News

Abraxis BioScience (Schaumburg, IL, www.abraxisbio.com) has entered into a definitive agreement to purchase Pfizer?s (New York, NY, www.pfizer.com) Cruce D?vila manufacturing facility in Barceloneta, Puerto Rico.

Novartis (Basel, Switzerland) has closed on its $5.4-billion acquisition of Chiron Corporation (Emeryville, CA), paving the way for the creation of a new Novartis division focusing on vaccines and diagnostics.

The US Food and Drug Administration (Rockville, MD, www.fda.gov) will hold a public meeting in the fall of this year to gather information about current developments in the uses of nanotechnology materials in FDA-regulated products.

Interphex Mexico, Pfizer, Dalton Pharma Services...

Boca Medical Products, Inc. (Coral Springs, FL) has initiated a recall of 3984 boxes of its 30-g, 0.5-cc "Ultilet" insulin syringe.

Sandoz (Holzkirchen, Germany), the generics division of Novartis (Basel, Switzerland) received European marketing authorization for its recombinant human growth hormone, ?Omnitrope? (somatropin), making it the first biogeneric product approved under the biosimilar pathway of the European Commission.

Pfizer, Stevens Institute of Technology, Sanofi-Aventis...

The custom manufacturer Lonza Group (Basel, Switzerland) will invest $200 million in Nansha Guangzhou, China, for production of active pharmaceutical ingredients (APIs) and intermediates.

Total employment in the biosciences in the United States reached 1.2 million in 2004, the latest year for which data are currently available, according to the study, "Growing the Nation's Bioscience Sector: State Bioscience Initiatives 2006," which was released this week at BIO 2006

The US Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) is again extending an invitation to biologics facilities for participation in its Regulatory Site Visit Training Program (RSVP). The program, initiated in 2005, aims to give CBER's regulatory review, compliance, and other relevant staff an opportunity to visit biologics facilities and allow CBER staff to directly observe routine manufacturing practices. The objective is to give its staff a better understanding of the biologics industry, including its challenges and operations, and improve communication with CBER staff and industry.

On Feb. 21, the US Food and Drug Administration issued a warning letter to Wockhardt (Mumbai, India), a drug manufacturer. FDA cited the company for violations of CGMPs in the manufacture of drug products and active pharmaceutical ingredients.

The Chemical Heritage Foundation and the Biotechnology Industry Organization presented the 8th Annual Biotechnology Heritage Award to Alejandro Zaffaroni, PhD, a biotechnology pioneer and entrepreneur. The award was presented on April 10 at BIO 2006 in Chicago.

The global biotechnology industry earned record revenues in 2005 while moving toward profitability as it reduced its collective net losses.

FTC Plans to Study Competitive Impacts of Authorized Generic Drugs

Reverse Genetics Avian Influenza Vaccine Approved in France

GSK Begins Clinical Trials of Two H5N1 Vaccines

Company Notes for Apr. 6, 2006

Hubert J.P. Schoemaker and William T. McCormick. Perhaps we could have not a special day, but just a moment to remember what we owe and who we we owe it to.

Eisai plans $105-million plant. Novartis to build plant in China. BMS building $660-million biologics facility. Slow adoption of RFID. Vaccines update. $14.7 billion in pharma construction in 2006. Chiron sells Betaseron to Schering. Baxter to develop cell based H5N1 vaccine. Drug sales up 5.4%, but growth slowing.

Despite worries that industry is slow to adopt anticounterfeiting technologies, the 2006 Interphex program is rife with new methods for securing the supply chain.

Senior management must be the champions of change in companies that are struggling financially or organizationally.

Vitamin D and a sunny window shed som light on product stability.

No one is better than Europe when it comes to innovative products at the forefront of the industry

The right choice [of coding and marking technology] depends upon the company's top priorities regarding legibility, cost, speed, ease of use, cleanliness and security.

Once the brightest students are interested in bioprocessing, it is vital that they are prepared and inducted into industry.

Global Pharmaceutical Market Shows Moderate Growth

Vertex Pharmaceuticals? CEO Outlines Strategy for Growth

New Biodegradable Polyketals Developed for Drug Delivery

India and China Position for Growth in APIs

Progress Continues in Vaccine and Antiviral Development