News

FDA will strengthen its collaborative relationships with federal agencies participating in the National Nanotechnology Initiative.

No matter how much we scamper about, the sheep just won't go where we want them to.

Apparently, the inspector would sneak off to visit his relatives on FDA time, instead of visiting us.

Now is the time to get ahead of the learning curve and explore options for meeting pedigree guidelines.

The worldwide market for biopharmaceuticals was estimated to be $50 billion in 2005. North America accounts for 60% in terms of revenue and R&D. Europe accounts for 20% and Japan 10%. It is also estimated that 400–500 biotech drugs are under clinical development for various disease conditions. Biopharmaceuticals are being developed to fight cancer, viral infections, diabetes, hepatitis and multiple sclerosis. The distinct families of biopharmaceuticals include

It's been a while since I last wrote my last editor's comment - a combination, during the last few months, of attending a variety of industry events (as the conference and exhibition season peaked before the summer) and being on holiday. I apologize for the poor excuses, but it's certainly better than saying the dog ate my homework.

With a finger on the pulse of an evolving market, the sales and marketing team can visually demonstrate trends and new market opportunities to the R&D team

Cardinal Health halted production, sales, repairs, and installations of its "Alaris Signature Edition Gold" infusion pump after the US Food and Drug Administration (Rockville, MD) seized approximately 1300 units last Friday. The seized infusion pumps (model numbers 7130, 7131, 7230, and 7231) have a "key bounce" defect that may cause overinfusion of medications by more than 10 times the intended infusion rate.

The generic drug company Mylan Laboratories, Inc. (Pittsburgh, PA) plans to acquire a controlling interest (71.5%) in the Indian pharmaceutical company Matrix Laboratories, Ltd (Hyderabad, India) for $736 million.

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.

Merck KGaA (Darmstadt, Germany) plans to invest 190 million euros ($245 million) to build a biopharmaceutical plant in Darmstadt, Germany. Production is expected to begin in 2010.

Washington, DC (Aug. 14)?A new report issued by the Pharmaceutical Research and Manufacturers of America identifies 418 drugs and vaccines developed through biotechnology. All of the biotechnology medicines and vaccines are now in clinical trials or awaiting approval by the US Food and Drug Administration (Rockville, MD).

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.

Teva Pharmaceutical Industries Ltd. announced that the company will cease production at its manufacturing facility in Cidra, Puerto Rico during the fourth quarter of 2006.

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.

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

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).