Rimegepant

Scilex Holding Company Presented Oral and Poster Presentations on Elyxyb at the 2023 Annual Brain Week Conference Held in Las Vegas, NV

Retrieved on: 
Tuesday, September 12, 2023
NNT, New England Institute of Religious Research, PALO, Acute, CGRP, Headache, NNH, MD, Patient, Rimegepant, Post hoc analysis, Hour, OTC, Neurology, Ubrogepant, Therapy, Calcitonin gene-related peptide, Chronic pain, Conference, Pharmaceutical industry, Migraine

PALO ALTO, Calif., Sept. 12, 2023 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), a majority-owned subsidiary of Sorrento Therapeutics, Inc. (OTC: SRNEQ), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, announced that it presented oral and poster presentations at the 2023 Annual Brain Week Conference on the benefits of Elyxyb (celecoxib oral solution).

Key Points: 
  • PALO ALTO, Calif., Sept. 12, 2023 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), a majority-owned subsidiary of Sorrento Therapeutics, Inc. (OTC: SRNEQ), an innovative revenue-generating company focused on acquiring, developing and commercializing non-opioid pain management products for the treatment of acute and chronic pain, announced that it presented oral and poster presentations at the 2023 Annual Brain Week Conference on the benefits of Elyxyb (celecoxib oral solution).
  • The conference was held from September 6-8, 2023 in Las Vegas, NV.
  • Taken together, these data suggest that to achieve pain freedom with Elyxyb, fewer patients need to be treated and may have less likelihood of being harmed, than with ubrogepant or rimegepant.
  • Elyxyb is a remarkable addition to armamentarium for treatment of acute migraine.” said Stewart Tepper, MD, The New England Institute for Neurology and Headache, Stamford, CT, USA.

Trigeminal Neuralgia Drug Pipeline Research Report 2023: Comprehensive Insights on 10 Companies and 10 Pipeline Drugs Featuring Biogen, Biohaven Pharmaceuticals, Noema Pharma, & Pfizer - ResearchAndMarkets.com

Retrieved on: 
Tuesday, September 12, 2023
Health, Pharmaceutical, Biogen, II, Mergers and acquisitions, Trigeminal neuralgia, Discovery, Therapy, III, News, Rimegepant, Nursing, Pharmaceutical industry

The "Trigeminal Neuralgia- Pipeline Insight, 2023" report offers comprehensive insights into the Trigeminal Neuralgia pipeline landscape, featuring information on more than 10 companies and over 10 pipeline drugs.

Key Points: 
  • The "Trigeminal Neuralgia- Pipeline Insight, 2023" report offers comprehensive insights into the Trigeminal Neuralgia pipeline landscape, featuring information on more than 10 companies and over 10 pipeline drugs.
  • Leading companies and academic institutions are dedicated to addressing challenges and exploring opportunities that can shape the future of Trigeminal Neuralgia research and development.
  • The therapies currently in development focus on innovative approaches to enhance the treatment and management of Trigeminal Neuralgia.
  • This segment of the report provides insights about the different Trigeminal Neuralgia drugs segregated based on following parameters that define the scope of the report, such as:
    There are approx.

Successful FDA inspection at Aurisco's manufacturing site in Yangzhou, China

Retrieved on: 
Tuesday, August 15, 2023
GMP, Dydrogesterone, US Foods, Good manufacturing practice, USFDA, API, Medication, FDF, Tablet, CDMO, CGMP, Rimegepant, Peptide, Capital Markets Authority of Kenya, FDA, NMPA, Safety, Fine chemical, Semaglutide

YANGZHOU, China, Aug. 15, 2023 /PRNewswire/ -- Aurisco Pharmaceutical announced today that its API and FDF plant in Yangzhou, China has successfully passed a cGMP inspection by the US Food and Drug Administration (USFDA).

