20:40 , Jun 14, 2018 |  BC Week In Review  |  Clinical News

Allergan's atogepant meets in Phase IIb/III to prevent migraine

Allergan plc (NYSE:AGN) said all doses of oral atogepant (MK-8031) met the primary endpoint in the double-blind, U.S. Phase IIb/III CGP-MD-01 trial to prevent episodic migraine. The company declined to disclose next steps for the...
21:23 , Jun 11, 2018 |  BC Extra  |  Clinical News

Allergan's atogepant meets in Phase IIb/III to prevent migraine

Allergan plc (NYSE:AGN) said all doses of oral atogepant (MK-8031) met the primary endpoint in the Phase IIb/III CGP-MD-01 trial to prevent episodic migraine. The company declined to disclose next steps for the small molecule...
19:42 , May 18, 2018 |  BC Week In Review  |  Clinical News

FDA approves Aimovig as first CGRP inhibitor for migraines

FDA approved Aimovig erenumab from Amgen Inc. (NASDAQ:AMGN) and Novartis AG (NYSE:NVS; SIX:NOVN) late on May 17 to prevent migraine in adults. The drug is the first calcitonin gene-related peptide (CGRP) inhibitor approved for the...
04:05 , May 18, 2018 |  BC Extra  |  Company News

FDA approves Aimovig as first CGRP inhibitor for migraines

FDA approved Aimovig erenumab from Amgen Inc. (NASDAQ:AMGN) and Novartis AG (NYSE:NVS; SIX:NOVN) late Thursday to prevent migraine in adults. The drug is the first calcitonin gene-related peptide (CGRP) inhibitor approved for the indication. Amgen said...
02:31 , May 18, 2018 |  BC Week In Review  |  Clinical News

FDA frowns on Evolus

Evolus Inc. (NASDAQ:EOLS) said FDA issued a complete response letter for a BLA for prabotulinumtoxinA (DWP-450) to treat adults with glabellar lines (frown lines between the eyebrows). Evolus shed over $90 million in market cap...
16:48 , May 16, 2018 |  BC Extra  |  Company News

FDA frowns on Evolus

Evolus Inc. (NASDAQ:EOLS) fell $3.95 (27%) to $10.70 on Wednesday after it said FDA issued a complete response letter for a BLA for prabotulinumtoxinA (DWP-450) to treat adults with glabellar lines (frown lines between the...
16:10 , May 4, 2018 |  BC Week In Review  |  Clinical News

Allergan reports mixed data for acute migraine candidate in second Phase III

Allergan plc (NYSE:AGN) said the 50 mg dose of ubrogepant (MK-1602) met the co-primary endpoints in the double-blind, U.S. Phase III ACHIEVE II trial for the acute treatment of migraine. However, the 25 mg dose...
22:22 , May 3, 2018 |  BC Extra  |  Company News

Amgen says ICER underestimates migraine patient burden

Amgen Inc. (NASDAQ:AMGN) said that the Institute for Clinical and Economic Review's cost-effectiveness analysis of calcitonin gene-related peptide (CGRP) inhibitors for migraine prevention underestimates patients' healthcare cost footprint. ICER's draft evidence report, published April 11, estimated...
21:09 , Apr 27, 2018 |  BC Extra  |  Clinical News

Allergan reports mixed Phase III data for acute migraine candidate

Allergan plc (NYSE:AGN) said the 50 mg dose of ubrogepant (MK-1602) met the co-primary endpoints in the Phase III ACHIEVE II trial for the acute treatment of migraine. However, the 25 mg dose of the...
18:47 , Apr 20, 2018 |  BC Week In Review  |  Clinical News

Evolus’ prabotulinumtoxinA meets in head-to-head Phase III for glabellar lines

Evolus Inc. (NASDAQ:EOLS) reported data from the Phase III EVB-003 trial in 540 patients with moderate to severe glabellar lines (frown lines between the eyebrows) showing that a single dose of 20 U prabotulinumtoxinA (DWP-450)...