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INTERVIEW #SpeakPharma
[Sponsored by another company]https://www.pharmacompass.com/speak-pharma/50-years-of-innovation-mikart-s-legacy-and-what-s-next-in-cdmo-excellence
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09 Jul 2025
// PRESS RELEASE
27 Jun 2025
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=125166
27 Jun 2025
// FDA
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761108
12 Feb 2025
// FIERCE PHARMA
https://www.fiercepharma.com/marketing/astrazenecas-alexion-creates-interactive-fantasy-storybook-help-kids-ahus-understand-rare
07 Feb 2025
// FIERCE BIOTECH
https://www.fiercebiotech.com/biotech/astrazeneca-resets-big-bets-taking-1b-charges-ex-alexion-fusion-assets-suffer-setbacks
12 Nov 2024
// BUSINESSWIRE
Details:
Koselugo (selumetinib) blocks MEK1/2, which are involved in stimulating cells to grow. It is approved for the treatment of symptomatic, inoperable PNs in aged 2 years and above.
Lead Product(s): Selumetinib
Therapeutic Area: Oncology Brand Name: Koselugo
Study Phase: Approved FDFProduct Type: Cytotoxic Drug
Sponsor: Merck & Co
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 11, 2024
Lead Product(s) : Selumetinib
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Merck & Co
Deal Size : Inapplicable
Deal Type : Inapplicable
KOSELUGO Shows Significant Improvement in Neurofibromatosis Type 1
Details : Koselugo (selumetinib) blocks MEK1/2, which are involved in stimulating cells to grow. It is approved for the treatment of symptomatic, inoperable PNs in aged 2 years and above.
Product Name : Koselugo
Product Type : Cytotoxic Drug
Upfront Cash : Inapplicable
December 11, 2024
Details:
Ultomiris (ravulizumab) is approved in the US as the first long-acting C5 complement inhibitor for patients with anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder.
Lead Product(s): Ravulizumab
Therapeutic Area: Rare Diseases and Disorders Brand Name: Ultomiris
Study Phase: Approved FDFProduct Type: Antibody
Sponsor: AstraZeneca
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 25, 2024
Lead Product(s) : Ravulizumab
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : AstraZeneca
Deal Size : Inapplicable
Deal Type : Inapplicable
ULTOMIRIS® Approved for Neuromyelitis Optica Spectrum Disorder Treatment
Details : Ultomiris (ravulizumab) is approved in the US as the first long-acting C5 complement inhibitor for patients with anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder.
Product Name : Ultomiris
Product Type : Antibody
Upfront Cash : Inapplicable
March 25, 2024
Details:
ULTOMIRIS (ravulizumab-cwvz), the first and only long-acting C5 complement inhibitor, offers immediate, complete and sustained complement inhibition. The medication works by inhibiting the C5 protein in the terminal complement cascade, a part of the body’s immune system.
Lead Product(s): Ravulizumab
Therapeutic Area: Rare Diseases and Disorders Brand Name: Ultomiris
Study Phase: Phase IIIProduct Type: Antibody
Sponsor: AstraZeneca
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 10, 2022
Lead Product(s) : Ravulizumab
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : AstraZeneca
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : ULTOMIRIS (ravulizumab-cwvz), the first and only long-acting C5 complement inhibitor, offers immediate, complete and sustained complement inhibition. The medication works by inhibiting the C5 protein in the terminal complement cascade, a part of the body...
Product Name : Ultomiris
Product Type : Antibody
Upfront Cash : Inapplicable
December 10, 2022
Details:
The data will show there were zero adjudicated on-trial relapses observed in patients with AQP4 Ab+ NMOSD with a median treatment duration of 73 weeks, representing a relapse risk reduction of 98.6% (p<0.0001) compared to the external placebo arm.
Lead Product(s): Ravulizumab
Therapeutic Area: Rare Diseases and Disorders Brand Name: Ultomiris
Study Phase: Phase IIIProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 10, 2022
Lead Product(s) : Ravulizumab
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The data will show there were zero adjudicated on-trial relapses observed in patients with AQP4 Ab+ NMOSD with a median treatment duration of 73 weeks, representing a relapse risk reduction of 98.6% (p<0.0001) compared to the external placebo arm.
Product Name : Ultomiris
Product Type : Antibody
Upfront Cash : Inapplicable
December 10, 2022
Details:
ULTOMIRIS (ravulizumab-cwvz), the first and only long-acting C5 complement inhibitor, offers immediate, complete and sustained complement inhibition. The medication works by inhibiting the C5 protein in the terminal complement cascade, a part of the body’s immune system.
Lead Product(s): Ravulizumab
Therapeutic Area: Rare Diseases and Disorders Brand Name: Ultomiris
Study Phase: Phase IIIProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 10, 2022
Lead Product(s) : Ravulizumab
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Alexion Aims To Advance NMOSD Treatment Landscape With Exceptional ULTOMIRIS® (ravulizumab-cwvz) ...
Details : ULTOMIRIS (ravulizumab-cwvz), the first and only long-acting C5 complement inhibitor, offers immediate, complete and sustained complement inhibition. The medication works by inhibiting the C5 protein in the terminal complement cascade, a part of the body...
