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Rockville, MD (Jan. 30)-The White House proposes a record $2 billion budget for FDA for the year that starts Sept. 30, 2007, an amount that consists of $1.6 billion in appropriated funds, plus some $450 million user fees for drugs, biologics, medical devices and other products.

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When it comes to ethics, the adage "hindsight is 20/20" is especially applicable. Countless medical and psychological experiments-such as the 1932 Tuskegee syphilis study or Zimbardo's 1972 Stanford mock-prison experiment-were conducted in the name of science and are now plainly recognized as enormous violations of ethical and human rights.

ePT--the Electronic Newsletter of Pharmaceutical Technology

London (Feb. 1)-AstraZeneca PLC unveiled a plan to improve asset utilization within its global supply chain that involves rationalizing production assets and cutting staff. The company made the announcement as part of its fourth quarter and full-year 2007 financial results.

ePT--the Electronic Newsletter of Pharmaceutical Technology

The US Department of Health and Human Services (HHS, Washington, DC) has awarded three vaccine makers a total of $132.5 million to advance their strategies for adjuvant-containing vaccines to combat the H5N1 strain of avian influenza. Under the contracts, each company will build capacity to produce either 150 million does of the vaccine or enough adjuvant for 150 million doses within six months after the onset of an influenza pandemic.

ePT--the Electronic Newsletter of Pharmaceutical Technology

Indianapolis, IN (Jan. 11)-Eli Lilly and Company announced several strategic changes to its global manufacturing operations. The changes include termination of construction of a planned insulin manufacturing plant in Virginia, staff reductions in its operations for small-molecule active pharmaceutical ingredients (APIs), and investments in manufacturing biotech-based drug products

ePT--the Electronic Newsletter of Pharmaceutical Technology

Rockville, MD (Jan. 12)-To prevent the spread of bovine spongiform encephalopathy (BSE) and related diseases, the US Food and Drug Administration has proposed banning certain cattle tissues and tissue-products from the manufacture of drugs for human and ruminant use. Though cattle products are used in 75% of pharmaceutical processes and 90% of biotechnology processes, the Agency says that no approved or investigational drug appears to contain bovine material that would be prohibited under the rule.

ePT--the Electronic Newsletter of Pharmaceutical Technology

Darmstadt Germany (Jan. 8)-Merck KGaA closed on its roughly CHF 16.6 billion ($13.3 billion) deal to acquire a majority stake in the European biotechnology company Serono (Geneva, Switzerland), officially launched Merck Serono SA as a new entity within Merck KGaA, outlined its integration strategy, and announced plans to divest its generics business.

ePT--the Electronic Newsletter of Pharmaceutical Technology

Berlin and Leverkusen, Germany (Dec. 29)? Bayer Schering Pharma AG was officially launched as a new company following the acquisition of Schering AG (Berlin, Germany) by the Bayer Group (Leverkusen, Germany).

ePT--the Electronic Newsletter of Pharmaceutical Technology

Stockholm, Sweden (Dec. 15)-As part of a plan to expand its biotechnology production capacity, Pfizer, Inc. commissioned the construction company Skanska AB to build a plant in Strangnas, Sweden for manufacturing Pfizer's human growth hormone product "Genotropin" (somatropin [rDNA origin] for injection).

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The recent struggles of Cardinal Health's and Patheon's contract dose manufacturing businesses offer a lesson on good business practices.