Navidea Biopharmaceuticals (NYSE:NAVB) is getting some financial support from the NIH for its Alzheimer’s diagnostic technology as it advances into Phase 3 development. The National Institute of Aging awarded up to $1.8 million for a late-stage clinical trial of the Navidea’s PET beta-amyloid imaging agent, the company said. NAV4694 is designed to help clinicians detect […]
After more than a decade of development and a couple regulatory delays, Navidea Biopharmaceuticals (NYSE:NAVB) finally got the FDA approval it needs to begin marketing its radiopharmaceutical Lymphoseek. In a conference call today, company executives declined to discuss the third-party manufacturing issues raised by the FDA’s complete response letter issued in September. They said the […]
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
Shares of Navidea Biopharmaceuticals (NYSEAMEX:NAVB) went tumbling in after-hours Monday when the company announced that the U.S. Food and Drug Administration did not approve its cancer diagnostic Lymphoseek. Navidea received a complete response letter from the FDA, rather than approval, because of issues related to third-party manufacturing, the company said in a statement. The rejection […]
Radiopharmaceuticals company Navidea Biopharmaceuticals (NYSE Amex:NAVB) announced that the PDUFA date for its cancer diagnostics drug Lymphoseek has been pushed back three months to Sept. 10. The reason Dublin, Ohio-based Navidea gave for the U.S. Food and Drug Administration’s request was that the agency sought more data related to chemistry and manufacturing, according to a […]
Radiopharmaceuticals developer Navidea Biopharmaceuticals (NYSE Amex:NAVB) said early results from a phase 3 clinical study suggest that a targeting agent from the company could be effective in detecting head and neck cancer. Dublin, Ohio-based Navidea recently presented interim results from a head and neck cancer trial of its drug Lymphoseek, a targeting agent used by […]
Cardinal Health (NYSE:CAH) will set the price for Navidea Biopharmaceuticals‘ (NYSE Amex:NAVB) cancer drug that could be approved as soon as this summer. While Navidea, developed the drug, called Lymphoseek, Cardinal will distribute it and collect half of its sales in the U.S., Navidea has said. “In the final analysis, Cardinal will set the pricing,” […]
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
Radiopharmaceuticals company Navidea Biopharmaceuticals (NYSE Amex:NAVB) has opened a Boston-area commercialization office. Employees at Navidea’s new Andover, Massachusetts office will focus much of their attention on the expected launch later this year of drug candidate Lymphoseek, a targeting agent used by surgeons to identify lymph nodes in patients with breast cancer or melanoma and to […]
A public ethics group is calling on the U.S. Securities and Exchange Commission to investigate a hedge fund manager who made headlines last year for being an outspoken short seller of Navidea Bioscience‘s (NASDAQ:NAVB) stock. Citizens for Responsibility and Ethics in Washington (CREW) said it’s looking into whether investors such as Martin Shkreli of MSMB […]
Radiopharmaceuticals developer Navidea Biopharmaceuticals (NYSE Amex:NAVB) has signed a deal that gives it the option to license a Parkinson’s disease imaging agent from Alseres Pharmaceuticals. Under the terms of the deal, Navidea (formerly known as Neoprobe) pays Alseres $500,000 for exclusive rights during a six-month period when it can perform due diligence and negotiate a […]
Radiopharmaceuticals developer Navidea Biopharmaceuticals (NYSE Amex:NAVB) has secured up to $10 million in debt financing that strengthens the company’s balance sheet and could help with future acquisitions or licensing deals. The debt funding comes from Hercules Technology Growth Capital (Nasdaq:HTGC), a financial firm that provides loans to technology companies, according to a statement from Dublin, […]
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Neoprobe‘s (NYSE Amex:NEOP) newly licensed drug candidate that could aid in the diagnosis of Alzheimer’s disease has a potential worldwide market of more than $1 billion, a company official said. Further, Dublin, Ohio-based Neoprobe expects to secure a “significant portion” of that market if and when the drug is commercialized, said Thomas Tulip, Neoprobe’s chief […]
Neoprobe (NYSE Amex:NEOP) has licensed from AstraZeneca (NYSE:AZN) the worldwide rights to an imaging drug candidate that could aid in the diagnosis of Alzheimer’s disease. Neoprobe said it plans to begin a phase 3 clinical program involving the radiopharmaceutical imaging agent, called AZD4694, in early 2013, according to a statement from the Dublin, Ohio-based company. […]
Cancer diagnostics company Neoprobe (NYSE Amex:NEOP) has a new name: Navidea Biopharmaceuticals. The Dublin, Ohio company chose the new moniker because it represents Neoprobe’s commitment to “NAVigating IDEAs” that translate innovation into commercial products that improve patient care, according to a statement. The name change became necessary earlier this year when Neoprobe sold off its […]