INN

Curium Announces First Commercial Doses in Italy of PYLCLARI® – An Innovative 18F-PSMA PET Tracer Indicated in Patients With Prostate Cancer

Retrieved on: 
Thursday, March 7, 2024

PARIS, March 07, 2024 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, announced today that the first commercial doses of PYLCLARI® have been sold in Italy.

Key Points: 
  • PARIS, March 07, 2024 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, announced today that the first commercial doses of PYLCLARI® have been sold in Italy.
  • Today’s announcement follows the decision in July 2023 by the European Commission granting marketing authorization for PYLCLARI® in the European Union.
  • On 3rd February 2024 The Italian Medicines Agency (Agenzia Italiana del Farmaco) published the decision for PYLCLARI® in Italy.
  • The European rights were licensed by Curium from Progenics, a Lantheus company, in 2018.

Curium Announces Submission of the Marketing Authorization Application for PYLCLARI®, an Innovative (18F)-PSMA PET Tracer Indicated in Adults With Prostate Cancer to Swissmedic

Retrieved on: 
Thursday, February 22, 2024

Dr. Michel Wuillemin, Head of Radiopharmaceuticals at b.e.imaging, commented, “b.e.Imaging is proud of the submission of the marketing authorization application for PYLCLARI® to Swissmedic ahead of schedule.

Key Points: 
  • Dr. Michel Wuillemin, Head of Radiopharmaceuticals at b.e.imaging, commented, “b.e.Imaging is proud of the submission of the marketing authorization application for PYLCLARI® to Swissmedic ahead of schedule.
  • We are fully dedicated to improving the situation of prostate cancer patients in Switzerland.”
    Benoit Woessmer, PET Europe CEO at Curium, commented, “The acceptance of the marketing authorization application by Swissmedic for PYLCLARI® is another important milestone for prostate cancer patients in Switzerland.
  • We look forward to providing an improved choice of tools available to physicians for the diagnosis of prostate cancer patients.
  • Marketing authorization for PYLCLARI® (also known as (18F)-DCFPyL) was granted in July 2023 by the European Commission.

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.

SolasCure Publishes Phase IIa Clinical Trial Report in Leading Wound Care Journal

Retrieved on: 
Monday, March 4, 2024

SOLASCURE Ltd (SolasCure), a biotechnology company developing a novel treatment to transform chronic wound care, has today announced the publication of its CLEANVLU Phase IIa clinical trial report in the International Wound Journal, a leading wound care journal.1 SolasCure’s first investigational product, Aurase Wound Gel, is a hydrogel releasing tarumase (provisional INN), a recombinant enzyme derived from medical maggots, which aims to promote wound healing through debridement and wound bed preparation.

Key Points: 
  • SOLASCURE Ltd (SolasCure), a biotechnology company developing a novel treatment to transform chronic wound care, has today announced the publication of its CLEANVLU Phase IIa clinical trial report in the International Wound Journal, a leading wound care journal.1 SolasCure’s first investigational product, Aurase Wound Gel, is a hydrogel releasing tarumase (provisional INN), a recombinant enzyme derived from medical maggots, which aims to promote wound healing through debridement and wound bed preparation.
  • The Phase IIa data, which demonstrates proof-of-concept and safety of Aurase Wound Gel in humans, has now been peer-reviewed and published, providing strong validation as SolasCure progresses into further clinical studies, and marks a significant milestone for the Company.
  • SolasCure’s CLEANVLU Phase IIa trial was performed in venous leg ulcer (VLU) patients across centers in the US, UK, and Hungary.
  • The trial compared five escalating dose concentrations to baseline the use of tarumase for enzymatic debridement and wound bed preparation.

InFlectis BioScience Completes Enrollment of Its Phase 2 Trial of IFB-088 for the Treatment of Amyotrophic Lateral Sclerosis; Anticipates Initial Results Later This Year

Retrieved on: 
Wednesday, January 31, 2024

Nantes, France--(Newsfile Corp. - January 31, 2024) - InFlectis BioScience, a pioneer in developing first-in-class therapies for neuromuscular diseases, announced that it has completed enrollment in its Phase 2 clinical trial of IFB-088 (INN: icerguastat), a novel investigational treatment of Amyotrophic Lateral Sclerosis (ALS).

Key Points: 
  • Nantes, France--(Newsfile Corp. - January 31, 2024) - InFlectis BioScience, a pioneer in developing first-in-class therapies for neuromuscular diseases, announced that it has completed enrollment in its Phase 2 clinical trial of IFB-088 (INN: icerguastat), a novel investigational treatment of Amyotrophic Lateral Sclerosis (ALS).
  • To view the full announcement, including downloadable images, bios, and more, click here .
  • InFlectis completed enrollment in its Phase 2 clinical trial of IFB-088 in ALS.
  • Initial findings to be reported as early as the end of 2024.

