News

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.

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.

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

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

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.

The Novo Nordisk Foundation will invest up to DKK 950 million (€127 million, US$136 million) in a new cell therapy manufacturing facility in Lyngby, Denmark.

FUJIFILM Diosynth Biotechnologies has finished its new viral vector gene therapy manufacturing facility in Darlington, United Kingdom.

The AstraZeneca rare disease group hopes to use these new gene therapy programs to bolster its work on genomic medicine.

Samsung Biologics and Bristol Myers Squibb have further expanded their strategic manufacturing agreement to include the large-scale manufacture of an antibody cancer drug substance.

CN Bio and LifeNet Health LifeSciences have teamed up to provide direct access to a portfolio of highly characterized hepatic cells for the creation of advanced liver-on-a-chip assays.

Leaders at CDER and CBER give update on organizational changes at FDA.

The finalists for this year’s CPHI Barcelona Pharma Awards span 12 categories with awards ranging from accelerating innovations through to improved sustainability and best start-up initiative.

The agency’s work with EUnetHTA 21 helped it to prepare the EU for implementation of the regulation.

Experts discussed how to transform companies into learning organizations at the 2023 PDA/FDA Joint Regulatory Conference.