Drug Development

Do patients get what they pay for when they demand cheaper drugs?

Understanding the API, delivery mechanism, and excipient functionality is essential to solving drug solubility challenges.

As biologics continue to push boundaries, the industry needs to take a holistic approach to formulation to ensure success.

Harmonization of best practices and regulatory requirements will enable developers to find the best stability testing approach.

Optical coherence tomography can improve quality control and development of coated dosage forms by allowing film thickness to be measured in real time.

STA Pharmaceuticals and BioLingus have announced the formation of an exclusive technology and marketing collaboration for sublingual delivery.

The technology uses a silica nanoparticle to deliver vaccines and cancer treatments.

Valitacell and Solentim, have announced a collaboration aimed at the acceleration of discovery and development of biologic drugs and advanced cell therapies.

Mustang intends to combine an oncolytic virus with an interleukin-13 Rα2-(IL13Rα2)-specific chimeric antigen receptor to potentially enhance efficacy in treating glioblastoma multiforme.

The agency clarified the process for development programs for regenerative medicine therapies.

In a deal worth $530 million, the companies will develop and commercialize an anti-epileptic drug candidate in Europe.

The partners will collaborate on the development and commercialization of a B-cell maturation antigen-targeting immunotherapeutic for treating multiple myeloma.

CatSci has announced an expansion of its offering to include end-to-end services with an additional focus on lead optimization.

Pathios Therapeutics and Sygnature Discovery have signed a strategic and innovative partnership agreement aimed at accelerating Pathios’ drug discovery and development programs.

The multi-year agreement will give Novartis access to AbCellera’s expertise and state-of-the-art antibody discovery technology for up to ten clinically-relevant disease targets.

The companies will jointly develop and commercialize an investigational bifunctional fusion protein immunotherapy currently in clinical development for cancer treatment.

PDA survey and conference discussion will generate information to guidance on technology transfer.

A study funded by the National Institutes of Health has created a virtual library expected to expand the availability of “make-on-demand” molecules for drug discovery.

The companies will develop Amprologix’s lead epidermicin-based antibiotic candidate.

In a deal potentially worth up to $460 million, Genentech and Xencor will develop and commercialize novel cytokine therapeutics.

A solid lipid excipient from ABITEC is designed for multiple dosing forms.

Company launches new services dedicated to emerging biotech and biopharma companies.

Spectroscopic-based control methods were introduced as equivalent alternative methods, first to a gas chromatographic method to monitor an in-process solvent exchange step and second to a potentiometric titration method to release a process input material for drug substance manufacturing.

Using a QbD approach in the development and formulation of topical products will enable the drug developer to provide a robust control strategy for manufacturing.

The challenge of achieving sustained delivery of an active ingredient or nutrient can be achieved with extended-release formulations.