Product Name : Ultomiris
Product Type : Antibody
Upfront Cash : Inapplicable
December 10, 2022
Details:
The Phase III trial evaluating danicopan (ALXN2040) met its primary endpoint of change in haemoglobin from baseline at 12 weeks and key secondary endpoints, including transfusion avoidance and change in Functional Assessment of Chronic Illness Therapy (FACIT) Fatigue score.
Lead Product(s): Danicopan,Ravulizumab
Therapeutic Area: Rare Diseases and Disorders Brand Name: ALXN2040
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: AstraZeneca
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 16, 2022
Lead Product(s) : Danicopan,Ravulizumab
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : AstraZeneca
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : The Phase III trial evaluating danicopan (ALXN2040) met its primary endpoint of change in haemoglobin from baseline at 12 weeks and key secondary endpoints, including transfusion avoidance and change in Functional Assessment of Chronic Illness Therapy (F...
Product Name : ALXN2040
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 16, 2022
Details:
Danicopan (ALXN2040) plus ULTOMIRIS or SOLIRIS demonstrated superiority compared to placebo plus ULTOMIRIS or SOLIRIS for specific population and clinically meaningful improvements in hb levels, transfusion avoidance and FACIT Fatigue scores from baseline.
Lead Product(s): Danicopan,Ravulizumab
Therapeutic Area: Rare Diseases and Disorders Brand Name: ALXN2040
Study Phase: Phase IIIProduct Type: Other Small Molecule
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 16, 2022
Lead Product(s) : Danicopan,Ravulizumab
Therapeutic Area : Rare Diseases and Disorders
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Danicopan (ALXN2040) Add-On to ULTOMIRIS® (ravulizumab-cwvz) or SOLIRIS® (eculizumab) Met Primar...
Details : Danicopan (ALXN2040) plus ULTOMIRIS or SOLIRIS demonstrated superiority compared to placebo plus ULTOMIRIS or SOLIRIS for specific population and clinically meaningful improvements in hb levels, transfusion avoidance and FACIT Fatigue scores from baselin...
Product Name : ALXN2040
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
September 16, 2022
Details:
Approval by FDA was based on positive results from CHAMPION-MG Phase III trial, in which Ultomiris was superior to placebo in primary endpoint of change from baseline in the MG-ADL total score at Week 26, abilities to perform daily activities.
Lead Product(s): Ravulizumab
Therapeutic Area: Immunology Brand Name: Ultomiris
Study Phase: Approved FDFProduct Type: Antibody
Sponsor: AstraZeneca
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 28, 2022
Lead Product(s) : Ravulizumab
Therapeutic Area : Immunology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : AstraZeneca
Deal Size : Inapplicable
Deal Type : Inapplicable
Ultomiris Approved in The US for Adults with Generalised Myasthenia Gravis
Details : Approval by FDA was based on positive results from CHAMPION-MG Phase III trial, in which Ultomiris was superior to placebo in primary endpoint of change from baseline in the MG-ADL total score at Week 26, abilities to perform daily activities.
Product Name : Ultomiris
Product Type : Antibody
Upfront Cash : Inapplicable
April 28, 2022
Details:
FDA approval based on positive results from CHAMPION-MG Phase III trial, in which ULTOMIRIS was superior to placebo in primary endpoint change from baseline in MG-ADL at Week 26, a patient-reported scale that assesses patients’ abilities to perform daily activities.
Lead Product(s): Ravulizumab
Therapeutic Area: Immunology Brand Name: Ultomiris
Study Phase: Approved FDFProduct Type: Antibody
Sponsor: AstraZeneca
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 28, 2022
Lead Product(s) : Ravulizumab
Therapeutic Area : Immunology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : AstraZeneca
Deal Size : Inapplicable
Deal Type : Inapplicable
ULTOMIRIS® (ravulizumab-cwvz) Approved in the US for Adults with Generalized Myasthenia Gravis
Details : FDA approval based on positive results from CHAMPION-MG Phase III trial, in which ULTOMIRIS was superior to placebo in primary endpoint change from baseline in MG-ADL at Week 26, a patient-reported scale that assesses patients’ abilities to perform dai...
Product Name : Ultomiris
Product Type : Antibody
Upfront Cash : Inapplicable
April 28, 2022
Details:
AstraZeneca's acquisition of Alexion, with its strong commercial portfolio and robust pipeline, will support its long-term ambition to develop novel medicines, which includes Soliris, in areas of immunology with high unmet medical needs.
Lead Product(s): Eculizumab
Therapeutic Area: Immunology Brand Name: Soliris
Study Phase: Approved FDFProduct Type: Antibody
Sponsor: AstraZeneca
Deal Size: $39,000.0 million Upfront Cash: Undisclosed
Deal Type: Acquisition July 21, 2021
Lead Product(s) : Eculizumab
Therapeutic Area : Immunology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : AstraZeneca
Deal Size : $39,000.0 million
Deal Type : Acquisition
Acquisition of Alexion Completed
Details : AstraZeneca's acquisition of Alexion, with its strong commercial portfolio and robust pipeline, will support its long-term ambition to develop novel medicines, which includes Soliris, in areas of immunology with high unmet medical needs.
Product Name : Soliris
Product Type : Antibody
Upfront Cash : Undisclosed
July 21, 2021
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