Observational data have suggested no increased risk of adverse pregnancy outcomes associated with exposure to interferon-beta (IFNB) before or during pregnancy. After the emergence of these data, the European Medicines Agency approved a label change for IFNB in September 2019, stating that use of IFNB during pregnancy may be considered, if clinically needed. However, limited data on pregnancies exposed in the 2nd and 3rd trimesters were observed.
INFORM is a secondary use of data drug utilisation study (DUS) to determine late pregnancy exposure (i.e. during the 2nd and 3rd trimester) to IFNB in Finland and Sweden, which will inform whether the number of exposed pregnancies is adequate to conduct a cohort study on adverse pregnancy outcomes, with a focus on late pregnancy exposure.
The number of pregnancies will be initially reported three years after the revised label implementation (September 2019) and will include data on pregnancies from 1996 in Finland and from 2005 in Sweden up through 31 December 2022. If the number of pregnancies is deemed adequate for conducting the cohort study on adverse pregnancy outcomes, this DUS will be finalised with the drug utilisation data accrued up through 31 December 2022. If the number of pregnancies until 31 December 2022 is deemed inadequate, this study may be continued and the primary and secondary objectives may be examined five years after the revised label implementation, including pregnancies until 31 December 2024.

Start Date20 Mar 2024

Sponsor / Collaborator

Bayer AG

[+3]

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.

PACTR202205508723236

/ SuspendedPhase 3IIT

A multi-centre, placebo-controlled studyof interferon beta-1a in high risk COVID-19 outpatients (InterCoV)

Start Date15 May 2022

Sponsor / Collaborator-

100 Clinical Results associated with Interferon Beta-1a (Biogen, Inc.)

100 Translational Medicine associated with Interferon Beta-1a (Biogen, Inc.)

100 Patents (Medical) associated with Interferon Beta-1a (Biogen, Inc.)

1,510

Literatures (Medical) associated with Interferon Beta-1a (Biogen, Inc.)

01 Jun 2025·NEUROREHABILITATION

What Is the Evidence on Immunomodulators and Immunosuppressants for Progressive Multiple Sclerosis? - A Cochrane Review Summary with Commentary.

Review

Author: Moretti, Antimo

BackgroundMultiple sclerosis (MS) is a chronic inflammatory demyelinating disease affecting the central nervous system and is a major cause of disability in adults, particularly in those affected by progressive MS. A variety of drugs with different effects, some carrying significant risks, are currently available, making evidence-based approach essential for clinicians treating MS patients.ObjectiveTo compare the efficacy and safety of immunomodulators and immunosuppressants for progressive multiple sclerosis (PMS).MethodsA systematic search was performed in CENTRAL, MEDLINE, Embase, and trials registers on 8 august 2022, including RCTs comparing immunomodulators and immunosuppressants versus placebo or another drug.ResultsThe network meta-analysis (NMA) included 23 RCTs (with 10,167 participants). Moderate certainty of evidence suggests that rituximab probably not reduce the risk of relapse at 2 years, while interferon beta-1b probably reduces the risk of relapses at 3 years (-18%) compared to placebo in PMS people. Regarding SAE, low-to-very-low certainty of evidence for no increased risk with disease-modifying therapies (DMTs) versus placebo is available, except for immunoglobulins that seem to have a 7-fold increased risk of serious adverse events (SAEs). Only low-to-very low certainty of evidence is available about disability progression and SAEs in PMS people treated with DMTs versus placebo. On the other side, the risk for treatment discontinuation due to AEs is increased with interferon beta-1a by 2.93-fold, and probably increased with interferon-beta-1b, glatiramer acetate, and fingolimod by 2.98-fold, 3.98-fold, and 2.29-fold, respectively. Also, rituximab, natalizumab, siponimod, and ocrelizumab probably do not increase the risk for treatment discontinuation due to AEs, while laquinimod may not increase the risk treatment discontinuation due to AEs.ConclusionsCompared with placebo, two-, and three-year treatment with rituximab or interferon beta-1b, respectively, probably slightly reduce relapses in PMS people. A slight increase of treatment discontinuation due to AEs has been reported for rituximab, interferon beta-1b, interferon beta-1a, immunoglobulins, glatiramer acetate, natalizumab, fingolimod, siponimod, and ocrelizumab. No reliable evidence is available for disability progression and SAEs with available DMTs compared to placebo.

