Drug Development

Hovione plans to continue to expand its sites in Portugal and Ireland for chemical synthesis, spray drying, and laboratory analysis.

Biogen will acquire an AMPA receptor potentiator for cognitive impairment associated with schizophrenia in a deal worth approximately $590 million.

The companies intend to jointly develop and commercialize Lenvima (lenvatinib mesylate) as a monotherapy and an in-combination therapy for treating multiple cancer types.

Sartorius Stedim Biotech has launched a new automated parallel bioreactor system for perfusion culture.

Nanologica AB has entered into a service agreement with CDMO Sterling Pharma Solutions for the large-scale production of silica particles.

Sensors and devices being developed by nGageIT Digital Health Solutions can track patient use of oral solid-dosage or injectable drugs.

Revisions to chapters on glass containers and elastomeric closures were canceled following review of comments.

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.