Vetter, AAI, Merck, Eli Lilly, More

Brussels, Belgium (Mar. 22)-The European Commission?s (EC) Directorate-General for Enterprise and Industry (Brussels, Belgium) is asking manufacturers, distributors, and users of human-pharmaceutical excipients to participate in an online questionnaire on the effect of various policy options. Responses will be used to prepare a directive on good manufacturing practices (GMPs) for certain excipients.

Washington, DC (Apr. 2)-The US Department of Homeland Security released an interim final rule that imposes federal security regulations for high-risk chemical facilities.

Rockville, MD (Mar. 1)-The number of US Food and Drug Administration inspections of biologic and drug-manufacturing facilities declined to 4237 in fiscal 2006, according to a report by the Office of Regulatory Affairs.

Inaccuracies in Chapter ‹1072› of the current USP 29 reveal problems in USP's revision and proofreading process.

BIO Raises Concerns About Studies on Follow-On Biologics; Green Chemistry Reduces Costs and Waste; Novel Polymer–DNA Delivery System; WHO Stresses Lack of Capacity for Pandemic Flu Vaccine; EGA Concerned About Regulatory Workload in Approving Generics

Mishaps in packaging labels serve as a reminder: the recall is in the details.

To effectively grow in the biotech industry, companies must develop multiphase plans that focus on regulation and efficiency.

Indian pharmaceutical machine manufacturers (IPMMs) are exceptional among their foreign counterparts. Historically similar to the Chinese with regard to copycat practices, patent infringements, and substandard quality, the IPMMs have made great strides in innovation and collaboration to break free from the shackles of this paradigm.

South San Francisco, CA (Mar. 28)-Genentech, Inc. announced plans to invest $140 million in 1000-liter manufacturing facility in Singapore.

Washington, DC (Mar. 26)-The congressional Committee on Oversight and Government Reform held a hearing to evaluate the cost of biotech drugs as well as strategies for establishing an approval process for the US Food and Drug Administration approval of generic versions of these drugs.

Midland, MI (Mar. 21)-The Dow Chemical Company formed an alliance with Colorcon, Inc. for the global marketing, sales, technical service and development, and distribution of Dow pharmaceutical excipient products for use in controlled-release applications.

Improving performance at an active pharmaceutical ingredient manufacturing plant involves an integrated approach that incorporates methods for optimizing total production management, quality control and assurance, and inventory management. The authors analyze results from a recent benchmarking study to evaluate the critical success factors in high-performing API manufacturing plants.

Rockville, MD (Mar. 23)-The US Food and Drug Administration has submitted to Congress its final proposals for reauthorizing the fourth Prescription Drug User Fee Act (PDUFA IV), which will follow the expiration of the current user-fee on September 30, 2007.

Aventrx, ImmBio, Eli Lilly, more

Berlin and Basel, Switzerland (Mar. 26)-Bayer Schering Pharma AG and Novartis reached an agreement over multiple sclerosis therapy ?Betaseron.?

Cobra, InterMune, Pall, More

Paris (Mar. 15)-Sanofi-Aventis plans to close its manufacturing site in Waterford, Ireland.

Buffalo, NY (Mar. 7)-Scientists at the University at Buffalo?s Institute for Lasers, Phtonics, and Biophotonics and Roswell Park Cancer Institute have developed a drug delivery system comprising 100-nm nanocrystals of pure HPPH, (2-devinyl-2-1'-hexyloxyethyl pyropheophorbide).

Bangalore, India, (March 14)-Bristol-Myers Squibb Company is expanding its research and development (R&D) capabilities in India.

Kenilworth, NJ (Mar. 12)-Schering-Plough Corporation agreed to acquire Organon BioSciences N.V., the human and animal health businesses of Akzo Nobel N.V., for EUR 11 billion ($14.4 billion) in cash.

Gurgaon, Haryana, India (Mar. 13)-Ranbaxy Laboratories Limited confirmed that it has made a nonbinding bid for the generic drug business of Merck KGaA.

Avantium, Eisai, Generex, Lonza, more

Vancouver, BC, Canada-Researchers from the University of British Columbia are developing a new method for delivering Amphotericin B, a potent antifungal agent for fatal blood-borne fungal infections that currently must be administered intravenously.

Berlin, Germany (Mar. 2)-Estimating it would save approximately EUR 700 million ($917.7 million), Bayer HealthCare will integrate the activities of its Pharma division with those of the former Schering AG, Germany.

Affectis, Dalton, Celgene, Novartis, GSK, More

Rockville, MD (Mar. 1)-Sending Warning Letters to 8 manufacturers and 12 distributors, The US Food and Drug Administration ordered a stop to the manufacture and distribution of unapproved drug products containing ergotamine tartrate.

Just because the wheels are turning doesn't mean they're going forward.