INN

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: 
Donnerstag, April 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: 
Donnerstag, April 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.

Table of decisions of labelling exemption requests falling under article 63 of Directive 2001/83/EC examined by the Quality Review of Documents (QRD) Group

Retrieved on: 
Donnerstag, April 25, 2024
Artesunate, QRD, Cysteamine, Daunorubicin/cytarabine, Sutimlimab, Authorization, Positive, SFL, Latanoprost, Obiltoxaximab, Mitapivat, European Medicines Agency, Janssen COVID-19 vaccine, Potassium, Ertapenem, Etranacogene dezaparvovec, Request, MVA, Brexucabtagene autoleucel, Ebola, Imipenem/cilastatin/relebactam, Relugolix/estradiol/norethisterone acetate, CHMP, Pfizer–BioNTech COVID-19 vaccine, Pitolisant, Naloxone, Bupivacaine, Atidarsagene autotemcel, Defibrotide, Rilpivirine, Moderna COVID-19 vaccine, Filo, Pertuzumab, Tafasitamab, Trastuzumab, AstraZeneca, Potassium citrate, COVID-19, INN, JCOVDEN, N/A, Alfa, Assessment, Setmelanotide, Casirivimab/imdevimab, Fair

18 April 2024

Key Points: 
    • 18 April 2024
      EMA/934543/2022 Rev.3
      Human Medicines Division

      Table of decisions of labelling exemption requests falling under article 63 of Directive 2001/83/EC examined by the Quality Review of Documents (QRD) Group
      Related information
      Exemptions to labelling and package-leaflet obligations | European Medicines Agency
      Recommendations for the implementation of the exemptions to the labelling and package leaflet obligations in the centralised procedure

      MA status

      Product number

      Product name

      Article 63(1) request (orphan
      products)2

      Outcome 63(1)
      orphan products2

      Article 63(3) request for omission of
      certain particulars

      Outcome 63(3) omission of
      certain particulars

      Outcome date

      Product information

      Authorised

      EMEA/H/C/005352

      Upstaza

      Translation exemption (outer and
      immediate labelling)

      Positive (partial)

      Omission of particulars (immediate labelling)

      Positive (partial)

      07/Mar/24

      Upstaza (eladocagene exuparvovec) - N/A
      Product information

      Authorised

      EMEA/H/C/005269/X/0033

      Kaftrio

      Translation exemption (outer,
      intermediate and immediate
      labelling)

      Positive (partial)

      21/Nov/23

      Kaftrio
      (elexacaftor/tezacaftor/ivacaftor) Product information
      Rezzayo (rezafungin) - Product
      information

      N/A

      Authorised

      EMEA/H/C/005900

      Rezzayo

      Omission of particulars (immediate labelling)

      Positive

      30/Aug/23

      Authorised

      EMEA/H/C/005933

      Catiolanze

      Omission of particulars (immediate labelling)

      Positive

      13/Jul/23

      Catiolanze (latanoprost) - Product
      information

      N/A

      Authorised

      EMEA/H/C/005756

      Apretude

      Omission of particulars (immediate labelling)

      Positive (partial)

      03/Jul/23

      Apretude, (cabotegravir) - Product
      information

      Apretude (cabotegravir) Assessment report

      Authorised

      EMEA/H/C/005985

      Tepkinly

      Positive (partial)

      14/Jun/23

      Tepkinly (epcoritamab) - Product
      information

      Tepkinly (epcoritamab) Assessment report

      Authorised

      EMEA/H/C/005849/X/0003

      Vyvgart

      Positive

      10/Mar/23

      Vyvgart (efgartigimod alfa) - Product Vyvgart (efgartigimod alfa) information
      Assessment report

      Authorised

      EMEA/H/C/005122

      Omvoh

      Omission of particulars (immediate labelling)

      Positive

      04/Jan/23

      Omvoh (mirikizumab) - Product
      information

      Omvoh (mirikizumab) Assessment report

      Authorised

      EMEA/H/C/004258

      Alofisel

      Omission of particulars (outer labelling)

      Positive (temporary)

      17/Nov/22

      Alofisel (darvadstrocel) - Product
      information

      N/A

      Authorised

      EMEA/H/C/005343

      Mvabea

      Omission of particulars (outer labelling)

      Positive (partial)

      Translation exemption (outer and immediate Positive
      labelling)

      26/Oct/22

      N/A

      EMEA/H/C/005337

      Zabdeno

      Omission of particulars (outer labelling)

      Positive (partial)

      Translation exemption (outer and immediate Positive
      labelling)

      26/Oct/22

      Authorised

      EMEA/H/C/005343

      Mvabea

      Omission of particulars (outer labelling)

      Positive (partial)

      Translation exemption (outer and immediate Positive (partial)
      labelling)

      13/Oct/22

      Authorised

      EMEA/H/C/005337

      Zabdeno

      Omission of particulars (outer labelling)

      Positive (partial)

      Translation exemption (outer and immediate Positive (partial)
      labelling)

      13/Oct/22

      Authorised

      EMEA/H/C/005484

      Loargys

      Mvabea (Ebola vaccine (MVA BN Filo
      [recombinant]) - Product
      information
      Zabdeno (Ad26.ZEBOV-GP
      [recombinant]) - Product
      information
      Mvabea (Ebola vaccine (MVA BN Filo
      [recombinant]) - Product
      information
      Zabdeno (Ad26.ZEBOV-GP
      [recombinant]) - Product
      information
      Loargys (pegzilarginase) - Product
      information

      Authorised

      Authorised

      EMEA/H/C/005703

      Pombiliti

      Omission of particulars (immediate labelling)

