A Phase I/II Study of Natalizumab as a Single Agent in Children, Adolescents and Young Adults With Recurrent, Refractory or Progressive Pulmonary Metastatic Osteosarcoma

The purpose of this study is to evaluate the safety and tolerability of Natalizumab in children, adolescent and young adult patients with pulmonary metastatic osteosarcoma (pOS) and to assess clinical response associated with this treatment as well as overall survival.

Start Date01 Dec 2024

Sponsor / Collaborator

The Case Comprehensive Cancer Center

NCT05658497

/ RecruitingNot Applicable

Vumerity (Diroximel Fumarate) Prospective MS Pregnancy Exposure Registry

The primary objectives of the study are to estimate the risk of major congenital malformations (MCMs) in infants born to women with multiple sclerosis (MS) who were exposed to diroximel fumarate (DRF) at any time from 2 weeks after the first day of their last menstrual period (LMP) up through the first trimester of pregnancy and to comparatively evaluate pregnancy outcomes with MCMs in women with MS who were exposed to DRF at any time from 2 weeks after the first day of their LMP through the first trimester of pregnancy with the following: i) women with MS who were unexposed to disease modifying therapies (DMTs) and, ii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries).
The secondary objective of the study is to evaluate pregnancy outcomes in women with DRF exposure at any time from 2 weeks after the first day of their LMP through the end of pregnancy compared with the following: i) women with MS who were unexposed to DMTs, ii) women with dimethyl fumarate (DMF) exposure, iii) women with MS who were exposed to other DMTs (e.g., Avonex and Tysabri Pregnancy Registries), and iv) women without MS (e.g., women from external, general population comparators).

Start Date27 Oct 2023

Sponsor / Collaborator

Biogen, Inc.

NCT05618301

/ Active, not recruitingPhase 1IIT

A Pilot Safety and Feasibility Study to Evaluate Motixafortide (CXCR4/SDF-1 Inhibition) and Natalizumab (VLA-4/VCAM-1 Inhibition) as a Novel Regimen to Mobilize CD34+ Hematopoietic Stem Cells for Gene Therapies in Sickle Cell Disease (SCD)

Hematopoietic stem cell (HSC)-based gene therapies now offer curative potential for patients with sickle cell disease (SCD), with decreased toxicity compared to allogeneic hematopoietic cell transplantation. However, effective HSC-based gene therapy depends on collecting sufficient HSCs to generate the therapeutic product, and currently available mobilization regimens carry unacceptable risk for patients with SCD or do not reliably yield optimal numbers of HSCs for gene therapy.
The investigators hypothesize that HSC mobilization with motixafortide (CXCR4i) alone and the combination of motixafortide plus natalizumab (VLA-4i) will be safe and tolerable in SCD patients. In addition, the investigators hypothesize that combined CXCR4 and VLA-4 blockade with motixafortide plus natalizumab will result in a rapid, robust, and synergistic increase in HSC mobilization to peripheral blood (PB) in patients with SCD, when compared to motixafortide alone.

Start Date07 Jul 2023

Sponsor / Collaborator

Washington University School of Medicine

[+2]

100 Clinical Results associated with Natalizumab

100 Translational Medicine associated with Natalizumab

100 Patents (Medical) associated with Natalizumab

3,103

Literatures (Medical) associated with Natalizumab

01 Jun 2025·Multiple Sclerosis and Related Disorders

Serological screening and Vaccine Update in a cohort of Multiple Sclerosis Patients as a strategy to prevent infection reactivation during immunosuppressant therapy

Article

Author: Reis, Gelvana Flávio Barreto ; Berezin, Eitan Naaman ; de Castro, Andrea de Carvalho Anacleto Ferrari

