Pharmaceutical Technology Editors

On May 26, AstraZeneca (Wilmington, DE) announced it would invest $100 million in research and development in China over the next three years.

Pharmaceutical Science & Technology News

Abraxis BioScience Inc., Bristol-Myers Squibb Company, Cambrex Corporation, Sigma-Aldrich Corporation, SkyePharma

The CDER and CBER have released a new "Guidance for Industry: Q8 Pharmaceutical Development," outlining what drug manufacturers should include in the Pharmaceutical Development section of International Council on Harmonization (ICH) Common Technical Document (CTD) submissions.

Spectrum Laboratory Products (Gardena, CA) recalled its active pharmaceutical ingredient, tacrolimus, after learning that some lots of the ingredient are subpotent. At least one injury has been reported.

Research and Markets (Dublin, Ireland) has released ?Annual Investment Analysis Report of the Chinese Pharmaceutical Logistics Industry, 2005-2006.? The report provides analysis of the pharmaceutical logistics characteristics, conditions, pharmaceutical market and pharmaceutical retail dynamics.

The US Food and Drug Administration (Rockville, MD) seeks volunteers to take part in a pilot project to test a Health Level 7 (HL7) data-interchange standard for submitting product stability data.

Boehringer Ingelheim, Crucell, Eisai, Laureate Pharma, Pall Corp., Tunnell Consulting

Roche (Basel, Switzerland) has entered into a nonexclusive agreement with Aspen Pharmacare (Port Elizabeth, South Africa) to speed up production and supply of a generic version of oseltamivir ("Tamiflu") for Africa.

The US Food and Drug Administration?s Center for Drug Evaluation and Research (CDER, Rockville, MD) formally put into action its reorganization plan, effective May 15.

Seven automation suppliers have joined with users on the Instrumentation, Systems, and Automation Society (ISA, Research Triangle Park, NC) "Wireless Standards for Automation (SP100)" committee to develop wireless network structures for manufacturing plants.

The US Department of Health and Human Services (HHS, Washington, DC) will distribute more than $1 billion in contracts to accelerate the development of cell-based production technologies for influenza vaccines.

Johnson & Johnson, Mesa Labs, Mar Cor, FDA, Andrx

On April 28, the US Food and Drug Administration's Center for Drug Evaluation and Research (Rockville, MD) issued a Warning Letter to Pliva Hrvatska d.o.o., a subsidiary of Pliva d.d. (Zagreb, Croatia).

On May 8, Thermo Electron Corporation (Waltham, MA) and Fisher Scientific International Inc. (Hampton, NH) announced they would merge in a tax-free, stock-for-stock exchange.

The US Food and Drug Administration?s (FDA, Rockville, MD, www.fda.gov) Center for Drug Evaluation and Research (CDER) is studying its own Advisory Committee Meeting system to identify best practices for this process.

The US Food and Drug Administration?s (Rockville, MD) Center for Drug Evaluation and Research (CDER) received 637 commercial investigational new drug (IND) applications in 2005, a 20-year high.

In a May 2 Federal Register notice (1), the US Food and Drug Administration withdrew its Jan. 17 direct final rule, "Current Good Manufacturing Practice Regulation and Investigational New Drugs" (2), which would have exempted manufacturing of drugs for Phase I clinical trials from most provisions of 21 CFR 211.

Cobra Biomanufacturing, Avecia, Dynavax Technologies, BASF, Codexis

Sigma-Aldrich Corporation (St. Louis, MO) has acquired Iropharm, Honeywell International's custom chemical synthesis business in Arklow, Ireland. Terms of the cash purchase were not disclosed.

Gottlieb challenges industry. First GenerationNext Awards. Implementing PAT. Optimizing site risk. RFID in the supply chain. Biodegradable polyketals. Global drug-market growth moderates.

Bang & Olufsen Medicom (Copenhagen, Denmark, www.medicom.bang-olufsen.com), a drug-delivery device solutions provider, and Bespak (Milton Keynes, UK, www.bespak.com), a medical-devices and inhalation-valve technologies company, established an exclusive partnership to codevelop and comarket the ?Assist Actuated Inhaler,? a single-increment, dose-counting inhaler. The integrated device features an assisted firing mechanism for easier patient use, according to a company release.

Agilent Technologies Inc. (Palo Alto, CA, www.agilent.com) announced April 17 that it acquired SynPro Corp. (Boulder, CO), a contract manufacturer of oligonucleotide active pharmaceutical ingredients. Earlier, Dalton Pharma Services (Toronto), announced that it had completed a multi-gram CGMP oligonucleotide production facility.

Millipore Corporation (Billerica, MA, www.millipore.com) and Serologicals Corporation (Norcross, GA, www.serologicals.com) have announced an agreement in which Millipore will acquire Serologicals in a cash transaction valued at approximately $1.4 billion and set to close by June 30, 2006.

Cardinal Health, Hospira, Siemens, Ranbaxy, World Health Organization

On April 24, Antares Pharma (Exton, PA, www.antarespharma.com) unveiled its new ?TecTix? advanced transdermal delivery system for the transport of topical drug and excipients across the skin by changing the melting point of the active ingredient. Whereas previous methods focused on the delivery of the drug through the dermis and directly into the bloodstream, the TecTix method can be used locally for dermatological treatments and local anesthetics.

Abraxis BioScience (Schaumburg, IL, www.abraxisbio.com) has entered into a definitive agreement to purchase Pfizer?s (New York, NY, www.pfizer.com) Cruce D?vila manufacturing facility in Barceloneta, Puerto Rico.

The US Food and Drug Administration (Rockville, MD, www.fda.gov) will hold a public meeting in the fall of this year to gather information about current developments in the uses of nanotechnology materials in FDA-regulated products.

Interphex Mexico, Pfizer, Dalton Pharma Services...

Boca Medical Products, Inc. (Coral Springs, FL) has initiated a recall of 3984 boxes of its 30-g, 0.5-cc "Ultilet" insulin syringe.