Drug Development

API permeation into the skin modulates the efficacy of topical treatments.

It is possible to overcome some of the limitations of traditional dosage forms by employing alternative drug delivery formulation strategies.

Forecyte Bio and Cytiva will team up to accelerate the development and manufacturing of cell and gene therapies.

Pharmaceutical Technology spoke with Andrew Anderson, Global Head Strategic Account Management and Mary Todas, Director Technical Development and Regulatory Affairs, both with Pfizer CentreOne, about best practices for API quality.

Scientists have developed a mouse model that could be a promising model system for research into factors affecting mammalian embryonic development and disease.

ProBioGen will collobarate with NextPoint Therapeutics to develop and manufacture its lead antibody candidate.

In this episode of the Drug Solutions Podcast, John Koleng, VP of product development and manufacturing for TFF Pharmaceuticals shares outsourcing strategies in biopharma.

Merck, known as MSD outside of the United States and Canada, will collaborate with Cerevance to identify novel targets for Alzheimer’s disease.

Amgen’s acquisition of Chemocentryx includes the autoimmune disease drug Tavneos (avacopan).

Synthego has launched new engineered cell libraries to validate targets for quicker drug discovery timelines.

This article reviews sources of excipient variability, including raw materials and processing, both of which may vary from supplier to supplier and from plant to plant for a single manufacturer.

Industry is adapting to the increasing complexity and poor solubility and bioavailability of molecules in the pipeline.

The purpose of this article was to demonstrate the application of a new thermogelling matrix in the healing of wounds.

Further advances in construct design and manufacturing scalability are still needed.

Bio-Rad has expanded its range of recombinant monoclonal anti-idiotypic antibodies.

The new facility in Albany, Ore., will support biopharmaceutical development and lyophilization services.

Novasep-PharmaZell will increase API production capacity at its Mourenx site with €7.3M investment.

FDA and the USPTO hope to promote competition by challenging strategies designed to block timely approval of generics and biosimilars.

Promising applications for targeted delivery may be cresting the horizon.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about biologics license applications.

In this episode, Fernando Muzzio provides greater insight into a novel approach to improving drug solubility—continuous melt coating.

Merck, known as MSD outside the United States and Canada, now offers the Merck Digital Sciences Studio, designed to enable innovative tech for drug discovery and development.

Coya Therapeutics has secured intellectual property rights to the research, development, and manufacturing of exosome-polymer hybrids.

VeriSIM Life and Mayo Clinic are collaborating to develop new promising drug candidates.

NRG Therapeutics and Domainex aim to develop novel small-molecule drugs to treat neurodegenerative disorders, such as Parkinson’s disease.

LG Chem has decided to proceed with IND-enabling studies and has renewed a license with Avacta.

In this exclusive Drug Digest video, experts from Roche and MilliporeSigma divulge factors that could influence an organization to pursue specific biomolecules for development.

Biologics are forming a greater proportion of the development pipeline, but there are still some formulation difficulties to overcome to ensure clinical and commercial success.

Single-cell analytical technologies can deepen the understanding of cell biology and, therefore, disease mechanisms.

Lack of toxicity data and poor physicochemical properties must be overcome.