      Positive

      13/Oct/22

      Pombiliti (cipaglucosidase alfa) Product information

      Pombiliti (cipaglucosidase alfa) Assessment report

      Authorised

      EMEA/H/C/005695

      Opfolda

      Omission of particulars (immediate labelling)

      Positive

      13/Oct/22

      Opfolda (miglustat) - Product
      information

      N/A

      Authorised

      EMEA/H/C/006016

      Imjudo

      Omission of particulars (immediate labelling)

      Positive

      13/Oct/22

      IMJUDO - Product information

      Imjudo - Assessment report

      Authorised

      EMEA/H/C/004650

      Tremelimumab
      AstraZeneca

      Omission of particulars (immediate labelling)

      Positive

      13/Oct/22

      Tremelimumab AstraZeneca Product information

      Tremelimumab AstraZeneca Assessment report

      Authorised

      EMEA/H/C/005776

      Enjaymo

      13/Sep/22

      Enjaymo (Sutimlimab) - Product
      information

      N/A

      Authorised

      EMEA/H/C/005035

      Filsuvez

      Authorised

      EMEA/H/C/004827

      Hemgenix

      Authorised

      EMEA/H/C/005751

      Columvi

      Translation exemption (outer,
      immediate labelling and package
      leaflet)
      Translation exemption (outer
      labelling)

      Translation exemption (outer,
      immediate labelling and package
      leaflet)

      Article 63(3) request for translation
      exemption

      Positive (partial)

      13/Oct/22

      Translation exemption (outer, immediate
      labelling and package leaflet)

      Translation exemption (outer,
      immediate labelling and package
      leaflet)

      Outcome 63(3) request for
      translation exemption

      Positive (partial)

      Positive

      Assessment report

      N/A

      N/A

      N/A

      N/A

      Loargys (pegzilarginase) Assessment report

      Omission of particulars (immediate labelling)

      Positive

      08/Aug/22

      Filsuvez (birch bark extract) Product information

      N/A

      Omission of particulars (outer labelling)

      Negative

      14/Jun/22

      Hemgenix - Product information

      Hemgenix - Assessment report

      Omission of particulars (immediate labelling)

      Positive

      14/Jun/22

      Columvi, INN-glofitamab
      (europa.eu)

      N/A

      Authorised

      EMEA/H/C/005848

      Pemetrexed Baxter

      Omission of particulars (immediate labelling)

      Positive

      14/Jun/22

      Pemetrexed Baxter - Product
      information

      Pemetrexed Baxter - Assessment
      report

      Authorised

      EMEA/H/C/005246/X/0002

      Byfavo

      Omission of particulars (immediate labelling)

      Negative

      14/Jun/22

      Byfavo - Product information

      N/A

      Authorised

      EMEA/H/C/005815

      Ertapenem SUN

      Omission of particulars (immediate labelling)

      Positive

      11/May/22

      Ertapenem SUN (ertapenem) Product information

      Ertapenem SUN (ertapenem) Assessment report

      Authorised

      EMEA/H/C/004850

      Xenpozyme

      12/Apr/22

      Xenpozyme (olipudase alfa) Product information

      Xenpozyme (olipudase alfa) Assessment report

      Authorised

      EMEA/H/C/005769

      Herwenda

      10/Mar/22

      Herwenda (trastuzumab) - Product
      information

      N/A

      Authorised

      EMEA/H/C/005540

      Pyrukynd

      10/Mar/22

      Pyrukynd - Product information

      N/A

      Authorised

      EMEA/H/C/005680

      Lunsumio

      10/Mar/22

      Lunsumio (mosunetuzumab) Product information

      N/A

      Authorised

      EMA/H/C/004577

      Ebvallo

      Translation exemption (outer,
      immediate labelling and package
      leaflet)

      Positive (partial)

      10/Mar/22

      Ebvallo - Product information

      Ebvallo - Assessment report

      Authorised

      EMEA/H/C/004929

      Kimmtrak

      Translation exemption (outer and
      immediate labelling)

      Positive

      16/Nov/21

      Kimmtrak (tebentafusp) - Product
      information

      Kimmtrak (tebentafusp) Assessment report

      Authorised

      EMEA/H/C/005378

      Nulibry

      Translation exemption (outer and
      immediate labelling)

      Positive (partial)

      16/Nov/21

      Nulibry - Product information

      N/A

      Authorised

      EMEA/H/C/005849

      Vyvgart

      Omission of particulars (outer and immediate Positive (partial)
      labelling)

      16/Nov/21

      Vyvgart (efgartigimod alfa) - Product Vyvgart (efgartigimod alfa) information
      Assessment report

      Authorised

      EMEA/H/C/005973

      Paxlovid

      Omission of particulars (outer labelling)

      Positive

      Translation exemption (outer, immediate
      labelling and package leaflet)

      Positive (partial)

      16/Nov/21

      Paxlovid (nirmatrelvir + ritonavir) Product information

      Authorised

      EMEA/H/C/005788

      Evusheld

      Omission of particulars (outer labelling)

      Positive

      Translation exemption (outer, immediate
      labelling and package leaflet)

      Positive (partial)

      13/Oct/21

      Evusheld (ixagevimab, cilgavimab) - N/A
      Product information

      Authorised

      EMEA/H/C/005553

      Aspaveli

      Omission of particulars (immediate labelling)

      Positive

      08/Oct/21

      Aspaveli (pegcetacoplan) - Product
      information

      Aspaveli (pegcetacoplan) Assessment report

      Authorised

      EMEA/H/C/005814

      Ronapreve

      Omission of particulars (immediate labelling)

