News

The US Food and Drug Administration?s (FDA, Rockville, MD, www.fda.gov) Center for Drug Evaluation and Research (CDER) is studying its own Advisory Committee Meeting system to identify best practices for this process.

The US Food and Drug Administration?s (Rockville, MD) Center for Drug Evaluation and Research (CDER) received 637 commercial investigational new drug (IND) applications in 2005, a 20-year high.

In a May 2 Federal Register notice (1), the US Food and Drug Administration withdrew its Jan. 17 direct final rule, "Current Good Manufacturing Practice Regulation and Investigational New Drugs" (2), which would have exempted manufacturing of drugs for Phase I clinical trials from most provisions of 21 CFR 211.

Clariant (Muttenz, Switzerland) has agreed to sell its pharmaceutical fine chemicals unit to the private equity firm TowerBrook Capital Partners LP (New York, NY) for CHF 110 million ($89 million). The price includes an earn-out participation of CHF 40 million ($32 million) to be paid in two years.

Cobra Biomanufacturing, Avecia, Dynavax Technologies, BASF, Codexis

Sigma-Aldrich Corporation (St. Louis, MO) has acquired Iropharm, Honeywell International's custom chemical synthesis business in Arklow, Ireland. Terms of the cash purchase were not disclosed.

China's State Food and Drug Administration prepares to strengthen the enforcement of good manufacturing practices.

Animal testing and accounting can both be hazardous.

At this year's BIO conference, US Health and Human Services Secretary Mike Leavitt predicted that over the coming decade, "Medicine will be transformed from an instinctive art of alleviating symptoms to a science of personalized healthcare." Is industry ready?

From the most frenetic conference season in recent memory, trying to distill perspective from mental snapshots of Interphex, Wisconsin, and BIO 2006.

Gottlieb challenges industry. First GenerationNext Awards. Implementing PAT. Optimizing site risk. RFID in the supply chain. Biodegradable polyketals. Global drug-market growth moderates.

The principle of free movement of goods entrenched in the European Treaty makes it difficult for anyone to stop trading of a product between member states

The PAT market is developing and evolving rapidly as pharmaceutical firms strive to implement the framework set in place by the regulators. As with all new markets, people will engage at different times, at differing rates, and for different reasons. This editorial seeks to treat PAT in classical marketing terms, describing four phases of the PAT market evolution and discussing how the PAT market will likely mature.

How can we improve trust in medicines bought in foreign countries? After all, they will have been manufactured to the same standards and specifications as the medicines back home.

Bang & Olufsen Medicom (Copenhagen, Denmark, www.medicom.bang-olufsen.com), a drug-delivery device solutions provider, and Bespak (Milton Keynes, UK, www.bespak.com), a medical-devices and inhalation-valve technologies company, established an exclusive partnership to codevelop and comarket the ?Assist Actuated Inhaler,? a single-increment, dose-counting inhaler. The integrated device features an assisted firing mechanism for easier patient use, according to a company release.

The biotechnology company Discovery Laboratories Inc. (Warrington, PA, www.discoverylabs.com) reports that analysis of ongoing stability data from "Surfaxin" process validation batches indicates that certain stability parameters have not been achieved, and additional process validation batches will likely have to be produced.

Agilent Technologies Inc. (Palo Alto, CA, www.agilent.com) announced April 17 that it acquired SynPro Corp. (Boulder, CO), a contract manufacturer of oligonucleotide active pharmaceutical ingredients. Earlier, Dalton Pharma Services (Toronto), announced that it had completed a multi-gram CGMP oligonucleotide production facility.

Millipore Corporation (Billerica, MA, www.millipore.com) and Serologicals Corporation (Norcross, GA, www.serologicals.com) have announced an agreement in which Millipore will acquire Serologicals in a cash transaction valued at approximately $1.4 billion and set to close by June 30, 2006.

Cardinal Health, Hospira, Siemens, Ranbaxy, World Health Organization

On April 24, Antares Pharma (Exton, PA, www.antarespharma.com) unveiled its new ?TecTix? advanced transdermal delivery system for the transport of topical drug and excipients across the skin by changing the melting point of the active ingredient. Whereas previous methods focused on the delivery of the drug through the dermis and directly into the bloodstream, the TecTix method can be used locally for dermatological treatments and local anesthetics.

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.