Novartis AG | MedPath

Samsung Biologics to Spin Off Biosimilar Business to Focus on Core CDMO Services

a day ago

• Samsung Biologics announced plans to establish Samsung Epis Holdings, which will incorporate Samsung Bioepis as a wholly owned subsidiary, separating its biosimilar development from CDMO operations. • The strategic spinoff aims to streamline operations by allowing each business to focus on their different revenue models, with final shareholder approval scheduled for September 16. • As one of the world's leading CDMO firms, Samsung Biologics reported impressive financial performance with $3.3 billion in sales and $1 billion in net profit in 2024.

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

a day 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.

FTC Issues New Warnings to Teva and Novartis Over Improper Orange Book Patent Listings

a day ago

• The Federal Trade Commission has renewed challenges against Novartis, Teva, and other pharmaceutical companies for allegedly improper patent listings in the FDA's Orange Book. • The disputed listings involve more than 200 patents across 17 brand-name products, primarily for asthma, diabetes, epinephrine autoinjectors, and COPD medications. • According to the FTC, these improper device patent listings may delay generic competition, artificially inflate drug prices, and restrict patient access to affordable medications.

New Global Report Reveals Comprehensive Landscape of Chemotherapy-Induced Diarrhea Clinical Trials

2 days ago

• A new comprehensive report analyzing the global clinical trial landscape for Chemotherapy-Induced Diarrhea (CID) has been released, providing crucial insights for stakeholders in pharmaceutical R&D. • The report details trial distribution across G7 and E7 countries, enrollment trends over five years, and classifies trials by phase, status, endpoint status, and sponsor type. • Key companies involved in CID therapeutics include Novartis AG, Jaguar Health, and Guangzhou Zhiyi Biotechnology, with the report drawing data from over 80 clinical trial registries worldwide.

GSK and iTeos Terminate TIGIT Cancer Drug Development After Phase 2 Failure

10 days ago

• GSK and iTeos Therapeutics have discontinued development of belrestotug, their TIGIT-targeting immunotherapy, after it failed to significantly delay tumor progression in non-small cell lung cancer patients. • The companies are terminating all ongoing trials, including a Phase 3 study, ending their four-year collaboration that began with GSK's $625 million upfront payment and potential $1.45 billion in milestone payments. • iTeos is now conducting a strategic review to preserve capital, as the failure eliminates its most advanced drug candidate and represents another setback for TIGIT-targeting therapies in oncology.

CDSCO Approves Novartis' Protocol Amendment for Iptacopan Study in Rare Kidney Disorders

12 days ago

• India's CDSCO expert committee has approved Novartis Healthcare's protocol amendment for a Phase IIIb extension study of iptacopan in patients with C3 glomerulopathy and idiopathic immune-complex-membranoproliferative glomerulonephritis. • Iptacopan, an oral complement factor B inhibitor, works by preventing the formation of C3 convertase in the alternative complement pathway, potentially addressing the underlying pathology in these rare kidney disorders. • The approved amendment (version 04 dated November 30, 2023) will allow researchers to further evaluate the long-term efficacy, safety, and tolerability of iptacopan in these difficult-to-treat glomerular diseases.

FDA Requests Additional Trial for Novavax COVID-19 Vaccine Before Full Approval

a month ago

• The FDA has asked Novavax to conduct an additional randomized, controlled study of its COVID-19 vaccine NVX-CoV2601 before considering full approval, despite the vaccine having emergency use authorization since 2022. • Interim results from a phase 2/3 study showed Novavax's updated XBB.1.5 variant vaccine generated 5.8 times higher neutralizing antibody levels compared to the original formulation, with a favorable safety profile. • The FDA's request represents a significant setback for Novavax, which had expected approval based on prior conversations with regulators and had already passed its April 1 PDUFA date.

Novel Oral Psoriasis Therapies Show Promise: TYK2 Inhibitors Lead Breakthrough Advances

3 months ago

• Deucravacitinib demonstrates superior efficacy over apremilast in psoriasis treatment, with over 53% of patients achieving significant skin clearance at week 16. • Apremilast maintains its position as a key therapy for mild-to-moderate psoriasis, with 21% of bio-naïve patients achieving treatment goals in the ADVANCE trial. • Next-generation oral therapies, including JNJ-77242114 and zasocitinib, show promising results in clinical trials, potentially expanding treatment options for psoriasis patients.

FDA Approves Roche's Susvimo for Diabetic Macular Edema, Offering Fewer Injections

4 months ago

• The FDA has approved Roche's Susvimo (ranibizumab injection) for treating diabetic macular edema (DME), a leading cause of vision loss in adults with diabetes. • Susvimo is the first FDA-approved treatment for DME that requires fewer injections than standard eye injections, helping to maintain vision for affected individuals. • The approval was based on the Phase 3 Pagoda study, which demonstrated non-inferior vision improvements with Susvimo refilled every six months compared to monthly ranibizumab injections. • Susvimo, a refillable eye implant, delivers a customized formulation of ranibizumab continuously, offering a convenient alternative to routine eye injections for DME patients.

Eylea HD Shows Promise in Macular Edema Following Retinal Vein Occlusion

5 months ago

• Eylea HD (aflibercept 8 mg) demonstrated non-inferior visual acuity gains compared to Eylea (aflibercept 2 mg) in patients with macular edema following retinal vein occlusion. • The Phase 3 QUASAR trial showed that Eylea HD, dosed every 8 weeks, achieved similar vision improvements to Eylea, dosed every 4 weeks. • A significant portion of patients on Eylea HD were able to maintain an 8-week dosing regimen, potentially reducing the burden of frequent injections. • Regeneron plans to submit these data to regulatory authorities, seeking approval for Eylea HD in this indication, offering a less frequent treatment option.

Novartis' Kisqali Receives EC Approval for Early Breast Cancer Treatment

6 months ago

• The European Commission (EC) has approved Novartis' Kisqali (ribociclib) in combination with an aromatase inhibitor for adjuvant treatment of HR+/HER2- early breast cancer. • The approval is based on the Phase III NATALEE trial, demonstrating a 25.1% reduction in the risk of disease recurrence compared to endocrine therapy alone. • Kisqali is now approved for a broader population of early breast cancer patients in Europe, including those with node-negative disease at high risk of recurrence. • The decision follows positive recommendations and aligns with recent FDA approvals and NCCN guidelines, reinforcing Kisqali's role in early breast cancer treatment.

FDA Accepts Satsuma and SNBL's NDA Resubmission for STS101 Migraine Treatment

7 months ago

• The FDA has accepted for review Satsuma Pharmaceuticals and SNBL's resubmitted NDA for STS101, a dihydroergotamine nasal powder, for acute migraine treatment. • The PDUFA date is set for April 30, 2025, offering hope for the nearly 40 million Americans suffering from migraine, especially women in their 20s to 40s. • STS101 is designed for quick self-administration, leveraging a proprietary nasal delivery device for rapid DHE absorption and sustained plasma concentrations. • The resubmission addresses FDA's previous concerns related to formulation, with no additional clinical trials requested, marking a significant step toward potential approval.