12:00 AM
Apr 06, 2009
 |  BioCentury  |  Finance

1Q setbacks

1Q setbacks

Company Setback
Acorda Therapeutics Inc. (NASDAQ:ACOR) FDA refuses to file an NDA for Fampridine-SR to improve walking ability in patients with multiple sclerosis, raising issues with the formatting of the electronic application and requesting additional pharmacokinetic data
Arena Pharmaceuticals Inc. (NASDAQ:ARNA) Lorcaserin meets the co-primary endpoints in the Phase III BLOOM trial but achieves only one of two FDA benchmarks for developing obesity compounds
Arpida Ltd. (SWX:ARPN) Receives a complete response from FDA for an NDA for IV iclaprim to treat complicated skin and skin structure infections (cSSSIs), noting that the application did not demonstrate the efficacy of iclaprim to treat cSSSIs within an acceptable non-inferiority margin and requesting an additional study or studies
Basilea Pharmaceutica AG (SIX:BSLN)/ J&J (NYSE:JNJ) EMEA's CHMP will delay a decision on an MAA for Zevtera ceftobiprole to treat complicated skin and soft tissue infections (cSSTIs) pending Good Clinical Practice (GCP) inspections
Biogen Idec Inc. (NASDAQ:BIIB)/ Genentech Inc./Roche (SIX:ROG) Top-line data shows Rituxan rituximab plus mycophenolate mofetil missed the primary endpoint in the Phase III LUNAR trial to treat lupus nephritis
Cadence Pharmaceuticals Inc. (NASDAQ:CADX) Discontinues development of Omigard (MX-226) after the omiganan pentahydrochloride 1% topical gel missed the primary endpoint in the Phase III CLIRS trial to prevent infection from IV catheters
La Jolla Pharmaceutical Co. (NASDAQ:LJPC)

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