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news.Indevus obtains FDA approvable letter for hypogonadism drug
The letter indicated that the application may be approved if the company is able to adequately respond to certain clinical deficiencies related to the product. The FDA has
The letter indicated that the application may be approved if the company is able to adequately respond to certain clinical deficiencies related to the product. The FDA has
The company’s first product, the inReach System, provides minimally invasive electromagnetic navigation (similar to GPS) to distant regions of the lungs, enabling doctors to diagnose lung cancer at
Bavarian Nordic claims that the defendants have infringed its three patents by commercializing the patented technology in ways that have yielded large payments from Sanofi-Aventis under the agreement
The granting of this patent is expected to provide protection in the US as well as in major markets internationally. Russell Mitchell, CEO of PuraMed Bioscience, said: “The
The University of Missouri (MU) holds intellectual property for a system than can generate clinically relevant quantities of radioisotopes (including Mo-99), the production of which normally requires a
The parties have agreed to jointly move to dismiss the underlying arbitration action and all related claims and counterclaims, with prejudice. In addition, in connection with dismissing the
Par’s dronabinol is approved to treat nausea and vomiting associated with cancer chemotherapy in patients who have failed to respond adequately to conventional antiemetic treatments and is available
Acusphere’s Imagify is an ultrasound imaging agent for the detection of coronary artery disease. The new drug application (NDA) includes data from studies of Imagify in more than
Based on the results, the ChemoPhase combination treatment of mitomycin plus the recombinant human hyaluronidase (rHuPH20) enzyme was well-tolerated and appears safe, the company said. The study reported
As the first company to file an abbreviated new drug application (ANDA) containing a Paragraph IV certification for this product, Teva said that it has been awarded a