01 Jun 2025·EUROPEAN JOURNAL OF NEUROLOGY

Glial Fibrillary Acidic Protein as a Marker of Disease in Relapsing Multiple Sclerosis: Post Hoc Analysis of Phase 3 Ozanimod Trials

Article

Author: Comi, Giancarlo ; Arnold, Douglas L. ; Steinman, Lawrence ; Kappos, Ludwig ; Cohen, Jeffrey A. ; Cree, Bruce A. C. ; Harris, Sarah ; Maddux, Rachel ; Southworth, Harry ; Sheffield, James K.

ABSTRACT:

Background:

This post hoc analysis investigated relationships between baseline plasma glial fibrillary acidic protein (GFAP), a potential biomarker for multiple sclerosis (MS), and baseline characteristics and on‐treatment outcomes in participants with relapsing MS (RMS) from two Phase 3 trials that randomly assigned ozanimod 0.46 mg or 0.92 mg or interferon β‐1a 30 μg.

Methods:

In the Phase 3 trials (SUNBEAM [ClinicalTrials.gov: NCT02294058; EudraCT: 2014–002320‐27], duration: ≥ 12 months; and RADIANCE [ClinicalTrials.gov: NCT02047734; EudraCT: 2012–002714‐40], duration: 24 months) baseline plasma GFAP was measured via Simoa (Quanterix). Adjusted regression models were used to determine relationships between baseline GFAP and baseline participant characteristics and to predict on‐treatment outcomes.

Results:

Baseline GFAP was associated with sex and had inverse associations with baseline body mass index and whole brain volume (WBV). Baseline GFAP had positive associations with baseline age, neurofilament light chain, numbers of gadolinium‐enhancing (GdE) and T2 lesions, and Expanded Disability Status Scale (EDSS) score. Baseline GFAP had inverse associations with on‐treatment WBV and the proportion of participants with no evidence of disease activity‐3. Baseline GFAP had positive associations with on‐treatment number of relapses through Months 12 and 24, number of GdE lesions at Month 12, number of new/enlarging T2 lesions over 12 months, and Month 12 EDSS score. In a multivariable lasso model, baseline GFAP concentration independently predicted only the number of relapses through Month 12.

Conclusions:

These data suggest that plasma GFAP is a relapse‐independent metric of baseline disease severity and a predictor of treatment response in participants with RMS.

01 May 2025·NATURE IMMUNOLOGY

Interferon-β treatment restores myeloid function and reverses immunosuppression in sepsis

Article

Systemic inflammation, such as sepsis, starts with excessive inflammation and is followed by a long-lasting immunosuppressed state.Using single-cell transcriptomics and functional assays, we show that the immunosuppression is driven by impaired monocyte maturation and reduced type I interferon signaling, which could be reversed by treatment with interferon-β.

News (Medical) associated with Interferon Beta-1a (Biogen, Inc.)

02 Jul 2025

·www.einpresswire.com

Amyotrophic Lateral Sclerosis (ALS): Competitive Intelligence Insight into Next-Gen Therapies | DataM Intelligence

