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Repatha is intended for adults with established or high risk of atherosclerotic cardiovascular disease (ASCVD) and aims to reduce the risk by decreasing low-density lipoprotein cholesterol (LDL-C) levels, The post Amgen's Repatha receives positive CHMP opinion for broader cardiovascular use appeared first on Pharmaceutical Business review....

The companies will become 100%-owned subsidiaries of Caldera Therapeutics, a newly formed holding company. This combined company intends to apply for a listing on the Nasdaq Capital Market The post Synlogic and Caldera sign merger agreement appeared first on Pharmaceutical Business review....

Targeting long non-coding ribonucleic acid (lncRNA), HTX-001 is being evaluated in a Phase Ia/b clinical trial. The first cohort in this trial was dosed in May. This antisense The post FDA grants fast track designation for HAYA Therapeutics' HTX-001 appeared first on Pharmaceutical Business review....

The deal grants CORE Biomedicine rights to develop and commercialise a portfolio of cancer therapies originally discovered by Eisai and its affiliates. The licensed assets focus on targeting The post Eisai and CORE Biomedicine agree on global licence for oncology pipeline appeared first on Pharmaceutical Business review....

ReNU syndrome is a rare neurodevelopmental disorder that is caused by variants in the RNU4-2 gene. The agreement aims to address an estimated 75% of ReNU syndrome cases. The post BioMarin and n-Lorem partner on early research for ReNU syndrome therapy appeared first on Pharmaceutical Business review....

Approved by both companies' boards of directors, the transaction is expected to close in the third quarter of 2026, contingent upon standard closing conditions. The main asset involved The post argenx signs agreement to buy Forte Biosciences for $2.2bn appeared first on Pharmaceutical Business review....

This integrated service platform is designed to meet growing demand as computational methods increasingly generate large numbers of candidate antibody sequences in a single design cycle. However, the The post Biointron introduces RushData platform for AI-driven antibody discovery appeared first on Pharmaceutical Business review....

This combination aims to provide an additional non-opioid pain relief option without the need for prescriptions. The approval introduces a new choice for individuals seeking relief from persistent The post Kenvue's Tylenol with Naproxen gains FDA approval appeared first on Pharmaceutical Business review....

The new investment increases BeOne Medicines' total spend on US manufacturing facilities to exceed $1bn. This expansion will increase the company's production capacity for its cancer medicines and The post BeOne to invest $300m in US manufacturing facility expansion appeared first on Pharmaceutical Business review....

Lu AH69593 is an oral, small-molecule agonist of the orexin 2 receptor (OX2R). The compound is currently being studied in a Phase Ib clinical trial focused on patients The post FDA grants fast track designation for Lundbeck's Lu AH69593 appeared first on Pharmaceutical Business review....

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....