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10 Products |  |
2 Diseases | | 10 Products |
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8 Trials |  |
225 News |  |
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- || CinnoVex (IFN-β-1a biosimilar) / CinnaGen
Clinical, PK/PD data, Journal: A randomized pharmacokinetic-pharmacodynamic evaluation of the potential biosimilar interferon beta-1a product, CinnoVex®. (Pubmed Central) - Apr 7, 2022
The objective of the trial was to evaluate the bioequivalence of the interferon beta-1a (IFN beta-1a) biosimilar product candidate CinnoVex® with the reference product Avonex® by comparing the pharmacokinetics/pharmacodynamics (PK/PD), safety and immunogenicity of the two products in healthy subjects. Clinical trials registration: EudraCT Number 2016-000139-41.
- |||| Reditux (rituximab biosimilar) - Dr. Reddy's, Abbott, EMD Serono, CinnaGen, Fresenius Kabi, R / Pharm
Enrollment closed, Trial completion date, Trial primary completion date: RI-01-007: A Phase III Transition Study of DRL Rituximab to Reference Medicinal Products (clinicaltrials.gov) - Apr 7, 2022
P3, N=140, Active, not recruiting, Sponsor: Dr. Reddy's Laboratories Limited
Clinical trials registration: EudraCT Number 2016-000139-41. Recruiting --> Active, not recruiting | Trial completion date: May 2021 --> Apr 2022 | Trial primary completion date: May 2021 --> Jan 2022
- || COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
Perhaps we need to individually import Vaxine Spikogen directly from the overseas manufacturer. The Australian product is not advertised but is discussed privately in a closed group on facebook. It is obvious @TGAgovau is politically biased and not fit to adjudicate on new vax (Twitter) - Mar 27, 2022
- ||| COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
Enrollment open, Phase classification, Enrollment change, Trial completion date, Trial initiation date, Trial primary completion date: Australian Phase 2b Study to Assess Effect of Dose Interval on Spikogen Covid-19 Vaccine (clinicaltrials.gov) - Mar 21, 2022
P2b, N=200, Recruiting, Sponsor: Vaxine Pty Ltd
Recruiting --> Active, not recruiting | Trial completion date: May 2021 --> Apr 2022 | Trial primary completion date: May 2021 --> Jan 2022 Not yet recruiting --> Recruiting | Phase classification: P2/3 --> P2b | N=2000 --> 200 | Trial completion date: Dec 2022 --> Mar 2023 | Initiation date: Dec 2021 --> Mar 2022 | Trial primary completion date: Jul 2022 --> Oct 2022
- ||| COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
New trial: Immunogenicity and Safety of a Booster Dose of the SpikoGen Vaccine in Kidney Transplant Recipients After Two Doses of Sinopharm Vaccine (clinicaltrials.gov) - Mar 16, 2022
P=N/A, N=100, Recruiting, Sponsor: Cinnagen
- | COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
New P2/3 trial: A Phase 3b/4 Randomised Trial of 3 Doses of Protein-based Covid-19 Vaccine (SpikoGen) (clinicaltrials.gov) - Mar 15, 2022
P2/3, N=200, Not yet recruiting, Sponsor: Professor Nikolai Petrovsky
- ||||||| COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
Trial completion: Phase III Clinical Trial of CinnaGen COVID-19 Vaccine (SpikoGen) (clinicaltrials.gov) - Mar 15, 2022
P3, N=16876, Completed, Sponsor: Cinnagen
Not yet recruiting --> Recruiting | Phase classification: P2/3 --> P2b | N=2000 --> 200 | Trial completion date: Dec 2022 --> Mar 2023 | Initiation date: Dec 2021 --> Mar 2022 | Trial primary completion date: Jul 2022 --> Oct 2022 Active, not recruiting --> Completed
- ||| COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
