23:44 , Nov 1, 2018 |  BC Extra  |  Company News

FDA panel snubs Alkermes’ antidepressant

An FDA panel voted 21-2 that Alkermes plc (NASDAQ:ALKS) did not demonstrate a favorable benefit risk profile for ALKS 5461 to support approval for adjunct treatment of major depressive disorder. Panelists also voted 20-3 that...
20:26 , Feb 2, 2018 |  BC Week In Review  |  Company News

EPO revokes Forward patent related to Tecfidera

Forward Pharma A/S (NASDAQ:FWP) said the European Patent Office revoked Forward's European Patent No. EP2801355, which Forward claims is infringed by blockbuster multiple sclerosis drug Tecfidera dimethyl fumarate from Biogen Inc. (NASDAQ:BIIB). The company told...
23:36 , Jan 29, 2018 |  BC Extra  |  Company News

EPO revokes Forward patent related to Tecfidera

Forward Pharma A/S (NASDAQ:FWP) lost $1.49 (28%) to $3.87 on Monday after the European Patent Office revoked Forward's European Patent No. EP2801355, which Forward claims is infringed by blockbuster multiple sclerosis drug Tecfidera dimethyl fumarate...
00:38 , Jan 6, 2018 |  BioCentury  |  Finance

Burgeoning bellwethers

  The miserable performance of large cap biotechs last quarter is likely to be a boon for small- and mid-cap players this year, in more ways than one. Buysiders spent most of 2017 focusing to...
00:03 , Dec 1, 2017 |  BC Week In Review  |  Company News

Biogen gains MS candidate from Alkermes

On Nov. 27, Biogen Inc. (NASDAQ:BIIB) obtained an exclusive, worldwide license to commercialize multiple sclerosis candidate ALKS 8700 from Alkermes plc (NASDAQ:ALKS), removing a potential competitor to Biogen’s blockbuster MS drug Tecfidera dimethyl fumarate and...
00:25 , Nov 28, 2017 |  BC Extra  |  Company News

Biogen gains MS candidate from Alkermes

Biogen Inc. (NASDAQ:BIIB) obtained an exclusive, worldwide license to commercialize multiple sclerosis candidate ALKS 8700 from Alkermes plc (NASDAQ:ALKS), removing a potential competitor to Biogen’s blockbuster MS drug Tecfidera dimethyl fumarate and potentially extending the...
13:00 , Mar 17, 2017 |  BC Week In Review  |  Clinical News

ALKS 8700: Ph III started

Alkermes began a double-blind Phase III trial to compare 462 mg oral ALKS 8700 twice daily for 5 weeks vs. 240 mg oral Tecfidera dimethyl fumarate twice daily in about 420 patients. The study is...
08:00 , Nov 9, 2015 |  BC Week In Review  |  Clinical News

ALKS 8700: Phase I data

A double-blind, crossover Phase I trial in 35 healthy volunteers showed that a single dose of ALKS 8700 was bioequivalent to a single dose of Tecfidera dimethyl fumarate. The most common ALKS 8700-related adverse events...
00:51 , Oct 30, 2015 |  BC Extra  |  Financial News

Earnings roundup: Baxalta, Alkermes, Alexion, BioMarin

Alexion Pharmaceuticals Inc. (NASDAQ:ALXN), Baxalta Inc. (NYSE:BXLT), BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) and Alkermes plc (NASDAQ:ALKS) reported 3Q15 earnings on Thursday. Alexion reported non-GAAP diluted EPS of $1.16, topping analysts' consensus of $1.01. Its $666.6 million...
08:00 , Feb 16, 2015 |  BC Week In Review  |  Clinical News

ALKS 8700: Phase I data

Top-line data from a double-blind, placebo- and active-controlled Phase I trial in 104 healthy volunteers showed that multiple formulations of 49-980 mg oral ALKS 8700 were generally well tolerated with no serious adverse events reported....