INTRODUCTIONSerological screening and vaccination play a crucial role in preventing infectious complications in patients with Multiple Sclerosis (MS). Standardization of tests and vaccination protocols are essential in patients undergoing treatment.OBJECTIVEThis study aimed to assess susceptibility to infectious diseases through serological tests and vaccine update of MS patients.METHODSA cross-sectional study was conducted on patients treated by the neurology service of the Metropolitan University of Santos between February 2021 and June 2023. Serological screening and vaccine recommendations were performed by an infectious disease specialist.RESULTSA total of 119 patients were included, with a mean age of 45.7 years. The sample was 68.1 % female and 31.9 % male, and vaccination update was performed for 64 (53.8 %) patients. MS treatments included: Glatiramer Acetate, Natalizumab, Fingolimod, Dimethyl Fumarate, Ocrelizumab and cladribine (Cladribine) and corticoid for MS flare-ups. Seroprevalence was: 66.0 % for the JC virus, 61.4 % Toxoplasmosis, 50.9 % Mononucleosis, 84.5 % Cytomegalovirus, 85.4 % Measles, 72.2 % Mumps, 92.6 % Rubella, and 94.2 % Varicella. No cases of HIV, HCV, HBV, HTLV or syphilis were detected. Vaccine cover was: 75 % influenza, 68.7 % Hepatitis B, 64.2 % Hepatitis A, 34.4 % HPV, 85 % COVID-19, 1.56 % Herpes Zoster, Diphtheria, Tetanus and Pertussis, 70 % DT, 6.5 % DTaP, 53 % anti-pneumococcal with Pn-23 and 31 % with Pn-13, 48.4 % Haemophilus influenzae b, 39 % Meningococcal C and 20.3 % ACWY.CONCLUSIONMS patients using immunosuppressant therapy may be susceptible to vaccine-preventable infectious diseases. The study demonstrates the feasibility of vaccine updates, and infectious diseases specialists can contribute assessing infection risks and providing individualized vaccines recommmendations.

01 May 2025·Journal of Neurology

Measuring cognitive change in secondary progressive MS: an analysis of the ASCEND cognition substudy

Article

Author: Bowen, James D ; Repovic, Pavle ; Leavitt, Victoria ; Cutter, Gary ; Comtois, Jacynthe ; Brieva, Luis ; Uitdehaag, Bernard ; Koch, Marcus W ; Mostert, Jop ; Strijbis, Eva ; Moral, Ester

BACKGROUNDCognitive impairment is common in multiple sclerosis (MS). Accurate measurement of cognitive change is essential for clinical trials.METHODSThe change in cognitive scores, clinical metrics of physical disability, and neuroradiological metrics was quantified in data from a phase-3 randomized controlled trial of natalizumab in secondary progressive MS (SPMS). The adults diagnosed with SPMS for ≥ 2 years and Expanded Disability Status Scale (EDSS) scores from 3 to 6.5 were randomized to receive natalizumab or placebo for 96 weeks. We evaluated change in Symbol Digit Modalities Test (SDMT), Paced Auditory Serial Addition Test (PASAT), Selective Reminding Test (SRT), Brief Visuospatial Memory Test (BVMT-R), two subjective cognitive measures, Beck Depression Inventory (BDI-FS), Timed 25-foot Walk Test, Nine Hole Peg Test, measures of brain volume, and T2 lesion volume.RESULTSThe outcomes were evaluated at baseline, 48-, and 96-week follow-up. There were no significant differences in cognitive change between treatment arms. SDMT and PASAT scores improved over 96-weeks: mean SDMT scores by 4.5 points (SD 9.3), mean PASAT scores by 2.4 points (SD 9.4). Verbal and visuospatial memory test performance showed no consistent change. All MRI measures showed decreased brain volumes. NHPT scores worsened little and T25FW showed steadily worsening scores.CONCLUSIONSImprovements in SDMT and PASAT performance were observed regardless of treatment arm. These findings are consistent with prior studies in MS. As it is unlikely that cognition improves over time in people with a chronic neurologic disease, these results support the need for cognitive outcomes that overcome practice and learning effects to accurately quantify change.

07 Apr 2025·Current Neuropharmacology

Comparing STRATIFY JCV™ DxSelect™ and IMMUNOWELL™ JCV IgG Tests in RRMS to Assess PML Risk

Article

Author: Zanghì, Aurora ; Marinelli, Fabiana ; D’Amico, Emanuele ; Filippo, Paola Sofia Di ; Avolio, Carlo

Background:The risk of developing progressive multifocal leukoencephalopathy (PML), a rare but potentially fatal opportunistic infection of the Central Nervous System caused by the J.C. virus (JCV), remains a primary concern associated with natalizumab therapy in the clinical management of patients diagnosed with multiple sclerosis (MS).Materials and Methods:This study compared two tests, STRATIFY JCV™ DxSelect™, and IMMUNOWELL ™ JCV IgG, for assessing the risk of PML in patients diagnosed with relapsingremitting multiple sclerosis (RRMS) who had received disease-modifying therapy (DMT) with branded natalizumab (Tysabri®). The main objective was to determine the comparability of these tests in classifying PML risk. Eligible patients were selected from a database, and all specimens for the STRATIFY JCV™ DxSelect™ and IMMUNOWELL™ JCV IgG tests were collected on the same day. Patients were classified into three risk categories (low, intermediate, or high) based on threshold values for each test.Results:The analysis showed 85.5% agreement between the two tests for risk classification. Ten discordant cases were identified, mainly between intermediate- and high-risk categories. Compared to STRATIFY JCV™ DxSelect™, IMMUNOWELL™ tended to categorize more patients as higher risk. No significant association was found between discordance and prior use of immunosuppressant drugs and >24 doses of natalizumab. The agreement between tests, assessed with the weighted Kappa coefficient, was moderate (κ=0.6222).Conclusions:Compared to the STRATIFY JCV™ DxSelect™, the IMMUNOWELL™ JCV test tends to place more patients in higher risk categories. Further, longitudinal studies are needed to evaluate the clinical impact of these differences in PML risk assessment.

