Summer 2011 - Vaccines

People and Places in the News

FDA Approvals

Grifols has received FDA approval to revise its labeling for Alphanate Antihemophilic Factor/von Willebrand Factor Complex (Human) indicating that certain manufacturing steps have been shown to reduce the infectivity of an experimental TSE agent that is a model for variant Creutzfeldt Jakob Disease (vCJD). The labeling revisions stem from extensive Grifols research into the capacity for various manufacturing steps to eliminate a TSE experimental model agent.


Dendreon Corp. has received clearance from the FDA to expand manufacturing facilities for its cancer vaccine Provenge in the U.S. The company’s New Jersey facility, which is currently operating at 25 percent capacity with 12 workstations, can now be fully operational with 48 workstations. The company also is building additional capacity in its Atlanta, Ga., and Los Angeles facilities, each of which will have 36 workstations. Dendreon expects to have 500 centers where patients can be treated with Provenge by the end of 2011, well above the current 50 centers.


Appointments

Sandra Haberichter, PhD, has joined BloodCenter of Wisconsin as director of the Hemostasis Reference Laboratory. Prior to joining BloodCenter, Dr. Haberichter worked at the Medical College of Wisconsin for more than eight years as assistant professor in the department of pediatrics.


Dr. Aldar Bourinbaiar, a cofounder of Immunitor Inc., has joined Immune Network Ltd.’s board of directors. Immune Network is completing its acquisition of 50 percent of Immunitor, a company that has global rights to a patented product called V5, clinically shown to be effective against hepatitis B, hepatitis C and recently demonstrated as a potent immune adjunct for chemotherapeutic management of tuberculosis.


Acquisitions/Alliances

Spain’s Grifols SA has acquired Talecris Biotherapeutics for $3.4 billion, becoming a global producer of plasma protein therapies. It is estimated that the deal will generate $230 million of synergies from a more efficient network and optimized sales, marketing and research.


Sanofi-aventis has entered into a research collaboration with Columbia University Medical Center to develop innovative diabetes medicines. The three-year research collaboration, with the laboratory of Dr. Gerard Karsenty, will investigate the role of the osteoblast-secreted peptide, osteocalcin, in diabetes management.


Gilead Sciences Inc., Foster City, Calif., is buying Calistoga Pharmaceuticals Inc. for $375 billion. Calistoga makes drugs that target diseases such as autoimmune disease, hematological cancers, non-Hodgkin’s lymphoma and chronic lymphocytic leukemia.


Biothera has acquired the anti-cancer monoclonal antibody AS1402 from Antisoma for undisclosed terms. AS1402 targets an aberrant form of the cellsurface protein MUC1 that is widely expressed in many types of cancer.

BSTQ Staff
BioSupply Trends Quarterly [BSTQ] is the definitive source for industry trends, news and information for the biopharmaceuticals marketplace. With timely and critical information, each themed issue covers topics ranging from product breakthroughs, industry insights and innovations, up-to-the-minute news on the latest clinical trials, accessibility, and service and safety concerns.