Results of IV Hectorol trials announced
Bone Care International, a pharmaceutical company in Madison, WI, recently announced results of two Phase 3 clinical studies using the intravenous (IV) formulation of Hectorol (one-alpha D2). The drug is under development as a new treatment for secondary hyperparathyroidism associated with end-stage renal disease.
The trials included 64 hemodialysis patients at 16 study centers in the United States. In these IV trials, Hectorol effectively controlled moderate to severe secondary hyperparathyroidism with no clinically important side effects, notably hypercalcemia or hyperphosphatemia. Data from these trials are consistent with results obtained from the completed Phase 3 trials for oral Hectorol supporting the Company’s New Drug Applica tion (NDA) currently under review by the Food and Drug Administration (FDA). The Company submitted an NDA for IV Hectorol to the FDA in late 1998.
Amedisys acquires Columbia sites in six states
Amedisys of Baton Rouge, LA, recently signed an asset purchase agreement to acquire Columbia/HCA home care operations in Alabama, Georgia, Louisiana, North Carolina, Oklahoma, and Tennessee. This will give Amedisys more than 80 home care and infusion therapy offices.
Chairman and CEO William Borne said the acquisitions allow Amedisys to further penetrate its markets and provide additional platforms to grow its infusion therapy services.
Becton Dickinson reports record revenues
Becton Dickinson of Franklin Lakes, NJ, reported record results for its operations in fiscal year 1998 of $3.117 billion, an 11% increase over 1997’s revenues. Revenues from medical supplies and devices were $1.715 billion, a growth of 14% over 1997 numbers. The company reports that customer conversions to safety devices for health care workers remain consistent in generating underlying growth in the infusion therapy and injection systems businesses.
Olsten announces third-quarter results
Melville, NY-based Olsten Corporation announced third-quarter net earnings of $13 million, compared to $25 million for the same period in 1997. The company notes that the reduced profitability was primarily the result of a loss in health services operations. This offset growth in Olsten’s infusion therapy services.
Baxter to distribute IV Express in U.S.
Round Lake, IL-based Baxter Healthcare Corporation’s IV Systems/Medical Products group recently signed an agreement with Switzerland’s Debiotech SA to distribute Debiotech’s IV Express pump. The pump is an ambulatory multitherapy electronic infusion pump capable of delivering multiple infusion profiles.
In addition to ramped, intermittent, continuous, and patient-controlled infusion, the pump’s small size (5.5 inches wide by 1.7 inches high) gives patients a convenient and discreet method of receiving their infusion. The total weight of the pump is just 13 ounces including the rechargeable battery.
Alpha recalls infused plasma products
Los Angeles-based Alpha Therapeutic Corpor ation recently announced the recall of some of its plasma products designed for intravenous infusion for treatment of hemophilia and immune disorders. The Food and Drug Admini stration is inspecting Alpha’s facilities and has ordered the recall as a precautionary measure.
The products being recalled are those filled in one particular area of the Alpha facility between Dec. 11, 1997, and June 25, 1998, under the trade names Alphanate Antihemophilic Factor (Human), AlphaNine SD Coagulation Factor IX (Human), Albutein Albumin (Human) — 20 ml size only, Profilate SD Antihemophilic Factor (Human), Profilnine SD Factor IX Complex, and Venoglobu lin-S Immune Globulin Intravenous (Human). Specific lot numbers of the above products being recalled can be obtained on the Food and Drug Administration Web site at www.fda.gov/cber/recalls.htm or by calling Alpha at (800) 292-6118.
INCC announces 1999 CRNI exam info
The Intravenous Nurses Certification Corpor ation (INCC) of Cambridge, MA, recently announced test dates of May 2 and Sept. 18, 1999, for the CRNI exam, as well as dozens of locations across the country to take the exam.
The 200-question multiple-choice test is based on nine clinical areas of IV practice: technology and clinical applications (14% of questions on the exam); fluid and electrolyte therapy (14% of questions); pharmacology (13%); infection control (12.5%); pediatrics (7.5%); transfusion therapy (10%); antineoplastic therapy (10%); parenteral nutrition (10%); and quality assurance (9%).
For more information on the CRNI exam, contact the INCC at (800) 434-4622.
• The Role of Nutrition in Cancer Prevention Video Conference — Feb. 2, 5 p.m. EST. For more information on broadcast sites, contact the American Society for Parenteral and Enteral Nutrition at (301) 587-6315.
• Center for Healthcare Environmental Management certification seminar — Feb. 1-5, Oakland, CA. For more information, call (610) 825-6000, ext. 145.
• LITE 99 — Feb. 25-27, Marriott City Center, Pittsburgh. For more information, contact the League of Intravenous Therapy Education at (412) 678-5025.
• American Society for Parenteral and Enteral Nutrition teleconference on Nutrition Support in Critical Care — March 18. For more information, call (301) 587-6315, e-mail firstname.lastname@example.org, or go to ASPEN’s Web site at www.clinnutr.org.
• INS Annual Meeting and Industrial Exhibition — May 1-6, Charlotte, NC. For more information, call INS at (800) 694-0298.
• Center for Healthcare Environmental Management certification seminar — May 17-21, 1999, Plymouth Meeting, PA. For more information, call (610) 825-6000, ext. 145.
• HIDA/99 Trade Show — Oct. 10-12, Chicago. For more information, call (703) 549-4432.
• How to Build an Ambulatory Infusion Center — Jan. 20th, 1999, Philadelphia; Jan. 22, Atlanta. For more information, call (800) 395-9495, or visit www.pgigpo.com.