Manufacturing

Company and People Notes: Wyeth and Ambrx form development pact; Elite Pharma appoints CEO and CSO; more...

The US Food and Drug Administration sent Bayer Schering Pharma (Berlin) a Warning Letter on Aug. 5, 2009, citing deviations from current good manufacturing practice in the manufacture of nonsterile active pharmaceutical ingredients (APIs).

Semisolid Formulation Development: The CRO Approach - SP Formulations Whitepaper

The FDA has approved four vaccines for the H1N1 influenza virus, while other companies, including UK pharma giant GlaxoSmithKline (GSK), have reported promising results from clinical studies with a single dose vaccine.

The current pharmaceutical model is in danger of becoming "irrelevant in the context of 21st century's global healthcare needs", according to a white paper published by global management consultancy firm A.T. Kearney.

AM Technology (UK) has joined an EU-funded project that seeks to develop flow processes for the industrial synthesis of pharmaceutical compounds.

Vaccine makers and other pharmaceutical manufacturers using yeast protein-expression systems are taking note of a discovery this week by a team of researchers who have found RNA interference in Saccharomyces castellii.

Eli Lilly and Company (Indianapolis, IN) is undergoing a companywide reorganization that is intended to accelerate the progress of the company's pipeline.

The US Food and Drug Administration has approved four vaccines for the H1N1 influenza virus, while other companies, including GlaxoSmithKline (GSK), have reported promising results from clinical studies with a single dose vaccine.

Company and People Notes: Sanofi Pasteur signs H1N1 vaccine deal with Brazilian government; Helsinn Group appoints CEO of US business; more...

PharmTech's monthly newsletter, Equipment & Processing Report, reviews the Editor's Picks for the September 2009 edition from Gore and Oystar.

Small-format packaging equipment can provide benefits to the pharmaceutical industry such as quick changeover and low tooling costs. The machines also can shorten the time it takes to bring a product to the market.

Investing time and money in auditing and optimizing a steam system can pay off quickly, especially because the costs of energy, maintenance, and downtime are steadily rising.

Humidity Measurement in Cleanrooms - Vausaka Whitepaper

The European Commission (EC) has made EUR 1 billion available for new projects involving micro and nanotechnology.

Generic-drug companies are increasingly viewing the development of controlled-release formulations as a way of obtaining a competitive edge, according to a report published by Espicom Business Intelligence in late August 2009.

Company and People Notes: Neoprobe and Laureate Pharma form manufacturing agreement; Akela Pharma appoints CEO and chairman; more...

In move designed to increase its position in North America, Dainippon Sumitomo Pharma (DSP, Osaka, Japan) has agreed to acquire the specialty pharmaceutical company Sepracor (Marlborough, MA) for $2.6 billion.

Now expected to obtain its production license during the next few days, an H1N1 vaccine developed by Sinovac Biotech (China) has passed the experts' evaluation by the Chinese State Food and Drug Administration (SFDA).

Merck & Co. (Whitehouse Station, NJ) outlined a new organizational structure and named top management and senior leaders for the company, effective upon the completion of its merger with Schering-Plough (Kenilworth, NJ).

The US Pharmacopeial Convention (USP) and the Permanent Commission of the Pharmacopeia of the United Mexican States (FEUM) signed a memorandum of understanding (MOU) last week.

Also, Orexo and Novartis form agreement; Affitech appoints Robert Burns CEO; more...

The US Food and Drug Administration last week issued the final draft of its guidance for industry titled Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers.

Brief pharmaceutical news items for September 2009.

Oostdyk discusses the latest industry developments and trends.