      Positive

      24/Sep/21

      Ronapreve (casirivimab and
      imdevimab) - Produt information

      Ronapreve (casirivimab and
      imdevimab) - Assessment report

      Authorised

      EMEA/H/C/005550

      Artesunate Amivas

      14/Sep/21

      Artesunate Amivas (artesunate) Product information

      Artesunate Amivas (Artesunate) Assessment report

      Authorised

      EMEA/H/C/005854

      Regkirona

      Omission of particulars (outer and immediate Positive
      labelling)

      Translation exemption (outer, immediate
      labelling and package leaflet)

      Positive (partial)

      28/Jul/21

      Regkirona (regdanvimab) - Product
      information

      Regkirona (regdanvimab) Assessment report

      Authorised

      EMEA/H/C/005676

      Xevudy

      Omission of particulars (outer labelling)

      Positive

      Translation exemption (outer, immediate
      labelling and package leaflet)

      Positive (partial)

      28/Jul/21

      Xevudy (sotrovimab) - Product
      information

      Xevudy (sotrovimab) Assessment report

      Authorised

      EMEA/H/C/005182

      Trodelvy

      Omission of particulars (immediate labelling)

      Positive

      17/Jun/21

      Trodelvy (sacituzumab govitecan) Product information

      Trodelvy (sacituzumab govitecan)
      - Assessment report

      Authorised

      EMEA/H/C/005681

      Pepaxti

      Omission of particulars (immediate labelling)

      Positive

      17/Jun/21

      Pepaxti (melphalan flufenamide) Product information

      N/A

      Authorised

      EMEA/H/C/005035

      Filsuvez

      Translation exemption (outer,
      intermediate, immediate labelling
      and package leaflet)

      Positive (partial)

      17/Jun/21

      Filsuvez (birch bark extract) Product information

      N/A

      Authorised

      EMEA/H/C/005095

      Carvykti

      Translation exemption (outer and
      immediate labelling)

      Positive

      17/Jun/21

      Carvykti (Ciltacaptagene autoleucel) - Carvykti (ciltacabtagene
      Product information
      autoleucel) - Assessment report

      Authorised

      EMEA/H/C/005467

      Voraxaze

      Translation exemption (outer,
      intermediate, immediate labelling
      and package leaflet)

      Positive (partial)

      17/Jun/21

      Voraxaze (glucarpidase) - Product
      information

      Authorised

      EMEA/H/C/005501

      Nexviadyme

      Omission of particulars (immediate labelling)

      17/Jun/21

      Nexviadyme (avalglucosidase alfa) - Nexviadyme (avalglucosidase
      Product information
      alfa) - Assessment report

      Authorised

      EMEA/H/C/004662

      Abecma

      Omission of particulars (outer and immediate Positive (partial)
      labelling)

      03/Jun/21

      Abecma (idecabtagene vicleucel) Product information

      Abecma (idecabtagene vicleucel) Assessment report

      Authorised

      EMEA/H/C/004275/II/0021

      Crysvita

      Positive

      06/May/21

      Crysvita (burosumab) - Product
      information

      N/A

      Authorised

      EMEA/H/C/005475

      Voxzogo

      Positive (partial)

      04/Mar/21

      Voxzogo (vosoritide) - Product
      information

      Voxzogo (vosoritide) - CHMP
      assessment report

      Authorised

      EMEA/H/C/005737

      Jcovden

      Omission of particulars (outer, immediate
      labelling and package leaflet)

      Positive

      01/Mar/21

      Authorised

      EMEA/H/C/005327

      Abevmy

      Omission of particulars (immediate labelling)

      Positive

      JCOVDEN [COVID-19 vaccine
      (Ad26.COV2-S [recombinant]) Product information
      Abevmy (bevacizumab) - Product
      information

      JCOVDEN [COVID-19 Vaccine
      Janssen (Ad26.COV2-S,
      recombinant)] - Assessment
      Abevmy (bevacizumab) Assessment report

      Translation exemption (outer,
      immediate labelling and package
      leaflet)

      Positive

      Omission of particulars (immediate labelling)

      Translation exemption (outer,
      intermediate and immediate
      labelling)

      Translation exemption (outer,
      immediate labelling and package
      leaflet)

      Translation exemption (outer,
      immediate labelling and package
      leaflet)
      Translation exemption (outer and
      immediate labelling)

      Positive

      Positive (partial)

      Omission of particulars (immediate labelling)

      Positive

      Omission of particulars (immediate labelling)

      Positive (partial)

      Translation exemption (outer labelling)

      Positive

      Positive (partial)

      Positive

      Translation exemption (outer, immediate
      labelling and package leaflet)

      Positive

      13/Jan/21

      Paxlovid (nimatrelvir + ritonavir) Assessment report

      Voraxaze (glucarpidase) Assessment report

      Authorised

      EMEA/H/C/005791

      Spikevax

      Omission of particulars (outer, immediate
      labelling and package leaflet)

      Translation exemption (outer, immediate
      labelling and package leaflet)

      Positive

      01/Jan/21

      Spikevax - Product information

      Spikevax - Assessment report

      Authorised

      EMEA/H/C/005735

      Comirnaty

      Omission of particulars (outer and immediate Positive
      labelling)

      Translation exemption (outer and immediate
      labelling)

      Positive

      17/Dec/20

      Comirnaty (tozinameran,
      tozinameran/riltozinameran,
      tozinameran/famtozinameran) Alymsys (bevacizumab) - Product
      information

      Comirnaty (tozinameran,
      tozinameran/riltozinamearn,
      tozinamearn/famtozinameran) N/A