ALS treatment is evolving from symptom management to disease-modifying strategies gene therapies, antisense drugs, & neuroprotective agents promise real impact ALS, once incurable, is seeing remarkable progress. With gene interventions and neuroprotective molecules entering late-stage trials, the vision of slowing or halting progression is closer than ever.” — DataM Intelligence AUSTIN, TX, UNITED STATES, July 2, 2025 / EINPresswire.com / -- Amyotrophic Lateral Sclerosis (ALS) , often known as Lou Gehrig’s disease, is a fatal neurodegenerative disorder that progressively destroys motor neurons, leading to paralysis and death. It remains one of the most complex and devastating neurological diseases, with a prognosis of just 2 to 5 years post-diagnosis for most patients. However, the landscape in 2025 reflects significant progress. With deeper genetic insights and a diversified therapeutic pipeline, ALS is transitioning from symptom management toward disease modification. Download CI Sample Report: https://www.datamintelligence.com/strategic-insights/ci/amyotrophic-lateral-sclerosis-als 🧬 Disease Overview ALS causes the degeneration of both upper and lower motor neurons, disrupting voluntary muscle activity. This leads to severe muscle wasting, difficulties in swallowing and breathing, and ultimately, respiratory failure. While about 90% of ALS cases are sporadic, the remaining 10% are familial, frequently linked to mutations in genes such as SOD1, C9orf72, TARDBP, and FUS. Diagnosis is typically clinical, supported by electromyography (EMG), nerve conduction studies, and exclusion of mimicking conditions. Biomarker development is ongoing, aiming to enable earlier diagnosis and patient stratification for clinical trials. 🌍 Epidemiology & Market Landscape Globally, ALS affects an estimated 2–5 people per 100,000, with an annual incidence of 1–2 per 100,000. The disease is more common in individuals aged 55–75 and is slightly more prevalent in men. Due to its high mortality and lack of curative therapies, ALS qualifies for orphan drug status in major markets. This regulatory incentive, combined with strong advocacy and rising R&D investment, is accelerating the therapeutic pipeline. The ALS treatment market, valued at around USD 2 billion in 2024, is projected to grow steadily with the entry of novel disease-modifying therapies over the next five years. 💊 Current Treatment Paradigm The current standard of care is limited to supportive and symptomatic therapies. These include: - Riluzole: Approved in 1995, it modestly extends survival by a few months by reducing glutamate-mediated excitotoxicity. - Edaravone: Approved in 2017, it acts as a free radical scavenger, slightly delaying functional decline in early-stage ALS. - Nuedexta: Although not approved specifically for ALS, it is commonly used to manage pseudobulbar affect (PBA), improving emotional stability. While helpful, these therapies do not halt or reverse the disease, highlighting a clear unmet need for disease-modifying approaches. Book Free CI Consultation Call: https://www.datamintelligence.com/strategic-insights/ci/amyotrophic-lateral-sclerosis-als 🔬 Pipeline Innovation and Competitive Momentum The ALS pipeline in 2025 is driven by a multi-pronged approach, including gene silencing, neuroprotection, immunomodulation, and cellular therapies. Key areas of innovation include: Gene-Targeted Therapies - Biogen’s Tofersen, an antisense oligonucleotide (ASO) targeting SOD1 mutations, has shown promise in reducing SOD1 protein levels and slowing disease progression in familial ALS. It represents the first real attempt at targeting a genetic driver in ALS with precision. - Another gene-targeted agent, BIIB100, is in early-phase trials to treat C9orf72-associated ALS, a common cause of familial and sporadic cases. These therapies are designed to address root-cause mutations and could revolutionize ALS management in genetically stratified patients. Neuroprotective and Combination Therapies - AMX0035, a fixed-dose combination of sodium phenylbutyrate and taurursodiol, showed significant survival benefit and slower functional decline in late-phase trials. With a favorable safety profile and oral administration, it’s emerging as a strong candidate for broad use across ALS populations. - Other agents in this class aim to support mitochondrial function, reduce ER stress, or