News

Akorn, Natco, Illumigen, Avecia

Dallas, TX (Nov. 7)-The US Food and Drug Administration has posted a Warning Letter from its Dallas District office to Matheson Tri-Gas, Inc.

St. Paul, MN (Nov. 9)-3M Co. will carve up and sell its global branded pharmaceuticals businesses for a total of $2.1 billion, the company announced this morning.

AAPS, San Antonio (Oct. 31)-Industry and regulatory agency concerns over process variability have prompted both groups to take a closer look at analytical method transfer processes.

South San Francisco, CA and Basel, Switzerland (Nov. 8)-Genentech, Inc. and the contract manufacturer Lonza Group entered into an agreement under which Lonza will buy Genentech's mid-scale mammalian biopharmaceutical manufacturing facility in Porri?o, Spain, supply certain products to Genentech, and provide Genentech with the option to purchase Lonza's planned biopharmaceutical manufacturing facility in Singapore.

AAPS, San Antonio (Oct. 30)-Although the analysis of impurities in drug substances and drug products is not a new topic, new regulations are increasing concern in the industry.

AAPS, San Antonio (Oct. 31)-As biologic-based drugs become an increasingly larger part of pharmaceutical product portfolios, strategies for optimizing their formulation become increasingly important.

AAPS, San Antonio (Oct. 31)-Excipient manufacturers are raising concerns over recently adopted European guidelines, set to become effective January 1, 2007, which provide a framework and approach for dealing with genotoxic impurities in new active substances.

Avecia, Illumigen, Biomira, ProIX

AAPS, San Antonio (Oct. 30)-Aiming to provide a greater understanding of coating processes, speakers at the 20th Annual Meeting of the American Association of Pharmaceutical Scientists presented some of the difficulties, tools, and strategies for obtaining adequately uniform films in pan and fluid-bed coating processes.

Liverpool, UK (Oct. 20)-Novartis Vaccines and Diagnostics Limited is recovering two lots totaling 500,000 doses of its ?Fluvirin? influenza virus vaccine after reports that the product had been received from distributor Cardinal Health Care in either a frozen state or below the required storage temperature range of 35?46 degrees F.

Philadelphia (Oct.24)?Failures to review batch failures and unexplained discrepancies are the leading cause of Food and Drug Administration Form 483 observations and Warning Letter citations issued to pharmaceutical companies.

Baxter Healthcare, Merck, Teledyne

San Antonio, TX (Nov. 1)?Market growth in the pharmaceutical outsourcing industry is strong, but slowing, according to Jim Miller, president of PharmSource Information Services, Inc. and publisher of Bio/Pharmaceutical Outsourcing Report.

San Antonio, TX (Nov. 1)-Though the US Food and Drug Administration's final guidance on process analytical technology (PAT) was published in Sept. 2004, companies are still unsure about how exactly to implement PAT in their processes.

Wilmington, NC (Oct. 26)?AAIPharma Inc. has completed its acquisition of contract research organization Cvitkovic & Associes Consultants S.A.

San Antonio, TX (Nov. 1)-The opening session of the ?Pharmaceutical Technologies? track at the 2006 Annual Meeting of the American Association of Pharmaceutical Scientists in San Antonio, Texas was standing room only as R. Christian Moreton, PhD, vice-president of pharmaceutical science at Idenix Pharmaceuticals, and Richard O. Mannion of Purdue Pharma discussed ?Product Development Using a Virtual Company Model.?

Mid-size regional players have little chance for success in an industry increasingly dominated by large global players.

FDA conducted 163 inspections of foreign API manufacturers in 2005.

Applied Biosystems, Aptuit, Barr, Bioenvision, Bioject, Bionomics, Charles Ross, Connetics, Curalogic, Cytogen, Doxa, Eli Lilly, FDA, Imclone, Laureate, Luciano Packaging, Microtest, Orexo, PLIVA, SAFC, Sanofi-Aventis, SSCI, SSI, Stiefel, Teva

Robin Hwang, a senior principal scientist at Amgen (Thousand Oaks, CA), led the team that developed the first commercial disposable auto-injector for a biopharmaceutical: a prefilled three-step "SureClick" for delivering Enbrel (etanercept), a treatment for autoimmune diseases.

The US Food and Drug Administration issued a guidance document to provide manufacturers of biological products (other than blood and blood components) with its current thinking on reporting requirements on deviations from current good manufacturing practices for biological products.

Growth in the global pharmaceutical market is expected to slow in 2007, based on the industry's increasing reliance on niche and specialty products and greater generic drug penetration, according to a forecast by IMS Health. Generic drugs, along with biotechnology and specialist-initiated products, are expected to outperform the overall market in 2007. Despite slower growth in the United States and Europe, growth in emerging countries, including China, is projected in the double digits.

The US Food and Drug Administration's Center for Drug Evaluation and Research executed 45 Class I, 193 Class II, and 128 Class III recalls of human drugs between Oct. 1, 2005 and Sept. 30, 2006.

Cambrex Corp. signed a definitive stock-purchase agreement to sell two of its human-health facilities to a holding company controlled by International Chemical Investors II S.A. (Frankfurt, Germany).

Boehringer Ingelheim, Chemir Analytical Services, Millennium Pharmaceuticals

Indianapolis, IN (Oct. 17)-Eli Lilly and Company agreed to acquire ICOS Corporation (Bothell, WA) for $2.1 billion.

Washington, DC (Oct. 13)-In a four-year study of pharmaceutical manufacturing, two business scholars found that initiative and information correlate with high productivity.

New York, NY (Oct. 19)-Pfizer, Inc. plans to implement a new company-wide cost-cutting initiative in 2007 as part of strategy to improve operating performance. The cuts are in addition to a previous cost-reduction program that Pfizer launched in 2005.

CPhI Worldwide, Paris (Oct. 3)-Archimica, participating in its first CPhI Worldwide exhibition since being launched as new company earlier this year, outlined manufacturing expansions, technology additions, and recent projects at its facilities in the United States and Europe.