Back to School: How biopharma can reboot drug development. Access exclusive analysis here

Highlights of weekly biotech stock moves

Regulatory, clinical and other milestones

Allergan Inc. (NYSE:AGN) fell $10.71 (12%) to $81.99 on Monday after FDA issued draft guidance on developing generic versions of Allergan's Restasis 0.05% cyclosporine ophthalmic emulsion that could lead to earlier than expected competition for the product. The U.S. patent covering Restasis expires in 2014. Allergan markets the product to treat moderate to moderately severe dry eye disease in about 40 countries (see B10).

Allergan was down $8.46 to $84.24 on the week.

Avanir Pharmaceuticals Inc. (NASDAQ:AVNR) rose $0.29 to $4.60 last week after the European Commission approved an MAA for Nuedexta dextromethorphan/quinidine to treat pseudobulbar affect (PBA). The company already markets the product in the U.S. for PBA, which is characterized by involuntary episodes of laughing and/or crying.

Shares of Biogen Idec Inc. (NASDAQ:BIIB) gained $6.39 to $215.20 on Friday after a CHMP recommendation on a rival's MS drug apparently cheered investors concerned over a pending EMA decision on exclusivity for Biogen's Tecfidera dimethyl fumarate (BG-12).

In a reversal of a March decision, the EMA committee recommended that Aubagio teriflunomide from Sanofi (Euronext:SAN; NYSE:SNY), which is under review to treat relapsing-remitting multiple sclerosis (RRMS), be considered a new active substance (NAS). Last month,

Read the full 1919 word article

Trial Subscription

Get a two-week free trial subscription to BioCentury


Article Purchase

This article may not be distributed to non-subscribers