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06 Oct 2021
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CPhI WW FrankfurtCPhI WW Frankfurt
Industry Trade Show
Booth #9.1D64
28-30 October, 2025
BioProcess Internation...BioProcess International
Industry Trade Show
Booth #319
15-18 September, 2025
Gulf Coast ConferenceGulf Coast Conference
Industry Trade Show
Booth #209
14-15 October, 2025
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04 Oct 2022
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https://www.sigmaaldrich.com/IN/en/collections/press/boost-commercial-capacity-ctdmo-services
11 Nov 2021
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06 Oct 2021
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05 Oct 2021
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26 Aug 2021
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20 Nov 2020
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GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 26513
Submission : 2012-09-28
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 4478
Submission : 1982-03-10
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-09-24
Pay. Date : 2013-04-09
DMF Number : 27017
Submission : 2013-03-26
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 8024
Submission : 1989-04-12
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 23098
Submission : 2009-09-08
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2013-02-07
Pay. Date : 2013-01-16
DMF Number : 22540
Submission : 2009-02-19
Status : Active
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 10293
Submission : 1993-06-11
Status : Inactive
Type : II
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11995
Submission : 1996-06-10
Status : Inactive
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2014-05-24
Pay. Date : 2014-03-25
DMF Number : 18502
Submission : 2005-07-01
Status : Active
Type : II
GDUFA
DMF Review : Complete
Rev. Date : 2018-03-02
Pay. Date : 2018-02-20
DMF Number : 5261
Submission : 1984-01-23
Status : Active
Type : II
Details:
The collaboration will focus on the discovery of novel RNA-targeting small molecules in select neurological indications with high unmet medical need.
Lead Product(s): Undisclosed,Inapplicable
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: Discovery PlatformProduct Type: Other Small Molecule
Recipient: Skyhawk Therapeutics
Deal Size: $2,000.0 million Upfront Cash: Undisclosed
Deal Type: Collaboration August 18, 2025
Lead Product(s) : Undisclosed,Inapplicable
Therapeutic Area : Neurology
Highest Development Status : Discovery Platform
Recipient : Skyhawk Therapeutics
Deal Size : $2,000.0 million
Deal Type : Collaboration
Merck KGaa Swoops to $2b Neurological Disease Pact with Skyhawk
Details : The collaboration will focus on the discovery of novel RNA-targeting small molecules in select neurological indications with high unmet medical need.
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Undisclosed
August 18, 2025
Details:
Follitropin Alfa is a Hormone drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of Hypogonadism.
Lead Product(s): Follitropin Alfa,Goserelin Acetate
Therapeutic Area: Endocrinology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Hormone
Recipient: EMD Serono
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 31, 2025
Lead Product(s) : Follitropin Alfa,Goserelin Acetate
Therapeutic Area : Endocrinology
Highest Development Status : Phase I
Recipient : EMD Serono
Deal Size : Inapplicable
Deal Type : Inapplicable
Follitropin Alfa Pen Vs Powder Bioequivalence In Healthy Males
Details : Follitropin Alfa is a Hormone drug candidate, which is currently being evaluated in Phase I clinical studies for the treatment of Hypogonadism.
Product Name : Undisclosed
Product Type : Hormone
Upfront Cash : Inapplicable
July 31, 2025
Details:
Cetuximab is a Antibody drug candidate, which is currently being evaluated in Phase IV clinical studies for the treatment of Colorectal Neoplasms.
Lead Product(s): Cetuximab,Irinotecan Hydrochloride,Oxaliplatin,Calcium Folinate,Fluorouracil
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IVProduct Type: Antibody
Recipient: Gruppo Oncologico del Nord-Ovest
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable July 31, 2025
Lead Product(s) : Cetuximab,Irinotecan Hydrochloride,Oxaliplatin,Calcium Folinate,Fluorouracil
Therapeutic Area : Oncology
Highest Development Status : Phase IV
Recipient : Gruppo Oncologico del Nord-Ovest
Deal Size : Inapplicable
Deal Type : Inapplicable
Anti-EGFR Therapy in Right-sided Advanced Colorectal Cancer with WT RAS & High AREG/EREG
Details : Cetuximab is a Antibody drug candidate, which is currently being evaluated in Phase IV clinical studies for the treatment of Colorectal Neoplasms.
Product Name : Undisclosed
Product Type : Antibody
Upfront Cash : Inapplicable
July 31, 2025
Details:
Through the acquisition, Merck will leverage SpringWorks’ oncology portfolio, including Ogsiveo (Nirogacestat HBr). It is being indicated for adult patients with progressing desmoid tumors.
Lead Product(s): Nirogacestat Hydrobromide,Inapplicable
Therapeutic Area: Oncology Brand Name: Ogsiveo
Study Phase: Approved FDFProduct Type: Other Small Molecule
Recipient: SpringWorks Therapeutics
Deal Size: $3,900.0 million Upfront Cash: $3,900.0 million
Deal Type: Acquisition July 01, 2025
Lead Product(s) : Nirogacestat Hydrobromide,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Recipient : SpringWorks Therapeutics
Deal Size : $3,900.0 million
Deal Type : Acquisition
Merck Completes Acquisition of SpringWorks Therapeutics
Details : Through the acquisition, Merck will leverage SpringWorks’ oncology portfolio, including Ogsiveo (Nirogacestat HBr). It is being indicated for adult patients with progressing desmoid tumors.