      Authorised

      EMEA/H/C/005286

      Alymsis

      Omission of particulars (immediate labelling)

      Positive

      20/Oct/20

      Authorised

      EMEA/H/C/005556

      Oyavas

      Omission of particulars (immediate labelling)

      Positive

      20/Oct/20

      Oyavas (bevacizumab) - Product
      information

      N/A

      Authorised

      EMEA/H/C/005145

      Evrysdi

      Omission of particulars (immediate labelling)

      Negative

      20/Oct/20

      Evrysdy (risdiplam) - Product
      information

      Evrysdi (risdiplam) - Assessment
      report

      Authorised

      EMEA/H/C/005089

      Imcivree

      20/Oct/20

      Imcivree (setmelanotide) - Product
      information

      Imcivree (setmelanotide) Assessment report

      Authorised

      EMEA/H/C/004662

      Abecma

      Omission of particulars (outer and
      intermediate labelling)

      Positive (partial)

      20/Oct/20

      Abecma (idecabtagene vicleucel) Product information

      Abecma (decabtagene vicleucel) Assessment report

      Authorised

      EMEA/H/C/004731

      Breyanzi

      Omission of particulars (outer and
      intermediate labelling)

      Positive (partial)

      20/Oct/20

      Breyanzi (lisocabtagene maraleucel) - N/A
      Product information

      Authorised

      EMEA/H/C/005386

      Phesgo

      Omission of particulars (immediate labelling)

      Positive

      13/Oct/20

      EMEA/H/C/005102

      Tecartus

      Omission of particulars (immediate labelling)

      Positive

      05/Oct/20

      Authorised

      EMEA/H/C/005675

      Vaxzevria

      Omission of particulars (outer and immediate Positive
      labelling)

      Phesgo (pertuzumab/trastuzumab) - Phesgo (pertuzumab /
      Product information
      trastuzumab) - Assessment
      report
      Tecartus (autologous anti-CD19Tecartus (autologous anti-CD19transduced CD3+ cells) - Product
      transduced CD3+ cells) information
      Assessment report
      Vaxzevria - Product information
      Vaxzevria - Assessment report

      Authorised

      Authorised

      EMEA/H/C/005246

      Byfavo

      Omission of particulars (immediate labelling)

      Positive

      16/Jun/20

      Byfavo (remimazolam) - Product
      information

      Byfavo (remimazolam) Assessment report

      Authorised

      EMEA/H/C/004586

      Exparel liposomal

      Omission of particulars (immediate labelling)

      Positive

      16/Jun/20

      Exparel liposomal (bupivacaine) Product information

      Exparel liposomal (bupivacaine) Assessment report

      Authorised

      EMEA/H/C/004954/X/0004/G

      Ultomiris

      Omission of particulars (immediate labelling)

      Positive

      16/Jun/20

      Ultomiris (ravulizumab) - Product
      information

      N/A

      Authorised

      EMEA/H/C/004976

      Vocabria

      Omission of particulars (immediate labelling)

      Positive

      16/Jun/20

      Vocabria (cabotegravir) - Product
      information

      N/A

      Authorised

      EMEA/H/C/005060

      Rekambys

      Omission of particulars (immediate labelling)

      Positive

      16/Jun/20

      Rekambys (rilpivirine) - Product
      information

      N/A

      Authorised

      EMEA/H/C/005436

      Minjuvi

      Omission of particulars (immediate labelling)

      Positive

      16/Jun/20

      Minjuvi (tafasitamab) - Product
      information

      N/A

      Authorised

      EMEA/H/C/005681

      Pepaxti

      Omission of particulars (immediate labelling)

      Positive

      16/Jun/20

      Pepaxti (melphalan flufenamide) Product information

      N/A

      Authorised

      EMEA/H/C/004379

      Amglidia

      Translation exemption (outer,
      immediate labelling and package
      leaflet)

      Negative

      16/Jun/20

      Amglidia (glibenclamide) - Product
      information

      N/A

      Authorised

      EMEA/H/C/005271

      Zokinvy

      Translation exemption (outer,
      immediate labelling and package
      leaflet)

      Positive

      16/Jun/20

      Zokinvy (lonafarnib) - Product
      information

      N/A

      Authorised

      EMEA/H/C/002393

      Defitelio

      Translation exemption (outer,
      immediate labelling and package
      leaflet)

      Positive (partial)

      16/Jun/20

      Defitelio (defibrotide) - Product
      information

      N/A

      Authorised

      EMEA/H/C/005622

      Veklury

      15/May/20

      Veklury (remdesivir) - Product
      information

      Veklury (remdesivir) Assessment report

      Authorised

      EMEA/H/C/005269

      Kaftrio

      Translation exemption (outer,
      intermediate, immediate labelling
      and package leaflet)

      Positive (partial)

      22/May/20

      Kaftrio
      (elexacaftor/tezacaftor/ivacaftor) Product information

      N/A

      Authorised

      EMEA/H/C/005167

      Dovprela

      Translation exemption (outer and
      immediate labelling)

      Positive

      27/Mar/20

      Dovprela (pretomanid) - Product
      information

      Dovprela (pretomanid) Assessment report

      Authorised

      EMEA/H/C/004077/X/0032

      Darzalex

      20/Mar/20

      Darzalex (daratumumab) - Product
      information

      N/A

      Authorised

      EMEA/H/C/002614

      Sirturo

      Translation exemption (outer and
      immediate labelling)

      Positive

      03/Mar/20

      Sirturo (bedaquiline) - Product
      information

      N/A

      Authorised

      EMEA/H/C/005321

      Libmeldy

      Translation exemption (outer,
      intermediate, immediate labelling
      and lot information sheet)

