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Impel NeuroPharma Expands Commercial Team
contractpharma
March 03, 2021
Prepares for the potential launch of TRUDHESA for the acute treatment of migraine headaches, pending FDA approval.
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FDA Approves Nerivio for Acute Treatment of Migraine in Adolescents
americanpharmaceuticalreview
January 26, 2021
Theranica announced its Nerivio® therapeutic device has received the U.S. Food and Drug Administration (FDA) clearance to market for an expanded indication for acute treatment of episodic or chronic migraine in people 12 years and older.
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NICE u-turn on Novartis' migraine drug Aimovig
pharmatimes
December 15, 2020
In a rare move, NICE has reconsidered its position on Novartis migraine prevention treatment Aimovig (erenumab), now recommending the drug's NHS use in a Final Appraisal Document (FAD) on the back of further analysis submitted by the company.
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NICE recommends Lilly’s migraine med Emgality
pharmatimes
November 20, 2020
The UK’s National Institute for Health and Care Excellence (NICE) has recommended Eli Lilly’s Emgality as a preventative treatment for migraine in adults with episodic and chronic migraine.
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Impel Neuropharma Announces FDA NDA Submission of INP104 for Migraine
americanpharmaceuticalreview
November 19, 2020
Impel NeuroPharma has submitted a New Drug Application (NDA) for INP104 (dihydroergotamine mesylate) or DHE to the U.S. Food and Drug Administration (FDA) for the acute treatment of migraine headaches with or without aura in adult patients.
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Impel NeuroPharma Submits NDA for INP104 in Acute Migraine
contractpharma
November 10, 2020
Impel NeuroPharma has submitted a New Drug Application (NDA) to the U.S. FDA for its lead product candidate, INP104 (dihydroergotamine mesylate, or DHE) for review as a possible new treatment of acute migraine in adult patients.
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FDA Accepts sNDA Of NURTEC ODT for Preventive Treatment of Migraine
americanpharmaceuticalreview
October 21, 2020
Biohaven Pharmaceutical announced the U.S. Food and Drug Administration (FDA) has filed and accepted for review its recently submitted supplemental New Drug Application (sNDA) for NURTEC™ ODT (rimegepant) for the preventive treatment of migraine.
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REYVOW C-V Demonstrated Pain Freedom from Migraine at 60 Minutes in New Study
americanpharmaceuticalreview
September 18, 2020
Adults who took REYVOW™ (lasmiditan) C-V for their migraine attacks at doses of 100 mg or 200 mg had 3.8 and 4.6 times greater odds, respectively, of achieving pain freedom at 2 hours compared to those taking placebo (co-primary endpoint) ...
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AbbVie Announces Positive Phase 3 Data for Atogepant in Migraine Prevention
americanpharmaceuticalreview
August 06, 2020
AbbVie announced that the Phase 3 ADVANCE trial evaluating the investigational medicine atogepant, an orally administered calcitonin gene-related peptide (CGRP) receptor antagonist (gepant) met its primary endpoint of statistically significantly ...
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NICE publishes final guidance backing Teva's Ajovy for migraine
pharmatimes
June 05, 2020
The National Institute for Health and Care Excellence (NICE) has now published final guidelines endorsing the NHS use of Teva’s Ajovy (fremanezumab) to prevent migraine.