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 January 2024

Retrieved on: 
Sunday, February 4, 2024

Three new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended three medicines for approval at its January 2024 meeting.The committee recommended…, Positive recommendations on new medicines, Exblifep International non-proprietary name (INN)cefepime / enmetazobactam Marketing-authorisation applicantAdvanz Pharma LimitedTherapeutic indicationTreatment of: 1)…, Ryzneuta INNefbemalenograstim alfaMarketing-authorisation applicantEvive Biotechnology Ireland LimitedTherapeutic indicationReduction in the duration of neutropenia and…, Positive recommendations on new generic medicines, Niapelf INNpaliperidoneMarketing-authorisation applicantNeuraxpharm Pharmaceuticals S.L.Therapeutic indicationTreatment of schizophreniaMore informationNiapelf: Pending…, Negative recommendations on new medicines, Nezglyal INNleriglitazoneMarketing-authorisation applicantMinoryx Therapeutics S.L.Therapeutic indicationTreatment of cerebral progression and myelopathy in male…, Syfovre INNpegcetacoplanMarketing-authorisation applicantApellis Netherlands B.V.Therapeutic indicationTreatment of geographic atrophy (GA) secondary to age-related…, Positive recommendations on extensions of indications, Abecma INNidecabtagene vicleucel Marketing-authorisation holderBristol-Myers Squibb Pharma EEIGMore informationAbecma: Pending EC decision, Prevenar 20 (previously Apexxnar) Common namepneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed)Marketing-authorisation holderPfizer Europe MA EEIGMore…, Aspaveli INNpegcetacoplanMarketing-authorisation holderSwedish Orphan Biovitrum AB (publ)More informationAspaveli: Pending EC decision, Retsevmo INNselpercatinibMarketing-authorisation holderEli Lilly Nederland B.V.More informationRetsevmo: Pending EC decision, Outcome of re-examination of recommendation on non-renewal of Conditional Marketing Authorisation, Translarna INNataluren Marketing-authorisation holderPTC Therapeutics International LimitedNewsEMA confirms recommendation for non-renewal of authorisation of Duchenne…, Outcome of referral, Pseudoephedrine Marketing-authorisation holderVarious companiesMore informationPseudoephedrine-containing medicinal products, Re-examination of conclusion of referral, Synapse Labs Pvt.

Key Points: 
  • Three new medicines recommended for approvalEMA’s human medicines committee (CHMP) recommended three medicines for approval at its January 2024 meeting.The committee recommended…, Positive recommendations on new medicines, Exblifep International non-proprietary name (INN)cefepime / enmetazobactam Marketing-authorisation applicantAdvanz Pharma LimitedTherapeutic indicationTreatment of: 1)…, Ryzneuta INNefbemalenograstim alfaMarketing-authorisation applicantEvive Biotechnology Ireland LimitedTherapeutic indicationReduction in the duration of neutropenia and…, Positive recommendations on new generic medicines, Niapelf INNpaliperidoneMarketing-authorisation applicantNeuraxpharm Pharmaceuticals S.L.Therapeutic indicationTreatment of schizophreniaMore informationNiapelf: Pending…, Negative recommendations on new medicines, Nezglyal INNleriglitazoneMarketing-authorisation applicantMinoryx Therapeutics S.L.Therapeutic indicationTreatment of cerebral progression and myelopathy in male…, Syfovre INNpegcetacoplanMarketing-authorisation applicantApellis Netherlands B.V.Therapeutic indicationTreatment of geographic atrophy (GA) secondary to age-related…, Positive recommendations on extensions of indications, Abecma INNidecabtagene vicleucel Marketing-authorisation holderBristol-Myers Squibb Pharma EEIGMore informationAbecma: Pending EC decision, Prevenar 20 (previously Apexxnar) Common namepneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed)Marketing-authorisation holderPfizer Europe MA EEIGMore…, Aspaveli INNpegcetacoplanMarketing-authorisation holderSwedish Orphan Biovitrum AB (publ)More informationAspaveli: Pending EC decision, Retsevmo INNselpercatinibMarketing-authorisation holderEli Lilly Nederland B.V.More informationRetsevmo: Pending EC decision, Outcome of re-examination of recommendation on non-renewal of Conditional Marketing Authorisation, Translarna INNataluren Marketing-authorisation holderPTC Therapeutics International LimitedNewsEMA confirms recommendation for non-renewal of authorisation of Duchenne…, Outcome of referral, Pseudoephedrine Marketing-authorisation holderVarious companiesMore informationPseudoephedrine-containing medicinal products, Re-examination of conclusion of referral, Synapse Labs Pvt.
  • Ltd. Marketing-authorisation holderVarious companiesMore informationSynapse

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.

Human medicines European public assessment report (EPAR): Mycamine, micafungin, Date of authorisation: 25/04/2008, Revision: 18, Status: Authorised

Retrieved on: 
Tuesday, January 9, 2024

Human medicines European public assessment report (EPAR): Mycamine, micafungin, Date of authorisation: 25/04/2008, Revision: 18, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Mycamine, micafungin, Date of authorisation: 25/04/2008, Revision: 18, Status: Authorised

Human medicines European public assessment report (EPAR): Neupro, rotigotine, Date of authorisation: 15/02/2006, Revision: 33, Status: Authorised

Retrieved on: 
Tuesday, January 9, 2024

Human medicines European public assessment report (EPAR): Neupro, rotigotine, Date of authorisation: 15/02/2006, Revision: 33, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Neupro, rotigotine, Date of authorisation: 15/02/2006, Revision: 33, Status: Authorised

Human medicines European public assessment report (EPAR): Mysimba, naltrexone,bupropion, Date of authorisation: 26/03/2015, Revision: 26, Status: Authorised

Retrieved on: 
Tuesday, January 9, 2024

Human medicines European public assessment report (EPAR): Mysimba, naltrexone,bupropion, Date of authorisation: 26/03/2015, Revision: 26, Status: Authorised

Key Points: 


Human medicines European public assessment report (EPAR): Mysimba, naltrexone,bupropion, Date of authorisation: 26/03/2015, Revision: 26, Status: Authorised