Drug Development

Requirements for early- and late-stage trial manufacturing may differ, but complying with good practices, maintaining blind studies, and considering logistics remain crucial at all times.

Successful development requires coordinating and aligning drug and device design, focusing on a complete drug delivery system that meets patients’ needs.

Investigational failures and discrepancies can be avoided through the proper execution and documentation of investigations.

The agency is asking public consultation on the concept paper.

Weak or faulty quality systems can hurt a company at every stage of a product’s lifecycle.

The agency is offering patients with life-threatening diseases a how-to tool on accessing investigational drugs.

ipharm set up a manufacturing line at its facility in Sweden using LIDD’s NanoZolid technology.

Contract manufacturers await a promising pipeline of drug products to jump-start stagnant growth.

The new label-free method for quantifying intracellular bioavailability can be used to predict drug exposure to target cells and hence its efficacy.

The addition of 20,000 sq. ft. of manufacturing and office space increases Avecia’s Milford, Ma, oligonucleotide capacity to 3.0 mol.

Researchers have demonstrated how an investigational drug currently in testing works against Niemann-Pick type C1, which may lead to treatments for other similar disorders.

Pfizer’s new format of ibuprofen (AdvilR Liqui-GelsR Minis) uses Catalent’s softgel technology to deliver the formulation in a more concentrated fill, resulting in smaller capsules.

New study shows that an antimicrobial peptide packaged in a silicon nanoparticle significantly reduced bacteria load in the lungs of mice infected with Pseudomonas aeruginosa.

In an FDAVoice blog post, the CDER director highlighted two recent scientific advances.

The National Institutes of Health says a new study showed that hydroxychloroquine reduced the transmission of Zika in pregnant mice.

Sienna Biopharmaceuticals has filed for an IPO, expecting to raise over $74 million

Cannabinoids have potential to treat a variety of diseases, but pharmaceutical companies must first develop cost-effective ways to access pharmaceutically pure materials without marijuana cultivation.

A Supreme Court decision and improvements in analytical processes may speed the biosimilar approval process.

SOBI003 is a chemically modified variant of a recombinant human sulfamidase product candidate, using Sobi’s proprietary glycan modification technology.

Partners will use an AI-enabled platform to discover new small molecules across different therapeutic areas.

ADV7103 is being evaluated in a Phase III trial in Europe in children and adults with distal renal tubulopathy acidosis. Results from the study are expected in the coming months.

The collaboration will focus on the discovery, development, and commercialization of novel therapeutics targeting an undisclosed G protein-coupled receptor (GPCR) that plays an important role in inflammatory diseases.

Anil Kane, executive director, Global Head of Technical & Scientific Affairs at Patheon, shared his perspective of changes to solid-dosage pharmaceutical manufacturing.

Poly(lactide-glycolide) has been used for drug-delivery applications because of its beneficial physicochemical properties, long safety record, and reliable commercial supply.

Materials and equipment innovations have advanced tablet coating from sugar to copolymers and simplified pharma production.

Industrial-scale continuous API manufacturing may offer cost and safety benefits.

New ADC therapies must overcome manufacturing challenges to reach market.

As pharma models changed during the past 40 years, contract manufacturing capacity and services evolved to meet demand.

The more pharma science and technology change, the more business and policy concerns stay the same.

Polymers and surfactants impact stability and long-term performance.