Formulation and Drug Delivery

The author describes the development of small-angle X-ray scattering and analyzes its advantages in the characterization of drug-delivery systems and large molecules. This article is part of a special Analytical Technology issue.

The authors review and discuss the influence of glycans on the conformation of a representative IgG1 biopharmceutical using H/DX-MS as an analytical tool.

Novartis Sells US Enablex Rights; Ricerca Names Chemistry Director; And More.

DSM and PolyTherics in Development Deal; Kite Pharma Appoints President and CEO, And More.

Genzyme Sells Genetics Business; Bausch and Lomb Names Vice-President; and More.

The generic-drug company Actavis (Hafnarfjordur, Iceland) is considering acquiring a 51% stake in the biopharmaceutical company BioPartners Holdings (Barr, Switzerland) from Bioton, a Polish biotechnology company.

The author describes the types and sources of rouge and explains ways to prevent and mitigate this problem.

US Pharmacopeia apparatuses for testing the dissolution of transdermal drugs produce good, reproducible results. Yet some scientists believe that further modifications could improve the instruments? suitability for this application.

Pfizer to Acquire FoldRx; Protalix Appoints COO; And More.

Company and People Notes: Lonza Acquired Vivante; PPD Appoints VP of Quality Management; And More.

Pending legislation may give FTC the authority to regulate all Hatch-Waxman settlements.

Industry participation is crucial as USP embarks on far-reaching monograph modernization initiative. This is an online-exclusive article.

New data provide insight into pharma-industry professionals' daily lives.

Changing demands in drug development lead to new service combinations and models.

Both biosimilar and generic drugs have an abbreviated approval process; however, the clinical trial requirements differ enormously.

Bristol-Myers Squibb's fit-for-purpose mode for clinical-trial materials for early-stage development seeks to achieve a better way in resource allocation. This article is part of a special issue on API Development, Formulation, Synthesis and Manufacturing.

In light of the impressive size and predicted growth of the market, there has been a rising interest in the development of biosimilars.

One particularly crucial parameter for nasal sprays is the size of the droplets produced during actuation, which can potentially impact bioavailability.

Week of Aug. 23, 2010: Company and People Notes: Quark and Novartis Form Agreement; Hospira CEO Retires; And More.

Two new reports describe the vaccine market's recent growth and predict future market expansions.

Eli Lilly Ends Semagacestat Program; Selecta Appoints CEO; And More.

Penwest and Endo to Merge; Watson Makes Senior Appointments; And More.

In a draft guidance published this week, the US Food and Drug Administration recommended that makers of transdermal and transmucosal drug-delivery systems use "an appropriate scientific approach" during product design, development, and manufacturing to minimize the amount of residual drug substance present at the end of the products' labeled use periods.

FDA Approves Flu Vaccines; Caraco Names COO; And More.

Industry's focus on cost cutting has led to a dangerous gap in training and knowledge.

Industry can meet its responsibility to society by considering innovative pricing and partnerships.

Pharmaceutical Technology talked to experts in siRNA-drug development to gain insight into the characteristics, processes, and challenges of this class of therapeutics.

As emerging markets become increasingly important for the pharmaceutical majors, companies are re-evaluating their outsourcing strategies. This article is part of the 2010 Outsourcing Resources special issue.

The different pathways to regulatory approval of a biosimilar vary worldwide, ranging from no pathways at all in some developing countries, to the complex and precise mechanism that exists in Europe.

The authors describe recent market trends and indicate the likely future direction of the pharmaceutical and biopharmaceutical industries. This article is part of the 2010 Outsourcing Resources special issue.