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news.Genta says EU to issue negative opinion on Genasense
The company said it anticipates this decision based on feedback provided subsequent to a meeting with the agency this week. Genta can request a re-examination of the initial
The company said it anticipates this decision based on feedback provided subsequent to a meeting with the agency this week. Genta can request a re-examination of the initial
The decision came after the company’s investigation of a previously reported precipitation issue. As a result, Hana has chosen to withdraw a new drug application previously submitted to
The FDA did not raise any concerns about the safety of Cimzia or any issues concerning chemistry, manufacturing and controls but asked for an extra study because of
The approved indication is specifically for the short term treatment of impetigo and infected small lacerations, abrasions or sutured wounds. The active substance of Altargo is retapamulin, a
Merck will develop and commercialize Cubicin through its wholly-owned subsidiary, Banyu Pharmaceutical. In exchange for development and commercialization rights in Japan, Merck will pay Cubist $6 million cash
Results showed that cetrorelix, the company’s lead luteinizing hormone-releasing hormone (LHRH) antagonist, was safe and well tolerated at all dosage regimens. Furthermore, Japanese patients responded to cetrorelix with
The SPARC trial is evaluating satraplatin plus prednisone versus placebo plus prednisone in 950 patients with hormone-refractory prostate cancer who have failed prior chemotherapy. “If approved, satraplatin will
This open-label study is designed to access the occupancy of the monoamine oxidase B enzyme (MAO-B) in brain after administration of single oral doses of EVT 302 by
Upon completion of the transaction, which is expected to close sometime during Eisai’s first fiscal quarter of 2007, Morphotek will become part of Eisai’s growing global discovery and
The combined company, renamed CVS/Caremark Corporation, unifies the top US pharmacy chain with a leading pharmaceutical services company. The combined company will trade on the New York Stock