Drug Development

AbbVie has closed the Phase III trial that was evaluating Rova-T as no survival benefit for patients receiving treatment for advanced small-cell lung cancer (SCLC) was found during the interim analysis.

A District Court for the US District of Delaware has ruled in favor of Sanofi and Regeneron in the patent case targeting proprotein convertase subtilisin/kexin type 9 (PCSK9).

The new facility, located in Ness Ziona, Israel, will support clinical phage manufacturing and can be expanded in the future to support commercial-scale manufacturing.

A global agreement with Polpharma Biologics gives Sandoz commercialization rights to a proposed biosimilar natalizumab for relapsing-remitting multiple sclerosis.

In this interview, the main uses and benefits of NIR spectroscopy in tableting are discussed.

Regulatory bodies are taking a more stringent approach to excipient quality, but unlike guidance on GMP for APIs, those for excipients offer a framework only, meaning the onus lies with the manufacturer or supplier.

The editors welcome technical article contributions from the bio/pharma industry.

Innovation in manufacturing technologies must occur to ensure the availability of gene therapies and cell therapies.

Research compared the properties of corticosteroids processed by wet and dry milling for use in inhalation formulations.

Front-end focus and new approaches are speeding scale-up and reducing costs, while scale-down and scale-out become increasingly important.

AstraZeneca has confirmed that its triple combination therapy, Breztri Aerosphere, has met its primary endpoint in a Phase III clinical trial (ETHOS).

Medical researchers from the Centenary Institute and the University of Sydney in Australia have managed to successfully develop and test a new vaccine targeting tuberculosis.

GSK will handle the development, regulatory, commercialization activities, and costs of the drug, while Ionis will obtain license fees and milestone payments of up to $262 million, including a $25 million license fee.

A ruling in Oklahoma that Johnson & Johnson’s marketing efforts created a public nuisance may establish a precedent of other jurisdictions.

AstraZeneca announced that its therapy for the treatment of patients with heart failure, Farxiga (dapagliflozin), has met the DAPA-HF trial primary endpoint.

Exscientia has revealed that Sanofi will be advancing an innovative bispecific small-molecule project that was discovered through the companies’ modality collaboration.

A New Jersey court upheld the validity of patent claims for Amgen’s anti-inflammatory blockbuster biologic, Enbrel (etanercept).

The acquisition will boost Bayer’s cell-therapy development programs, with an initial focus on neurology, cardiology, and immunology.

Under an agreement, Colorcon will incorporate TruTag’s edible microtag technology in its coatings.

Fifty years after the man walked on the Moon, space-based science is benefiting Earth.

A design strategy can ensure conflicting properties are managed appropriately for multi-API controlled-release formulations.

A risk-based approach to CMC enables drug sponsors to focus on clinical and manufacturing development paths.

Pharmaceutical Technology Europe celebrates 30 years in publishing the latest insights, analysis, and developments of the bio/pharma industry.

The evolution of CDMOs has led to increased investment in new technologies, capabilities, and expertise.

Rapid change towards industry developing and manufacturing niche APIs is leading to smaller-scale facilities that offer higher containment and flexibility.