Pharmaceutical Technology Editors

Late last week, Pliva d.d. (Zagreb, Croatia) announced that the US Food and Drug Administration had granted final approval for its warfarin sodium tablets and azithromycin for oral suspension.

The US Food and Drug Administration (Rockville, MD) announced that Baxter Healthcare Corp. (Deerfield, IL) signed a consent decree relating to the company's "Colleague" volumetric infusion pump and "Syndeo" patient-controlled analgesic syringe pump.

Vaccine maker Sanofi Pasteur, Inc. received a US Food and Drug Administration Warning Letter, dated June 30, citing "significant deviations" from current good manufacturing practices in the production of monovalent concentrates used in the company?s ?Fluzone? influenza vaccine.

Abbott Labs, Cambrex, Cardinal Health, Charles Ross and Son Co., Janssen, West Pharmaceutical Services

Does the competition from authorized generics really help lower drug prices and boost healthcare savings?

The sixth CPhI China exhibition, presented June 27?29 in Shanghai, offered a showcase for the explosive growth of the Chinese pharmaceutical sector.

University of Buffalo (Buffalo, NY, www.buffalo.edu) researchers have developed a drug delivery system that uses an external magnetic field to guide drug-filled nanocarriers to cultured tumor cells.

Biopharmaceutical company Lipoxen PLC (London, UK) has developed a Hepatitis E vaccine using its novel vaccine delivery technology "ImuXen," which the company claims to be easy to manufacture. According to the company, the proprietary liposomal formulation method delivers vaccine materials to the immune system in a manner designed to emulate the response of a natural encounter with the infection agent.

Pharmaceutical Science & Technology News

Last week, the Generic Pharmaceutical Association (GPhA Arlington, VA) praised a proposal by the Senate Agricultural Appropriations Subcommittee that, if approved, would provide $10 million in additional funding for the US Food and Drug Administration?s (Rockville, MD) Office of Generic Drugs.

Baxa Corporation, Eli Lilly, PLIVA, SkyePharma, Wyeth

The US Food and Drug Administration (Rockville, MD) is restructuring its Office of Regulatory Affairs (ORA) into two offices.

On June 15, 2006, the US Food and Drug Evaluation?s Center for Drug Evaluation and Research (Rockville, MD) issued a 7-page warning letter to Ranbaxy Laboratories (Himachal Pradesh, India) for violations to US current good manufacturing practices.

Coinciding with the 100th anniversary of the US Food and Drug Administration (Rockville, MD), Representative Henry A. Waxman (D-CA) released a statement this week expressing his concern over ?an agency that is adrift and floundering.?

This week, the US Food and Drug Administration (Rockville, MD) posted a Warning Letter issued May 31 by its New Jersey District Office (Parsippany, NJ) to Neil Laboratories (East Windsor, NJ) for CGMP deviations.

Drug development opportunities, specification development, and new vaccine technologies were highlighted at the AAPS National Biotechnolgy Conference in Boston this week. More than 1100 attendees from 19 countries participated in the event.

Microsoft Corporation (Redmond, WA) announced the winners of the Microsoft Pharmaceuticals and Life Sciences Innovation Awards 2006 at this year?s meeting of the Drug Information Association in Philadelphia, Pennsylvania. A four-person panel of industry experts selected winners for the innovative use of Microsoft products in pharmaceutical and life sciences business processes and practices.

Avant, Barr, BASF, Degussa, Laureate Pharma, Millennnium Pharmaceuticals, Northfield Labs

Alpharma, Bayer, MicroTest, NexMed, Penwest

This week?s PharmTech Annual Event (www.pharmtechevent.com) in Somerset, New Jersey, targeted approaches to improving drug development and quality through optimizing processes, managing risk, and controlling variations in manufacturing operations.

The US Food and Drug Administration?s Counterfeit Drug Task Force (Rockville, MD, www.fda.gov) is recommending regulatory actions and the implementation of new technologies for reducing the risk of counterfeit drugs entering the United States. The group has followed up on its original 2004 report, in which it outlined the framework for protecting the public from counterfeit medicines, and an updated 2005 report with a third document encouraging electronic pedigrees, improved traceability in the drug supply chain, and the adoption of radio-frequency identification (RFID) tools.

The US Department of Health and Human Services (HHS, Washington, DC) awarded biotech company Cangene (Winnipeg, MB, Canada) a $362-million Project Bioshield supply contract for 200,000 doses of botulinum toxin immune globulin (heptavalent botulism antitoxin).

The Parenteral Drug Association (PDA, Bethesda, MD) finished the second stage of GMP training for representatives from the Republic of Kazakhstan?s Ministry of Health.

Abemarle, Aceto, Nastech Pharmaceutical Company, Novartis, Novo Nordisk, PerkinElmer, Inc.

RNAi therapeutics company SR Pharma plc (London, UK) has developed a process that allows it proprietary liposomal-based siRNA formulations ?AtuRNAi? drugs to be stored at room temperature and reconstituted in one step.

Recombinomics (Pittsburgh, PA) is again urging the World Health Organization to fully release all H5N1 avian influenza sequences, claiming their release would improve the selection of vaccines by helping scientists to identify the origin of the isolates and predict sequence changes.

Solutia Inc. (St. Louis, MO) announced that its subsidiary, Solutia Europe SA/NV (SESA), had reached a definitive agreement to sell its pharmaceutical services business, which comprises CarboGen AG and AMCIS AG. Under the terms of the agreement, Dishman Pharmaceuticals and Chemicals Ltd. (Ahmedabad, India) will purchase 100 percent of CarboGen and AMCIS stock and related assets for $74.5 million, subject to a working capital adjustment.

Noting several violations in current good manufacturing practice regulations, the US Food and Drug Administration has issued a Warning Letter to Wyeth Pharmaceuticals?s (Collegville, PA) manufacturing facility in Puerto Rico.

BASF, Bayer, NovaDel, Parexel, Schering

The US Food and Drug Administration (Rockville, MD) is withdrawing seven guidance documents "because some of the principles in these guidances are inconsistent with the agency's initiative, Pharmaceutical Current Good Manufacturing Practices (CGMPs) for the 21st Century (CGMP Initiative) .