modulate excitotoxicity-core mechanisms implicated in ALS pathogenesis. Immuno-inflammatory Modulators - Masitinib, a tyrosine kinase inhibitor, targets neuroinflammation and microglial activation. Now in Phase III, it could become the first oral immune-modulating agent with broad applicability in ALS if efficacy is confirmed. - Avonex (interferon-beta) and other repurposed immune therapies are being evaluated to address inflammatory aspects of ALS, particularly in patients showing elevated biomarkers of immune activation. Stem Cell and Cellular Approaches Stem cell infusions, particularly mesenchymal stem cells (MSCs), are under evaluation for their potential to protect or repair damaged motor neurons. These approaches remain experimental but are gaining attention for their regenerative promise. 🔍 Competitive Intelligence – Descriptive Landscape Tofersen is leading the field in genetically targeted therapy for SOD1-mutated ALS. Its ability to slow functional decline and reduce neurofilament biomarkers puts it ahead in terms of precision and biological targeting. In the broader ALS population, AMX0035 offers a disease-modifying option with strong survival data and ease of use. It stands out as the first combination therapy likely to gain global traction for sporadic ALS. Masitinib, still under evaluation, represents a promising oral option for patients with inflammatory phenotypes. Its oral route and broad immunologic targeting could position it as a foundational therapy if efficacy and tolerability are confirmed. Meanwhile, stem cell therapies and early-stage gene-editing solutions such as BIIB100 are advancing with hopes of establishing novel, durable interventions. These will likely serve as adjuncts or niche solutions depending on patient genotype and disease stage. 🎯 Target Opportunity Profile (TOP): What Success Looks Like For any new therapy to thrive in the ALS market, it must deliver across a range of clinical and strategic attributes: - Clinical Efficacy: Demonstrated improvement in survival and/or functional endpoints such as ALSFRS-R or time to tracheostomy. - Safety and Tolerability: Minimal systemic side effects, especially critical in a fragile patient population with reduced physiological reserve. - Mechanism Differentiation: Gene-targeted therapies should address known mutations; other candidates must tackle neuroinflammation, oxidative stress, or neuronal energy failure. - Ease of Administration: Oral or infrequent dosing regimens are preferred. Intrathecal administration may be acceptable for precision therapies like ASOs. - Payer & Access Considerations: Orphan status, cost-effectiveness, and robust real-world data will be vital for widespread adoption and reimbursement. - Patient Stratification: Success depends on biomarker-driven selection, especially for genetic or inflammatory subtype-specific therapies. Ask for Customized CI Service as per Your Business Requirement: https://www.datamintelligence.com/strategic-insights/ci/amyotrophic-lateral-sclerosis-als 🔮 Market Outlook: 2025 and Beyond The years ahead will witness critical inflection points: - Tofersen is expected to reshape treatment in genetically confirmed SOD1-ALS, catalyzing greater adoption of genetic testing. - AMX0035 will likely establish itself as the first broadly used disease-modifying therapy. - Masitinib may expand treatment choices for sporadic ALS if it confirms efficacy in ongoing trials. - Gene therapies and cell-based innovations will push the envelope toward true disease reversal or stabilization. ✅ Conclusion After decades of frustration, the ALS field is entering a breakthrough era. New therapies are moving beyond symptomatic support to targeting the underlying biology of the disease. From gene silencing to neuroprotection and immunomodulation, the coming years hold unprecedented potential to extend and improve lives. For patients, caregivers, and industry stakeholders, ALS is no longer a closed chapter-it’s a rapidly unfolding story of innovation. Read Related CI Reports: 1. Focal Segmental Glomerulosclerosis | Competitive Intelligence 2. Vitiligo | Competitive Intelligence Sai Kumar DataM Intelligence 4market Research LLP +1 877-441-4866 sai.k@datamintelligence.com Visit us on social media: LinkedIn X Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Phase 3Drug ApprovalOrphan DrugOligonucleotideImmunotherapy

