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The program will improve access to adeno-associated virus gene therapy vectors.

Spinning off Sandoz allows Novartis to focus on the areas of cardiovascular, immunology, renal and metabolic, and oncology.

Bassem Gayed, PhD, Senior Technical Director of CAR-T Process Engineering, Manufacturing Science & Technology at Bristol Myers Squibb, discusses the connection of process validation and CAR-T processes.

Orakl Oncology has raised funds to develop its precision oncology platform and accelerate drug development.

Eli Lilly and Company has received a complete response letter from FDA for its anti-dermatitis biologic therapeutic, lebrikizumab.

The commission’s membership will help facilitate reach and impact for standards harmonization.

Laks Pernenkil, principal and practice leader, US Life Sciences Product & Supply Operations, Deloitte, discusses the impact that digitalization is having on data generation and data integrity in bio/pharma manufacturing.

The agreement will enable CTMC to strategically scale the recently completed good manufacturing practice facility to drive high-throughput manufacturing utilizing the automated, closed system capabilities of the Fresenius Kabi Lovo and Cue cell processing systems.

Biosynth has further strengthened its peptide division with the acquisition of Pepceuticals.

The BioIndustry Association reports that with a strong foundation in research and development in mRNA the United Kingdom will be a major player in this rapidly growing industry.

The Japanese biotech company plans to make good use of Orchard’s portfolio, furthering its goal of providing life-changing medical care through cell and gene therapy.

With the acquisition, Sharp plans on offering fully integrated small-to-medium scale sterile injectable services.

POINT is a radiopharmaceutical company with a pipeline of clinical and preclinical-stage radioligand therapies in development for the treatment of cancer.

The program will allow sponsors of certain CBER and/or CDER-regulated products more frequent communication with FDA staff.

The prize was awarded jointly to Katalin Karikó and Drew Weissman for their groundbreaking discovery regarding modification of the bases in mRNA.

EMS is a leader in the cleanroom industry, delivering complete cleanroom monitoring and control solutions, services to customers, and ensuring quality by design from inception to process control.

Pfizer has entered into a collaboration with Ginkgo Bioworks to discover novel RNA molecules across priority research areas.

The new customized system is designed for fully automated and integrated labeling, orientation, and palletization, and it is expected to streamline the current manual processes, according to the press release.

The newly established business under Advent International and Warburg Pincus will be named Simtra BioPharma Solutions.

Government provides a spoonful of sugar, and genuine leadership, for good medicines.

Under the partnership, Sartorius will leverage SPARTA Biodiscovery’s technology to accelerate development of nanoparticles used for drug delivery.

The contract is part of US Department of Health and Human Services’ ‘Project NextGen’ initiative, aimed at pushing forward new and stronger COVID-19 vaccines and therapies.

With the two new GMP-grade mRNA manufacturing sites in Germany, MilliporeSigma can now offer fully integrated mRNA services.

The European Commission has granted approval for Tyruko (natalizumab), a biosimilar developed by Polpharma Biologics for treating multiple sclerosis.

The tools, originally utilized during the COVID-19 pandemic, are now intended to work alongside FDA’s standard procedures.

Under a new pact, Genentech and PeptiDream will collaborate to discover and develop novel peptide-radioisotope drug conjugates.

The companies plan on targeting the production of abundant, low-cost messenger RNA from C1-cells.

BenevolentAI will leverage its suite of AI chemistry design tools in combination with its fully equipped wet lab facility in Cambridge, UK, to deliver small molecule drug development candidates into the Merck pipeline, according to the press release.

The company is currently developing EVX-101 as an adjunctive treatment for MDD due to patients experiencing an inadequate response to first-line antidepressants such as selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors SNRIs.