Drug Development

The new guidance offers information for new drug application and biologics license application sponsors regarding population pharmacokinetic analysis.

The draft guidance provides industry with a guide for using the database to assist in the development of drug products.

FDA released draft guidance on using the USP pending monograph process in the drug application process.

The companies announced their collaboration to provide a human-induced pluripotent stem cell (iPSC)-based integrated platform for drug discovery solutions.

To rapidly achieve high-quality pharmaceutical manufacturing processes, industry must develop prospective, management-based approaches instead of retrospective performance-based measures.

This article discusses current methods of endotoxin testing, its importance to the industry, sustainability issues relating to the process, and best practices.

Several trends are driving change in oral solid‑dosage forms and giving rise to the requirement of ‘fit-for-purpose’ excipients.

Nanotechnology is enabling enhanced bioavailability, improved stability, and targeted delivery of challenging APIs.

Research from the Institute for Research in Biomedicine offers insight into the source of asymmetry between nucleic acid hybrids.

A presentation at the Leistritz Pharmaceutical-Nutraceutical Extrusion Seminar explained how simulation tools benefit the development process.

New CDMO facility supports early-stage API manufacturing and scale up.

GSK has revealed that it has entered into a five-year collaboration with the University of California to advance genomic research and improve drug discovery.

A groundbreaking ceremony was held in Rahway, NJ for Merck’s new FLEx facility that incorporates G-CON’s prefabricated cleanroom units.

In this collaboration, AbCellera will apply its expertise to generate panels of antibody candidates for Gilead to evaluate.

The acquisition will boost Biogen’s gene-therapy pipeline with the addition of two mid- to late-stage clinical assets and preclinical programs.

Cambrex has announced the completion of its new facility at its Karlskoga site in Sweden that combines new laboratories for process and analytical development.

CPI, has supported a project focused on developing and integrating novel recombinant prokaryotic lectins (RPLs) into a biosensor-based platform.

Excipients and new processing techniques can make a real difference in the development of highly potent therapies.

Nanobiotix has launched Curadigm, a spinoff company that will specialize in developing a nanotechnology platform for healthcare applications.

MilliporeSigma awarded its Advance Biotech Grant to three US companies that are focused on traumatic brain injury, vaccine development, and chronic pain.

New offering from Catalent targets integrated development and manufacturing of biologic drugs.

Eli Lilly is set to acquire exclusive worldwide rights for potential non-opioid treatment CNTX-0290 from Centrexion Therapeutics in a deal potentially worth $997.5 million.

Researchers at the University of Sheffield, Sheffield, UK, have discovered and developed a new compound that can kill antibiotic-resistant bacteria, including Escherichia coli.

Expanded controlled substance capabilities enables Particle Sciences to develop and manufacture Schedule I–V drugs.

The companies will develop a new generation of biotherapeutics from cell-line development through to GMP manufacturing.

The guidance discusses the design and evaluation of comparative analytical studies used to support the biosimilarity of a proposed therapeutic protein product to a reference product licensed under section 351(a) of the Public Health Service Act.

AbbVie grants Boehringer Ingelheim a non-exclusive license to its intellectual property for Humira (adalimumab) in the United States.

Regulatory, cultural, and technical differences between drug and device development can pose challenges to pharmaceutical combination product development.

The company announced plans to construct a 1.3 million-ft2 integrated manufacturing center in Chengdu, China.

Locate Bio has been granted additional investment to the tune of £2 million (US$2.6 million) for the expansion of its cell and gene therapy pipeline.