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.

Novozymes (Bagsvaerd, Denmark) made an offer to acquire the the biotechnology company GropPep Ltd (Adelaide, Australia) for DKK 375 million ($65 million) to build its position in supplying ingredients to the biopharmaceutical industry. Novozymes is a major producer of enzymes, including biocatalysts used in pharmaceutical synthesis.

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.

Akzo Nobel (Arnhem, Netherlands) is moving forward with plans to separate its pharmaceutical business into a separate company, Organon Biosciences

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 US Food and Drug Administration has opened the FDA Electronic Submissions Gateway (ESG) to receive and process regulatory submissions to the Center For Biologics Evaluation and Research, the Center for Drug Evaluation and Research, and the Center for Devices and Radiological Health.

The US Food and Drug Administration has published a draft guidance, Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria (RAAPAC).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

MSD Technology Singapore Pte Ltd., a wholly owned subsidiary of Merck & Co., Inc. (Whitehouse Station, NJ) dedicated an expansion of its production facilities in Singapore on July 28.

GlaxoSmithKline (London, England) has developed a vaccine against the H5N1 bird flu strain that, the company says, shows better immune response than other vaccines in development.

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.

Contract service providers should be concerned about the market perceptions of their performance.

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%.

Street-corner oratory may seem like a dying art, but if there's one place you can still find people literally up on their soapboxes, spewing views on religion, politics, or ethics, it's New York City. And, if there's one time I religiously follow the advice of my native New Yorker father ("Look down while you're walking and don't make eye contact with people you pass"), it's when I see these soapbox stars and the crowds surrounding them.

Thanks to you, we have this month's column. Keep those cards, letters, and e-mails coming.

Returnees and home-grown talent aim to make China a pharmaceutical powerhouse.

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

Indian suppliers of active pharmaceutical ingredients and dosage formulations expand in India, the United States, and Europe.

How does the latest agency task force report resonate for pharma and radio-frequency identification?

Industry must look at manufacturing as a competitive advantage, not just a way to get product out the door.

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

Genzyme Corporation (Cambridge, MA) reports the US Food and Drug Administration (Rockville, MD) has approved the fill?finishing, packaging, and labeling of "Thymoglobulin" (antithymocyte globulin, rabbit) at its Waterford, Ireland facility. The approval allows Genzyme to begin manufacturing and distribution of Thymoglobulin from this facility.

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.