X
API Suppliers
0
US DMFs Filed
0
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
0
Other Suppliers
0
0
0
USA (Orange Book)
Europe
0
Canada
Australia
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
0
Annual Reports
0
0
Details:
Under the agreement, Organon becomes the sole distributor and promoter of Emgality (galcanezumab), a humanized monoclonal antibody calcitonin gene-related peptide (CGRP) antagonist, and RAYVOW™ (lasmiditan), a first-in-class serotonin 5-HT1F receptor agonist, in Europe.
Lead Product(s): Galcanezumab
Therapeutic Area: Neurology Product Name: Emgality
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Eli Lilly
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement December 18, 2023
Details:
Under the agreement, Affamed will obtain sole commercialization rights upon regulatory approval in Mainland China to Emgality (galcanezumab), a monoclonal antibody that selectively binds to calcitonin gene-related peptide (CGRP).
Lead Product(s): Galcanezumab
Therapeutic Area: Neurology Product Name: Emgality
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: AffaMed Therapeutics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Agreement January 17, 2023
Details:
The study is evaluating once-monthly Emgality® (galcanezumab-gnlm) injection compared to Nurtec® ODT (rimegepant), a tablet patients take every other day, on patient-centric measures, including reductions in monthly migraine headache days and quality of life improvement.
Lead Product(s): Galcanezumab
Therapeutic Area: Neurology Product Name: Emgality
Highest Development Status: Phase IVProduct Type: Large molecule
Partner/Sponsor/Collaborator: Biohaven Pharmaceuticals
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 18, 2021
Details:
Emgality, a once-monthly injectable monoclonal antibody CGRP antagonist (CGRP mAb), as it compares to Nurtec ODT, a small molecule oral CGRP receptor antagonist (gepant), for the prevention of migraine.
Lead Product(s): Galcanezumab
Therapeutic Area: Neurology Product Name: Emgality
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 15, 2021
Details:
A profile comparable to the Emgality device had the highest likelihood of being preferred by nearly half of participants (45.6%) compared to a device profile comparable to Aimovig and AJOVY (29.4% and 25%, respectively).
Lead Product(s): Galcanezumab
Therapeutic Area: Neurology Product Name: Emgality
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 03, 2021
Details:
Second indication for Emgality, making it the first and only CGRP binding monoclonal antibody approved in Canada to reduce frequency of episodic cluster headache attacks that is also approved for the prevention of migraine in adults who have at least 4 migraine days per month.
Lead Product(s): Galcanezumab
Therapeutic Area: Neurology Product Name: Emgality
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 25, 2021
Details:
Under the terms of the agreement, Eli Lilly Japan will hold a marketing authorization for galcanezumab and Daiichi Sankyo will take charge of its distribution and sales after marketing approval.
Lead Product(s): Galcanezumab
Therapeutic Area: Neurology Product Name: Emgality
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Daiichi Sankyo
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration October 30, 2020
Details:
The guidance said that galcanezumab can be used to prevent migraine in adults who have at least four days with migraine each month and in whom at least three previous preventive treatments which failed.
Lead Product(s): Galcanezumab
Therapeutic Area: Neurology Product Name: Emgality
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 16, 2020
Details:
The Phase 3 CONQUER study evaluated the efficacy and safety of Emgality for the preventive treatment of episodic and chronic migraine in patients with documented previous treatment failures on two to four different standard-of-care migraine preventive medication categories.
Lead Product(s): Galcanezumab
Therapeutic Area: Neurology Product Name: Emgality
Highest Development Status: ApprovedProduct Type: Large molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 26, 2020
FULL SCREEN VIEW Click here to open all results in a new tab [this preview display 10 results] 
Market Place