      Positive

      03/Mar/20

      Libmeldy (atidarsagene autotemcel) - Libmeldy (atidarsagene
      Product information
      autotemcel) - Assessment report

      Authorised

      EMEA/H/C/004849

      Idefirix

      Translation exemption (outer and
      immediate labelling)

      Positive

      03/Mar/20

      Idefirix (imlifidase) - Product
      information

      Idefirix (imlifidase) - Assessment
      report

      Authorised

      EMEA/H/C/000829/X/0122/G

      Pradaxa

      03/Mar/20

      Pradaxa (dabigatran etexilate) Product information

      Pradaxa (dabigatran etexilate) Assessment report

      Translation exemption (outer and
      immediate labelling)

      Positive

      Positive

      Omission of particulars (immediate labelling)

      Omission of particulars (immediate labelling)

      Omission of particulars (immediate labelling)

      Omission of particulars (immediate labelling)

      Positive

      Positive

      Positive

      Positive

      Translation exemption (outer and immediate
      labelling)

      Positive

      07/Jul/20

      Authorised

      EMEA/H/C/003855

      Coagadex

      Translation exemption (outer and
      immediate labelling)

      Positive

      Authorised

      EMEA/H/C/005352

      Upstaza

      Translation exemption (outer and
      immediate labelling)

      Positive (partial)

      Authorised

      EMEA/H/C/003855

      Coagadex

      Translation exemption (outer and
      immediate labelling)

      Positive

      Authorised

      EMEA/H/C/004829

      Fetcroja

      Authorised

      EMEA/H/C/005169

      Obiltoxaximab SFL

      Translation exemption (outer
      labelling and package leaflet)

      Authorised

      EMEA/H/C/005830

      Roctavian

      Translation exemption (outer
      labelling and package leaflet)

      Authorised

      EMEA/H/C/005205

      Zynrelef

      Omission of particulars (immediate labelling)

      Positive

      08/Oct/19

      Authorised

      EMEA/H/C/003860/N/0027

      Nucala

      Omission of particulars (immediate labelling)

      Positive

      08/Oct/19

      Nucala (mepolizumab) - Product
      information

      N/A

      Authorised

      EMEA/H/C/004808

      Recarbrio

      Omission of particulars (immediate labelling)

      Positive

      08/Oct/19

      Authorised

      EMEA/H/C/004750

      Zolgensma

      Translation exemption (outer and
      immediate labelling)

      Positive (partial)

      26/Mar/19

      Recarbrio
      (imipenem/cilastatin/relebactam) Product information
      Zolgensma (Onasemnogene
      abeparvovec) - Product information

      Authorised

      EMEA/H/C/005407

      Sibnayal

      Translation exemption (outer and
      immediate labelling)

      Positive

      26/Mar/19

      Sibnayal (potassium citrate and
      potassium hydrogen carbonate) Product information

      Recarbrio
      (imipenem/cilastatin/relebactam) Assessment report
      Zolgensma (Onasemnogene
      abeparvovec) - Assessment
      report
      Sibnayal (potassium citrate and
      potassium hydrogen carbonate) Assessment report

      Authorised

      EMEA/H/C/005830

      Roctavian

      Translation exemption (outer and
      immediate labelling)

      Positive (partial)

      26/Mar/19

      Authorised

      EMEA/H/C/004282

      Vyxeos liposomal

      Translation exemption (outer,
      immediate labelling and package
      leaflet)

      Positive (partial)

      09/Oct/18

      ROCTAVIAN (valoctocogene
      Roctavian (valoctocogene
      roxaparvovec) - Product information roxaparvovec) - Assessment
      report
      Vyxeos liposomal
      N/A
      (daunorubicin/cytarabine) - Product
      information

      Authorised

      EMEA/H/C/005407

      Sibnayal

      Translation exemption (outer and
      immediate labelling)

      Positive

      09/Oct/18

      Sibnayal (potassium citrate and
      potassium hydrogen carbonate) Product information

      Sibnayal (potassium citrate and
      potassium hydrogen carbonate) Assessment report

      Authorised

      EMEA/H/C/004275

      Crysvita

      Translation exemption (outer,
      immediate labelling and package
      leaflet)

      Positive (partial)

      Oct/17

      Crysvita (burosumab) - Product
      information

      Crysvita (busorumab) Assessment report

      Omission of particulars (immediate labelling)

      Positive (partial)

      03/Mar/20

      Coagadex (human coagulation factor N/A
      X) - Product information

      03/Mar/20

      Upstaza (eladocagene exuparvovec) - Upstaza (eladocagene
      Product information
      exuparvovec) - Assessment
      report
      Coagadex (human coagulation factor N/A
      X) - Product information

      13/Jan/20

      Omission of particulars (immediate labelling)

      19/Nov/19

      Fetcroja (cefiderocol) - Product
      information

      Positive (partial)

      08/Oct/19

      Positive (partial)

      08/Oct/19

      Obiltoxaximab SFL (obiltoxaximab) - Obiltoxaximab SFL
      Product information
      (obiltoxaximab) - Assessment
      report
      ROCTAVIAN (valoctocogene
      Roctavian (valoctocogene
      roxaparvovec) - Product information roxaparvovec) - Assessment
      report
      Zynrelef (bupivacaine/meloxicam) - Zynrelef (bupivacaine/meloxicam)
      Product information
      - Assessment report

      Omission of particulars (immediate labelling)

      Omission of particulars (outer labelling)