15 May 2025

·www.prnewswire.com

Abzena Announces Establishment of Scientific Advisory Board to Support Innovation Strategy

SAN DIEGO, May 15, 2025 /PRNewswire/ -- Abzena, the leading end-to-end integrated CDMO + CRO for complex biologics and bioconjugates, has announced today the formation of its Scientific Advisory Board (SAB) comprised of biopharma industry experts with diversified expertise in Discovery Research & Development (R&D) and Chemistry, Manufacturing, and Controls (CMC). The new advisory board will work closely with Abzena's scientific and commercial leadership to provide strategic guidance and expert insights that support Abzena's continued commitment to growth and innovation. Matt Stober, CEO of Abzena, said, "The establishment of the Scientific Advisory Board was a strategic decision to help guide the future of Abzena. We have seen considerable momentum over the past few years in supporting complex and innovative modalities, such as Antibody-drug conjugates (ADCs), Antibody-oligonucleotide conjugates (AOCs), and bispecifics. We aim to continue building upon this by offering the most state-of-the-art technologies and capabilities to support our customers' programs. These experts will be instrumental in assisting us with this mission by evaluating our strategies and providing recommendations that will further enhance our ability to move medicines forward to patients faster." Joe Principe, CCO of Abzena, said, "We are honored to welcome these distinguished individuals to our Scientific Advisory Board. These founding members are recognized leaders in our industry, bringing a wealth of expertise that will help guide us as we continue through this significant phase of our growth. We look forward to their contributions and the positive impact that they will have on our organization." Founding members of Abzena's Scientific Advisory Board are: John Knight, Ph.D., is the founder of JKONSULT, a UK-based consulting firm, where he provides process chemistry and CMC consulting services for early-stage chemical development and transfer-to-plant projects, with a primary focus on material supplies for toxicological studies, Phase I, and Phase II clinical trials. Dr Knight has 38 years of pharmaceutical industry experience, with prior roles at GSK, Vernalis, and Evotec. Kamal Egodage, Ph.D., MBA, is the President of Lasanth® Consulting, where he provides consultation services for biologics that span from discovery through commercialization, including CMC development, regulatory strategy, interactions with health authorities, and corporate development strategy. Prior to establishing his consultancy in 2017, Dr. Egodage accumulated over 20 years of industry experience at Eli Lilly, Pharmacia, Monsanto, Symic Bio, and Novartis (Switzerland), where he was the Head of Strategy and Business Development for Biologics. Morris Rosenberg, D.Sc., is an independent consultant with over 25 years of experience in the development of therapeutic agents to treat a variety of human diseases. As a consultant, he provides advisory services to early research and clinical-stage companies on product development strategies for biologics, biosimilars, and ADC therapies. Prior to this, Dr Rosenberg played a key role in the development and commercialization of ADC-based therapies at Seattle Genetics and Immunomedics and participated in the development and launch of Trodelvy®, Adcetris®, Avonex®, Angiomax®, Xigris®, and Forteo®. Scott Rudge, Ph.D., co-founded RMC Pharmaceutical Solutions in 2004, which was acquired by Syner-G BioPharma Group in January 2023. He is a Principal Consultant with Syner-G, and leads its Commercial and Scientific Advisory Boards, and is a member of the Syner-G Board. He also currently serves as SVP of Product Development at Margaux Biologics, Head of CMC for Antidote Therapeutics and Optigo Biotherapeutics, is a Key Advisor to Jurata, and is an Adjunct Professor of Chemical Engineering at the University of Colorado. Dr Rudge has over 33 years of experience directing Process Engineering, Process Development, Product Development, and overall Pharmaceutical Operations, and has built and led several organizations in the biopharmaceutical industry. Steven Sandoval is the founder and serves as the CEO/ Operations Head of Pharmaceutical Technical Solutions, Inc. (PTSI). Providing technical oversight and client representative support to the Biotechnology, Gene Therapy, Viral Vector, Cell Therapy, T-CELL, CAR T, mRNA, 503a/ 503b Compounding, and Vaccine Pharmaceutical Industries since 2010. Prior to this, he held senior leadership roles at Pfenex Inc., Parsons (BMS), and Amgen. He has over 30 years of experience in biopharmaceutical manufacturing, operations, CMC tech transfer, engineering, facilities, and quality leadership services. Tatyana Touzova is the Chief Pharmaceutical Development & Manufacturing Officer at SERA Medicines, where she oversees CMC, regulatory, and nonclinical development from drug discovery through clinical stages. Prior to this, she held the position of Chief Operating Officer at AstralBio, AlmataBio, and ValenzaBio, where she directed CMC, manufacturing, and regulatory operations for multiple clinical-stage programs. She has over 35 years of experience in drug development, regulatory affairs, and commercial manufacturing of biologics and complex therapeutics and is recognized as an expert in CMC strategy, GMP compliance, and global regulatory submissions. About Abzena Abzena is the leading end-to-end bioconjugate and complex biologics CDMO + CRO. From discovery through commercial launch, we support customers with fully integrated programs or individual services designed to de-risk and streamline the development of new treatments for patients in need. With the ability to tailor its strategy and customer experience to each project, Abzena develops and implements innovative solutions that enable biotech and biopharma companies to realize the full potential of their molecule and move medicines forward faster. The company has research, development, and cGMP facilities across locations in San Diego, CA, Bristol, PA, and Cambridge, UK. Abzena is owned by Welsh, Carson, Anderson & Stowe, one of the world's leading private equity investors. Learn more at abzena.com. SOURCE Abzena WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

