AbbVie, Inc. | MedPath

Sanofi to Acquire Vigil Neuroscience for Up to $600 Million, Expanding Alzheimer's Disease Pipeline

3 days ago

• Sanofi has entered into a definitive merger agreement to acquire Vigil Neuroscience for $8.00 per share in cash upfront, with an additional $2.00 per share contingent value right tied to VG-3927's first commercial sale. • The acquisition strengthens Sanofi's neurology pipeline with VG-3927, a Phase 2-ready oral small molecule TREM2 agonist being developed for Alzheimer's disease, targeting microglial dysfunction in neurodegenerative disorders. • The transaction, valued at approximately $600 million including the potential CVR payment, is expected to close in the third quarter of 2025, with Vigil's monoclonal antibody program iluzanebart not included in the acquisition.

New Global Review Reveals Comprehensive Landscape of Interstitial Cystitis Clinical Trials in 2025

5 days ago

• A newly released global clinical trials review provides extensive data on Interstitial Cystitis research, tracking trial numbers and enrollment trends across major countries worldwide. • The report categorizes trials by region, phase, status, and sponsorship, highlighting key pharmaceutical companies including Astellas Pharma, AbbVie, Johnson & Johnson, and Pfizer as prominent sponsors. • This comprehensive analysis serves as a strategic resource for stakeholders making investment decisions in IC research, offering insights into trial success rates and identifying optimal locations for clinical studies.

Robust Pipeline of 50+ Therapies Reshaping Moderate to Severe Atopic Dermatitis Treatment Landscape

6 days ago

• The moderate to severe atopic dermatitis market is experiencing significant growth with 45+ companies developing over 50 pipeline therapies, driven by rising global prevalence and increased awareness of the condition. • Recent advancements include promising biologics like rezpegaldesleukin (granted FDA fast-track designation), JAK inhibitors such as VC005 and QY201, and novel mechanisms targeting IL-4/IL-13 pathways, offering new hope for patients with inadequate response to current treatments. • Key players including Nektar Therapeutics, Corvus Pharmaceuticals, and Apogee Therapeutics are advancing clinical trials with significant milestones expected in late 2025, potentially transforming the therapeutic landscape for this chronic inflammatory skin condition.

Bristol Myers Squibb's Cobenfy Fails to Meet Primary Endpoint as Adjunctive Schizophrenia Treatment in Phase 3 ARISE Trial

a month ago

• Bristol Myers Squibb's Cobenfy (xanomeline and trospium chloride) did not achieve statistical significance as an adjunctive therapy for schizophrenia in the Phase 3 ARISE trial, showing only a 2.0-point reduction in PANSS scores compared to placebo. • Post-hoc analysis revealed that patients on non-risperidone antipsychotics showed significant improvement with Cobenfy (-3.4 points, p=0.03), while those on risperidone did not benefit from the adjunctive treatment. • Despite the primary endpoint miss, researchers noted "noteworthy improvement" in most patients and a tolerable safety profile, with Bristol Myers Squibb planning to discuss potential next steps with regulators.

Omeros Forms Elite Clinical Steering Committee to Advance Novel AML Therapeutic Program

a month ago

• Omeros Corporation has established an Oncology Clinical Steering Committee comprising eight distinguished leukemia experts from leading cancer centers to guide its OncotoX-AML program development. • The OncotoX-AML therapeutic has demonstrated superior efficacy to current standard treatments in preclinical studies, effectively targeting 90% of common AML mutations while showing excellent tolerability at high doses. • The novel engineered molecules, approximately half the size of antibodies, selectively kill dividing cancer cells including treatment-resistant leukemia stem cells, addressing a significant unmet need in AML treatment.

CDMO Market Report: Key Regulatory Approvals and Clinical Advances in March-April 2025

2 months ago

• Multiple CDMOs secured significant contract manufacturing opportunities as regulatory bodies approved new indications for established drugs, particularly in oncology and rare diseases. • AstraZeneca's portfolio saw substantial growth with expanded approvals for Imfinzi, Tagrisso, and Lynparza, strengthening partnerships with contract manufacturers including Lonza, Dottikon, and Samsung Biologics. • Contract manufacturers supporting treatments for autoimmune conditions showed strong performance, with Argenx's Vyvgart Hytrulo receiving expanded indications for myasthenia gravis and CIDP.

Global Stroke Clinical Trials Landscape Analysis Reveals Key Market Trends for 2025

3 months ago

• A comprehensive analysis of global stroke clinical trials shows significant research activity across G7 and E7 countries, with detailed tracking of trial phases, status, and enrollment trends. • Leading pharmaceutical companies including Boehringer Ingelheim, Bayer, and AstraZeneca emerge as prominent sponsors in stroke therapeutics research, shaping the competitive landscape. • The report highlights strategic opportunities in clinical trial locations and investment, offering valuable insights for stakeholders in cardiovascular research and development.

