News

FDA's approval makes Orchard Therapeutics' Lenmeldy (atidarsagene autotemcel) the first gene therapy approved to treat pediatric metachromatic leukodystrophy in the US.

Ricoh aims to create novel disease models for R&D using ERS Genomics’ CRISPR/Cas9 genome editing technology.

Cellares CEO Fabian Gerlinghaus discusses the nuts and bolts of counterflow centrifugal elutriation and electroporation innovations and optimization, while hinting at big news on future release testing of products, as a product itself.

Mapp Biopharmaceutical will use ProBioGen’s GlymaxX technology for the development of an afucosylated antibody against Marburg virus infection

The draft guidance document provides support to sponsors with drugs in clinical development that treat the states of sporadic Alzheimer’s disease.

Noramco Group will be an integrated North American-based API and supply chain services provider.

In a new manufacturing pact, Chime Biologics will produce DT-7012, Domain Therapeutics' antibody candidate for treating cancer that will soon be entering Phase I studies.

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

In an interview, Fabian Gerlinghaus of Cellares outlines a paradigm change in both hardware and software, regulatory expansions, and some positive cost outcomes for the CGT field.

The Cell Shuttle platform will manufacture cell therapies for its first clinical trials by the end of the year.

The European company has seen its business increase by 47% in North America.

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 facility producer’s new innovation hub will offer manufacturing, life sciences, and infrastructure services.

EMA plans to add 10 partners to its real-world data initiative, DARWIN EU, in 2024.

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

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

New plans laid out by AstraZeneca will see £650 million ($828 million) be invested into the UK.

Cellares CEO Fabian Gerlinghaus shares how an automated, closed-production platform with a small footprint can dramatically impact cost savings and scalability for cell and gene therapies.

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 power of collaboration is a critically important for the bio/pharma industry.

Wider life sciences industries in the UK and Europe are receiving favourable financial support from governing bodies.

While Catalent’s acquisition is definitely about making drugs, it’s also very much about making money.

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.