Viragen is seeking to have the approval include the first-line adjuvant treatment of high-risk malignant melanoma following dacarbazine (DTIC) after surgical removal of tumors. This submission represents the
The suit challenges the FDA’s policy of awarding generic exclusivity on a patent-by-patent basis. Barr believes that this policy is contrary to the Hatch-Waxman Act, and that it
Novavax’ virus like particle (VLP) technology uses recombinant protein technology to imitate the structure of a virus to provide protection without the risk of infection or disease. Unlike
The preclinical study evaluated the local administration of Combretastatin A4P (CA4P) in the treatment of a murine model of retinoblastoma. Results showed that a subconjunctival delivery of CA4P
The phase II trial evaluated four intravenous doses of secretin versus a placebo in refractory schizophrenia. Initial results showed that secretin did not significantly improve symptoms as measured
Orphan drug designation entitles Viventia to various incentives, including seven years of exclusive marketing rights if Proxinium receives marketing approval by the FDA. Historically, many orphan drugs have
The Division of Drug Marketing, Advertising, and Communications (DDMAC) reviewed advertising information for Coreg (carvedilol) tablets and found it to be false or misleading, as it omits material
Pegamotecan is a PEGylated cytotoxic drug of the topoisomerase I inhibitor class. The company’s decision to discontinue the drug’s development program is based on an interim analysis of
Under the Prescription Drug User Fee Act (PDUFA), the FDA review of the resubmission for BiDil (a fixed combination of isosorbide dinitrate and hydralazine) is expected to be
The award, from the Department of Development Cooperation of the Netherlands Ministry of Foreign Affairs (DGIS), comes after the Dutch government concluded its presidency of the EU in
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