Key Points: 
  • YANGZHOU, China, Aug. 15, 2023 /PRNewswire/ -- Aurisco Pharmaceutical announced today that its API and FDF plant in Yangzhou, China has successfully passed a cGMP inspection by the US Food and Drug Administration (USFDA).
  • The inspection, carried out by the FDA Consumer Safety Officer, Mrs. Michele Glendenning, lasted 5 days (7–11.Aug.2023) as initially planned.
  • The FDA inspection confirmed the site to be compliant with the principles and guidelines of Good Manufacturing Practices (GMP) and no Form 483 observations were issued.
  • Dr. Li Jinliang, Board Director of Aurisco, said "We are pleased to have another successful FDA inspection.

Successful FDA inspection at Aurisco's manufacturing site in Yangzhou, China

Retrieved on: 
Tuesday, August 15, 2023
GMP, Dydrogesterone, US Foods, Good manufacturing practice, USFDA, API, Medication, FDF, Tablet, CDMO, CGMP, Rimegepant, Peptide, Capital Markets Authority of Kenya, FDA, NMPA, Safety, Fine chemical, Semaglutide

YANGZHOU, China, Aug. 15, 2023 /PRNewswire/ -- Aurisco Pharmaceutical announced today that its API and FDF plant in Yangzhou, China has successfully passed a cGMP inspection by the US Food and Drug Administration (USFDA).

Key Points: 
  • YANGZHOU, China, Aug. 15, 2023 /PRNewswire/ -- Aurisco Pharmaceutical announced today that its API and FDF plant in Yangzhou, China has successfully passed a cGMP inspection by the US Food and Drug Administration (USFDA).
  • The inspection, carried out by the FDA Consumer Safety Officer, Mrs. Michele Glendenning, lasted 5 days (7–11.Aug.2023) as initially planned.
  • The FDA inspection confirmed the site to be compliant with the principles and guidelines of Good Manufacturing Practices (GMP) and no Form 483 observations were issued.
  • Dr. Li Jinliang, Board Director of Aurisco, said "We are pleased to have another successful FDA inspection.

Pfizer Completes Acquisition of Biohaven Pharmaceuticals

Retrieved on: 
Monday, October 3, 2022
Biotechnology, Neurology, Health, Pharmaceutical, Clinical Trials, Migraine, New Drug Application, CGRP, CYP3A, PDUFA, Phonophobia, Myostatin, Pregnancy, Review, Disease, Hypersensitivity, Food, CYP3A4, Calcitonin, PFE, Inc., FDA, NDA, Internal medicine, Sound, Food and Drug Administration, Vomiting, Regulation of tobacco by the U.S. Food and Drug Administration, NYSE, Headache, Lactation, Patient, Rash, Acquisition, Breathe Me, New, Nausea, KV7, Contraindication, Rimegepant, Pharmaceutical industry, Fine chemical, Aroma compound, Pfizer

As a result of the acquisition, Biohaven became a wholly-owned subsidiary of Pfizer.

Key Points: 
  • As a result of the acquisition, Biohaven became a wholly-owned subsidiary of Pfizer.
  • Effective immediately prior to the closing of the acquisition, Biohaven completed the spin-off of Biohaven Ltd. (NYSE: BHVN), distributing Biohaven Ltd.s shares to Biohavens shareholders.
  • Biohaven Ltd., a new company that retained Biohavens non-CGRP development stage pipeline compounds, holds the Kv7 ion channel activators, glutamate modulation, and myostatin inhibition platforms, preclinical product candidates, and certain corporate infrastructure assets excluded from the Pfizer acquisition.
  • Pfizer, a Biohaven shareholder, received a pro rata portion of Biohaven Ltd.s shares in the distribution and owns approximately 3% of Biohaven Ltd. Biohaven Ltd. will continue to trade on the New York Stock Exchange under the ticker BHVN.