      Positive

      Negative

      Positive

      Fetcroja (cefiderocol) Assessment report

      18 April 2024
      EMA/934543/2022 Rev.3
      Human Medicines Division

      Table of decisions of labelling exemption requested with the aim to create multilingual packages and examined by the Quality Review of Documents (QRD) Group
      Related information
      Exemptions to labelling and package-leaflet obligations | European Medicines Agency
      Recommendations for the implementation of the exemptions to the labelling and package leaflet obligations in the centralised procedure

      MA status

      Product number

      Product name

      Request for omission of particulars

      Outcome request for Request for translation exemption
      omission of
      particulars

      Authorised

      EMEA/H/C/005107/N/0022

      Roclanda

      Omission of particulars (immediate labelling)

      Positive

      Authorised

      EMEA/H/C/004452/X/0028

      Erleada

      Omission of particulars (immediate labelling)

      Authorised

      EMEA/H/C/000697

      Suboxone

      Authorised

      EMEA/H/C/005843

      Authorised

      Product information

      Assessment report

      21/Nov/23

      Roclanda (netarsudil
      mesylate/latanoprost) - Product
      information

      N/A

      Positive

      10/Mar/23

      Erleada, INN - apalutamide
      (europa.eu)

      Erleada (apalutamide) Assessment report

      Omission of particulars (immediate labelling)

      Positive

      13/Oct/22

      Suboxone (naloxone) - Product
      information

      N/A

      Opzelura

      Omission of particulars (immediate labelling)

      Positive (partial)

      13/Oct/22

      Opzelura (ruxolitinib) - Product
      information

      Opzelura (Ruxolitinib ) Assessment report

      EMEA/H/C/005361

      Akeega

      Omission of particulars (immediate labelling)

      Positive

      14/Jun/22

      Akeega (niraparib/abiraterone
      acetate) - Product information

      N/A

      Authorised

      EMEA/H/C/002465/X/0035

      Procysbi

      Omission of particulars (immediate labelling)

      Positive

      16/Nov/21

      Procysbi (mercaptamine
      bitartrate) - Product information

      N/A

      Authorised

      EMEA/H/C/005367

      Skytrofa

      Omission of particulars (immediate labelling)

      Positive (partial)

      17/Jun/21

      Skytrofa (lonapegsomatropin) Product information

      Skytrofa (lonapegsomatropin) Assessment report

      Authorised

      EMEA/H/C/000610/X/0063

      Noxafil

      Omission of particulars (immediate labelling)

      Positive

      17/Jun/21

      Noxafil (posaconazole) - Product
      information

      N/A

      Authorised

      EMEA/H/C/005267

      Ryeqo

      Omission of particulars (immediate labelling)

      Positive

      04/Mar/21

      Ryeqo
      N/A
      (Relugolix/Estradiol/Norethistero
      ne acetate) - Product information

      Authorised

      EMEA/H/C/005117

      Ozawade

      Omission of particulars (outer and immediate labelling)

      Positive

      04/Mar/21

      Ozawade (Pitolisant) - Product
      information

      Ozawade (Pitolisant) Assessment report

      Authorised

      EMEA/H/C/005208

      Ayvakyt

      Omission of particulars (immediate labelling)

      Negative

      20/Jun/20

      AYVAKYT (avapritinib) - Product
      information

      N/A

      Authorised

      EMEA/H/C/004835

      Zeposia

      Omission of particulars (immediate labelling)

      Positive (partial)

      08/Oct/19

      Zeposia (ozanimod) - Product
      information

      Zeposia (ozanimod) - Public
      assessment report

      Authorised

      EMEA/H/C/005243

      Lacosamide UCB

      Omission of particulars (immediate labelling)

      Positive

      08/Oct/19

      Lacosamide UCB (lacosamide) Product information

      N/A

      Authorised

      EMEA/H/C/004452

      Erleada

      Omission of particulars (immediate labelling)

      Positive

      09/Oct/18

      Erleada (apalutamide) - Product
      information

      Erleada (apalutamide) - Public
      assessment report

      Translation exemption (immediate labelling)

      Outcome translation Outcome date
      exemption

      Positive

Draft revised Heads of Medicines Agency / European Medicines Agency guidance document on the identification of personal data and commercially confidential information within the structure of the marketing authorisation application dossier

Retrieved on: 
Donnerstag, April 18, 2024
Steps, Union, Patient, CTD, Syndrome, CCI, Local, Disclosure, Toxicity, Process validation, MAH, Clinical trial, IP, RMP, Pharmacovigilance, Cell, Legislation, Annex, Trial of the century, Escherichia coli, Safety, Pediatrics, INTRODUCTION, Documentation, Prevalence, Vital signs, Tablet, Design, Transparency, Conclusion, Pip, Analysis, European Parliament, INN, Record, Quality, Generic, Biology, CMO, Genotoxicity, Composition, CTIS, Uncontrolled, Health care, European Medicines Agency, Prejudice, Committee, Policy, HCP, Animal, Characterization, Cell bank, Fertility, IRB, CMOS, Risk management, Private law, European Pharmacopoeia, Telephone, Research, Good, Data Protection Directive, Ampere-hour, IEC, QP, Human, Personal data, Labelling, Bibliography, Figure, MAA, R4, Institutional review board, Elucidation, Marketing, M4, ChromeOS, Contract research organization, Mental, Impairment, Toxicokinetics, NCA, Independent, Metabolite, Drug, Risk, Metabolism, GMO, Organ, EMA, Common Technical Document, General Data Protection Regulation, Confidentiality, PPD, PI, Language, DRUG, Privacy, Result, Claimed, Medication, Comparison, Ethics, Drive, PD, Narrative, EEA, Developmental toxicity, Saccharomyces cerevisiae, Pharmacopoeia, PIP, MCB, HMA, Physical chemistry, Midol, Particle size, Council, GCP, European Economic Area, Draft, Fermentation, Overview, Justification, Control, Dicarboxylic acid, Pharmacology, WCB, Expert, Immunogenicity, Data, Study, Publication, European, ICH, Element, Analytical procedures (finance auditing), Name, Common, Guideline, Exceptional circumstances, ID, Liver, Chin Na, Toxicology, Protein primary structure, Immunosuppressive drug, Vaccine