AcquisitionPhase 2Executive Change

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

100 Deals associated with Interferon Beta-1a (Biogen, Inc.)

External Link

KEGG	Wiki	ATC	Drug Bank
D04554	Interferon Beta-1a (Biogen, Inc.)	L03AB07	DB00060

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Multiple Sclerosis, Secondary Progressive	Australia	Biogen Australia Pty Ltd.	04 May 2004
Multiple sclerosis relapse	European Union	Biogen Netherlands BV	13 Mar 1997
Multiple sclerosis relapse	Iceland	Biogen Netherlands BV	13 Mar 1997
Multiple sclerosis relapse	Liechtenstein	Biogen Netherlands BV	13 Mar 1997
Multiple sclerosis relapse	Norway	Biogen Netherlands BV	13 Mar 1997
Multiple Sclerosis	United States	Biogen, Inc.	17 May 1996

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Colitis, Ulcerative	Phase 2	United States	Biogen, Inc.	01 May 2008
Colitis, Ulcerative	Phase 2	Canada	Biogen, Inc.	01 May 2008
Colitis, Ulcerative	Phase 2	Czechia	Biogen, Inc.	01 May 2008
Colitis, Ulcerative	Phase 2	Hungary	Biogen, Inc.	01 May 2008
Colitis, Ulcerative	Phase 2	Poland	Biogen, Inc.	01 May 2008
Colitis, Ulcerative	Phase 2	Russia	Biogen, Inc.	01 May 2008
Colitis, Ulcerative	Phase 2	Slovakia	Biogen, Inc.	01 May 2008
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	Phase 2	United States	Biogen, Inc.	01 Feb 2004
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	Phase 2	Australia	Biogen, Inc.	01 Feb 2004
Polyradiculoneuropathy, Chronic Inflammatory Demyelinating	Phase 2	Canada	Biogen, Inc.	01 Feb 2004

