News

The collaboration’s enhanced data exchange combined with advanced analytics are expected to reduce raw material variability and improve biomanufacturing performance reliability.

Ned Sharpless is tapped to take on acting commissioner role following Gottlieb’s resignation.

The companies will join forces to improve gene- and cell-therapy manufacturing using the cloud and machine learning.

The acquisition of the site in Copenhagen, Denmark, will significantly expand Fujifilm’s capacity and capabilities.

The new facility, located at the company’s headquarters in Pittsburgh, PA, is expected to meet all clinical and commercial development needs of the company’s lead gene therapy program.

Procarta Biosystems has received investment from Novo Holdings REPAIR Impact Fund to the tune of €1.5 million, which will be used to develop a new class of antibiotics to tackle AMR.

The agency sent a warning letter to ANDAPharm, LLC after inspectors found the company’s cleaning and stability testing procedures were inadequate.

Iksuda Therapeutics and Femtogenix, have signed a license agreement aimed at progressing Iksuda’s lead ADC to clinic, with the aim of targeting difficult-to-treat solid tumors.

OSE Immunotherapeutics has been granted authorization to commence a Phase I clinical trial for checkpoint inhibitor BI 765063 (previously OSE-172).

FDA Commissioner Gottlieb released a statement on the agency’s efforts to refine the naming convention for biosimilars to balance competition and to help ensure patient safety.

Gottlieb’s tenure included record new drug approvals and steps taken to curb opioid abuse.

The companies will use GeoVax’s vaccine technology to develop malaria vaccine candidates.

Sartorius Stedim Biotech (SSB) and Novasep will partner to develop systems for membrane chromatography using Novasep’s BioSC platform and SSB’s single-use technology.

The acquisition will establish a clinical pipeline for Biogen of gene-therapy candidates in ophthalmology.

The FDA commissioner plans to leave the agency in April.

The technology uses a silica nanoparticle to deliver vaccines and cancer treatments.

The Coalition for Epidemic Preparedness Innovations (CEPI) and CureVac partner to develop a transportable mRNA vaccine manufacturing platform.

A project conducted by research institute CEA-Leti led to the development of a new HIV vaccine approach based on engineered lipid nanoparticles.

The TSKgel FcR-IIIA-NPR HPLC column from Tosoh Bioscience is a FcRγ affinity chromatography analysis column suited for the analysis of immunoglobulin G glycoforms.

The $4.3-billion acquisition is expected to strengthen Roche’s gene therapy pipeline.

The $21.4-billion acquisition will create stand-alone business within Danaher’s life-sciences portfolio.

Valitacell and Solentim, have announced a collaboration aimed at the acceleration of discovery and development of biologic drugs and advanced cell therapies.

A multi-partner collaboration has been announced, which will target the acceleration of the development of automated microfluidic systems for rapid and high-throughput gene editing in mammalian cell lines.

In a statement, FDA Commissioner Scott Gottlieb laid out the case for the safety and effectiveness of generic drugs compared to brand drugs.

Mustang intends to combine an oncolytic virus with an interleukin-13 Rα2-(IL13Rα2)-specific chimeric antigen receptor to potentially enhance efficacy in treating glioblastoma multiforme.

Teva will apply Insilico’s technology for predictive biomanufacturing to create more efficient biomanufacturing processes.

The Swiss Agency for Therapeutic Products has begun entering GMP compliance information in the European Union’s EudraGMDP database.

India’s Bharat Biotech is set to acquire GlaxoSmithKline’s Chiron Behring Vaccines, a World Health Organization-prequalified global manufacturer of rabies vaccines.