Biopharma News

FDA’s priority review status was granted based on positive results from a Phase III study evaluating Sarclisa in combination with VRd in treating transplant-ineligible newly diagnosed multiple myeloma.

Bkemv (eculizumab-aeeb) is the first interchangeable biosimilar to Soliris (eculizumab) to treat paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome.

Under an agreement, Johnson & Johnson will acquire Numab Therapeutics’ wholly owned subsidiary to gain global rights to NM26, a bispecific antibody targeting atopic dermatitis.

The partnership will create therapeutic assets and new discovery platforms and potentially reshape drug discovery.

Biogen’s acquisition of HI-Bio includes lead investigational mAb, felzartamab, under development for treating a range of immune-mediated diseases.

The organizations plan to combine etherna’s experience in mRNA and lipid-based nanoparticles with UHasselt’s autoimmune research to treat a variety of auto-immune diseases.

This new facility will allow AstraZeneca to offer full manufacturing processing for antibody drug conjugates.

Breyanzi is made from the patient’s own T cells, which are genetically reengineered into CAR-T cells and then delivered through infusion as a one-time treatment.

The company presented results from its programs for Duchenne muscular dystrophy and facioscapulohumeral muscular dystrophy.

Regeneron’s work in CAR-T cell therapy development includes engineering receptor architecture to improve CAR-T cell sensitivity and improve immune response.

The company’s presentation at ASGCT includes preliminary data results for a child who received the gene therapy.

The company is presenting preclinical data at the American Society of Gene & Cell Therapy annual meeting that supports the potential of the company’s CAP-002 gene therapy for correcting neurological phenotypes associated with genetic epilepsy due to syntaxin-binding protein 1 (STXBP1) mutations.

The collaboration will target solid tumors using Poseida’s allogeneic CAR-T platform to develop convertibleCAR programs.

Mariana’s portfolio of radioligand therapies will strengthen Novartis’ radioligand therapy pipeline.

Shanghai Henlius Biotech’s first biosimilar has previously received approvals by the European Commission and National Medical Products Administration.

Beqvez (fidanacogene elaparvovec-dzkt), a one-time gene therapy, helps adults with hemophilia B produce factor IX themselves instead of receiving regular intravenous infusions.

The collaboration aims to scale-up TreeFrog’s process to produce and amplify cells for Vertex’s type 1 diabetes cell therapies.

The collaboration will focus on differentiated cancer vaccine candidates in hematological and solid tumor indications to treat unmet medical needs.

In a $1.8 billion transaction, Genmab will gain three clinical-stage next-generation ADC candidates with its acquisition of ProfoundBio.

J&J’s nipocalimab is in development for reducing the risk of FNAIT in alloimmunized pregnant adults, a rare disease that may risk the life of the fetus or newborn.

AstraZeneca notes that Ultomiris is the first and only long-acting C5 complement inhibitor that offers NMOSD patients the potential to live without relapsing.

AbbVie’s acquisition of Landos includes a lead asset that boosts its portfolio in autoimmune and inflammatory diseases, while the ADC, ELAHERE, gets full FDA approval.

Orchard Therapeutics’ Lenmeldy (atidarsagene autotemcel) marks the first gene therapy approved in the US for treating children with metachromatic leukodystrophy.

ProBioGen and Mapp Biopharmaceutical will use the former’s GlymaxX technology to develop a cell line for an afucosylated antibody that targets Marburg virus infection

Under a new agreement, Chime Biologics will manufacture Domain Therapeutics’ antibody cancer immunotherapy candidate, DT-7012.

EMA has validated two MAAs submitted by AstraZeneca and Daiichi Sankyo for datopotamab deruxtecan in two types of cancer.

Johnson & Johnson’s $2 billion acquisition of Ambrx boosts its pipeline of next-generation ADCs for cancer treatment.

Under a global license and collaboration agreement, AbbVie and OSE Immunotherapeutics will aim to develop OSE-230, a mAb for treating chronic inflammation.