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12:00 AM
Jan 04, 2010
 |  BioCentury  |  Finance

4Q setbacks

4Q setbacks

Company Setback
Acorda Therapeutics Inc. (NASDAQ:ACOR)/ Elan Corp. plc (NYSE:ELN) FDA extends the PDUFA date for an NDA for Fampridine-SR to improve walking ability in patients with multiple sclerosis by three months to Jan. 22 after Acorda submitted additional information on its proposed risk evaluation and mitigation strategy (REMS)
Addex Pharmaceuticals Ltd. (SIX:ADXN) Discontinues development of ADX10059 for chronic indications based on elevated levels of alanine transaminase (ALT) in the Phase IIb ADX10059-206 trial to prevent migraine
Aeterna Zentaris Inc. (TSX:AEZ; NASDAQ:AEZS) sanofi-aventis Group (Euronext:SAN; NYSE:SNY) ends deal after cetrorelix fails in the Phase III Z-036 trial in benign prostatic hyperplasia (BPH)
Amarin Corp. plc (NASDAQ:AMRN) Withdraws MAA for AMR101 to treat Huntington's disease after EMEA's CHMP indicated that additional clinical trials would be needed
Amgen Inc. (NASDAQ:AMGN) Receives complete response letters from FDA for BLAs for Prolia denosumab to treat and prevent postmenopausal osteoporosis (PMO) and to treat and prevent bone loss due to hormone ablation therapy in breast and prostate cancer patients. FDA requests "a new clinical program" for prevention of PMO and data from additional trials in cancer to show Prolia has no detrimental effects on time to disease progression (TTP) or overall survival.
Amicus Therapeutics Inc. (NASDAQ:FOLD) Ends deal with Shire plc (LSE:SHP; NASDAQ:SHPGY) after saying it does not expect to move Plicera afegostat into Phase III trials based on results from a Phase II trial to treat Type I Gaucher's disease
Antigenics Inc. (NASDAQ:AGEN) Withdraws MAA for Oncophage vitespen for the adjuvant treatment of RCC after EMEA's CHMP issued a negative opinion because Oncophage did not increase TTP
Antisoma plc (LSE:ASM) Discontinues development of AS1411 to...

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