
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.

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.

A genetic medicines customer has selected the company’s binders for commercial development of the customer’s product.

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.

Merck is acquiring the Yale-spinout, which develops direct DNA modification-enabled cancer treatments.

Laks Pernenkil, Brian Feth, and Alex Philippidis go behind the headlines to discuss the impact of recent news, including FDA’s drug shortage list update, Nobel prize winners in microRNA and AI, and a big-potential research win for RNA editing.

In this episode of the Ask the Expert video series, Peter Walters, Fellow of Advanced Therapies at CRB Group, discusses how facilities used for solid dosage manufacturing may be retrofitted into sustainable cell and gene therapy production facilities.

The agreement follows Agilent’s acquisition of Canada-based CDMO BIOVECTRA in July 2024.

Pfizer’s bivalent RSV prefusion F vaccine has been approved to prevent lower respiratory tract disease resulting from the respiratory syncytial virus in adults 18 to 59 years of age who are at increased risk.

The merger will create a specialty company, REGiMMUNE/Kiji TX, for regulatory T cells.