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Biohaven Pharmaceuticals Reports First Quarter 2020 Financial Results and Recent Business Developments
5/7/2020
NURTEC™ ODT (rimegepant) received FDA-approval for acute treatment of migraine on February 27, 2020 and Biohaven reports net revenues of $1.2M in March 2020 after launch in U.S. Pharmacies
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Biohaven Enters Into Agreement With Genpharm for Distribution of NURTEC™ ODT in the Middle East
4/27/2020
- Biohaven and Genpharm's agreement will bring NURTEC™ ODT, the first oral, quick-dissolve, calcitonin gene related peptide (CGRP) antagonist to patients in the Middle East and the Gulf Region - Registration in the Middle East is based upon Biohaven's NURTEC™ ODT approval in the US [27-April-2020] NEW HAVEN, Conn. , April 27, 2020 /PRNewswire/ -- Biohaven Ph
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Biohaven Enters Into Partnership With Medison Pharma To Distribute NURTEC™ ODT In Israel
4/16/2020
- Biohaven and Medison Pharma's partnership will bring NURTEC ODT, the first oral, quick-dissolve, calcitonin gene related peptide (CGRP) antagonist to patients in Israel - Registration in Israel based upon Biohaven's NURTEC ODT approval in the US
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Biohaven Receives FDA May Proceed Letter to Begin Phase 2 Trial of Intranasal Vazegepant to Treat Lung Inflammation After COVID-19 Infection
4/9/2020
-- Biohaven plans to study intranasal vazegepant, a third generation, high affinity, selective and structurally unique, small molecule CGRP receptor antagonist, in pulmonary complications of COVID-19 disease -- Phase 2 study to start within weeks, in collaboration with Thomas Jefferson University and other academic medical institutions -- The clinical trial will assess the potential benefits of CGRP receptor-blockade in mitigating an excessive immune response which in some ca
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Biohaven Enters Into Collaboration With Cove, Leading Migraine Telemedicine Platform, To Enhance Accessibility Of NURTEC™ ODT
4/7/2020
Telemedicine collaboration expands comprehensive NURTEC ODT patient affordability and access programs
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This Clinical Catch-Up has been split into three sections: COVID-19-Related Clinical Trials; Non-COVID-19-Related Clinical Trials; and Trials Affected by the COVID-19 Pandemic. Here’s a look.
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Biohaven Preps to Submit Expanded Label for Nurtec Following Positive Migraine Trial Results
3/30/2020
Biohaven Pharmaceutical announced positive topline data from its Phase III trial of oral rimegepant (Nurtec) for preventing migraine headaches in both episodic and chronic migraine patients. -
Biohaven Achieves Positive Results in Pivotal Trial of Oral NURTEC™, Dosed Every Other Day, for the Preventive Treatment of Migraine
3/30/2020
- Rimegepant 75 mg, dosed every other day, demonstrates statistically significant superiority, compared to placebo, on the primary endpoint of reduction in the mean number of migraine days per month - Orally administered rimegepant 75 mg, approved earlier this year for the acute treatment of migraine, is the only CGRP targeting therapy to demonstrate efficacy in both the acute and preventive treatment of migraine - Biohaven plans to engage the FDA and European
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The company said the decision to advance the CGRP receptor antagonist into late-stage studies followed a successful end-of-phase meeting with the U.S. Food and Drug Administration.
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Biohaven to Advance Vazegepant into Phase 3 for the Acute Treatment of Migraine Following Successful End of Phase 2 Meeting with FDA
3/23/2020
- In previously reported positive topline results from pivotal Phase 2/3 clinical trial in December 2019, vazegepant achieved statistical superiority to placebo on the co-primary regulatory endpoints of pain freedom and freedom from most bothersome symptom at 2 hours - Vazegepant is a third generation, high affinity, selective and structurally unique, small molecule CGRP receptor antagonist from Biohaven's NOJECTION™ Migraine Platform and the only intranasal CGRP receptor antagonist in
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Biohaven's Verdiperstat Receives Fast Track Designation For The Treatment Of Multiple System Atrophy
3/18/2020
Biohaven Pharmaceutical Holding announced today that the Company's received fast track designation from FDA
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Biohaven Announces Patient Savings Program Where Patients Can Pay as Little as $0 for NURTEC™ ODT (rimegepant 75 mg) for the Acute Treatment of Migraine in Adults
3/13/2020
Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) today announced a Patient Savings Program for NURTEC™ ODT (rimegepant) that is now available for eligible commercially insured patients.
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Biohaven's NURTEC™ ODT (rimegepant 75mg) is Now Available in U.S. Pharmacies for the Acute Treatment of Migraine in Adults
3/12/2020
Provides fast pain relief, returns patients to normal function within one hour and delivers sustained efficacy that lasts up to 48 hours for many patients
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GlobalData, a leading data and analytics company, pegged the 10 drugs to hit sales of $1 billion and more per year.
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Biohaven's NURTEC™ ODT (rimegepant) Receives FDA Approval for the Acute Treatment of Migraine in Adults
2/27/2020
-Biohaven Pharma Holding Company Ltd. (NYSE: BHVN) today announced that the U.S. Food and Drug Administration (FDA) has approved NURTEC™ ODT (rimegepant) for the acute treatment of migraine in adults.
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Biohaven Pharmaceuticals Reports Second Quarter 2019 Financial Results and Recent Business Developments
8/8/2019
Submitted Two New Drug Applications to FDA for Zydis® Orally Dissolving Tablet and tablet formulations of rimegepant in the second quarter of 2019
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Biohaven's Nurtec 505(b)2 Application for Amyotrophic Lateral Sclerosis Affected by Issues Related to Apotex Plant: Complete Response Letter (CRL) Received From FDA Related to Isolated Drug Substance Supply Used in Bioequivalence Study
7/19/2019
Biohaven Pharmaceutical Holding Company Ltd. announced that it has received a Complete Response Letter from the FDA for the 5052 application seeking approval for NURTEC™ for ALS.
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Biohaven Pharmaceuticals Reports First Quarter 2019 Financial Results And Advancements In Neuroinnovation Platforms
5/7/2019
Secured Priority Review Voucher (PRV) enabling expedited regulatory review of rimegepant Zydis® ODT New Drug Application (NDA)
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Biohaven Broadens Senior Leadership Team With Veteran Pharma Commercial Experience
4/3/2019
William "BJ" Jones joins Biohaven as Chief Commercial Officer, Migraine and Common Diseases
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Biohaven Pharmaceuticals Reports Fourth Quarter And Full Year 2018 Financial And Recent Business Results
2/28/2019
Positioned to submit New Drug Applications (NDA) for rimegepant Zydis ODT and tablet formulations for the acute treatment of migraine in 2Q2019