See websites for contact details

Key Points: 
    • See websites for contact details
      Heads of Medicines Agencies www.hma.eu
      European Medicines Agency www.ema.europa.eu

      11

      Table of contents

      12

      Abbreviations .............................................................................................. 3

      13

      Definitions ................................................................................................... 4

      14

      1.

    • redaction, masking,

      68

      hiding) in such a manner that the recipient can no longer attribute the resulting information to a data

      69

      subject and make it identifiable.

    • 81

      Contract Manufacturing Organisation (CMO): shall mean an arrangement under which a

      82

      manufacturer provides upstream manufacturing services under contract on behalf of third-party

      83

      pharmaceutical companies.

    • 94

      Protected Personal Data (PPD): shall mean any personal data which should be protected from

      95

      disclosure.

    • ?Finalised? shall mean that the marketing

      102

      authorisation (MA) has been granted or refused or that the MAA has been withdrawn.

    • The application of the general principles laid down in this guidance is without prejudice to

      106

      national rules on transparency.

    • The guidance should be read in conjunction with the relevant applicable

      107

      legislation and case law on transparency and data protection.

    • 117

      This guidance document is intended to apply to information/documents on medicinal products for

      118

      human use, for which the procedure has been finalised under the national, mutual recognition,

      119

      decentralised and centralised procedures.

    • Third

      124

      parties shall be informed or consulted as needed depending on respective national and European legal

      125

      frameworks.

    • 140

      In the following sections, the agreed principles on PD and CCI are presented, including guidance on

      141

      whether such information can be disclosed.

    • EMA/131365/2024

      Page 5/50

      142

      Any information identified as PD or CCI must be subject to a preliminary review by the EMA/NCA prior

      143

      to the possible disclosure of the information/documents.

    • Principles on the protection of personal data (PD)

      145

      The protection of PD is enshrined in EU legislation; it is a fundamental right of EU citizens.

    • In

      146

      compliance with the applicable European/national legislation, PD should be anonymised in order to

      147

      avoid the disclosure of the document undermining the privacy and integrity of any individual.

    • EMA/NCA applies a risk-based approach to assess which PD elements are to be

      152

      removed from the information/documents in order to limit the risk of re-identification.

    • are included in the MAA dossier because they have a legally

      164

      defined role or responsibility and it is in the public interest to disclose this data.

    • 168

      Applicants are advised that non-essential information (e.g., personal address, personal phone number)

      169

      should not be included in the MAA dossier.

    • The

      183

      confidentiality of records that could identify subjects should be protected, respecting the privacy and

      184

      confidentiality rules in accordance with the applicable regulatory requirement(s).

    • 185

      The applicant remains responsible for compliance with the relevant legislation in cases where such data

      186

      is inadvertently included in the MAA dossier.

    • 188

      EMA/NCA applies a risk-based approach to assess which personal data elements need to be removed

      189

      from the information/documents in order to limit the risk of re-identification.

    • 194

      EMA/NCA applies a risk-based approach to assess which personal data elements need to be removed

      195

      from the information/documents in order to limit the risk of re-identification.

    • 205

      Any proposal to consider information as commercially confidential should be properly justified by the

      206

      owner of the information.

    • In this respect, any reference(s) to the risk of that interest being

      209

      undermined should be foreseeable and not purely hypothetical.

    • 210

      Information that is already in the public domain is not considered to be commercially confidential.

    • Information on the Quality and Manufacturing of medicines

      226

      A general principle regarding quality and manufacturing information is that detailed information could

      227

      be considered commercially confidential but general information should be disclosed.

    • 234

      In general, and if not in the public domain, the names of manufacturers or suppliers of the active

      235

      substance or the excipients are considered commercially confidential.

    • 248

      A general description of the type of test methods used and the appropriateness of the specification is

      249

      not commercially confidential.

    • General information on the fermentation and purification process

      259

      is not commercially confidential, although details including operating parameters and specific material

      260

      requirements are commercially confidential.

    • 273

      A general description of the type of test methods used and the appropriateness of the specification is

      274

      not commercially confidential.

    • In general, the data included in clinical trial study reports is considered to be data that can be

      283

      disclosed once PD has been anonymised.

    • 338

      In each module, a non-exhaustive list of information that may be considered protected personal data (PPD) or commercially confidential information

      332
      333

      339

      (CCI) is included.

    • ?

      Direct contact details such as telephone

      Therefore, please refer to the appropriate sub-

      number, fax number, email, postal address,

      modules hereafter for guidance.

    • ?

      Information that may reveal strategic
      (contractual) agreements

      ?

      Any quality information on the clinical batches

      principal investigator

      that might be included here (such as e.g.

    • ?

      Information that may reveal strategic
      (contractual) agreements

      principal investigator

      Study Reports
      5.3.3.3

      as the evaluation of new formulation, innovative

      number, fax number, email, postal

      Paediatric Development Plan (PIP), etc.

