Quality/GMPs

Developing a process validation strategy early in clinical development is critical for a successful validation program.

Many companies acknowledged that Western regulatory standards are tougher than those in China.

The personalized medicine bandwagon is on a roll, offering a new model for calculating reimbursement of high-cost biotech therapies. Strategies for identifying patients who will respond to a certain therapy, as well as those most likely to suffer adverse events, promise to improve healthcare quality while eliminating waste and inappropriate spending. Interventions based on individual genetic characteristics may have limited sales, but support higher prices and less costly clinical research methods.

Congress postpones debate on follow-on biologics while adopting new policies likely to reshape drug development

Contrary to popular belief, the out-of-specification problem started years before the Barr Decision.

A true visionary leadership is required to drive the progress of operational excellence programs in biopharmaceutical organizations

The industry needs a clear regulatory pathway for the approval of biosimilars.

The upcoming Quality by Design (QbD) pilot program for biotech filings will focus on comparability protocols, Helen Winkle, director of the Office of Pharmaceutical Science at the FDA's Center for Drug Evaluation and Research, said on September 20, 2007.

Isis Pharmaceuticals, Inc. (Carlsbad, CA), has purchased Symphony GenIsis for $120 million.

Bayer Schering Pharma AG, (Berlin, Germany) has completed the acquisition of a biologics manufacturing facility in Emeryville, CA, from Novartis.

Discovery Laboratories (Warrington, PA) could see the end of its struggle to launch its Surfaxin (lucinactant) drug on the US market soon, as the manufacturing issues it has faced have been resolved.

PAREXEL Consulting (Boston, MA) has hired three senior GMP consultants based in Europe with the hope of helping its clients address complexities of European Union directives in areas such as manufacturing regulations, quality, and safety.

The US Patent & Trademark Office has issued the fifth US patent to MorphoSys AG (Munich, Germany) stemming from MorphoSys’s base HuCAL (human combinatorial antibody library) patent family, providing extended protection to MorphoSys’s core technology.

Bristol-Myers Squibb (Princeton, NJ) will acquire privately held Adnexus Therapeutics (Waltham, MA), the developer of a new therapeutic class of biologics called Adnectins.

Idenix Pharmaceuticals, Inc. (Cambridge, MA), has announced a strategic restructuring and an amended collaboration agreement with Novartis Pharma AG related to Sebivo (also marketed as Tyzeka), an oral treatment for patients with chronic hepatitis B.

Five European organizations, including three companies and two hospitals, have joined forces to develop a novel pandemic influenza vaccine as a potential emergency vaccination.

Steven Galson, MD, has been appointed acting surgeon general beginning October 1, 2007.

Regulatory agencies have evolved along with the biotechnology industry to define quality standards.

Favrille, a San Diego-based biopharmaceutical company, is one of a handful of firms on the forefront of personalized medicine. Because personalized treatment is tailored to an individual's biology, it has the potential to be far more effective than current approaches to disease management.

It became a strategic imperative to find a better, more efficient way to manufacture our products. To continue with the status quo was untenable.

Federal regulation of biologics began more than 100 years ago with the enactment of the Biologics Control Act of 1902. That act required licensing of establishments to manufacture and sell vaccines, sera, antitoxins, and other similar products in order to prevent deaths from contaminated vaccines, as had recently occurred with the diphtheria antitoxin.

Multivariate data analysis can help biotech manufacturers deepen their process understanding.

Meeting service levels is a major challenge for pharmaceutical services providers because the requirements of their client base vary widely.

The new legislation authorizes the use of fee revenues for drug safety oversight and assessment throughout a product's lifecycle.