Drug Development

The use of more targeted therapies is expanding as the public gains access to low-cost genetic testing, and more advanced computer systems are offering data from healthcare systems.

Smaller review divisions will bring experts closer to decision processes and reduce bottlenecks, FDA leaders say.

Pharmaceutical companies should consider what is required for QIDP designation and whether they can use it to extend the protection afforded to their innovative products.

Choice of carrier can have a significant impact on the capsule filling process as well as the performance of the DPI formulation.

Determining the right process conditions for a freeze-drying cycle requires an understanding of the effect of each step on the drug product.

A skilled workforce is needed to deliver on technology’s promising medical advances.

Bioprocess understanding, the right equipment, and automation help, but multifunctional teamwork is the key to API production success.

Proteus Digital Health is collaborating on a pipeline of digital, oral solid-dosage drugs for various therapies, including cardiovascular and oncology drugs, based on its first NDA, which used ingestible sensors in an antipsychotic treatment.

The company will add a new $5-million drug development center of excellence at its facility and headquarters in Somerset, NJ.

Scientists at Washington University School of Medicine in St. Louis have developed a new method that could help increase the long-term effectiveness of gene therapy.

Research from Gladstone Institutes suggests that transplanting genetically altered interneurons could improve cognitive function for Alzheimer’s disease.

Porton will use biocatalyst technologies from Codexis to accelerate API development for clients.

Understanding the advantages and suitability of different methods to measure residual moisture content in lyophilized materials-and the respective limitations-aids in selecting the most appropriate method for testing.

The new platform is expected to speed up cell line development.

LNC Therapeutics has appointed a new CEO and is strengthening its R&D for gut microbiome-based drugs.

The contract renewal allows AMRI to continue to provide medicinal chemistry and ADME services for advancing drug discovery programs in neurotherapeutics.

Johnson & Johnson’s Janssen partners with Bristol-Myers Squibb to advance next-generation therapies for cardiovascular diseases.

The agency has granted breakthrough therapy designation to Roche’s hemophilia therapy for treating hemophilia A in patients without factor VIII inhibitors.

The company is launching a new pre-fabricated, ready-to-run manufacturing facility that is expected to significantly decrease the production timeline for viral vector-based therapeutics.

Sartorius Stedim Biotech will supply equipment for Penn State’s new Fermentation Facility in the university’s Center of Excellence in Industrial Biotechnology.

Under an Innovate UK grant for a three-year project, Arcinova and the University of Nottingham will develop a continuous, flexible modular manufacturing technology platform.

A new report gives an overview of the work of the International API Inspection Program.

Kemiex trading network is designed to increase safety in the sourcing of APIs and additives.

Innomech has developed an innovative new test station for Fluidic Analytics to streamline R&D programs. The new test station serves as a labor-saving R&D tool to help process multiple test samples and to ensure product quality.

Pharmaceutical Technology will host a panel discussion focused on early drug development on April 24, 2018 at CPhI North America.

The contract development and manufacturing organization will discuss its capabilities in topical drug products at CPhI North America, taking place April 24–26, 2018 in Philadelphia, PA.

The new facility, to be built in Toronto, Canada, will significantly increase capacity for pediatric and booster vaccines.

The biopharmaceutical firm has chosen Rhode Island as the site of its next-generation biomanufacturing plant, which will offer flexibility, speed, and efficiency.

The new 300,000-square-foot facility is considered the largest dedicated cell and gene therapy manufacturing facility with fully integrated services.

Roche has acquired a program to develop regenerative therapies for multiple sclerosis.