Product Name : Ogsiveo
Product Type : Other Small Molecule
Upfront Cash : $3,900.0 million
July 01, 2025
Details:
Through the acquisition, Merck will leverage SpringWorks’ oncology portfolio, including Ogsiveo (Nirogacestat HBr). It is being indicated for adult patients with progressing desmoid tumors.
Lead Product(s): Nirogacestat HBr,Inapplicable
Therapeutic Area: Oncology Brand Name: Ogsiveo
Study Phase: Approved FDFProduct Type: Other Small Molecule
Recipient: SpringWorks Therapeutics
Deal Size: $3,900.0 million Upfront Cash: $3900 million
Deal Type: Acquisition April 28, 2025
Lead Product(s) : Nirogacestat HBr,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Recipient : SpringWorks Therapeutics
Deal Size : $3,900.0 million
Deal Type : Acquisition
Merck KGaA in $3.9 Billion Deal to Buy US bIotech Firm SpringWorks
Details : Through the acquisition, Merck will leverage SpringWorks’ oncology portfolio, including Ogsiveo (Nirogacestat HBr). It is being indicated for adult patients with progressing desmoid tumors.
Product Name : Ogsiveo
Product Type : Other Small Molecule
Upfront Cash : $3900 million
April 28, 2025
Details:
Under the terms of the Agreement, Merck initially had an exclusive license to commercialize ABSK021 (pimicotinib) for all indications in the Chinese mainland, Hong Kong, Macau.
Lead Product(s): Pimicotinib,Inapplicable
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IIIProduct Type: Other Small Molecule
Recipient: Abbisko Therapeutics
Deal Size: $605.5 million Upfront Cash: $70.0 million
Deal Type: Licensing Agreement March 31, 2025
Lead Product(s) : Pimicotinib,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Phase III
Recipient : Abbisko Therapeutics
Deal Size : $605.5 million
Deal Type : Licensing Agreement
Merck Exercised the Option for the Global Rights of Abbisko Therapeutics's Pimicotinib
Details : Under the terms of the Agreement, Merck initially had an exclusive license to commercialize ABSK021 (pimicotinib) for all indications in the Chinese mainland, Hong Kong, Macau.
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : $70.0 million
March 31, 2025
Details:
VXM01 is an investigational oral anti-VEGFR-2 vaccine, which is being evaluated in combination with avelumab (PD-L1 inhibitor) for treating patients with recurrent glioblastoma.
Lead Product(s): VXM01,Avelumab
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase I/ Phase IIProduct Type: Vaccine
Recipient: Vaximm AG
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 26, 2025
Lead Product(s) : VXM01,Avelumab
Therapeutic Area : Oncology
Highest Development Status : Phase I/ Phase II
Recipient : Vaximm AG
Deal Size : Inapplicable
Deal Type : Inapplicable
Vaximm Shares VXM01-Avelumab Combo Results in Glioblastoma
Details : VXM01 is an investigational oral anti-VEGFR-2 vaccine, which is being evaluated in combination with avelumab (PD-L1 inhibitor) for treating patients with recurrent glioblastoma.
Product Name : Undisclosed
Product Type : Vaccine
Upfront Cash : Inapplicable
March 26, 2025
Details:
Undisclosed
Lead Product(s): M9140,Inapplicable
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Undisclosed
Sponsor: Merck Group
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 03, 2025
Lead Product(s) : M9140,Inapplicable
Therapeutic Area : Oncology
Highest Development Status : Phase I
Partner/Sponsor/Collaborator : Merck Group
Deal Size : Inapplicable
Deal Type : Inapplicable
Anti-CEACAM5 ADC M9140 in Chinese Participants With Solid Tumors (PROCEADE-CRC-02)
Details : Undisclosed
Product Name : Undisclosed
Product Type : Undisclosed
Upfront Cash : Inapplicable
February 03, 2025
Details:
The collaboration aims to conduct a Phase II to evaluate the combination of an experimental immunotherapy drug, AlloStim, and an immune checkpoint inhibitor, Bavencio avelumab from Merck.
Lead Product(s): AlloStim,Avelumab
Therapeutic Area: Oncology Brand Name: AlloStim
Study Phase: Phase IIProduct Type: Cell and Gene therapy
Recipient: Mirror Biologics
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Collaboration January 08, 2025
Lead Product(s) : AlloStim,Avelumab
Therapeutic Area : Oncology
Highest Development Status : Phase II
Recipient : Mirror Biologics
Deal Size : Undisclosed
Deal Type : Collaboration
Mirror Biologics, Merck KGaA Collaborate on Metastatic Colorectal Cancer
Details : The collaboration aims to conduct a Phase II to evaluate the combination of an experimental immunotherapy drug, AlloStim, and an immune checkpoint inhibitor, Bavencio avelumab from Merck.
Product Name : AlloStim
Product Type : Cell and Gene therapy
Upfront Cash : Undisclosed
January 08, 2025
Details:
Undisclosed
Lead Product(s): M9466,Carboplatin
Therapeutic Area: Oncology Brand Name: Undisclosed
Study Phase: Phase IProduct Type: Other Small Molecule
Recipient: EMD Serono
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 06, 2024
Lead Product(s) : M9466,Carboplatin
Therapeutic Area : Oncology
Highest Development Status : Phase I
Recipient : EMD Serono
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Undisclosed
Product Name : Undisclosed
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
December 06, 2024
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