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As part of the collaboration, Evogene will use its ChemPass AI platform, a computational chemistry system aimed at generative molecular design, to create, optimise, and rank prospective small-molecule The post Evogene and ELEO to develop new oral PCSK9 inhibitors appeared first on Pharmaceutical Business review....

The gene therapy is under investigation in adults living with BAG3 DCM, a genetic condition that leads to progressive heart failure and reduced survival despite existing treatments. AFTX-201 The post Affinia Therapeutics receives FDA orphan drug designation for AFTX-201 appeared first on Pharmaceutical Business review....

The announcement follows a positive recommendation issued in April 2026 by the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). This regulatory action permits The post Kyowa Kirin EMEA's Crysvita approved by EC for infants with XLH appeared first on Pharmaceutical Business review....

PPL-001 is a gene-corrected haematopoietic stem and progenitor cell (HSPC) therapy. Under the collaboration, Cellares will adapt the PPL-001 manufacturing process for its Cell Shuttle platform, and support The post Cellares and Papillon partner for PPL-001 manufacturing automation appeared first on Pharmaceutical Business review....

An autologous anti-cluster of differentiation 20/B-cell maturation antigen (CD20/BCMA) chimeric antigen receptor T-cell (CAR-T) therapy, C-CAR168 aims to treat refractory systemic lupus erythematosus (SLE), with or without lupus The post EMA's CHMP grants PRIME status to AbelZeta's C-CAR168 appeared first on Pharmaceutical Business review....

The partnership will use Halozyme's Enhanze drug delivery technology to potentially improve the convenience of administering INCA033989. Incyte will evaluate the benefits of the technology in creating subcutaneous The post Halozyme and Incyte sign licence agreement for INCA033989 formulations appeared first on Pharmaceutical Business review....

The proposed offer is set at SFr44.31 per share for 100% of PolyPeptide's fully diluted share capital, excluding treasury shares. Completion of the deal is anticipated towards the The post Samsung Biologics to acquire PolyPeptide in $1.81bn cash deal appeared first on Pharmaceutical Business review....

The framework will enable pharmaceutical partners to access integrated data packages combining system-level testing and performance data for injectable therapies. Aptar Pharma stated that demand for earlier insight The post Aptar unveils framework for injectable drug delivery systems appeared first on Pharmaceutical Business review....

This first-in-class complement inhibitor received the approval through a priority review process after its initial accelerated approval in August 2024 for reducing proteinuria in primary IgAN. Results from The post FDA grants traditional approval to Novartis' Fabhalta for IgAN appeared first on Pharmaceutical Business review....

The Department of Health and Social Care (DHSC) will consider the guidance before making any decisions about adjustments to the NHS Meningitis B (MenB) vaccination schedule. This latest The post JCVI issues recommendation on adolescent MenB vaccination in UK appeared first on Pharmaceutical Business review....

Known as Telix Manufacturing Solutions North Melbourne (TMSNM), the site is described as the country's first purpose-built facility to combine radiochemistry laboratories, clinical manufacturing, patient dose administration, and The post Telix opens radiopharmaceutical facility in Australia for cancer treatment appeared first on Pharmaceutical Business review....

HBM7575/SKB575 is designed to target thymic stromal lymphopoietin (TSLP) as well as an undisclosed antigen. The long-acting antibody uses a dual mechanism of action. It works to block The post Harbour BioMed and Kelun-Biotech receive China IND approval for asthma therapy appeared first on Pharmaceutical Business review....

The decision is based on results from the Phase III MAJESTY study, which indicated that Gazyva/Gazyvaro achieved a higher rate of complete remission at two years compared to The post FDA grants priority review to Roche's Gazyva/Gazyvaro for pMN appeared first on Pharmaceutical Business review....

IBI355 is an Fc-silent, third-generation anti-CD40L antibody that is expected to advance to Phase II trials for immunoglobulin G4 (IgG4)-related disease. Spero plans to launch a global Phase The post Innovent licenses IBI355 rights to Spero for up to $1.1bn appeared first on Pharmaceutical Business review....

The agreement grants Novartis access to Chai Discovery's latest AI models, including its Chai-3 model, to support antibody discovery efforts across a range of therapeutic targets. The partnership The post Novartis and Chai Discovery collaborate on antibody identification appeared first on Pharmaceutical Business review....

SBT-77-7101 is described as an autologous CAR-Treg cell therapy currently in Phase I clinical development to treat patients with poly-refractory rheumatoid arthritis (RA). These patients with RA have The post Cellares and Sonoma partner to automate cell therapy manufacturing appeared first on Pharmaceutical Business review....

The Ministry of Health of the Republic of Indonesia (BKPM) has issued a fractionation licence to Takeda, allowing the company to collect and process plasma as part of The post Takeda and Indonesia partner on plasma-derived therapies appeared first on Pharmaceutical Business review....

The new approvals for the anti-programmed death-1 (PD-1) therapies cover both neoadjuvant (pre-surgery) and adjuvant (post-surgery) treatment and apply to patients regardless of their eligibility for cisplatin. These The post FDA approves MSD's Keytruda combinations for MIBC appeared first on Pharmaceutical Business review....

Under the deal, Teva will hold exclusive rights to commercialise both intravenous and subcutaneous formulations of the biosimilar once it obtains regulatory approval. The arrangement covers markets, including The post Teva and Polpharma Biologics sign global deal for ocrelizumab biosimilar appeared first on Pharmaceutical Business review....

The company signed the agreement to test the investigational therapy with Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Human Genome The post Apertura and NIH institutes to test gene therapy for NPC1 appeared first on Pharmaceutical Business review....