|March 13, 2013|
|13:09 EDT||CAH, NAVB||FDA approves Navidea Lymphoseek injection for use in lymphatic mapping|
Navidea Biopharmaceuticals (NAVB) announced U.S. Food and Drug Administration approval of Lymphoseek Injection, a novel product indicated for use in lymphatic mapping procedures to assist in the localization of lymph nodes draining a primary tumor in patients with breast cancer or melanoma. Lymphoseek will be sold and distributed in the U.S. on an exclusive basis by Cardinal Health (CAH).
News For NAVB;CAH From The Last 14 Days
|November 21, 2014|
|07:08 EDT||CAH||Henry Schein, Cardinal Health Enter long-term strategic agreement |
Cardinal Health (CAH) and Henry Schein (HSIC) announced that the companies have entered into a long-term strategic agreement to provide one of the most comprehensive service and product offerings to office-based medical practices. This strategic agreement combines Cardinal Health's product line and extensive touch points across the health system with Henry Schein's outstanding service capabilities and history in serving office-based practices. Under the terms of the agreement, the physician office-focused commercial organization of Cardinal Health's Medical segment will be consolidated into the commercial organization of Henry Schein's Medical Group. Henry Schein has committed to purchase Cardinal Health Brand products and utilize Cardinal Health as a primary source for various medical products.
|November 20, 2014|
|07:31 EDT||NAVB||Navidea granted marketing authorization for Lymphoseek by European Commission|
Navidea Biopharmaceuticals has announced that the European Commission has granted marketing authorization for Lymphoseek 250 micrograms kit for radiopharmaceutical preparation. Lymphoseek is now approved in the European Union for use in imaging and intraoperative detection of sentinel lymph nodes draining a primary tumor in adult patients with breast cancer, melanoma, or localized squamous cell carcinoma of the oral cavity. The sentinel node detection label in Europe may now allow Lymphoseek to be used in approximately 367,000, 83,000 and 55,000 new cases of breast cancer, melanoma and oral cavity cancers diagnosed in Europe annually, respectively. Lymphoseek is approved in the U.S. for use in lymphatic mapping to locate lymph nodes draining a primary tumor site in patients with solid tumors for which this procedure is a component of intraoperative management and for guiding Sentinel Lymph Node Biopsy using a handheld gamma counter in patients with node negative squamous cell carcinoma of the oral cavity, breast cancer or melanoma.
|November 17, 2014|
|08:37 EDT||CAH||Cardinal Health management to meet with FBR Capital|
Meetings to be held in the Midwest November 17-18 hosted by FBR Capital.
|November 11, 2014|
|12:29 EDT||CAH||Cardinal Health management to meet with William Blair|
Meeting to be held in Toronto on November 12 hosted by William Blair.
|07:31 EDT||NAVB||Navidea receives $1.1M PDUFA filing free refund for award of orphan drug status|
Navidea Biopharmaceuticals announced it has received a $1.1M refund of the previously paid Prescription Drug User Fee Act filing fee related to the granting of orphan drug status of Lymphoseek injection in head and neck cancers. Lymphoseek was granted Orphan Drug Designation by the FDA in September 2014 for use in sentinel lymph node detection in patients with cancer of the head and neck. Additionally, Platinum Partners, Navidea’s major investor, reaffirmed its support of the company through the remaining $31.8M available under the previously announced line of credit. “We believe we have sufficient capital resources to attain our immediate goals and realize the full commercial potential for Lymphoseek,” said Rick Gonzalez, Navidea CEO. “We are in a position to manage our available cash with our expected growth in revenue and gross profit, our ability to further reduce our operating costs and, if needed, our access to capital under the line of credit from Platinum Partners.”
|November 10, 2014|
|07:19 EDT||CAH||Credit Suisse to hold a conference|
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