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The Naval Health Research Center (NHRC); Nastech Pharmaceutical Company Inc.; Amylin Pharmaceuticals, Inc.; Metabolex Inc.; Ortho-McNeil Inc.

Schering-Plough (Kenilworth, NJ, www.sch-plough.com) will establish Schering-Plough Produtos Farmaceuticos Limitada in Sao Paulo, Brazil, to market its core products.

GTC Biotherapeutics Inc. (Framingham, MA, www.gtc-bio.com) has been awarded a $1 million payment from LEO Pharma A/S (Ballerup, Denmark, www.leo-pharma.dk) for receiving a positive opinion on a market authorization application for ATryn, from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Evaluation Agency (EMEA).

Wayne T. Smith; Steven Niedelman; Diana Kolaitis; David Horowitz; Deborah M. Autor; Florence Houn, MD; Julie Beitz, MD

A symposium at the AAPS National Biotechnology Conference in Boston, June 19-22, 2006, addressed key concerns and new developments in manufacturing biologic products in a sterile environment.

"Clinical data is the gold standard" for setting manufacturing specifications, said Patrick Swann, PhD, acting deputy director of the Division of Monoclonal Antibodies at FDA, at a session on specification setting at the AAPS National Biotechnology Conference that was held June 19-21 in Boston.

Protein aggregation is a term that can include many types of aggregation, from rapidly reversible aggregation caused by non-covalent bonds to irreversible aggregation in the form of covalent oligomers.

On August 12, 2003, Johnson & Johnson began recalling certain batches of its anemia drug, Eprex (epoetin alfa, sold as Procrit in the US), in most countries outside of the United States.

Several recent approvals highlight progress in developing both prophylactic and therapeutic vaccines.

In the biotech industry, everyone wants to get to market fast. But what if you have to build a manufacturing facility first? At Interphex 2006, Roger Lias, PhD, vice-president of sales and business development at Cytovance Biologics (Oklahoma City, OK, www.cytovance.com), explained how his company did it quickly. In August of this year, the company expects to complete validation of a new cGMP contract manufacturing facility for biopharmaceuticals derived from mammalian cell culture ? just 25 months after the original groundbreaking.

Data from recent Biotech/Pharmaceutical Industry Conference/Events

Instead of investing in new facilities, the industry should focus on improving manufacturing technology to increase yields, says Timothy Charlebois, PhD, director of cell and molecular sciences for Wyeth (Madison, NJ, www.wyeth.com). Charlebois made these remarks in his introduction to the session, "Frontiers and Economics of Mammalian Cell Expression," at the BIO 2006 convention."I've seen examples where we took a process that produced 3 grams of protein per liter, and were able to optimize it so that it produced 9.6 g/L," he said, adding that future yields are likely to be above 10 g/L.

2 JANUARY - FDA has issued guidance for the blood industry regarding procedures for properly qualifying potential blood donors who have recently been inoculated with the smallpox vaccine (vaccinia virus) or those who may have had other direct exposure to smallpox vaccines.

25 OCTOBER - This guidance document provides our recommendations for assessing donor suitability and product safety for donors with proven West Nile Virus (WNV) infections or with illnesses potentially due to WNV. This guidance applies to Whole Blood and blood components intended for transfusion and blood components including recovered plasma, Source Leukocytes and Source Plasma intended for use in further manufacturing into injectable products or non-injectable products.

14 OCTOBER - German scientists believe they can almost instantly screen blood for the agent that causes the human form of mad cow disease, an achievement that could root out the risk of spreading the disorder by blood donation.

24 SEPTEMBER - CDER has released a list of guidances they plan to develop.

24 SEPTEMBER - Biotechnology Industry Organization (BIO) President Carl B. Feldbaum today issued the following statement regarding White House intentions to nominate Mark B. McClellan, M.D., Ph.D., for commissioner of the Food and Drug Administration, according to newspaper reports:

3 SEPTEMBER - Acambis has completed a Phase 1 trial of it's smallpox vaccine, ACAM1000.

12 AUGUST ? After its fastest review yet for a cancer drug, FDA has approved the colorectal cancer drug Eloxatin (oxaliplatin).

9 JULY - FDA has approved the first device that uses a genetically engineered human protein for use in the lower region of the spine to treat degenerative disc disease, a major cause of back pain for many adults.

8 JULY - FDA will soon publish a Federal Register notice extending the period for public comment on how the agency's regulation of commercial speech can best safeguard public health while complying with First Amendment protections.

1 JULY - NDA Approvals for Calendar Year 2001 http://www.fda.gov/cder/rdmt/ndaaps01cy.htm

28 JUNE - Comprehensive List of Guidance Documents http://www.fda.gov/cder/guidance/guidlist.pdf

FDA and AstraZeneca have added a boxed warning and strengthened the Warnings section of the Nolvadex (tamoxifen citrate) tablets label to inform healthcare professionals about new risk information. MedWatch Safety Information http://www.fda.gov/medwatch/SAFETY/2002/safety02.htm#nolvad

Industry news on investors, software validation guidance, mergers and aquisitions, new drugs on the market, a Science Advisory Board that helps vendors understand life-science needs, a new FDA inspection paradigm, and licensing priorities.

FDA Science Forum, info on contact lenses, FDA regional director becomes Rear Admiral

Flu vaccine, biologic product approvals, foreign establishment registration, and vacancy announcement

Original manufacturing supplements, original efficacy supplements, original and resubmitted NDAs, and new and generic drug approvals.

New guidances, meetings, and 2001 biologics product approval

Industry Business News: FOI Services, Inc. has provided access to Freedom of Information Act files covering virtually every aspect of the U.S. approval and regulation of pharmaceuticals, medical devices, biologics, and diagnostics.