Pharmaceutical Technology Editors

Hemispherx Biopharma, Inc., Boehringer Ingelheim Chemicals, Inc., MedImmune, Inc.

Biovail Corporation is demanding that the US Food and Drug Administration (Rockville, MD) enforce the proper criteria for determining bioequivalence of extended-release generic versions of bupropion products.

West Point, PA (Jul. 31)?A survey of 150 US pharmacists found that nearly 80% believe that "multiple look-alike medications" make it difficult for consumers to identify the correct medication, especially when the drugs are moved to unlabeled containers.

The International Organization for Standardization (ISO, www.iso.org) has formally issued and published standard ISO 4644-8:2006, Cleanrooms and associated controlled environments-Part 8: Classification of airborne molecular contamination. The document covers the classification of airborne molecular contamination (AMC) in cleanrooms and associated controlled environments in terms of airborne concentrations of specific chemical substances (individual, group, or category) and provides a protocol to include test methods, analysis, and time-weighted factors within the specification for classification.

Air Products, Althea Technologies, Inc., Bradley Pharmaceuticals, Bristol-Myers Squibb, Crucell N.V., Emergent Biosolutions

IBM Corporation (www.ibm.com) has combined radio-frequency identification (RFID) software, technology, and services to develop a track-and-trace system for pharmaceutical products.

Auriga, Balchem, Generex, ImClone, Intranasal Therapeutics, MedImmune, Schering

The US Food and Drug Administration's New Jersey District Office issued a Warning Letter to Concord Laboratories (Fairfield, NJ), citing the company for manufacturing three generic products without an ANDA, and for ten deviations from current good manufacturing practices.

ZymoGenetics (Seattle, WA) has sued Bristol-Myers Squibb (New York, NY) over alleged infringement of ZymoGentics's fusion-protein technology patents.

The US Food and Drug Administration (Rockville, MD) has sent warning letters to RoTech Healthcare, Inc. (Orlando, FL), CCS Medical (Clearwater, FL), and Reliant Pharmacy Services (Clearwater, FL), demanding that they stop manufacturing and distributing compounded, unapproved respiratory drugs.

North Carolina State University (Raleigh, NC) at the end of July celebrated the completion of the steel skeleton of its new Biomanufacturing Training and Education Center (BTEC, Raleigh, NC) with a topping-out ceremony attended by the construction workers and leaders from BioNetwork, BTEC, and the NC State Facilities Division.

AstraZeneca, Cambrex, Celsis, Cipher, Dimensione Ricerca

On Oct. 10, the US Food and Drug Administration (Rockville, MD) will hold a public meeting on products containing nanotechnology materials.

The Shenzhen government is planning to build a new national biopharmaceutical park in the Shenzhen Grand Industrial Zone.

The US Food and Drug Administration has published a draft guidance, Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria (RAAPAC).

Aegis Therapeutics (San Diego, CA) has launched a new formulation technology to increase the stability of proteins and peptides.

Adams Respiratory Therapeutics, Inc.

Schering AG (Berlin, Germany) voluntarily issued a worldwide recall of all lots of its X-ray contrast agent "Ultravist Injection" 370 mgI/mL (iopromide injection) because particulate matter and crystallization may be present in the product.

The US Food and Drug Administration announced its Prescription Drug User Fee Amendments of 2002 (PDUFA II) fees schedule for fiscal year 2007 (Oct. 1, 2006 - Sept. 30, 2007), including increases ranging from 17% to 19%.

Ranbaxy issued three responses (March 20, April 20, May 25) to FDA's Form 483.

Albany Molecular Research, Affymax, Antares Pharma, AstraZeneca, Brookwood Pharma, DelSite, Immtech, Nektar, VaxGen, Vical

The UK Medicines and Healthcare Products Regulatory Agency (MHRA, London) has reissued its recall of a specific batch of counterfeit ?Lipitor? 20-mg tablets. MHRA, in conjunction with Pfizer (New York City, NY), first issued the recall of batch number 004405K1 in July 2005. The new recall is in response to the discovery of more packages of the counterfeit drug in the United Kingdom.

Roxane Laboratories (Columbus, OH), a Boehringer Ingelheim company, is conducting a voluntary recall in the United States and Puerto Rico of a single manufacturing lot of "Azathioprine"tablets, USP 50 mg.

Antigenics, Gilead, Inyx, KVD Pharma, MedImmune, Novartis, Solvias

On July 18, the US Food and Drug Administration posted a Warning Letter issued Watson Laboratories Caribe, Inc. (Corona, CA) by FDA's San Juan (PR) district office.

Seeking more than $5.8 million in damages and the recovery of nearly $1.8 billion in punitive damages, RxUSA Wholesale (Port Washington, NY) filed a complaint against 16 major US pharmaceutical manufacturers and 5 drug wholesalers.

Vincent L. Vilker, Ph.D., has been appointed director of FDA's Office of Testing and Research (OTR). Vilker was formerly chief of the Biotechnology Division at the National Institute of Standards.

The US Food and Drug Administration today posted its final "Guidance for Industry: Providing Regulatory Submissions to the Center for Biologics Evaluation and Research (CBER) in Electronic Format: Lot Release Protocols."

AAI Pharma, Alexion Pharmaceuticals, Altana, Athenagen, Cardinal Health, Nektar, Roche

A group of researchers from Georgia Institute of Technology (Atlanta, GA) are using high-throughput ionization techniques to identify and measure the ingredients in counterfeit drugs.