Brian Feth and Jonathan Grinstein go behind the headlines to discuss the impact of a Republican administration on Federal Trade Commission actions, tax relief, and Health and Human Services (HHS) leadership; as well as advancements in CAR-T.

Under an ongoing partnership with Merck, known as MSD outside of the United States and Canada, Ginkgo Bioworks has achieved the first milestone in a project aimed at improving biologics production.

Manufacturers of five autologous or matched allogenic cell therapy products have selected TrakCel's IT platform, OCELLOS, to orchestrate the administration of these therapies, which are approved or expected to be approved in 2024.

Ascend is partnering with EW Healthcare Partners to expand capabilities in the United States.

The new Institute for Cell Therapy Discovery and Innovation will utilize expertise to develop cell therapies for cancer, autoimmune diseases, and infections.

Balversa (erdafitinib) marks the first and only bladder cancer therapy to target FGFR3 alterations, with a demonstrated increase in overall survival from 7.8 months to 12.1 months.

A £520 million investment for manufacturing capacity was announced by Chancellor of the Exchequer, Rachel Reeves, but academic and industry leaders stress the money should be used to train personnel.

The companies will work to create climate-friendly pMDIs using Orbia’s low global warming potential propellant.

In the collaboration, the new company, Oblenio Bio, has been granted an exclusive option to license LBL-051, a tri-specific T-cell engager antibody, from Leads Biolabs.

The merger agreement is valued at approximately $1.1 billion.

Synaffix, a Lonza company, has licensed its ADC technology to BigHat Biosciences to be combined with the latter's ML design platform to develop new ADCs

Data governance, data integrity, and data quality are all widely used terms, but what do they actually mean and how are they connected?

Recent hurricanes in the US close Baxter plant, shining a spotlight on supply chain fragility again.

The product license holder must have a supplier oversight system in place, says Siegfried Schmitt, PhD, vice president, Technical, Parexel.

CDER Director Patrizia Cavazzoni and CBER Director Peter Marks provided an update on the rare disease innovation hub in a new FDA Voices blog post.

The system is Hapman’s first major product launch since 2008, following a year of intensive R&D that builds upon the company’s eight decades of tubular drag conveyor expertise.

With DKK 600 million (US$87.4 million) in funding from the Novo Nordisk Foundation, the new supercomputer offers the potential to accelerate innovation in drug discovery.

The treatment for ATTR in certain adults with polyneuropathy had just been recommended for approval across the European Union and had gained regulatory approval in the United States at the end of 2023.

A new laboratory will be built in Oss, while additional capacity and capabilities will be added to the Bioanalytical Center of Excellence in Assen.

The partnership will use ViaNautis’ proprietary polyNaut technology platform to develop genetic medicines that can precisely target tissue types.

The company will be expanding its quality control testing capabilities at its San Diego, Calif. biologics development and manufacturing site.

WHO and its partners are providing support to countries dealing with mpox outbreaks.

Pauline Janssen of DFE Pharma gave a presentation on the utility of analyzing big data sets to better understand and diagnose variability in the production process.

The collaboration aims to advance clinical development of a Phase I drug candidate, MRT-6160, and to explore other therapeutic opportunities across multiple indications.

The laboratory is on the same site as BioDuro-Sundia’s new Compound Management Center, which was launched earlier in October 2024.

The report highlights international regulators’ plans for the development and availability of vaccines to prevent and drugs to treat mpox.

Pharmaceutical Technology Europe chats with Kevin Li, MBA, from BioDuro-Sundia about integrated services and the benefits these services can provide to pharma companies.

Vyalev, also known as Produodopa, has been approved in 35 countries, with more than 4200 patients having started treatment.