News

Foster City, CA (Oct. 2)-Gilead Sciences, Inc. has agreed to acquire the biopharmaceutical company Myogen, Inc. for $2.5 billion.

Rockville, MD (Oct. 2)-The US Food and Drug Administration has issued its final Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations.

SAFC, the custom manufacturing group of Sigma-Aldrich Corporation, announced at CPhI Worldwide that it will invest $16 million to expand its CGMP protein-purification capacity to meet increased market demand for therapeutic proteins from plant- and animal-sourced starting materials.

Missouri City, TX (Oct. 3)-The US District Court for the Western District of Texas denied the Department of Justice?s motion to alter its Aug. 30 decision that the US Food and Drug Administration does not have the ability to regulate drug compounding.

Rockville, MD (Sept. 28)-The US Food and Drug Administration has released the draft guidance for industry ?Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases.?

Paris (Oct. 3)-In gearing up for opportunities in the generic drug market, Codexis, which specializes in biocatalysis for pharmaceutical chemical development, is expanding into direct sale of pharmaceutical intermediates with the receipt of its first commercial orders from generic drug manufacturers for ATS-8, a chemical intermediate in atorvastatin, the API in Pfizer's top-selling drug ?Lipitor.?

Amgen, Ash Stevens, Aveo, Millipore

London (Sept. 29)-GlaxoSmithKline will invest more than ? 500 million in a vaccine-manufacturing plant in St-Amand-Les-Eaux, France. The investment will expand the company?s production capacity in formulation, filling, freeze-drying, and packaging in response to increasing worldwide demand for pediatric and adult vaccines.

Rockville, MD (Sept. 28)-The US Food and Drug Administration has withdrawn three guidances for industry: ?Providing Submissions in Electronic Format?NDAs? (e-NDA), ?Providing Regulatory Submissions in Electronic Format?ANDAs? (e-ANDA), and ?Providing Regulatory Submissions in Electronic Format: Annual Reports for NDAs and ANDAs.? These documents all recommend submitting information as portable document files (PDFs) or as SAS transport files.

Whether you advance your technology from concept to commercialization or use a third party for parts or all of this work, the ability to do technology transfer flawlessly is essential to successful, efficient pharmaceutical production.

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.

The market potential for high-potency active ingredients will be influenced by growth patterns in the cytotoxic drug market. Strong growth is projected for cytotoxics through 2009, but the market then will see generic drug erosion, according to Sarah Terry Johnston, vice-president, healthcare, Datamonitor PLC.

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