Dosage Forms

A Sanofi Pasteur flu-vaccine trial in adults 65 years of age and older meets a primary endpoint for superior efficacy.

FDA's draft guidance provides answers to questions received on FDA's abbreviated new drug application stability guidance.

Conventional cell-imaging systems that provide high quality data can be expensive and complex to use. New systems from Biotek Instruments are designed to overcome these issues.

Installation of a quaternary chiral center with high enantioselectivity using memory of chirality enabled the six-step synthesis of the desired active compound.

Direct tablet compression is simpler than wet or dry granulation, but obtaining the right flow properties to ensure good compaction and uniform drug distribution can be a challenge. Porous silica gel, when used as a glidant, can address these issues.

Extensive adoption of single-use technologies and unidirectional flow reduces cross-contamination risk in the company?s new biomanufacturing facility.

Conventional cell-imaging systems that provide high quality data can be very expensive and complex to use. New systems from Biotek Instruments are designed to overcome these issues.

Reversible nanoencapsulation technology may make it possible to deliver high molecular weight drugs directly to target cancer cells, increasing efficacy and reducing side effects.

Experts, including researchers at I Holland, Natoli, and Rutgers University’s Engineering Research Center for Structured Organic Particulate Systems, are seeking a greater understanding of the fundamental causes of tablet sticking and are developing predictive models to more quickly find solutions to specific sticking problems.

RABS is a flexible barrier system that maximizes product control but minimizes operator interaction when best practices are followed.

Rapid screening of critical API properties can quickly identify the best approach for increasing bioavailability.

The companies initially focused on five biosimilar products.

Adamis Pharmaceuticals agrees to license and potentially acquire 3M's Taper Dry Powder Inhaler technology.

Pfizer, Merck, Sanofi, and AstraZeneca are among the companies reporting revenue declines from generic-drug incursion. A look at what the companies are doing to stimulate growth.

A new study reveals how a promising anticancer specifically kills prostate cancer cells by compromising their ability to withstand environmental stress.

Extensive comparability testing is required to ensure that biosimilars have comparable profiles to their reference products.

The US Supreme Court's Myriad decision satisfied both patient groups and patent holders

Advances in techniques and single-use systems are revolutionizing vaccine manufacturing.

FDA releases FY 2014 generic-drug user fees.

FDA funds research to further development of innovative generics, while working to address review and approval issues.

A new method of vaccine design, called the Multiple Antigen Presentation System (MAPS), may result in vaccines that bring together the benefits of whole-cell and acellular or defined subunit vaccination.

Australian team develops method for making ultrafine particles for more efficient drug delivery.

Susan Schniepp, vice-president of quality and regulatory affairs at Allergy Laboratories and co-chair of the program planning committee for the 2013 PDA/FDA Joint Regulatory Conference, discusses quality systems and related considerations in parenteral drug manufacturing.

Continuous countercurrent tangential chromatography (CCTC) is a column-free process that provides a scalable, disposable, and cost-saving alternative to column chromatography.

New cartridges designed specifically for use on high-speed filling lines increase efficiency.

Molecular Profiles has opened a new facility in the UK following official approval from MHRA.

Report outlines recommended practices for control and evaluation of operations.

Novartis and Biological E, a biopharmaceutical company based in India, have entered into an agreement that aims to deliver affordable and accessible vaccines for typhoid and paratyphoid A fevers to developing countries and thereby address the unmet medical need in endemic regions.

Almac introduces handling and bottling capabilities in EU and US headquarters.

Risk management guides decisions in facility design and operation for highly potent drugs.