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,” […]
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 […]
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
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, […]
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. […]
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.
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 […]
After Neoprobe (NYSE Amex:NEOP) sold off its top revenue-producing asset (along with its name) to transform itself into a pure-play radiopharmaceutical company, it had to find itself a new brand. Now, the company is on the verge of announcing that brand, CEO Mark Pykett said in the Dublin, Ohio company’s third-quarter earnings release. “In the […]
Life science current events this week include Neoprobe gets Lymphoseek's New Drug Application accepted by FDA but hedge fund critic still predicts it will not win approval, and Cleveland Clinic's wellness chief Michael Roizen's new venture.
After remaining silent on Neoprobe (NYSE Amex:NEOP) the last few months, the cancer diagnostics company’s most outspoken critic and short seller has found himself back in the spotlight after the FDA accepted for review a drug application from the company. And that critic — Martin Shkreli of New York hedge fund MSMB Capital — is […]
The U.S. Food and Drug Administration has accepted cancer diagnostics company Neoprobe‘s (NYSE Amex:NEOP) New Drug Application for its radiopharmaceutical Lymphoseek. FDA acceptance of the Lymphoseek NDA is an important milestone for the Dublin, Ohio, company and provides vindication over a once-vocal hedge fund manager critic who raised questions about the design of the drug’s […]
