News

Waters XBridge Premier GTx BEH size exclusion chromatography (SEC) columns are designed to improve analysis while lowering the cost of gene therapies.

Kiefel’s new machine is designed to form, fill, and seal up to 6,000 infusion, parenteral nutrition, or dialysis bags per hour.

The program aims to aid submissions from external stakeholders and FDA staff.

Biogen’s acquisition of Reata will grant them access to Reata’s FDA-approved treatment for Friedreich’s ataxia.

AstraZeneca, via its subsidiary Alexion Pharmaceuticals, will purchase a portfolio of preclinical rare disease gene therapies from Pfizer in a deal worth up to $1 billion.

The guidance document outlines recommendations to limit potential carcinogenic risk.

Pandemic, PBM, and other policies on hold during the summer recess.

Teva Pharmaceuticals and Alvotech will expand their partnership for the development and commercialization of biosimilar candidates.

Roche will pay up to $2.8 billion for the rights to Alnylam’s RNA-based hypertension therapeutic.

MilliporeSigma has invested $25 million to expand its cell culture media production facility in Lenexa, Kan.

The damage to the facility, which produces 8% of US injectable drug consumption, should not significantly affect the current supply.

The framework is now expanded beyond COVID-19 vaccines and treatments.

The paper highlights the potential of AI in the medicinal product lifecycle and the approach that developers should take with it.

Newly launched Crossbow Therapeutics will work to advance a novel class of antibody therapies for treating cancers.

Under a global license agreement, Bristol Myers Squibb and Evotec will advance the development of neurodegeneration pipeline assets.

The proposed spin-off of Sandoz into an independent entity has been approved by Novartis’ board of directors.

The partnership will see Flagship and Pfizer work to create a new pipeline of innovative medicines.

The expanded deal, now potentially worth more than $1.2 billion, will work to develop in vivo therapies, including sickle cell disease.

Novartis’ acquisition of biotech company DTx Pharma boosts its neuroscience pipeline and expands its capabilities in RNA-based therapeutics.

The new drug may help vulnerable children resist RSV in the coming fall and winter season.

The document’s recommendations outline what studies and reports are required for changes to cell and gene therapy manufacturing.

These recommendations will keep key antibiotics for respiratory infections available when they are needed most.

Westlake’s third fund of $450 million will be used to grow early stage biotechnology companies.

German manufacturer metabion is conducting a multi-million euro expansion of its oligonucleotide manufacturing capacity in Munich East.

Eisai’s lecanemab-irmb was converted from an accelerated approval to a traditional approval.

The agency is reviewing the medicines after receiving reports of self-injury and suicidal thoughts in patients using the type 2 diabetes treatments.

FDA's approval of Leqembi paves the way for wider coverage of the drug by Medicare and establishes a process for further clinical testing and evaluation of treatments for this widespread, debilitating condition

Camena Bioscience has completed $10 million in Series A financing on the back of growing demand for DNA synthesis.