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Follow on Google News | NAPSR News: FDA Greenlights Baxter's OBIZUR for Acquired Hemophilia A“The approval of this product provides an important therapeutic option for use in the care of patients with this rare disease,” said Karen Midthun, MD, director of FDA’s Center for Biologics Evaluation and Research.
By: NAPSRx "The approval of OBIZUR is welcome news for the hemophilia community based on the data from the first clinical trial designed specifically for acquired hemophilia A, which found that all patients responded to treatment within 24 hours," said Dr. Rebecca Kruse-Jarres, Director of the Hemophilia Care Program at Puget Sound Blood Center in Seattle and the clinical trial's principal investigator. "Importantly, this new option to treat bleeding episodes will enable us to measure factor VIII levels, thus giving us an objective marker of hemostasis that can guide dosing and prevent overdosing." The FDA approval was based on Phase2/3 studies administered in a controlled, multi-center open-label clinical trial setting, analyzing the efficacy of OBIZUR in adult patients with AHA. All 28 patients treated with OBIZUR indicated a positive response, either bleeding stopped or was significantly reduced at 24 hours after the initial infusion. Overall 86 percent (24/28) had successful treatment of the initial bleeding episode. OBIZUR will be commercially available in the United States in a few a months and is currently under regulatory review in Europe and Canada. CANDIDATES WHO WANT TO BREAK INTO PHARMACEUTICAL SALES! With such industry leaders paving the way with new beneficial therapeutic breakthroughs, they will need both certified and qualified individuals to promote their diversified product portfolio. When industry leaders look for new candidates for sales/marketing positions, they look toward individuals that are industry trained. Companies are looking for people that have the background to sell their product both proficiently and efficiently. The CNPR is a federally trademarked certification you can earn by demonstrating the necessary knowledge in pharmacology, medical terminology, physiology, and regulations for selling pharmaceuticals. The CNPR examination is dedicated to increasing the professional level of NAPSR members and to developing meaningful and ethical standards fully accepted by both its members and members of the pharmaceutical community. The CNPR® Program represents a level of industry achievement and a demonstrated knowledge of pharmacology, medical terminology, pharmaceutical selling guidelines, physician selling techniques and industry standards. Pharmaceutical sales candidates who have this training will differentiate themselves from other individuals looking for open positions. Upon successful completion of the training each student will receive the Certification Mark of the CNPR®. CNPR® graduates should immediately utilize the NAPSRx® Career Center to apply for pharmaceutical sales positions. Individuals that are interested in becoming a Certified National Pharmaceutical Representative (CNPR) can contact the National Association of Pharmaceutical Sales Representatives( End
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