Enrollment open, Head-to-Head: Immunogenicity and Safety of the SpikoGen COVID-19 Vaccine in Children Aged 5 to <12 Years and 12 to <18 Years Compared With Adults Aged 18 to 40 Years (clinicaltrials.gov) - Feb 25, 2022
P=N/A, N=810, Recruiting, Sponsor: Cinnagen
Active, not recruiting --> Completed Not yet recruiting --> Recruiting
- |||||||| CinnoVex (IFN-β-1a biosimilar) / CinnaGen
New P3 trial, Head-to-Head: Efficacy and Safety of Peginterferon Beta-1a (CinnaGen) in Participants With Relapsing Remitting Multiple Sclerosis (clinicaltrials.gov) - Feb 16, 2022
P3, N=168, Active, not recruiting, Sponsor: Cinnagen
- ||| COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
New trial, Head-to-Head: Immunogenicity and Safety of the SpikoGen COVID-19 Vaccine in Children Aged 5 to <12 Years and 12 to <18 Years Compared With Adults Aged 18 to 40 Years (clinicaltrials.gov) - Feb 9, 2022
P=N/A, N=810, Not yet recruiting, Sponsor: Cinnagen
- ||| Covaxin (BBV152 COVID Vaccine) / Bharat Biotech, Indian Council of Medical Research, Ocugen, COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
Adverse events: Covaxin and Spikogen don’t have this side effect. Just sayin (Twitter) - Jan 17, 2022
- | COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
By the way, I'll join every one else! APROVE NOVAVAX and COVAX-19 (Twitter) - Jan 10, 2022
- || COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
Approve Novavax and Covax-19. (Twitter) - Jan 9, 2022
- | Tysabri (natalizumab) / Biogen, CinnoVex (IFN-β-1a biosimilar) / CinnaGen
Observational data, Journal, HEOR: Economic burden of multiple sclerosis: a cross-sectional study in Iran. (Pubmed Central) - Jan 5, 2022
Not yet recruiting --> Recruiting Considering the findings of this study and in order to reduce the burden of the disease, the following suggestions are presented: providing necessary facilities for the production of MS drugs in the country; proper and equitable distribution of neurologists; expanding the provision of home care services; and using the technologies related to the Internet, including WhatsApp, to follow up the MS patients' treatment.
- || Cinnal F (follitropin alfa biosimilar) / CinnaGen
Clinical, Journal: Comparing a biosimilar follitropin alfa (Cinnal-fⓇ) with Gonal-fⓇ in women undergoing ovarian stimulation: An RCT. (Pubmed Central) - Jan 4, 2022
Cinnal-fⓇ proved non-inferior to Gonal-fⓇ, based on the percentage of MII oocytes in women aged 35 yr undergoing ICSI. Our findings confirm that the efficacy and safety profiles of Cinnal-fⓇ and Gonal-fⓇ are similar.
- |||| COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
Trial completion: Phase II Clinical Trial of CinnaGen COVID-19 Vaccine (SpikoGen) (clinicaltrials.gov) - Jan 4, 2022
P2, N=400, Completed, Sponsor: Cinnagen
Our findings confirm that the efficacy and safety profiles of Cinnal-fⓇ and Gonal-fⓇ are similar. Active, not recruiting --> Completed
- |||||||||| COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
New P3 trial: Immunogenicity and Safety of a Booster Dose of the SpikoGen COVID-19 Vaccine (clinicaltrials.gov) - Jan 3, 2022
P3, N=300, Active, not recruiting, Sponsor: Cinnagen
- CinnoRA (adalimumab biosimilar) / CinnaGen, Humira (adalimumab) / Eisai, AbbVie
Comparison of two treatment strategies in IBD: Biosimilar adalimumab (CinnoRA®) in monotherapy and in combination with azathioprine (Virtual Poster exhibition) - Dec 29, 2021 - Abstract #ECCOIBD2022ECCO_IBD_1085;
Moreover, there was no association between ADA concentrations and the rate of remission in IBD patients. Hence, AZA does not affect the efficacy and pharmacokinetics of ADA in patients with IBD.
