare clients with industry-leading guidance pertaining to drug name safety, packaging, and labeling.

Brand Institute SVP of Nonproprietary Naming Division Shares Naming Guidance on Evolving Nomenclature Schemes Set Forth by Regulatory Agencies (USAN and INN)

Retrieved on: 
Wednesday, June 29, 2022
FDA, Negotiation, Indian Medical Association, Senior, Regulatory affairs, Classification, AMA, DSI, INN, Health Canada, EMA, United States Adopted Name, Associate, Brand Institute, Safety, American Medical Association, USAN, WHO, Medical device, Generic drug

This guidance affects any pharmaceutical manufacturers who have not yet received nonproprietary name approval for a monoclonal antibody under the previous nomenclature guidance.

Key Points: 
  • This guidance affects any pharmaceutical manufacturers who have not yet received nonproprietary name approval for a monoclonal antibody under the previous nomenclature guidance.
  • Ms. Van Laan has spent her entire professional career in nonproprietary naming, first as part of the USAN Secretariat, and now with Drug Safety Institute, Brand Institute's regulatory subsidiary, providing expert regulatory advice to clients on drug naming within USAN/INN parameters.
  • Handcrafted nonproprietary names are created using current guidelines and are carefully screened, thus having an increased chance of regulatory approval.
  • DSI is comprised of former naming regulatory officials from global government health agencies, including FDA, EMA, Health Canada, AMA, and the WHO.

DGAP-News: Abivax phase 2a study results of obefazimod (ABX464) in rheumatoid arthritis published in the journal “Annals of the Rheumatic Diseases” and selected for presentation at EULAR 2022

Retrieved on: 
Tuesday, June 7, 2022
USAN, Physiology, EST, Congress, EULAR, Ulcerative colitis, INN, Euronext Paris, FAS, RA, CEST, MTX, Inflammation, CEO, WHO, Maintenance, Therapy, United States Adopted Name, ARD, University Hospital (Newark, New Jersey), Degenerative disease, Hepatocellular carcinoma, ISIN, Patient, ACR20, Immune system, Rheumatoid arthritis, Twitter, Population, Teaching hospital, Infection, Cancer, Safety, Methotrexate, Pharmaceutical industry, Medical device, Generic drug, Abivax, Euronext, UC, Rheumatology, Fellow of the Academy of Medical Sciences

Further, the abstract on these phase 2a data has been selected for a poster presentation at the Annual European Congress of Rheumatology, EULAR 2022.

Key Points: 
  • Further, the abstract on these phase 2a data has been selected for a poster presentation at the Annual European Congress of Rheumatology, EULAR 2022.
  • I am looking forward to presenting obefazimod and its promising results to the international expert community, also taking into account the recently published very encouraging phase 2a one-year maintenance results in RA.
  • There is still a high unmet medical need for safe and durably efficient therapies for rheumatoid arthritis patients.
  • In June 2021, Abivax communicated the results of the induction phase of its phase 2a clinical study .

Eledon Pharmaceuticals Provides Corporate Update and 2022 Outlook

Retrieved on: 
Monday, February 14, 2022
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IRVINE, Calif., Feb. 14, 2022 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN), a patient-focused clinical stage biopharmaceutical company committed to the development of innovative and impactful treatments for organ and cell transplantation, autoimmune conditions, and neurodegenerative disease, today provided a summary of key 2021 accomplishments and previewed anticipated 2022 milestones.

Key Points: 
  • IRVINE, Calif., Feb. 14, 2022 (GLOBE NEWSWIRE) -- Eledon Pharmaceuticals, Inc. (Eledon) (NASDAQ: ELDN), a patient-focused clinical stage biopharmaceutical company committed to the development of innovative and impactful treatments for organ and cell transplantation, autoimmune conditions, and neurodegenerative disease, today provided a summary of key 2021 accomplishments and previewed anticipated 2022 milestones.
  • United States Adopted Names (USAN) Council adopted tegoprubart as the unique non-proprietary or generic name for AT-1501.
  • Eledon is headquartered in Irvine, Calif. For more information, please visit the companys website at www.eledon.com .
  • Follow Eledon Pharmaceuticals on social media: LinkedIn ; Twitter
    This press release contains forward-looking statements that involve substantial risks and uncertainties.