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Highlights of weekly biotech stock moves

Regulatory, clinical and other milestones

Regulatory milestones

Biogen Idec Inc. (NASDAQ:BIIB) was up $8.39 to $235.24 last week after submitting a BLA to FDA for Plegridy peginterferon beta-1a (BIIB017) to treat relapsing forms of multiple sclerosis (MS). The company said it expects to submit an MAA to EMA in the coming weeks.

Celgene Corp. (NASDAQ:CELG) was off $2.33 to $122.58 last week after FDA accepted and granted Priority Review to an sNDA to expand the label of Abraxane nab-paclitaxel to include first-line treatment of advanced pancreatic cancer in combination with gemcitabine. The PDUFA date is Sept. 21.

Celgene also saidEMA accepted for review an application for the indication in April. Abraxane is approved in the U.S. for first-line treatment of advanced non-small cell lung cancer (NSCLC) and in the U.S. and EU for second-line treatment of metastatic breast cancer.


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