News

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.

The new Verafit products from STERIS are designed to help manufacturers conform to regulatory requirements laid out in Annex 1.

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.

With the Vacaville, Calif., site acquisition, Lonza gains one of the largest biologics manufacturing sites for mammalian cell-based therapeutics.

CDMO White Raven aims to reduce contamination risk and gain the capability to handle multiple product formats with the installation of Cytiva’s SA25 Aseptic Filling Workcell.

The health data science division of Optima Partners, bioXcelerate, has released a tool aimed at accelerating the drug discovery process.

Cellares CEO Fabian Gerlinghaus explores advancements in counterflow centrifugal elutriation and electroporation, teasing exciting developments in product testing.

AstraZeneca’s acquisition of Amolyt Pharma includes eneboparatide, a Phase III therapeutic peptide for the treatment of hypoparathyroidism.

In a non-exclusive licensing agreement, Ricoh will have access to ERS Genomics’ CRISPR/Cas9 genome editing technology to create novel disease models.

FDA published the draft guidance to support sponsors in developing treatments for the states of sporadic Alzheimer’s disease.

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.

The company is investing more than $2 million in its analytical testing services and adding suppository manufacturing capabilities.

The Italian company’s North American business has seen an increase of 47%.

The Alliance will receive the NSF Regional Innovation Engines Development Award and $1 million in funding.

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

The Data Analysis and Real World Interrogation Network, DARWIN EU, is planning to add 10 new data partners in 2024.

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

The agency has published final guidance documents regarding validation and development of analytical procedures.

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

The company is expanding GMP capacities at its Frankfurt site to manufacture early clinical-phase peptide APIs.

Accurately targeted immunotherapies through reliable neoantigen recognition enable personalized medicine development.

The partnership will allow for both companies to provide end-to-end biopharmaceutical manufacturing solutions.

CordenPharma’s new starter kits are designed to enable effective formulation in the development of mRNA-based therapeutics.

The company is investing more than $250 million into its Bloomington, Ind. Manufacturing site.

Nona Biosciences and Boostimmune will collaborate to develop ADCs against novel targets using Nona’s proprietary platform technology.

Steffen Thirstrup, chief medical officer, EMA, emphasizes the importance of transparency in investigating potential safety issues of CAR-T therapies, while highlighting the need to balance regulatory diligence with maintaining trust within the community and among stakeholders.