News

Rockville, MD (May)-The US Food and Drug Administration issued a draft guidance, "Labeling for Human Prescription Drugs-Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information."

Darmstadt, Germany (May 13)-Mylan Laboratories Inc. and Merck KGaA have signed a share purchase agreement under which Mylan will acquire all of Merck's worldwide operations within Merck Generics, the company?s generics business.

Washington, DC (May 3)-The Biotechnology Industry Organization published a position paper stating that any legislation establishing a regulatory pathway for follow-on biologics should grant pioneering products 14 years of data exclusivity.

London (May 1)-The European Medicines Agency launched a database designed to facilitate the exchange of information about compliance with good manufacturing practices.

Boston, MA (May 8)-The global biotechnology industry showed several positive signs in 2006, including increases in overall revenues and financing, although the industry as a whole continues to operate at a loss, according to Ernst & Young's annual analysis of the biotechnology industry.

Rockville, MD (May 1)-The US Food and Drug Administration issued a report, "Critical Path Opportunities for Generic Drugs," to identify the scientific challenges, including those in manufacturing science, in developing generic drugs and the opportunities for collaborative solutions in resolving those challenges.

Dublin, OH (May 3)-In preparation for California?s new pedigree legislation, Cardinal Health plans to integrate radio frequency identification (RFID) technology into the operations at its pharmaceutical distribution center in Sacramento by fall 2007.

Althea, AstraZeneca, Bosch, more

Hamilton, OH (May 2)-Amylin Ohio LLC, a subsidiary of Amylin Pharmaceuticals, is expanding construction at its manufacturing facility in West Chester, Ohio. The expansion increases the company?s total investment to approximately $400 million.

Washington, DC (April 30)-Less than two weeks after the Senate Health, Education, Labor, and Pensions Committee voted to reauthorize the Prescription Drug User Fee Act (PDUFA), the bill this week moved onto the Senate floor.

Geneva, Switzerland (Apr. 27)-A meeting of the World Health Organization and the Committee for Medicinal Products for Human Use's approval of Novartis's new cell culture-derived influenza vaccine offered new hope that sufficient numbers of vaccines could be produced in case of a pandemic.

Devens, MA, Montes Claros, Brazil, and Florence, SC (May 2)-Bristol-Myers Squibb Company, Novo Nordisk A/S, and Roche provided updates to their companies? respective manufacturing expansions.

Rockville, MD (May 1)-The US Food and Drug Administration issued a guidance to alert pharmaceutical manufacturers, pharmacy compounders, repackers, and suppliers to the potential public health hazard of glycerin contaminated with diethylene glycol (DEG), a poison.

Albany Molecular Research, BAC, Crucell, More

Sanofi to Close Irish Plant, FDA Inspections and Warning Letters Continue to Decline, FDA Submits Final Proposals for PDUFA IV, and more.

Ricerca Biosciences LLC a contract drug-development company, is embarking on a growth strategy upon which it hopes to double its revenues by 2009. The company recently completed a financial restructuring that includes new equity and term facilities totaling nearly $50 million. That financing will enable Ricerca to implement a multiyear business plan, which includes a $15-million investment to add chemistry and biological laboratories to its site in Concord, Ohio.

A roundup of company moves and positioning from the pharmaceutical industry and biotechnology industries and contract service providers.

BioConvergence, PharmaFab, Johnson & Johnson, More

San Juan, PR (Apr. 25)-Regulatory and quality issues were prominent discussion topics at this year?s ExcipientFest conference and exhibition.

Basel, Switzerland (Apr. 26)-Roche outlined advances it is production strategy for "Tamiflu" (oseltamivir) for treating the H5N1 avian influenza virus.

London (Apr. 23)-AstraZeneca PLC agreed to acquire MedImmune, Inc. for approximately $15.6 billion. The deal is expected to close in June 2007.

New York (Apr. 26)-Bristol-Myers Squibb Company and Pfizer, Inc. entered into a collaborative agreement for the development and commercialization of apixaban, an anticoagulant that BMS discovered.

Interphex2007, New York, NY (Apr. 26)-Robustness studies for analytical methods are critical in being able to provide the assurance to the quality of an analytical method, a topic addressed in a conference session, "Performing Analytical Method Validation Robustness for Regulatory Compliance," at Interphex on Thursday.

Interphex2007, New York, NY (Apr. 26)-Maintaining reliable equipment in pharmaceutical manufacturing operations is critical not only for achieving productivity goals and safety, it also is a prerequiste for moving operations to a lean-manufacturing environment.

Interphex2007, New York, NY (Apr. 26)-As focus shifts away from "one-size-fits-all" medicines and begins centering on personalized medicines, many companies begin to wonder how they can manufacture such drugs economically. Mark Hirschel, chief scientific officer of BioVest International, addressed that issue in his presentation, "A Bioreactor System Designed for Production of Personalized Therapeutics," at Interphex on Thursday.

Interphex2007, New York, NY (Apr. 26)-Counterfeit medicines are of increasing concern to the pharmaceutical industry, both because of the potential health risks to patients and because of the effects on pharmaceutical companies' businesses. While technology such as e-pedigree and radio frequency identification (RFID) represent solutions to secure the supply chain, there are challenges.

Interphex2007, New York, NY (Apr. 27)-The Interphex2007 Conference and Exhibition concluded here on Thursday. As the three-day event reached its conclusion, however, Interphex will continue its global push, with several shows scheduled abroad this year.

Exhibitor News-Day 3

Interphex2007, New York, NY (Apr. 25)-The future of the life science industry lies in biotechnology, and the industry is set to see more heated debates on healthcare and drug safety, according to G. Steven Burrill, chief executive officer of Burrill & Company, who presented today?s keynote address, "The Future of the Life Science Industry."

Interphex2007, New York, NY (Apr. 25)-As manufacturers prepare for processing more-potent compounds, they seek effective clean-in-place (CIP) and wash-in-place (WIP) design systems.