Manufacturing

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

Last week, Lonza (Basel) agreed to support the ongoing development of GlaxoSmithKline?s (GSK, London) biopharmaceutical pipeline by supplying manufacturing capacity for five early-stage monoclonal antibodies.

Bristol-Myers Squibb (New York) has agreed to acquire the biopharmaceutical company ZymoGenetics (Seattle) for an aggregate purchase price of $885 million or $735 million net of cash.

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.

PharmTech's monthly newsletter, Equipment and Processing Report, reviews the Editor's Picks for the September 2010 edition from Alfa Laval and Gems Sensors and Controls.

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.

Roche (Basel) launched a groupwide operational-excellence initiative intended to modify the company's cost structures and accelerate its productivity improvements.

After hosting the first international scientific workshop on nanomedicines earlier this month, the European Medicines Agency (EMA) has concluded that further research is needed to provide an adequate scientific basis for evaluating the quality, safety, and efficacy of such medicines.

The Society for Chemical Manufacturers and Affiliates (SOCMA) issued recommendations relating to disclosure of confidential business information (CBI) in response to Environmental Protection Agency's (EPA) decision to limit CBI claims on chemical identity under the Toxic Substances Control Act (TSCA).

Director General of the European Generic Medicines Association (EGA), Greg Perry, has emphasized the need for EU biosimilar guidelines for monoclonal antibodies (mAbs), as well as a harmonized, global approach to biosimilars in general, at the agency's 8th International Symposium on Biosimilar Medicines.

The European Medicines Agency (EMA) has launched a review of GlaxoSmithKline's pandemic influenza vaccine Pandemrix to investigate whether there is a link between vaccination and cases of narcolepsy, a rare sleep disorder.

Editors' picks of pharmaceutical science and technology innovations.

Weighing the pros and cons of REMS for bringing risky products to market.

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

The authors present three approaches that a contract development and manufacturing organization can consider when designing development and process-optimization studies that will provide useful data for scaling up a project.

Industry efforts toward global healthcare surpass average expectations.

A look at why Brazil revised its GMP standards and how the changes will affect the local pharmaceutical industry.

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

Pharmaceutical Technology gains insight into approaches for producing aromatic amines.

From weekend deliveries to nonsterile gloves, a single exception can make a product fall flat.

Software and online monitoring are helping the pharmaceutical industry improve its corrective and preventive action programs. This article contains bonus online material.

PharmTech talked to anticounterfeiting experts to discuss terrorism as a source of counterfeit products.

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