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Details:
Through the acquisition, Organon will leverage the Dermavant pipeline, which includes Vtama (tapinarof) cream. It is indicated for the treatment of f plaque psoriasis in adults.
Lead Product(s): Tapinarof
Therapeutic Area: Dermatology Brand Name: Vtama
Study Phase: ApprovedProduct Type: Small molecule
Recipient: Dermavant Sciences
Deal Size: $1,200.0 million Upfront Cash: $175.0 million
Deal Type: Acquisition September 18, 2024
Lead Product(s) : Tapinarof
Therapeutic Area : Dermatology
Highest Development Status : Approved
Recipient : Dermavant Sciences
Deal Size : $1,200.0 million
Deal Type : Acquisition
Organon Pays up to $1.2B to Acquire Dermavant and its Steroid-Free Skin Cream Vtama
Details : Through the acquisition, Organon will leverage the Dermavant pipeline, which includes Vtama (tapinarof) cream. It is indicated for the treatment of f plaque psoriasis in adults.
Brand Name : Vtama
Molecule Type : Small molecule
Upfront Cash : $175.0 million
September 18, 2024
Details:
Keytruda (Pembrolizumab) is a IV infused PD-1 inhibitor antibody, it is indicated for several tumor or malignancy, including advanced melanoma.
Lead Product(s): Pembrolizumab
Therapeutic Area: Oncology Brand Name: Keytruda
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 15, 2024
Lead Product(s) : Pembrolizumab
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Ten-Year Data for KEYTRUDA Shows Survival Benefit vs. Ipilimumab in Advanced Melanoma
Details : Keytruda (Pembrolizumab) is a IV infused PD-1 inhibitor antibody, it is indicated for several tumor or malignancy, including advanced melanoma.
Brand Name : Keytruda
Molecule Type : Large molecule
Upfront Cash : Not Applicable
September 15, 2024
Details:
Keytruda (Pembrolizumab) is a PD-1 inhibitor antibody, being evaluated with Lenvima (lenvatinib) for unresectable, non-metastatic hepatocellular carcinoma.
Lead Product(s): Pembrolizumab,Lenvatinib
Therapeutic Area: Oncology Brand Name: Keytruda
Study Phase: Phase IIIProduct Type: Large molecule
Sponsor: Eisai
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 14, 2024
Lead Product(s) : Pembrolizumab,Lenvatinib
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Eisai
Deal Size : Not Applicable
Deal Type : Not Applicable
KEYTRUDA Plus LENVIMA Improves Progression-Free Survival in Hepatocellular Carcinoma
Details : Keytruda (Pembrolizumab) is a PD-1 inhibitor antibody, being evaluated with Lenvima (lenvatinib) for unresectable, non-metastatic hepatocellular carcinoma.
Brand Name : Keytruda
Molecule Type : Large molecule
Upfront Cash : Not Applicable
September 14, 2024
Details:
Gardasil (recombinant human papillomavirus quadrivalent vaccine), pentavalent rotavirus vaccine and other agreed products from MSD.
Lead Product(s): Human Papillomavirus 9-Valent Vaccine, Recombinant
Therapeutic Area: Infections and Infectious Diseases Brand Name: Gardasil 9
Study Phase: ApprovedProduct Type: Vaccine
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 11, 2024
Lead Product(s) : Human Papillomavirus 9-Valent Vaccine, Recombinant
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Merck Reports Positive Results from Phase 3 Trial of GARDASIL®9 in Japanese Males
Details : Gardasil (recombinant human papillomavirus quadrivalent vaccine), pentavalent rotavirus vaccine and other agreed products from MSD.
Brand Name : Gardasil 9
Molecule Type : Vaccine
Upfront Cash : Not Applicable
September 11, 2024
Details:
I-DXd (ifinatamab deruxtecan) is an engineered potential first-in-class B7-H3 directed ADC. It is being developed for extensive-stage small cell lung cancer.
Lead Product(s): Ifinatamab Deruxtecan
Therapeutic Area: Oncology Brand Name: I-DXd
Study Phase: Phase IIProduct Type: Large molecule
Recipient: Daiichi Sankyo
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 07, 2024
Lead Product(s) : Ifinatamab Deruxtecan
Therapeutic Area : Oncology
Highest Development Status : Phase II
Recipient : Daiichi Sankyo
Deal Size : Not Applicable
Deal Type : Not Applicable
Ifinatamab Deruxtecan Shows Promising Response Rates in Extensive-Stage SCLC
Details : I-DXd (ifinatamab deruxtecan) is an engineered potential first-in-class B7-H3 directed ADC. It is being developed for extensive-stage small cell lung cancer.
Brand Name : I-DXd
Molecule Type : Large molecule
Upfront Cash : Not Applicable
September 07, 2024
Details:
Restoret (MK-3000), a first-in-class tetravalent, tri-specific antibody and late-phase candidate for diabetic macular edema and neovascular age-related macular degeneration.
Lead Product(s): MK-3000
Therapeutic Area: Ophthalmology Brand Name: Restoret
Study Phase: Phase II/ Phase IIIProduct Type: Large molecule
Sponsor: Merck & Co
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 04, 2024
Lead Product(s) : MK-3000
Therapeutic Area : Ophthalmology
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Merck & Co
Deal Size : Not Applicable
Deal Type : Not Applicable
Merck and EyeBio Initiate Phase 2b/3 Trial for Restoret™ in Diabetic Macular Edema
Details : Restoret (MK-3000), a first-in-class tetravalent, tri-specific antibody and late-phase candidate for diabetic macular edema and neovascular age-related macular degeneration.