- ||| COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
Cause mRNA is a joke. Get a real wax like Novavax or COVAX-19 (Twitter) - Dec 24, 2021
- | COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
Covax-19 (Twitter) - Dec 19, 2021
- || COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
None unless @TGAgovau approve @Novavax or @vaxine_news covax-19!! (Twitter) - Dec 15, 2021
- | COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
When COVAX-19 (Twitter) - Dec 14, 2021
- |||||||||| COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
New P2/3 trial, New P2b trial: Australian Phase 2b Study to Assess Effect of Dose Interval on Spikogen Covid-19 Vaccine (clinicaltrials.gov) - Dec 7, 2021
P2/3, N=2000, Not yet recruiting, Sponsor: Vaxine Pty Ltd
- | COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
Also called Spikogen (Twitter) - Nov 29, 2021
- || COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
Even better COVAX-19 from Vaxine Pty Ltd in Adelaide. It gives you FULL IMMUNITY and prevents transmission. It has been approved by the regulator in Iran but not in Australia! Why? (Twitter) - Nov 29, 2021
- | COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
Covax-19 is the one we want.. made in and by an Aussie professor named Nikolai petrovsky (Twitter) - Nov 29, 2021
- Reditux (rituximab biosimilar) / Dr. Reddy's, Abbott, EMD Serono, CinnaGen, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
R-CHOP Chemotherapy Including Biosimilar Rituximab (Redditux ®) for De-Novo Diffuse Large B-Cell Lymphoma Patients: Real-Life Single Center Experience () - Nov 24, 2021 - Abstract #ASH2021ASH_6815;
The CNS relapse rate was relatively high (9.8%) in our cohort. Prospective randomized clinical trials are needed to determine the efficacy and safety profile of Redditux.
- | COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
One day @GregHuntMP going to have to explain why he didn't support Covax-19, its gana be a awkward conversation (Twitter) - Nov 14, 2021
- || COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
@Novavax COVAX-19 @TGAgovau https://t.co/9ITHZcAgyI (Twitter) - Nov 14, 2021
- | COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
Where is Covax-19 (Twitter) - Nov 10, 2021
- |||| COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
Clinical: If Australia has a Contract with Pfizer any Safe and Effective Vaccine Traditional hopefully with out Mercury, Aluminum etc will never be approved by TGA. It would be awesome Covax 19 does only one willing to risk my life with. (Twitter) - Nov 8, 2021
- | COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
@MelissaLDavey Surely over $326,000 raised by Australians to get Covax-19 considered by the @TGAgovau must warrant a line or two Melissa? (Twitter) - Nov 6, 2021
- || COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
Clinical: Where is the Australian made vaccine COVAX-19? @TGAgovau (Twitter) - Oct 27, 2021
- | Reditux (rituximab biosimilar) - Dr. Reddy's, Abbott, EMD Serono, CinnaGen, Fresenius Kabi, R / Pharm, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Trial completion date, Trial primary completion date: Rituximab Plus CHOP Chemotherapy for Diffuse Large B-cell Lymphoma (clinicaltrials.gov) - Oct 19, 2021
P2, N=39, Active, not recruiting, Sponsor: UNC Lineberger Comprehensive Cancer Center
Prospective randomized clinical trials are needed to determine the efficacy and safety profile of Redditux. Trial completion date: Dec 2022 --> Jul 2024 | Trial primary completion date: Mar 2021 --> Jul 2021
- | Reditux (rituximab biosimilar) - Dr. Reddy's, Abbott, EMD Serono, CinnaGen, Fresenius Kabi, R / Pharm, AcellBia (rituximab biosimilar) / Biocad, Kocak Farma, Rituxan (rituximab) / Biogen, Zenyaku Holdings, Roche
New P1 trial: Safety and Efficacy of Intrathecal Rituximab in Patients With Multiple Sclerosis (clinicaltrials.gov) - Oct 14, 2021
P1, N=40, Recruiting, Sponsor: St. Petersburg State Pavlov Medical University
- ||||| COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
Enrollment closed: Phase III Clinical Trial of CinnaGen COVID-19 Vaccine (SpikoGen) (clinicaltrials.gov) - Oct 4, 2021
P3, N=16876, Active, not recruiting, Sponsor: Cinnagen
Trial completion date: Dec 2022 --> Jul 2024 | Trial primary completion date: Mar 2021 --> Jul 2021 Recruiting --> Active, not recruiting
- | COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
Preclinical, Journal: Immunisation of ferrets and mice with recombinant SARS-CoV-2 spike protein formulated with Advax-SM adjuvant protects against COVID-19 infection. (Pubmed Central) - Sep 25, 2021
Notably, ferrets that received the two higher doses of Covax-19 vaccine had no detectable virus in their lungs or in nasal washes at day 3 post-challenge, suggesting that in addition to lung protection, Covax-19 vaccine may have the potential to reduce virus transmission. This data supports advancement of Covax-19 vaccine into human clinical trials.
- || CinnoVex (IFN-β-1a biosimilar) / CinnaGen
Clinical, Journal: An investigation into the beneficial effects of high-dose interferon beta 1-a, compared to low-dose interferon beta 1-a in severe COVID-19: The COVIFERON II randomized controlled trial. (Pubmed Central) - Sep 24, 2021
P2
The use of high-dose IFN-β 1a did not improve TTCI in hospitalized patients with moderate to severe COVID-19. Also, it did not have any significant effect on mortality reduction compared with treating with low-dose IFN-β 1a.
- | Reditux (rituximab biosimilar) / Dr. Reddy's, Abbott, EMD Serono, CinnaGen, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Journal: Simultaneous Monitoring of Monoclonal Antibody Variants by Strong Cation-Exchange Chromatography Hyphenated to Mass Spectrometry to Assess Quality Attributes of Rituximab-Based Biotherapeutics. (Pubmed Central) - Sep 19, 2021
Moreover, the two drug products showed differences in terms of basic variants such as C-terminal lysine and N-terminal truncation, present in Reditux™ but not in MabThera. This study demonstrates the capability of this fast SCX-HPLC-MS approach to compare different drug products and simultaneously assess some of their quality attributes.
- |||||||||| COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
New P3 trial: Phase III Clinical Trial of CinnaGen COVID-19 Vaccine (SpikoGen) (clinicaltrials.gov) - Aug 12, 2021
P3, N=16876, Recruiting, Sponsor: Cinnagen
- | Reditux (rituximab biosimilar) / Dr. Reddy's, Abbott, EMD Serono, CinnaGen, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Journal: Sedimentation Velocity Analytical Ultracentrifugation Analysis of Marketed Rituximab Drug Product Size Distribution. (Pubmed Central) - Aug 8, 2021
SV-AUC provides an orthogonal characterization tool for protein size distribution, composition and assay, which could be informative for biosimilar drug developers who mostly only have access to formulated mAb. However, AUC needs thorough validation on its accuracy, precision and sensitivity.
- |||||||| Ocrevus (ocrelizumab) / Roche, Biogen, Xacrel (ocrelizumab biosimilar) / CinnaGen
New P3 trial: Efficacy and Safety of Xacrel® (Ocrelizumab) in Participants With Relapsing Remitting Multiple Sclerosis (clinicaltrials.gov) - Jul 19, 2021
P3, N=170, Active, not recruiting, Sponsor: Cinnagen
- |||||||||| P013 (pertuzumab biosimilar) / CinnaGen, Perjeta (pertuzumab) / Roche
New P3 trial: Comparing Efficacy and Safety Between Pertuzumab (clinicaltrials.gov) - Jul 12, 2021
P3, N=214, Completed, Sponsor: Cinnagen
- || CinnoPar (teriparatide biosimilar) / CinnaGen
Clinical, P4 data, Journal: A Phase IV Study of the Safety and Efficacy of CinnoPar in Iranian Patients with Osteoporosis. (Pubmed Central) - Jul 2, 2021
Both changes were statistically significant (p < 0.001). Consistent with the findings of previous studies and the drug monograph, no new safety concern was observed with this biosimilar teriparatide, and the drug was effective based on the VAS score and EQ-5D in osteoporotic patients.
- ||||| COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
New P2 trial: Phase II Clinical Trial of CinnaGen COVID-19 Vaccine (SpikoGen) (clinicaltrials.gov) - Jun 29, 2021
P2, N=400, Active, not recruiting, Sponsor: Cinnagen
- | Exemptia (adalimumab biosimilar) / Zydus Cadila, CinnoRA (adalimumab biosimilar) / CinnaGen
Retrospective data, Journal: Comparative efficacy and safety of adalimumab biosimilars and adalimumab in patients with rheumatoid arthritis presenting an insufficient response to methotrexate: a network meta-analysis. (Pubmed Central) - May 20, 2021
Consistent with the findings of previous studies and the drug monograph, no new safety concern was observed with this biosimilar teriparatide, and the drug was effective based on the VAS score and EQ-5D in osteoporotic patients. No significant difference was detected between adalimumab biosimilars and the originator in terms of ACR20 response rates and SAEs in the studied patients.
- || COVAX-19 (GC004) / Flinders University, Vaxine, GeneCure Biotechnologies, Medytox, CinnaGen
Trial completion, Trial primary completion date: COVAX19: Monovalent Recombinant COVID19 Vaccine (clinicaltrials.gov) - Apr 20, 2021
P1, N=40, Completed, Sponsor: Vaxine Pty Ltd
No significant difference was detected between adalimumab biosimilars and the originator in terms of ACR20 response rates and SAEs in the studied patients. Recruiting --> Completed | Trial primary completion date: Jul 2021 --> Feb 2021
- || Reditux (rituximab biosimilar) / Dr. Reddy’s, Abbott, EMD Serono, CinnaGen
Clinical, PK/PD data, Journal: Pharmacokinetic Similarity and Comparative Pharmacodynamics, Safety, Efficacy, and Immunogenicity of DRL_RI Versus Reference Rituximab in Biologics-Naïve Patients with Moderate-to-Severe Rheumatoid Arthritis: A Double-Blind, Randomized, Three-Arm Study. (Pubmed Central) - Jan 28, 2021
P1/2
Recruiting --> Completed | Trial primary completion date: Jul 2021 --> Feb 2021 DRL_RI, a proposed biosimilar, demonstrated three-way PK similarity with RTX-EU and RTX-US, the reference innovator products, with comparable efficacy, PD, safety, and immunogenicity.
- || ivermectin / Generic mfg.
Clinical, Clinical protocol, Journal: The efficacy and safety of Ivermectin in patients with mild and moderate COVID-19: A structured summary of a study protocol for a randomized controlled trial. (Pubmed Central) - Jan 13, 2021
The inpatient group will receive 200/50 mg Lopinavir/Ritonavir (Heterd Company, India) twice a day for the seven days, plus five doses of 44 mcg Interferon beta-1a (CinnaGen, Iran) every other day...The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting the dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol.
- | Reditux (rituximab biosimilar) - Dr. Reddy's, Abbott, EMD Serono, CinnaGen, Fresenius Kabi, R / Pharm, Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
Enrollment closed: Rituximab Plus CHOP Chemotherapy for Diffuse Large B-cell Lymphoma (clinicaltrials.gov) - Dec 17, 2020
P2, N=39, Active, not recruiting, Sponsor: UNC Lineberger Comprehensive Cancer Center
In the interest in expediting the dissemination of this material, the familiar formatting has been eliminated; this letter serves as a summary of the key elements of the full protocol. Recruiting --> Active, not recruiting