    • This may include taking into

      More Than One Study
      5.3.5.4

      Other Clinical Study Reports

      5.3.6

      Reports of Post-Marketing
      Experience

      5.3.7

      Direct identifiers such as name,
      signature, contact details, etc.

Curium Announces First Commercial Dose in the Netherlands of PYLCLARI® – an Innovative 18F-PSMA PET Tracer Indicated in Patients With Prostate Cancer

Retrieved on: 
Dienstag, April 9, 2024
Curium, Civil service commission, Prostate cancer, Patient, PET, News, INN, Cancer, Prostate, European, European Commission, FDA, Nuclear medicine, Physician, PSMA, Food, Medical imaging

PARIS, April 09, 2024 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, announced that today in the Netherlands the first commercial dose of PYLCLARI® has been sold.

Key Points: 
  • PARIS, April 09, 2024 (GLOBE NEWSWIRE) -- Curium, a world leader in nuclear medicine, announced that today in the Netherlands the first commercial dose of PYLCLARI® has been sold.
  • In the U.S., Lantheus received approval for PYLARIFY® (Piflufolastat F 18 Injection) from the Food and Drug Administration (FDA) in May 2021.
  • It is the #1 utilized PSMA PET agent in the U.S. market.
  • The European rights were licensed by Curium from Progenics, a Lantheus company, in 2018.

Marker Therapeutics Reports Year-End 2023 Corporate and Financial Results

Retrieved on: 
Montag, März 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.

Procedural advice for orphan medicinal product designation: Guidance for sponsors

Retrieved on: 
Mittwoch, April 3, 2024
Community, Reproduction, Letter, European Commission, European Communities, Inn, Patient, Agency, Translation, European Medicines Agency, Council, European, Deference, VSI, Marketing, Legislation, Certification, MHLW, Annex, European Economic Area, PDF, Public, Medication, Committee, Policy, Bibliography, EMA, CAT, COMP, SME, Language, Ministry, CHMP, Decision, Cisco Webex, Prevalence, Disease, Part, Classification, Regulation (European Union), Privacy, Commission, RTF, EEA, Sponsor, PMDA, FDA, Guideline, Diagnosis, Civil service commission, European Council, European Parliament, Recognition, Art, INN, Official Journal, Record, TEAMS, Mutual, Microsoft PowerPoint, ID, Pharmaceutical industry

Frequently asked questions ................................................................... 10

Key Points: 
    • Frequently asked questions ................................................................... 10

      Procedural advice for orphan medicinal product designation
      EMA/420706/2018

      Page 2/13

      1.

    • This Regulation lays down the procedure for
      the designation of medicinal products as orphan medicinal products and provides incentives for the
      development and placing on the market of designated orphan medicinal products.
    • The Regulation also
      establishes the Committee for Orphan Medicinal Products (COMP) within the European Medicines
      Agency (EMA), which is responsible for examining applications for orphan medicinal product
      designation.
    • As of 28 April 2000, the date this Regulation entered into force, sponsors have been able to
      submit applications for orphan medicinal product designation to the EMA.
    • Procedural advice for orphan medicinal product designation
      EMA/420706/2018

      Page 3/13

      2.

    • Objectives
      In examining an application for orphan medicinal product designation, the COMP will focus on
      determining whether the sponsor has established that the designation criteria are met, i.e.
    • To assist in the development of a policy on orphan medicinal products, an expert network will
      be built up by the Committee, with expert(s) identified as appropriate to be involved in the evaluation
      of applications for orphan medicinal product designation.
    • ?

      The complete application should include:

      Procedural advice for orphan medicinal product designation
      EMA/420706/2018

      Page 5/13

      Document

      Format

      General administrative and scientific information completed online via the portal.

    • Important:
      In preparing an application for orphan medicinal product designation, sponsors are requested to follow
      the Commission guideline (2022/C 440/02) on the format and content of applications for designation
      as orphan medicinal products.
    • Please refer to the Procedural advice on
      appeal procedure for Orphan Medicinal Product Designation (EMEA/2677/01 Rev.3).
    • The grounds for the

      Procedural advice for orphan medicinal product designation
      EMA/420706/2018

      Page 9/13

      appeal should be based only on the original information provided in the application for orphan
      designation.

    • ?

      The European Commission will enter the designated medicinal product in the Community Register
      of Orphan Medicinal Products.

    • General advice
      ?

      Full information on the procedure for orphan medicinal products designation is available on the
      EMA orphan designation website.

    • In accordance with Regulation (EC) No 141/2000 of 16 December 1999, the sponsor may submit an
      application for orphan medicinal product designation to the Agency at any stage of development of the

      Procedural advice for orphan medicinal product designation
      EMA/420706/2018

      Page 10/13

      medicinal product as long as the criteria for designation may be justified.

    • A request for orphan medicinal product designation may be made for
      a new orphan indication for an already authorised medicinal product.
    • Procedural advice for orphan medicinal product designation
      EMA/420706/2018

      Page 11/13

      Which are the sponsor?s options in case of negative outcome for orphan designation?

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

Retrieved on: 
Donnerstag, März 7, 2024
Curium, European Commission, Physician, FDA, Food, PSMA, Prostate, INN, European, Civil service commission, Patient, Nuclear medicine, PET, Cancer, Prostate cancer, Medical imaging

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: 
Donnerstag, Februar 22, 2024
Radiopharmaceutical, European Commission, SPECT, Physician, Marketing, FDA, Food, Cancer, PSMA, Agency, INN, Death, Civil service commission, European Medicines Agency, AG, Patient, Nuclear medicine, Prostate cancer, Diagnosis, PCA, PET, Medical imaging

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: 
Donnerstag, März 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.