News

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

Breaking up is easy to do.

USP exercises a vigorous standards-setting process that draws on both public comments and meticulous scientific review.

A recent benchmarking report on pharmaceutical manufacturing raises questions about the performance of contract manufacturers, but further analysis also raises concerns about the process and data used to arrive at this conclusion.

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

USP applies metrological principles to the dissolution procedure alone and in collaborative studies to understand and minimize potential sources of variability.

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.

Interphex2007, New York, NY (Apr. 25)-One of the challenges facing pharmaceutical manufacturers is how to implement process analytical technology (PAT) into their commercial manufacturing processes. Michael Abad, engineering section manager, Abbott Laboratories shared insight from a project within Abbott in his presentation "Engineering for PAT" at Interphex today.

Interphex2007, New York, NY (Apr. 25)-As governments begin to contemplate the possibility of biological terrorism or a pandemic event, a new problem begins to emerge: in the case of a pandemic or an attack, even if a vaccine or treatment exists, how could it be produced in sufficient numbers to prevent the deaths of millions of people? That question was addressed in at the conference session, "Responding to Bioterrorism and Pandemic Events: A Case for Development of Flexible Manufacturing Space for Vaccine Production," at Interphex today.

Interphex2007 (Apr. 25)-As the pharmaceutical industry moves to a risk-based approach in manufacturing, analytics will play a critical role in not only meeting regulatory requirements but also in building needed collaboration between product development and manufacturing groups.

Interphex, New York, NY (Apr. 25)-Problems caused by the presence and movement of air in pharmaceutical powders are increasing, and many times these problems can be avoided. James K. Prescott, senior consultant at Jenike & Johanson reviewed these problems in his presentation, "Interstitial Air Effect on Powder Flow," at the Wednesday conference session at Interphex.