Talon Therapeutics, Inc. (OTCBB:TLON) today announced its NDA for Marqibo (vincristine sulfate liposomes injection) was submitted to the FDA seeking accelerated approval of Marqibo in adult Ph-ALL, in second or greater relapse or that has progressed following two or more prior lines of anti-leukemia therapy.
Nabi Biopharmaceuticals (Nasdaq:NABI) today announced that NicVAX(R) (Nicotine Conjugate Immunotherapeutic) did not meet its primary endpoint in the its first of two confirmatory Phase 3 clinical trials. A preliminary assessment of the trial data showed that subjects treated with NicVAX quit smoking at a similar rate of approximately 11% compared to subjects who received placebo.
Alkermes, Inc. (NASDAQ: ALKS) gave a pipeline update today noting that;
ALKS 9070 to enter pivotal trials for the treatment of Schizophrenia by end of 2011.
ALKS 37 Phase 2b study initiated for treatment of Opioid-Induced Constipation. Alkermes expects to provide topline results from the study mid-year calendar 2012.
ALKS 5461 Phase 1b topline results in treatment-Resistant Depression expected by end of 2011.
Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ), today announced that it had entered into an amendment of its license agreement with Daiichi Sankyo Company, Limited with regard to the its sapacitabine drug. Daiichi Sankyo has irrevocably waived a termination right it possessed under a provision of the License Agreement that required Cyclacel to obtain regulatory approval to sell sapacitabine in at least one country by September 2011, and has released Cyclacel from all claims and liability of any kind arising under such provision. The amendment further provides that the royalty due from Cyclacel to Daiichi Sankyo on future net sales of sapacitabine be increased by a percentage between 1.25% and 1.50% depending on the level of net sales of sapacitabine realized.
Optimer Pharmaceuticals, Inc. (NASDAQ: OPTR) today announced the commercial launch of DIFICID (fidaxomicin) tablets for the treatment of Clostridium difficile-associated diarrhea (CDAD) in patients 18 years of age and older.