Brand Name : Restoret
Molecule Type : Large molecule
Upfront Cash : Not Applicable
September 04, 2024
Details:
Keytruda (pembrolizumab), an anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), an ADC, is indicated for treating adults with locally advanced or metastatic urothelial carcinoma.
Lead Product(s): Pembrolizumab,Enfortumab Vedotin
Therapeutic Area: Oncology Brand Name: Keytruda
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 03, 2024
Lead Product(s) : Pembrolizumab,Enfortumab Vedotin
Therapeutic Area : Oncology
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
European Commission Approves KEYTRUDA® with Padcev® for Urothelial Carcinoma
Details : Keytruda (pembrolizumab), an anti-PD-1 therapy, in combination with Padcev (enfortumab vedotin-ejfv), an ADC, is indicated for treating adults with locally advanced or metastatic urothelial carcinoma.
Brand Name : Keytruda
Molecule Type : Large molecule
Upfront Cash : Not Applicable
September 03, 2024
Details:
Mavenclad (Cladribine) is a orally administered DNA synthesis inhibitor. It is being evaluated in for the treatment of Generalized Myasthenia Gravis.
Lead Product(s): Cladribine
Therapeutic Area: Immunology Brand Name: Mavenclad
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 29, 2024
Lead Product(s) : Cladribine
Therapeutic Area : Immunology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Merck Doses First Patient in Phase III Oral Cladribine Study for Myasthenia Gravis
Details : Mavenclad (Cladribine) is a orally administered DNA synthesis inhibitor. It is being evaluated in for the treatment of Generalized Myasthenia Gravis.
Brand Name : Mavenclad
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 29, 2024
Details:
MK-3543 (bomedemstat) is an investigational orally available small molecule that inhibits LSD1. It is under phase 3 clinical development for the treatment of essential thrombocythemia.
Lead Product(s): Bomedemstat
Therapeutic Area: Oncology Brand Name: MK-3543
Study Phase: Phase IIIProduct Type: Small molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 27, 2024
Lead Product(s) : Bomedemstat
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Merck Starts Phase 3 Trial of Bomedemstat for Essential Thrombocythemia Treatment
Details : MK-3543 (bomedemstat) is an investigational orally available small molecule that inhibits LSD1. It is under phase 3 clinical development for the treatment of essential thrombocythemia.
Brand Name : MK-3543
Molecule Type : Small molecule
Upfront Cash : Not Applicable
August 27, 2024
Details:
Winrevair (sotatercept) is the first activin signaling inhibitor therapy, which is approved for the treatment of adults with pulmonary arterial hypertension.
Lead Product(s): Sotatercept
Therapeutic Area: Cardiology/Vascular Diseases Brand Name: Winrevair
Study Phase: ApprovedProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 26, 2024
Lead Product(s) : Sotatercept
Therapeutic Area : Cardiology/Vascular Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Merck's WINREVAIR™ Approved by European Commission for Pulmonary Hypertension
Details : Winrevair (sotatercept) is the first activin signaling inhibitor therapy, which is approved for the treatment of adults with pulmonary arterial hypertension.
Brand Name : Winrevair
Molecule Type : Large molecule
Upfront Cash : Not Applicable
August 26, 2024
Regulatory Info :
Registration Country : Switzerland
15-valent pneumococcal polysaccharide CRM conjugat...
Dosage Form : Inj Susp
Dosage Strength :
Packaging :
Brand Name : Vaxneuvance
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
15-valent pneumococcal polysaccharide CRM conjugat...
Dosage Form : Inj Susp
Dosage Strength :
Packaging :
Brand Name : Vaxneuvance
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Dosage Form : Film-Coated Tablets
Dosage Strength : 300mg
Packaging :
Brand Name : Campral
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Dosage Form : Filmtablet
Dosage Strength : 300mg
Packaging :
Brand Name : Campral
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Acidum alendronicum; cholecalciferol (vitamin D3)
Dosage Form : Tabl
Dosage Strength : 70/2800
Packaging :
Brand Name : Fosavance weekly tablets
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Acidum alendronicum; cholecalciferol (vitamin D3)
Dosage Form : Tabl
Dosage Strength : 70/2800
Packaging :
Brand Name : Fosavance weekly tablets
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Acidum alendronicum; cholecalciferol (vitamin D3)
Dosage Form : Tabl
Dosage Strength : 70/5600
Packaging :
Brand Name : Fosavance weekly tablets
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Acidum alendronicum; cholecalciferol (vitamin D3)
Dosage Form : Tabl
Dosage Strength : 70/5600
Packaging :
Brand Name : Fosavance weekly tablets
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Italy
Dosage Form : Alendronic Acid 70Mg 4 Units' ...
Dosage Strength : 4 CPR 70 mg
Packaging :
Brand Name : Famax
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Dosage Form : Alendronic Acid 10Mg 14 Joined...
Dosage Strength : 14 CPR 10 mg
Packaging :
Brand Name : Famax
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Services
API & Drug Product Development
Excipients
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 3796
Submission : 1980-05-01
Status : Inactive
Type : IV
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 11859
Submission : 1996-02-16
Status : Inactive
Type : IV
Inspections and registrations
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