Biohaven Presents New Migraine Data at 64th Annual Scientific Meeting of the American Headache Society, including First of Its Kind Study for Nurtec® ODT (rimegepant), and Complete Phase 3 Data for Zavegepant Nasal Spray

Retrieved on: 
Monday, June 13, 2022
People, Albert Einstein College of Medicine, US, AHS, Research, Rimegepant, Pharmacokinetics, Headache (journal), Professor, Pain, Acute, CGRP, FDA, Patient, South Korea, NYSE, MD, NDA, Republic, Neurology, Pharmaceutical industry, Dietary supplement, Migraine, Safety

NEW HAVEN, Conn., June 13, 2022 /PRNewswire/ -- Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) today announced new data from three late-breakers and three oral presentations supporting the safety and efficacy of Nurtec® ODT (rimegepant) and zavegepant nasal spray for the treatment of migraine. The oral presentations included a first of its kind study in migraine reporting on the safety and benefits of Nurtec ODT when used as a preventive treatment and as-needed for acute treatment of migraine. The data were presented at the 64th Annual Scientific Meeting of the American Headache Society (AHS) held from June 9-12 in Denver, CO.

Key Points: 
  • We are committed to advancing research for migraine and bringing effective treatment options to the millions of patients living with it.
  • These new data reinforce Nurtec ODT's efficacy and safety for patients using it to both prevent and treat migraine attacks.
  • Biohaven also presented full Phase 3 efficacy and safety data for zavegepant nasal spray.
  • Given these positive outcomes coupled with a consistently safe and well-tolerated profile, the data continue to suggest that Nurtec ODT represents an effective, flexible treatment option for patients."

Biohaven and Pfizer Enter Strategic Collaboration for the Commercialization of Rimegepant Outside the United States

Retrieved on: 
Tuesday, November 9, 2021
Hart–Scott–Rodino Antitrust Improvements Act, Clinical trial, Phonophobia, News, Security (finance), Allergy, COVID-19, Amyotrophic lateral sclerosis, PFE, Vitamin, Pain, Mouth, Review, Alzheimer's disease, Risk, Safety, Neuroscience, Photophobia, Headache, Tic disorder, European Medicines Agency, NEW, Research, Rimegepant, Facebook, YouTube, Royalty Pharma, Woman, Vomiting, U.S. Securities and Exchange Commission, HSR, Marketing, Patient, Tongue, FDA, HCP, Migraine, Private Securities Litigation Reform Act, World, World Health Organization, Sound, Rash, Medication, Face, Twitter, Vaccine, Prescription, MPO, Spinocerebellar ataxia, Nausea, Science, Bristol Myers Squibb, CGRP, Annual report, Stomach, Women's health, Company, LinkedIn, NYSE, Pharmaceutical industry, Birth control

NEW HAVEN, Conn. and NEW YORK, Nov. 9, 2021 /PRNewswire/ --Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) and Pfizer Inc. (NYSE: PFE), today announced a strategic commercialization arrangement for rimegepant in markets outside of the United States upon approval.

Key Points: 
  • NEW HAVEN, Conn. and NEW YORK, Nov. 9, 2021 /PRNewswire/ --Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) and Pfizer Inc. (NYSE: PFE), today announced a strategic commercialization arrangement for rimegepant in markets outside of the United States upon approval.
  • Biohaven and Pfizer are entering into a collaboration and license agreement and related sublicense agreement pursuant to which Pfizer will acquire rights to commercialize rimegepant and zavegepant outside of the U.S. Biohaven will continue to lead research and development globally and Pfizer would execute commercialization globally, outside of the U.S.
  • As noted above, in connection with the transaction, Pfizer will make a $350 million investment in the common shares of Biohaven.
  • Biohaven and Pfizer global collaboration will be discussed on Biohaven 3Q Earnings Investor Call 8:00AM ET on November 9, 2021.

Showcasing Teva’s Commitment to Helping Patients Have More Migraine-Free Days, 18 Abstracts will be presented, Including One Late-Breaker, on AJOVY® (fremanezumab-vfrm) Injection at the International Headache Society and European Headache...

