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.

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.

The Cambridge-GSK Translational Immunology Collaboration builds on an existing scientific relationship between the biopharma company and the university, with the aim of improving outcomes for patients.

As many as 30% of people living with severe hemophilia A develop inhibitors such as TFPI, which can be produced by the body’s immune response to clotting factors in replacement therapy, often limiting the effectiveness of that therapy.

Wainzua had been previously approved for use by patients with ATTRv-PN in the United States, under the brand name Wainua.

Cell and gene therapy experts Fabian Gerlinghaus, Dr. Claudia Zylberberg, and Benjamin McLeod weigh in on hot topics in CGT.