Efforts to solicit new monographs have fallen behind the rate of NDA approvals, while analytical techniques have become outdated because of advances in analytical technologies.

GlycoFi's work could eliminate the need for mammalian cell culture and improve the performance of protein therapies.

Much is riding on the market success or failure of Pfizer's Exubera inhalable insulin.

Getting "swamped at work" takes on an entirely new meaning for these GMP Agents.

Teamwork, communication, and trust are as important as the technology.

More CMOs look to proprietary delivery technologies to enhance profitability.

Aptuit, Inc. (Greenwich, CT) has agreed to acquire the assets and operations of EaglePicher Pharmaceutical Services (EPPS, Lenexa, KS) as part of Aptuit?s strategies to build capabilities in active pharmaceutical ingredient (API) development and drug substance manufacturing.

The Bulk Pharmaceuticals Task Force (BPTF), an affiliate organization of the Synthetic Organic Chemical Manufacturers Association (SOCMA, Washington, DC) submitted a citizen petition to the US Food and Drug Administration (Washington, DC) requesting the agency to increase inspections of drug manufacturing facilities located outside of the United States.

High-containment manufacturing for highly potent active pharmaceutical ingredients (HPAPIs) represents a niche, but growing niche, in API manufacture. Strategies on serving this sector were discussed at a recent program, ?High-Potency Active Ingredients: Realizing the Opportunities,? organized by the Drug, Chemical, and Associated Technologies Association (Robbinsville, NJ) in conjunction with Pharmaceutical Technology.

Bentley, Cardinal, Saltigo, Sanofi pasteur

UCB SA has offered EUR 4.4 billion ($5.64 billion) in cash and stocks to acquire Schwarz Pharma AG.

In a move that continues the consolidation trend in the generic drugs market, Hospira Inc. agreed to acquire specialty injectables company Mayne Pharma Limited (Melbourne, Australia) for $2 billion.

Millennium Pharmaceuticals, Inc. entered into an agreement to acquire biopharmaceutical company AnorMED, Inc. (Langley, BC, Canada) for $515 million.

Washington, DC (Sept. 26): A much-publicized Institute of Medicine report, "The Future of Drug Safety: Promoting and Protecting the Health of the Public," though devoted to the assessment and perception of risk, focuses on premarketing clinical reviews and postmarketing pharmacovigilance. It does not address or make recommendations on drug manufacturing or quality assurance.

Altana AG plans to sell Altana Pharma AG and its entire pharmaceuticals business to Nycomed for EUR 4.5 billion (about $5.7 billion).

FDA issued a Warning Letter from its Minneapolis District Office to Hawkins, Inc., part of a diversified chemical company and pharmaceutical repackager here.

As with pharmaceutical manufacturing as a whole, a risk-based approach is important in manufacturing highly hazardous or potent compounds. Industry groups are working with US Food and Drug Administration (Rockville, MD) to develop a baseline guide for a risk-management approach to determine containment controls required to minimize cross contamination.

Kevin Sharer has become chairman of the board of the Pharmaceutical Research and Manufacturers of America upon the resignation of Peter R. Dolan.

AstraZeneca, Schering AG, Bioxel Pharma

Specialty Pharmaceutical Company Bentley Pharmaceuticals has entered into an agreement with Cardinal Health for the scale-up of clinical supplies for Bentley's intranasal insulin product candidate.

Albemarle Corporation signed an agreement with DSM Pharmaceutical Products to buy the assets and the fine chemistry services and pharma chemicals business associated with DSM's South Haven, Michigan facility.

Merck KGaA has agreed to buy a majority stake in the European biotechnology company Serono SA for CHF 16.6 billion ($13.3 billion).

Baltimore, MD (Sept. 10)-Researchers at Johns Hopkins University have devised a new controlled-delivery system that applies an electrical pulse to release drug molecules, nanoparticles, biopolymers such as peptides and proteins, and protein assemblies such as viruses from thin fabricated gold electrodes. Developers hope the technique will allow biocompatible implantable chips for precisely dispensing small amounts of drug into the body.

Chemir Analytical Services has launched IQsynthesis, formerly known as Gateway Chemical Technology, Inc. Chemir acquired Gateway Chemical Technology, which provides custom synthesis and process development services, in May 2006.

Barr Pharmaceuticals,Inc.; Cardinal Health; GlaxoSmithKline

MedImmune, Inc. has broken ground on an expansion to its biologics manufacturing facility in Frederick, Maryland. The $250-million expansion is the first phase of a multi-phase construction project that MedImmune announced last fall.

Arlington, VA (Sept. 12)-At the American Association of Pharmaceutical Scientists meeting here, &quote;Real World Applications of PAT and QbD in Drug Process Development and Approval" (Sept. 11-12), chemical engineer and process modeler Michael L. Thompson, PhD, described how Procter & Gamble (West Chester, OH, www.pg.com) applies these mathematical tools to increase product quality and reduce development and trouble-shooting time for consumer and pharmaceutical products.

Washington, DC (Sept. 12)-The Office of New Drug Quality Assessment (ONDQA) in the Center for Drug Evaluation and Research (CDER) has approved one new drug application (NDA) under its CMC Pilot Program and has two more applications are under review. The pilot was established last year to provide an opportunity for FDA and industry to explore strategies for including Quality by Design (QbD) principles and process analytical technology approaches in regulatory submissions, explained ONDQA deputy director Chi-wan Chen at the PDA-FDA Joint Regulatory Conference here