Retrieved on: 
Monday, August 30, 2021
Biotechnology, Pharmaceutical, Health, Clinical Trials, Hypersensitivity, Congress, Research, Travel, CM, Neutralizing antibody, FOCUS, Solution, Teva, Angioedema, Anxiety, Country, University, Health care, Migraine, Forward-looking statement, Investment, Meta-analysis, NMA, Itch, Rimegepant, MFD, Anaphylaxis, Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., TASE, MD, Scientific community, HALO, Medication overuse headache, IV, CEST, Vomiting, Abstract (summary), Perception, Contraindication, Failure, Reductions, Healthcare disparity in Massachusetts, International Headache Society, Private Securities Litigation Reform Act, Excipient, TEVA, Drug, Science, CGRP, Hives, NYSE, Compliance, Caregiver, Rash, Hypertension, Annual report, COVID-19, Headache, Pharmaceutical industry, Generic drug, Security printing, Aroma compound, Health insurance, Vaccine

Migraine affects over a billion people worldwide1, and its impact is felt by patients, caregivers, and society as a whole all around the world.

Key Points: 
  • Migraine affects over a billion people worldwide1, and its impact is felt by patients, caregivers, and society as a whole all around the world.
  • Migraine does not discriminate, and well discuss disparities in headache medicine across diverse populations during our Meet the Expert session.
  • Hypersensitivity Reactions: Hypersensitivity reactions, including rash, pruritus, drug hypersensitivity, and urticaria were reported with AJOVY in clinical trials.
  • Adverse Reactions: The most common adverse reactions in clinical trials (5% and greater than placebo) were injection site reactions.

FDA Approves Biohaven's NURTEC® ODT (rimegepant) for Prevention: Now the First and Only Migraine Medication for both Acute and Preventive Treatment

Retrieved on: 
Thursday, May 27, 2021
Calcitonin gene-related peptide receptor antagonists, Chemical compounds, Organic compounds, Migraine, Calcitonin gene-related peptide, Medical specialties, Rimegepant, CALCRL, Neurogenic inflammation, Prevention of migraines

This new approval makes NURTEC ODT the first oral CGRP antagonist approved for the preventive treatment of migraine, and the only migraine medication approved as a dual therapy for both the acute and preventive treatment.

Key Points: 
  • This new approval makes NURTEC ODT the first oral CGRP antagonist approved for the preventive treatment of migraine, and the only migraine medication approved as a dual therapy for both the acute and preventive treatment.
  • NURTEC ODT is approved for acute treatment in all eligible adult patients with migraine, regardless of the number of monthly migraine days.
  • NURTEC ODT, with its novel quick-dissolve tablet formulation, works by blocking the CGRP receptor, treating a root cause of migraine.
  • It is for the acute treatment of migraine attacks with or without aura and the preventive treatment of episodic migraine.

Biohaven Enters Into Partnership With Medison Pharma To Distribute NURTEC™ ODT In Israel

Retrieved on: 
Thursday, April 16, 2020
Chemical compounds, Organic compounds, Calcitonin gene-related peptide receptor antagonists, Piperidines, Medison, Calcitonin gene-related peptide, Rimegepant, Migraine, Pharmaceutical industry in China, Chemistry

NEW HAVEN, Conn., April 16, 2020 /PRNewswire/ --Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) ("Biohaven") and Medison Pharma, Israel's leading partner for innovative pharmaceuticals, announced today an agreement to distribute NURTEC ODT (rimegepant) in Israel.

Key Points: 
  • NEW HAVEN, Conn., April 16, 2020 /PRNewswire/ --Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) ("Biohaven") and Medison Pharma, Israel's leading partner for innovative pharmaceuticals, announced today an agreement to distribute NURTEC ODT (rimegepant) in Israel.
  • Medison has strong distribution, medical and access capabilities with a proven track record of delivering innovative products successfully to patients in Israel.
  • We are excited to partner with Medison to bring what we believe is the best-in-class oral small molecule CGRP-antagonist NURTECODT to migraine patients in Israel."
  • The agreement between Biohaven and Medison includes NURTEC ODT, approved in the USA on February 27, 2020 for the acute treatment of migraine.