Drug Development

The Natoli AIM Data Acquisition and Analytical Software for Natoli’s NP-RD10A single-station tablet press speeds research and development.

The FDA commissioner outlined the agency's initiatives to reward innovation and biosimilars development.

GlobalData reports the need to shift away from egg-based manufacturing of vaccines in light of influenza-related deaths.

Under this agreement, the companies will develop in parallel an antibody drug candidate and cell lines for other potential candidates.

In selling its contrast media business, Hovione will focus on API and drug product development and manufacturing.

The pharma major will spin out six molecules in early stage inflammation and autoimmune programs into a new company called Viela Bio.

This article describes a new, combined, quantitative method for assessing excipient risks that has been developed by the authors as one possible risk evaluation method.

Case studies compare efficacy testing of preservatives for topical formulations with probiotic actives.

Assessing potential formulation and manufacturing issues in early development phases can improve a drug’s chances for success.

Drug companies must consider all factors impacting the cost of drugs, including high costs of early development stages.

Aston Particle Technologies has developed a technology that produces functionalized particles in a one-step, environmentally friendly process.

Highly complex APIs developed to treat rare and orphan diseases present big technical questions for contract developers.

The performance of nanoparticles used as carriers in drug delivery is intimately linked to their physical properties. Nanoprecipitation is a common method for the preparation of drug-loaded polymer nanoparticles, but until recently, the reproducibility of the two primary dimensional descriptors-the average particle size and the breadth of the size distribution-has been a challenge due to the intrinsic variability of batch processes. Microfluidics-based flow techniques, however, reduce variation in drug-loaded polymer nanoparticle synthesis.

Tableting instruments (i.e., compaction simulators) that simulate high-speed presses can be used in a quality-by-design (QbD) approach to perform in-depth material characterization and direct scale-up.

The author discusses the advantages of high-throughput screening of drug formulation excipients by a fully automated Tecan-robotic system.

Integration of formulation development, real-time adaptive GMP manufacturing, and clinical testing using a consumer preference panel can save time and cost in performing taste-masking assessments.

Can an Irish analytics company and its CEO bring pharma closer to 21st-century practice?

A jury verdict requiring Gilead Sciences to pay $2.54 billion for patent infringement to competitor Merck & Co. over Gilead's Harvoni (ledipasvir and sofosbuvir) and Sovaldi (sofosbuvir), two best-selling hepatitis C drugs, has been overturned.

PharmaMar has released the results of MI130004, a novel antibody drug conjucate created using a molecule of marine origin.

The contract development and manufacturing organization has entered it first manufacturing contract worth $148 million for its recently completed Plant 3 facility.

Avid Bioservices will provide commercial manufacture of an enzyme replacement therapy by Roivant Sciences' Enzyvant subsidiary.

The research partnership will focus on advancing regenerative medicine using porcine bioproducts.

A new suite for the encapsulation of highly potent drugs will be added.

The study suggests that circumventing evolution in cell factories can enable the commercialization of new biobased chemicals to large-scale.

Colorcon's Opadry EZ provides superior slip and significantly reduces the probability of the tablet sticking to the throat or esophagus.

Researchers at the University of Illinois developed a method to transplant pancreatic islet cells from pigs more easily to treat type I diabetes.

Ferring Pharmaceuticals will expand its biologics capabilities at its headquarters and manufacturing site in Saint-Prex, Switzerland.

A new report states that more research and clinical development must be done in the treatment of pain and addiction.

The acquisition strengthens an already existing collaboration between the companies to advance clinical development of therapies across multiple drug categories.

The Awards honor innovations in drug delivery and packaging, for better patient safety and compliance.