Clinical Result

Indication

Phase

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NPMSC (AAN2024)	Not Applicable	-	254	Avonex	mvofnqrxbm(xnfyufplpy) = rwbodwueot yzwzwifxbr (rjhutrcdfh ) View more	Positive	09 Apr 2024
				Plegridy	mvofnqrxbm(xnfyufplpy) = gjgnypjchk yzwzwifxbr (rjhutrcdfh ) View more
PeMSDD (ACTRIMS2024)	Not Applicable	-	254	Avonex	kpglzigbad(xpvplimilk) = oariblycgr lyzhlgtnyu (fejbtskfnb ) View more	Positive	01 Mar 2024
				Plegridy	kpglzigbad(xpvplimilk) = fvpghlroja lyzhlgtnyu (fejbtskfnb ) View more
ACTRIMS2023	Not Applicable	Multiple Sclerosis	-	Interferon beta-1a	gphzgfjohs(guscdqcklt) = congestive heart failure nptwyxrxbj (loiykifzfm ) View more	Negative	30 May 2023
AAN2022	Not Applicable	Multiple Sclerosis	-	Subcutaneous Interferon β-1a	csnykdkhpo(vmqnfflspf) = the majority were non-serious events. Among confirmed cases (n=1029), 110 patients were hospitalized with 5 requiring mechanical ventilation. There were 24 fatalities (18 fatal COVID-19 events and 6 other fatalities unconfirmed for COVID-19 involvement). At time of reporting, around half of COVID-19 confirmed AEs were recovered or resolving. yrtdnvnswn (veteagycwm ) View more	-	03 May 2022
NCT04492475 (CTgov)	Phase 3	COVID-19	969	Remdesivir+Interferon beta-1a (Remdesivir Plus Interferon Beta-1a)	kiyosbxaji(rvyxvplwlv) = mucfhzzqid olcdmpclcc (gkkcumfmar, pwuamhpplv - tfhqedebkg) View more	-	22 Nov 2021
				Placebo+Remdesivir (Remdesivir Plus Placebo)	kiyosbxaji(rvyxvplwlv) = iyhqlciymf olcdmpclcc (gkkcumfmar, sbfhyemozm - sdhnhujazl) View more
REFLEX/ION study (ECTRIMS2021)	Not Applicable	Demyelinating Diseases	392	Early treatment with subcutaneous interferon beta-1a	gkonysrzsy(ybnlmfwfii) = qggrcmzibu xwzcoawnmk (jsrcqaixvz ) View more	-	12 Oct 2021
				Delayed treatment with subcutaneous interferon beta-1a	gkonysrzsy(ybnlmfwfii) = uqhpzscmyc xwzcoawnmk (jsrcqaixvz ) View more
ACTRIMS2021	Not Applicable	Multiple Sclerosis	-	Subcutaneous Interferon Î²-1a	ynkzbllkpj(macbbehfmk) = Cumulative to August 4, 2020, there was no increased risk of COVID-19 in sc IFN Î²-1a-treated patients with RMS and cases were relatively mild, consistent with previously reported registries. vqhghkzdba (mjfdyiqlmu ) View more	Positive	01 Jul 2021
NCT04521400 (Pubmed \| Int Immunopharmacol)	Phase 2	COVID-19	168	High-dose IFN-β 1a (Recigen) + lopinavir /ritonavir (Kaletra)	fkjhgynvod(gckxfxpbpl) = jgrsmphrim cliwggrlnu (tuotbzpbtk ) View more	Negative	29 Jun 2021
				Low-dose IFN-β 1a (Recigen) + lopinavir /ritonavir (Kaletra)	fkjhgynvod(gckxfxpbpl) = fcteahxaug cliwggrlnu (tuotbzpbtk ) View more
ECTRIMS2020	Not Applicable	Multiple Sclerosis	-	Subcutaneous interferon β-1a	uzwnqyckdq(sgtpujovzd) = 23 cases of confirmed COVID-19 in sc IFN β-1a treated MS patients vxnnbnfbae (lwkumbzlun ) View more	Positive	07 Dec 2020
ECTRIMS2020	Not Applicable	Multiple Sclerosis	-	subcutaneous interferon beta-1a (18-30 years)	yaxslbkfcb(oiqotdqdkn) = ydohlbuwyh yjrnwvmmjk (bamtlganfb, 0.16 - 0.34) View more	-	07 Dec 2020
				subcutaneous interferon beta-1a (31-40 years)	-

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Clinical Trial

Identify the latest clinical trials across global registries.

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Approval

Accelerate your research with the latest regulatory approval information.

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

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Regulation

Understand key drug designations in just a few clicks with Synapse.

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AI Agents Built for Biopharma Breakthroughs

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Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis