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Pharmaceutical Technology


GENERICS
Ranbaxy First to Offer Tablet and Suspension Forms


Company note
Ranbaxy (Haryana, India) received full market approval from the US Food and Drug Admnistration on Oct. 2 for its anti-infective agent clarithromycin oral suspension, USP (125 mg/5 mL and 250 mg/5 mL). The approval makes the company the first to win generic approval for the oral suspension form and the tablet form.

FDA's Office of Generic Drugs determined that Ranbaxy's formulation was bioequivalent and offers the same therapeutic effect as that of the reference listed drug, "Biaxin" granules of Abbott Laboratories. Total annual market sales for clarithromycin were $99.7 million, with suspension sales totaling $25.3 million.
-Maribel Rios

TRAINING FACILITY
New Center in North Carolina

North Carolina State University opened an 86,000-ft2 biotechnology training and education center on Sept. 18 to teach manufacturing sciences in a real-time environment. Commercial-grade equipment is being used for the first time in a pilot-scale training facility to train students in microbial fermentation and cell-structure biotechnologies for the development of protein-based therapeutic drugs and commercial products. The facility, called the Biomanufacturing Training and Education Center, employs ABB's "Industrial IT System 800xA Extended Automation" technology, instrumentation, analyzers, and variable speed drives to achieve continuous validation and control of the bioreactors for real-time release under strictly maintained and regulated conditions.
-Alexis Brekke

ACQUISITION
Bristol-Myers Squibb To Buy Adnexus Therapeutics for $430 Million


Company note
Reflecting a strategic interest to strengthen its position in biologics, Bristol-Myers Squibb (BMS) agreed to acquire the biopharmaceutical company Adnexus Therapeutics (Waltham, MA) for $430 million on Sept. 24. "Bringing Adnexus into the Bristol-Myers Squibb family builds upon a successful and productive collaboration between the two companies in oncology and is an important step in accelerating the strategic transformation of our pharmaceutical business to a biopharma business model," said Jim Cornelius, chief executive officer at BMS, in a company release.

"Biologics are one cornerstone of our growth strategy. This investment in biologics discovery complements our continued investment in a growing biologics pipeline and portfolio, and will benefit from our expanding biologics manufacturing capabilities, both at our existing site in Syracuse, New York, and our future large-scale bulk biologics facility in Devens, Massachusetts."

Adnexus is a developer of a proprietary class of biologics called "Adnectins," which are derived from fibronectin, an extracellular protein that is naturally abundant in human serum. Fibronectin binds to other proteins using protein structures called targeting domains. An Adnectin consists of a backbone of the natural amino-acid sequence of a certain domain of human fibronectin and one to three targeting loops redirected to enable an Adnectin to specifically recognize a therapeutic target of interest, according to the company. The Adnectins are generated using the company's "Profusion" proprietary protein-engineering system. According to Adnexus, although Adnectins and antibodies have targeting domains with three-dimensional shapes that resemble each other, the amino-acid sequences of each protein class are distinctly different.


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View Results
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Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAsymmetric Synthesis Continues to Advance
Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
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