AbbVie and Simcere Zaiming Partner to Develop Novel Trispecific Antibody for Multiple Myeloma

4 months ago

• AbbVie and Simcere Zaiming have entered into an agreement to develop SIM0500, a trispecific antibody for relapsed or refractory multiple myeloma. • SIM0500, currently in Phase 1 trials, targets GPRC5D, BCMA, and CD3, utilizing Simcere Zaiming's T-cell engager platform to enhance T cell cytotoxicity. • Simcere Zaiming is eligible to receive up to $1.055 billion in milestone payments and royalties on net sales outside of Greater China. • The collaboration aims to address the unmet medical needs of patients with multiple myeloma through innovative cancer treatments.

Global Diabetic Retinopathy Clinical Trials Landscape Analysis Reveals Key Research Trends for 2024

4 months ago

• A comprehensive analysis of global diabetic retinopathy clinical trials has been released, offering insights into trial distribution across G7 and E7 countries and various research phases. • The report highlights significant trends in trial enrollment patterns over the past five years, providing valuable data for healthcare stakeholders and pharmaceutical companies. • The analysis covers detailed assessment of trial statuses, sponsor types, and endpoint evaluations, helping identify key opportunities and challenges in diabetic retinopathy research.

Global Cerebral Palsy Clinical Trial Landscape Assessed in New 2024 Review

5 months ago

• A new report provides an overview of the global clinical trial landscape for cerebral palsy, including trial numbers and enrollment trends. • The review covers clinical trials by region, country (G7 & E7), phase, trial status, endpoint status, and sponsor type. • The report identifies prominent drugs in ongoing trials and key companies involved in cerebral palsy therapeutics. • It also analyzes unaccomplished trials and enrollment trends over the past five years, offering insights for strategic decision-making.

FDA Accepts Aldeyra's Reproxalap NDA for Dry Eye Disease Treatment

6 months ago

• The FDA has accepted Aldeyra Therapeutics' resubmitted NDA for reproxalap, a potential first-in-class treatment for dry eye disease, with a PDUFA date of April 2, 2025. • Aldeyra has expanded its option agreement with AbbVie, highlighting both companies' commitment to advancing a novel therapy for dry eye disease. • Reproxalap, a RASP modulator, has demonstrated statistically significant activity in clinical trials with over 2,500 patients, showing a favorable safety profile. • AbbVie may obtain a co-exclusive license, paying Aldeyra $100 million upfront (less previous fees) and up to $300 million in milestones, with a profit-sharing agreement.

AbbVie's Emraclidine Fails in Schizophrenia Trials, Analysts Still Bullish on Immunology Portfolio

6 months ago

• AbbVie's emraclidine failed to meet the primary endpoint in two Phase 2 trials for schizophrenia, showing no statistically significant improvement in PANSS scores compared to placebo. • Analysts suggest Bristol Myers Squibb's Cobenfy (xanomeline and trospium chloride) is now positioned to face less competition in the schizophrenia market following AbbVie's setback. • Despite the disappointing results, analysts maintain a positive outlook on AbbVie, emphasizing the strength and growth potential of its immunology franchise. • The failure raises questions about AbbVie's neuroscience strategy, though the company's acquisition of Cerevel still holds promise with Tavapadon showing positive Phase 3 results in Parkinson's disease.

Biopharma Sector Shows Recovery: Bristol-Myers Squibb and Gilead Lead Market Gains

7 months ago

• The biopharmaceutical sector is showing signs of recovery, with a 2% rise in combined market capitalization among the top 20 global companies. • Bristol-Myers Squibb led the recovery with a 24.6% increase in market capitalization, driven by the FDA approval of Cobenfy for schizophrenia. • Gilead Sciences experienced a 22.1% rise, spurred by FDA approvals for Livdelzi in primary biliary cholangitis and Trodelvy in HR-/HER2- breast cancer. • Novo Nordisk and Eli Lilly faced setbacks, with Novo Nordisk seeing an 18.2% drop after the FDA rejected its weekly insulin icodec application.

Clinical Trials Market to Reach $85.37 Billion by 2033, Driven by Globalization and Precision Medicine

7 months ago

• The clinical trials market is projected to reach USD 85.37 billion by 2033, driven by the increasing globalization of clinical trials and the need to access diverse patient populations. • The expansion of precision medicine is creating significant opportunities for clinical trials focused on validating targeted therapies and identifying relevant biomarkers. • North America currently dominates the clinical trials market due to its robust healthcare infrastructure and favorable regulatory environment, with Europe showing strong growth. • Recent developments include FDA approval of Spinogenix's ALS trial and the NHS launch of a platform to accelerate personalized cancer vaccine clinical trials.