174

News (Medical) associated with Natalizumab

01 May 2025

·www.pharmaceutical-technology.com

Biogen’s Q1 revenue soars past estimates as rare disease pivot pays off

Spinal muscular atrophy treatment Spinraza (nusinersen) became Biogen’s best-selling drug in Q1 2025. Image credit: Shutterstock/ Tada Images. Biogen has unveiled Q1 2025 revenues above estimates, spurred by strong sales of rare disease assets amid a sales dropoff from its multiple sclerosis business. Quarterly revenues for the neurological disease drugmaker were $2.43bn, above analyst group William Blair’s estimates of $2.3bn. The Q1 sales performance represents a 6% increase compared to the same period in 2024, with Biogen ramping up commercial duties for existing drugs and buying assets during that time. One of those assets is Skyclarys, a drug picked up in a $7.3bn acquisition of Reata Pharmaceuticals in September 2023. The treatment for the neurodegenerative disorder Friedreich’s ataxia generated revenue of $124m in Q1, a value that had already taken into account the impact seen in US sales due to Medicare discount dynamics. Approved in the US, Europe, and UK, amongst others, Skyclarys has a high growth ceiling. GlobalData’s Pharma Intelligence Centre forecasts sales of $1.3bn by 2031. GlobalData is the parent company of Pharmaceutical Technology . Skyclarys is one of the drugs spurring a change of the guard in Biogen’s pipeline. The company is well known for its host of multiple sclerosis treatments, such as Vumerity (diroximel fumarate), Tysabri (natalizumab), and Avonex (interferon beta-1a). But, sales for these treatments have declined over the years as biosimilars entered the market. The company’s multiple sclerosis business shrank 11% in Q1 2025 compared to the same period last year. GlobalData Strategic Intelligence US Tariffs are shifting - will you react or anticipate? Don’t let policy changes catch you off guard. Stay proactive with real-time data and expert analysis. By GlobalData Learn more about Strategic Intelligence “Biogen is really, a tale of two companies in my view. There’s one company which has been a multiple sclerosis company, and that portfolio, as you all know, has been gradually declining,” said Biogen’s CEO Chris Vibacher in a Q1 earnings call. “But there’s a new Biogen emerging. And when I look at the rare disease business […] we actually have a commercial portfolio that we’re actively promoting that’s now gotten to be about 45% of our product revenue. And those products mostly have a very long runway to continue to grow,” Vibacher added. Alongside Skyclarys, Biogen’s rare disease business is headed by spinal muscular atrophy treatment Spinraza (nusinersen). Spinraza generated global Q1 2025 sales of $423.9m, up from $341.3m in Q1 2024. This increase, coupled with the decline of Tysabri, meant Spinraza was Biogen’s best-selling drug in Q1 2025. Leqembi’s “modest growth” Another key part of Biogen’s business model is its Alzheimer’s segment, now solely headed by Leqembi (lecanemab) after the company discontinued Aduhelm (aducanumab) at the start of 2024. Biogen splits revenue from Leqembi with co-developer Eisai equally, the latter reporting Q1 sales of $96m for the drug. The US, where Leqembi got a full approval in July 2023, accounted for $52m of those sales. Biogen has already secured key milestones for Leqembi this year. In January, the US Food and Drug Administration (FDA) approved maintenance dosing of Leqembi, a move expected to expand its market share. Then in April, the Leqembi was authorised for use in the European Union (EU). Biogen said the Q1 sales for Leqembi represented “continued sequential growth.” William Blair analyst Myles R. Minter said in a research note that: “Skyclarys had a strong quarter, but the commercial focus remains on Leqembi, which has seen only modest growth, in our view.” In the mergers and acquisitions space, Biogen failed a $469m takeover bid of Sage Therapeutics in January.

Drug ApprovalAcquisitionBiosimilar

30 Apr 2025

·www.globenewswire.com

Sandoz reports Q1 2025 net sales in line with company expectations; full-year guidance confirmed

Ad-hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules MEDIA RELEASE Q1 2025 net sales of USD 2,480 million up by 3% in constant currencies (cc); stable in USDup by 5%[1] at a comparable growth rate (CGR), when adjusted for impact of 2024 acquisition of US biosimilar Cimerli® (ranibizumab) and 2024 divestment of China businessten largest-selling medicines grew by combined 4% and represented 33% of net sales Europe net sales grew by 7%[1]. International declined by 2%[1] and increased by 2% when adjusted for China divestment. Net sales in North America grew by 1%[1] and, adjusted for Cimerli acquisition, by 3%Anticipated biosimilar launches primarily weighted to second half of year. Launches include Wyost®/Jubbonti® (denosumab) in Europe and US, Tyruko® (natalizumab) in US[2] and Afqlir® (aflibercept) in EuropeFavorable moves towards regulatory streamlining of biosimilar development reflected in decision to minimize pembrolizumab Phase III trialFull-year impact of US government’s confirmed recent tariffs within guidanceFull-year 2025 guidance confirmed: mid single-digit net-sales growth[1] and core EBITDA margin of around 21% Basel, April 30, 2025 – Sandoz (SIX: SDZ / OTCQX: SDZNY), the global leader in generic and biosimilar medicines, today presents its net-sales update for the first quarter of 2025. Richard Saynor, Chief Executive Officer of Sandoz, commented: “With Q1 sales in line with our expectations, we have now delivered fourteen consecutive quarters of top-line growth. This reconfirms our growing track record of execution and performance, driven by commercial excellence and an expanding biosimilar pipeline and portfolio, underpinned by our generics base. I’m looking forward to additional growth in the second quarter and further progress this year as we launch more biosimilar medicines. “With our business continuing to grow, we are confident of delivering more affordable medicines for patients and savings for society, while producing sustainable growth in sales, profitability and cash generation. It is the powerful combination of delivery and pioneering access for patients that makes us proud to be part of the Sandoz growth journey.” FULL-YEAR 2025 GUIDANCE The Company expects further major biosimilar launches later this year, while price erosion is expected to return to normalised levels of a low to mid-single-digit percentage. Sandoz anticipates core EBITDA-margin expansion to reflect the mix of sales, simplification of the external network and the ongoing transformation program. As a result, the Company continues to expect: FY 2025 net sales to grow by a mid single-digit percentage[3] a core EBITDA margin in FY 2025 of around 21% This guidance excludes any impacts of unforeseen events or unconfirmed developments, such as significant further potential trade tariffs emanating from the US government. FIRST-QUARTER NET SALES Net sales for the first quarter amounted to USD 2,480 million, representing growth of 3%[3]. Volume contributed six percentage points of growth, partly offset by price erosion of three percentage points. Q1 2025% of Net SalesQ1 2024 % changeUSD m USD m USDccCGR[3] Generics1,809731,869 -302Biosimilars67127623 81114Net Sales2,4801002,492 035 Generics overviewNet sales for the first quarter were USD 1,809 million, reflecting a stable performance[3] (+2% on a CGR basis). Generics represented 73% of total net sales (Q1 2024: 75%). Europe sales of generics grew in the first quarter, driven by the effect of launches in 2024. International net sales declined, with the impact from the divested China business outweighing growth in other markets. In North America, generics’ net-sales growth benefitted from the successful recent launch of paclitaxel. Biosimilars overviewNet sales for the first quarter were USD 671 million, reflecting growth of 11%[3] (+14% on a CGR basis). Biosimilars represented 27% of total net sales (Q1 2024: 25%). Strong Europe biosimilars’ net-sales growth benefitted from a number of good performances, including Hyrimoz® (adalimumab) and recently launched Pyzchiva® (ustekinumab), while International biosimilar net sales also saw a strong contribution from Omnitrope® (somatropin). North America biosimilar net sales declined, reflecting the withdrawal of Cimerli during the quarter; excluding the impact of the 2024 acquisition Cimerli, North America biosimilar net sales increased. Net sales by region Q1 2025% of Net SalesQ1 2024 % changeUSD m USD m USDccCGR[4] Europe1,372551,326 377International59024642 -8-22North America51821524 -113Net Sales2,4801002,492 035 Europe overviewNet sales for the first quarter amounted to USD 1,372 million, reflecting growth of 7%[4]. Europe net sales of generics grew in the first quarter, with higher growth in biosimilars primarily a result of recent launches, including Pyzchiva. International overviewNet sales for the first quarter amounted to USD 590 million, reflecting a decline of 2%[4]. Excluding the impact of the divestment of the China business, growth amounted to 2%[4]. Pricing increased in both generics and biosimilars during the quarter, with strong biosimilar net sales partly a result of the continued good performance from Omnitrope. North America overviewNet sales for the first quarter amounted to USD 518 million, reflecting growth of 1%[4]. Excluding the impact of the withdrawal of Cimerli, growth amounted to 3%[4]. A good performance from generics was driven by the successful recent launch of paclitaxel, as well as continued strong growth in Canada. Biosimilar net-sales growth would have been positive when excluding the impact of the 2024 acquisition of Cimerli. Price erosion was driven by reduced Cimerli and private-label adalimumab pricing. US TARIFFS The only tariffs applicable to the Company, as part of recent implementation from the US government, is a total 20% China tariff, implemented on March 4, 2025, and a tariff on any medicines coming from Canada but outside the scope of the United States-Mexico-Canada Agreement. These impacts have been incorporated within full-year guidance. The Sandoz manufacturing footprint consists of 15 sites, including 11 in Europe and one in the US, from which the latter does not export to Europe. US first-quarter net sales represented less than one-fifth of total net Q1 sales. REGULATORY STREAMLINING: BIOSIMILARS Reflecting encouraging and favourable developments, Sandoz has decided to minimize its ongoing Phase III trial in patients with untreated metastatic non-squamous non-small cell lung cancer for the proposed biosimilar, pembrolizumab. The ongoing Phase I pharmacokinetic trial is continuing as planned. This decision was partly based on communications with the US FDA, as well as a reflection paper published by the European Medicines Agency. The Company is assessing implications, including for its wider biosimilars pipeline. In April 2025, Sandoz announced the filing of an antitrust lawsuit in the US against Amgen, Inc. (Amgen), for extending and entrenching the dominant market position of Enbrel®[5] (etanercept), first approved by the US FDA in 1998. Sandoz alleges that Amgen blocked competition from more cost-effective biosimilar competitors, including Sandoz etanercept biosimilar, Erelzi®[6] (etanercept-szzs), by unlawfully purchasing and using certain patent rights to entrench its position in the market. KEY LINKS A conference call and webcast for investors and analysts will begin today at 9am CET. Details can be found here, with the accompanying presentation here. CALENDAR The Company intends to publish its half-year results on August 7, 2025. [1] In constant currencies (cc).[2] Subject to FDA approval of John Cunningham virus assay.[3] In constant currencies (cc).[4] In constant currencies (cc).[5] Enbrel® is a registered trademark of Amgen, Inc.[6] Erelzi® is a registered trademark of Sandoz, Inc. CONTACTS Media Relations contactsInvestor Relations contactsglobal.mediarelations@sandoz.cominvestor.relations@sandoz.comAlex Kalomparis+41 79 279 02 85Craig Marks+44 7818 942 383Joerg E. Allgaeuer+49 171 838 4838Tamara Hackl+41 79 790 52 17Danja Spring+41 79 156 74 88Rupreet Sandhu+41 79 410 54 72 DISCLAIMER This media release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly update or revise any forward-looking statements, except as required by law. This media release includes non-IFRS financial measures as defined by Sandoz. An explanation of non-IFRS measures can be found in the Supplementary financial information of the latest Integrated Annual Report. ABOUT SANDOZ Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 people of 100 nationalities work together to ensure more than 900 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2024, Sandoz recorded net sales of USD 10.4 billion. APPENDIX QUARTERLY NET SALES The Company intends to provide the net-sales performance by region by generics/biosimilars at each half-year and full-year results. FY 2024 Q1 2024% change Q2 2024% change Q3 2024% change Q4 2024% change USD mUSD cc USD mUSDcc USD mUSDcc USD mUSDccGenerics 1,86901 1,835-11 1,85434 1,94614Biosimilars6232121 7203537 7413637 7692325Net Sales 2,49256 2,55579 2,5951112 2,71579 Q1 2024% change Q2 2024% change Q3 2024% change Q4 2024% change USD mUSD cc USD mUSDcc USD mUSDcc USD mUSDccEurope 1,32642 1,30823 1,3621312 1,36778International642412 62759 63528 65306North America52466 6202223 5981718 6951314Net Sales 2,49256 2,55579 2,5951112 2,71579 Attachment Media release_Q1 2025 sales.pdf

BiosimilarDrug ApprovalPhase 3Phase 1Acquisition

05 Mar 2025

·www.prnewswire.com

Global Interferons Market is Predicted to Reach ~USD 14 Billion by 2032 | DelveInsight

The increasing occurrence of chronic and infectious diseases is the main driver of the rising demand for interferon. Furthermore, advancements in interferon production and ongoing research and development of innovative interferon therapies are key factors fueling the expansion of the interferon market from 2025 to 2032. LAS VEGAS, March 5, 2025 /PRNewswire/ -- DelveInsight's Interferons Market Insights report provides the current and forecast market analysis, individual leading interferons companies' market shares, challenges, interferons market drivers, barriers, trends, and key market interferons companies in the market. Key Takeaways from the Interferons Market Report As per DelveInsight estimates, North America is anticipated to dominate the global interferons market during the forecast period. In the application segment of the interferon market, the leukemia category captured a significant revenue share in 2024. Notable interferons companies such as Bayer AG, Amega Biotech, Biogen, Merck KGaA, Novartis AG, Pfizer Inc., F. Hoffmann-La Roche Ltd., Biosidus, AOP Orphan Pharmaceuticals GmbH, Reliance Life Sciences, and several others, are currently operating in the interferons market. In September 2022, Eiger BioPharmaceuticals, a commercial-stage biopharmaceutical company focused on the development of innovative therapies for hepatitis delta virus (HDV) and other serious diseases, provided an update on the status of its planned request for emergency use authorization (EUA) of peginterferon lambda for the treatment of patients with mild-to-moderate COVID-19 based on its most recent communications with the U.S. Food and Drug Administration (FDA). To read more about the latest highlights related to the interferons market, get a snapshot of the key highlights entailed in the Global Interferons Market Report Interferons Overview Interferons (IFNs) are a group of signaling proteins that play a critical role in the immune response, particularly in defending against viral infections and modulating the activity of immune cells. They are classified into three main types: Type I (such as IFN-α and IFN-β), Type II (IFN-γ), and Type III (IFN-λ). Type I interferons are primarily produced in response to viral infections and function by activating antiviral pathways in host cells, inhibiting viral replication, and enhancing the activity of natural killer (NK) cells. IFN-γ, the sole Type II interferon, is crucial for activating macrophages and promoting adaptive immune responses, particularly in bacterial and tumor immunity. Type III interferons share functional similarities with Type I IFNs but act more selectively on epithelial cells, making them important in mucosal immunity. Beyond their antiviral properties, interferons have significant roles in cancer immunotherapy and autoimmune diseases. They enhance antigen presentation, stimulate cytotoxic T cells, and modulate the tumor microenvironment, contributing to immune surveillance against malignancies. Clinically, recombinant interferons have been used to treat conditions such as hepatitis B and C, multiple sclerosis, and certain cancers. However, prolonged interferon therapy can lead to adverse effects, including flu-like symptoms, fatigue, and autoimmune complications. Recent research is focused on optimizing interferon-based therapies and combining them with immune checkpoint inhibitors or other immunomodulators to improve efficacy while minimizing toxicity. Interferons Market Insights North America holds the largest interferons market share due to a strong presence of biopharmaceutical companies, robust R&D investments, and high healthcare expenditure. The U.S. market, in particular, benefits from a well-established regulatory framework and widespread adoption of advanced biotherapeutics. Meanwhile, Europe follows closely, with key contributions from Germany, France, and the UK, where government support for biotech innovation and access to novel biologics drive market expansion. In the Asia-Pacific region, the interferon market is witnessing rapid growth, fueled by rising healthcare infrastructure, an increasing prevalence of infectious diseases, and government initiatives to boost biopharmaceutical production. China and India are emerging as major players, with domestic companies investing heavily in biosimilar development and expanding manufacturing capacities. Latin America and the Middle East & Africa are also showing potential, albeit at a slower pace, due to improving healthcare access and growing awareness of biologic treatments. However, market expansion in these regions is challenged by high drug costs and regulatory hurdles, which may impact the adoption of interferon therapies. To know more about why North America is leading the market growth in the interferons market, get a snapshot of the Interferons Market Outlook Interferons Market Dynamics The interferons market is driven by their critical role in treating viral infections, autoimmune diseases, and various cancers. Interferons (IFNs) are a class of cytokines that modulate the immune response, making them valuable in antiviral therapies (such as hepatitis B and C), multiple sclerosis, and oncology applications. The increasing prevalence of these diseases, along with rising research into novel interferon-based therapies, continues to fuel market growth. However, the market faces challenges due to the emergence of alternative therapies, such as monoclonal antibodies and small-molecule inhibitors, which offer higher efficacy and fewer side effects. One of the key factors influencing market dynamics is the shift from traditional interferon therapies to newer, more targeted treatments. For instance, in the treatment of hepatitis C, direct-acting antiviral agents (DAAs) have largely replaced interferon-based regimens due to their superior cure rates and reduced adverse effects. Similarly, in multiple sclerosis, oral therapies and monoclonal antibodies such as ocrelizumab and natalizumab have overshadowed interferon-beta treatments. Despite this, interferons remain relevant in certain applications, such as rare cancers and specific immune disorders where alternative treatments are not as effective. Another factor shaping the interferons market is the regulatory landscape. Interferons are biologic drugs, meaning they are subject to stringent approval processes and high production costs. The development of biosimilar interferons has the potential to make these therapies more accessible, especially in emerging markets. However, biosimilars face challenges in gaining market traction due to concerns about immunogenicity and physician preference for established brands. Companies investing in next-generation interferons with improved efficacy and safety profiles may have an opportunity to capture a share of this evolving market. Looking ahead, the future of the interferons market will be shaped by ongoing innovation, competitive pressures, and the need for cost-effective biologics. While traditional interferon therapies may continue to decline in some areas, their role in niche indications and combination therapies could sustain market demand. Companies focusing on improving delivery methods, reducing side effects, and exploring novel interferon applications in immuno-oncology and rare diseases may unlock new growth opportunities in this evolving landscape. Get a sneak peek at the interferons market dynamics @ Interferons Market Dynamics Analysis Interferons Market Assessment Interferons Market Segmentation Interferons Market Segmentation By Type: Alpha, Beta, and Gamma Interferons Market Segmentation By Application: Hepatitis B, Hepatitis C, Leukemia, Multiple Sclerosis, and Others Interferons Market Segmentation By Distribution Channel: Hospital Pharmacies, Retail Pharmacies, and Others Interferons Market Segmentation By Geography: North America, Europe, Asia-Pacific, and Rest of World Porter's Five Forces Analysis, Product Profiles, Case Studies, KOL's Views, Analyst's View Which MedTech key players in the interferons market are set to emerge as the trendsetter explore @ Interferons Companies Table of Contents Interested in knowing the interferons market by 2032? 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Chronic Hepatitis B Pipeline Chronic Hepatitis B Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key chronic hepatitis B companies, including Vedanta Biosciences, Gilead Sciences, Dong-A ST Co, Assembly Biosciences, Arbutus Biopharma, Vir Biotechnology, Antios Therapeutics, Ascletis Pharmaceuticals, Shanghai HEP Pharmaceutical, Romark Laboratories, Qilu Pharmaceutical, Golden Biotechnology, Sunshine Lake Pharma, Ascentage Pharma, GlaxoSmithKline, Janssen Sciences, Henlix, Enyo Pharma, Tasly Tianjin Biopharmaceutical, Brii Biosciences, Vaxine Pty Ltd, Vaccitech limited, Zhejiang Palo Alto Pharmaceuticals, Suzhou Ribo Life Science, PharmaEssentia, Nucorion Pharmaceuticals, Jiangsu HengRui Medicine, Enanta Pharmaceuticals, Chong Kun Dang Pharmaceutical, Guangzhou Lupeng Pharmaceutical, VenatoRx Pharmaceuticals, Zhimeng Biopharm, among others. About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Immunotherapy

100 Deals associated with Natalizumab

External Link

KEGG	Wiki	ATC	Drug Bank
D06886	Natalizumab	L04AA23	DB00108

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Crohn Disease	United States	Biogen, Inc.	14 Jan 2008
Multiple Sclerosis, Relapsing-Remitting	Norway	Biogen Netherlands BV	27 Jun 2006
Multiple Sclerosis, Relapsing-Remitting	Liechtenstein	Biogen Netherlands BV	27 Jun 2006
Multiple Sclerosis, Relapsing-Remitting	European Union	Biogen Netherlands BV	27 Jun 2006
Multiple Sclerosis, Relapsing-Remitting	Iceland	Biogen Netherlands BV	27 Jun 2006
Multiple Sclerosis	United States	Biogen, Inc.	23 Nov 2004

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Multiple Sclerosis, Relapsing-Remitting	Phase 3	Canada	Biogen, Inc.	01 Nov 2001
Crohn Disease	Preclinical	European Union	Elan Pharma International Ltd.	15 Nov 2007
Multiple Sclerosis, Relapsing-Remitting	Preclinical	United Kingdom	Elan Corp. Plc	01 Nov 2001
Multiple Sclerosis, Relapsing-Remitting	Preclinical	United States	Elan Corp. Plc	01 Nov 2001
Multiple Sclerosis, Relapsing-Remitting	Preclinical	Canada	Elan Corp. Plc	01 Nov 2001
Crohn Disease	Discovery	European Union	Elan Pharma International Ltd.	15 Nov 2007
Multiple Sclerosis, Relapsing-Remitting	Discovery	Czechia	Elan Corp. Plc	01 Nov 2001
Multiple Sclerosis, Relapsing-Remitting	Discovery	United Kingdom	Elan Corp. Plc	01 Nov 2001
Multiple Sclerosis, Relapsing-Remitting	Discovery	Canada	Elan Corp. Plc	01 Nov 2001
Multiple Sclerosis, Relapsing-Remitting	Discovery	United States	Elan Corp. Plc	01 Nov 2001

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00027300 (AFFIRM, Pubmed \| Mult Scler) Manual	Phase 3	Multiple Sclerosis, Relapsing-Remitting	-	Natalizumab	qkyfsdmrbu(cbdlrksutt) = dpujvuztrl drvyiyuyyi (stzrydtyrk ) View more	Positive	12 Mar 2024
				placebo	-
ACTRIMS2024	Not Applicable	-	-	Natalizumab	lnsciaztjl(qjgkybyues) = The therapy was well tolerated, with COVID-19, nausea, and headache among the most common adverse events wkextqyuqh (vlelqkmdrp )	-	01 Mar 2024
				Cladribine tablets
ACTRIMS2024	Not Applicable	Multiple sclerosis relapse	69	Natalizumab	rwidlzvvqw(uiiolbaybx) = ifyqnuxvnc doysifxrix (clttjozoym ) View more	Positive	01 Mar 2024
				Ocrelizumab	rwidlzvvqw(uiiolbaybx) = kosyrazawo doysifxrix (clttjozoym ) View more
ACTRIMS2024	Not Applicable	Multiple Sclerosis	258	Natalizumab	dwgdbkqllr(ugnjeetfzh) = opqrukrhdo fkqdgpnhiz (nwcdxrfqpb )	Negative	01 Mar 2024
				Ocrelizumab	(yilsbsqnnd) = zzdwalolax nbgrxkdnvi (mglqviynpb ) View more
ACTRIMS2024	Not Applicable	Multiple sclerosis relapse John Cunningham Virus (JCV) serology	-	Extended Interval Dosing (EID) Natalizumab	unktnueevk(wepxxzerfh) = muikmafnta reihzmeedb (pprwxhqtst ) View more	Positive	29 Feb 2024
				Standard Interval Dosing (SID) Natalizumab	unktnueevk(wepxxzerfh) = ezpcjgzgnm reihzmeedb (pprwxhqtst ) View more
NCT05304520 (SISTER, Pubmed \| Ther Adv Neurol Disord) Manual	Not Applicable	Multiple Sclerosis, Relapsing-Remitting	262	Subcutaneous natalizumab	dsdzzxswfb(psbgbihbjl) = vlrskclrqj wgucifixdt (nljiofbojw )	Positive	01 Jan 2024
				Intravenous natalizumab	dsdzzxswfb(psbgbihbjl) = ihprczvbry wgucifixdt (nljiofbojw ) View more
NOVA trial (ECTRIMS2023)	Not Applicable	JCV+	220	Natalizumab (Extended Interval Dosing (EID))	pqjeclpmch(jnmqmxjbbv) = One case of PML occurred in each group tjfskquddd (zokuvzizfj ) View more	Negative	30 Sep 2023
				Natalizumab (Standard Dosing)
ECTRIMS2023	Not Applicable	Multiple Sclerosis, Relapsing-Remitting	69	Ocrelizumab	ebxkmyachr(mbxhwktwdb) = nniwbejjoi zbbwqcdibj (dktflwldyo, 8 - 16) View more	Positive	30 Sep 2023
				Natalizumab	(teibnsjuvn) = evzhdrresf rbehaqgeil (vxqwenqseu )
ECTRIMS2023	Not Applicable	Leukoencephalopathy, Progressive Multifocal JC virus (JCV)	86	Natalizumab (NTZ PML cases)	gzfbzyggqj(wgkdnyohnf) = bfafkvrice vxzdlgjlvj (bscxgreiwf )	Positive	30 Sep 2023
ECTRIMS2023	Not Applicable	COVID-19	-	Rituximab	iewsfehdke(drycujsrtc) = yxyqhqtxwg zuluqcccft (bydcwanlkf ) View more	-	30 Sep 2023
				Natalizumab	iewsfehdke(drycujsrtc) = tobfsypjtw zuluqcccft (bydcwanlkf ) View more

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