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INTERVIEW #SpeakPharma
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20 Nov 2024
// FIERCE BIOTECH
https://www.fiercebiotech.com/biotech/gsk-scratches-itch-phase-3-win-hitting-goal-liver-disease-trial-open-untapped-market
19 Nov 2024
// REUTERS
https://www.reuters.com/business/healthcare-pharmaceuticals/gsk-drug-meets-main-goal-late-stage-study-treat-relentless-itch-2024-11-19/
14 Nov 2024
// FIERCE PHARMA
https://www.fiercepharma.com/pharma/boost-gsks-ps3b-plan-blenrep-myeloma-adc-shows-survival-edge-over-jjs-darzalex
12 Nov 2024
// FIERCE BIOTECH
https://www.fiercebiotech.com/biotech/gsk-inks-parkinsons-pact-flagships-vesalius-570b-biobucks
12 Nov 2024
// FIERCE PHARMA
https://www.fiercepharma.com/marketing/gsk-survey-highlighting-challenges-facing-gynecological-cancer-patients-kicks-initiative
09 Nov 2024
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https://www.fiercepharma.com/pharma/gsk-calls-it-quits-trade-group-bio-2025-following-exits-takeda-ucb-and-more
Details:
Dovato combines the IST inhibitor, dolutegravir with the NRT inhibitor, lamivudine, is the first and only oral, two-drug, single-tablet regimen available for 12 and older living with HIV.
Lead Product(s): Dolutegravir Sodium,Lamivudine
Therapeutic Area: Infections and Infectious Diseases Brand Name: Dovato
Study Phase: Phase IVProduct Type: Small molecule
Sponsor: Fundación Huésped
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 11, 2024
Lead Product(s) : Dolutegravir Sodium,Lamivudine
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase IV
Partner/Sponsor/Collaborator : Fundación Huésped
Deal Size : Not Applicable
Deal Type : Not Applicable
ViiV Healthcare Announces Dovato is Effective in Treatment-Naïve HIV
Details : Dovato combines the IST inhibitor, dolutegravir with the NRT inhibitor, lamivudine, is the first and only oral, two-drug, single-tablet regimen available for 12 and older living with HIV.
Brand Name : Dovato
Molecule Type : Small molecule
Upfront Cash : Not Applicable
November 11, 2024
Details:
Through the acquisition, GSK plans to develop and commercialize CMG1A46 with a focus on B cell-driven autoimmune diseases, such as systemic lupus erythematosus (SLE) and lupus nephritis.
Lead Product(s): CMG1A46
Therapeutic Area: Immunology Brand Name: CMG1A46
Study Phase: PreclinicalProduct Type: Cell and Gene therapy
Recipient: Chimagen Biosciences
Deal Size: $850.0 million Upfront Cash: $300.0 million
Deal Type: Acquisition October 29, 2024
Lead Product(s) : CMG1A46
Therapeutic Area : Immunology
Highest Development Status : Preclinical
Recipient : Chimagen Biosciences
Deal Size : $850.0 million
Deal Type : Acquisition
GSK to Acquire Chimagen’s CMG1A46 for Autoimmune Disease
Details : Through the acquisition, GSK plans to develop and commercialize CMG1A46 with a focus on B cell-driven autoimmune diseases, such as systemic lupus erythematosus (SLE) and lupus nephritis.
Brand Name : CMG1A46
Molecule Type : Cell and Gene therapy
Upfront Cash : $300.0 million
October 29, 2024
Details:
GSK3511294 (depemokimab) is the first ultra-long-acting biologic with a binding affinity for IL-5. It is being evaluated for the treatment of chronic rhinosinusitis with nasal polyps.
Lead Product(s): Depemokimab
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: GSK3511294
Study Phase: Phase IIIProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 14, 2024
Lead Product(s) : Depemokimab
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
GSK Blockbuster Hope Depemokimab Shrinks Polyps in Ph. 3 Trials
Details : GSK3511294 (depemokimab) is the first ultra-long-acting biologic with a binding affinity for IL-5. It is being evaluated for the treatment of chronic rhinosinusitis with nasal polyps.
Brand Name : GSK3511294
Molecule Type : Large molecule
Upfront Cash : Not Applicable
October 14, 2024
Details:
Blenrep (belantamab mafodotin-blmf) is an anti-BCMA ADC. It is being evaluated in combination with pomalidomide, bortezomib and dexamethasone for the treatment of relapsed/refractory multiple myeloma.
Lead Product(s): Belantamab Mafodotin,Bortezomib,Dexamethasone
Therapeutic Area: Oncology Brand Name: Blenrep
Study Phase: Phase IIIProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 18, 2024
Lead Product(s) : Belantamab Mafodotin,Bortezomib,Dexamethasone
Therapeutic Area : Oncology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Japan's MHLW Reviews GSK's Blenrep Combo NDA for Multiple Myeloma
Details : Blenrep (belantamab mafodotin-blmf) is an anti-BCMA ADC. It is being evaluated in combination with pomalidomide, bortezomib and dexamethasone for the treatment of relapsed/refractory multiple myeloma.
Brand Name : Blenrep
Molecule Type : Large molecule
Upfront Cash : Not Applicable
September 18, 2024
Details:
AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) co-administered with SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) for treating RSV infections.
Lead Product(s): Respiratory Syncytial Virus Vaccine, Adjuvanted,Zoster Vaccine Recombinant, Adjuvanted
Therapeutic Area: Infections and Infectious Diseases Brand Name: Arexvy
Study Phase: ApprovedProduct Type: Vaccine
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 18, 2024
Lead Product(s) : Respiratory Syncytial Virus Vaccine, Adjuvanted,Zoster Vaccine Recombinant, Adjuvanted
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
GSK Announces Positive Topline Data on Co-Administration of AREXVY and SHINGRIX
Details : AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted) co-administered with SHINGRIX (Zoster Vaccine Recombinant, Adjuvanted) for treating RSV infections.
Brand Name : Arexvy
Molecule Type : Vaccine
Upfront Cash : Not Applicable
September 18, 2024
Details:
EOS-448 (belrestotug, TIGIT antibody) with dostarlimab is being investigated for previously untreated, unresectable, locally advanced or metastatic PD-L1 selected NSCLC.
Lead Product(s): Belrestotug,Dostarlimab
Therapeutic Area: Oncology Brand Name: EOS-448
Study Phase: Phase IIIProduct Type: Large molecule
Recipient: Iteos Therapeutics
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 14, 2024
Lead Product(s) : Belrestotug,Dostarlimab
Therapeutic Area : Oncology
Highest Development Status : Phase III
Recipient : Iteos Therapeutics
Deal Size : Not Applicable
Deal Type : Not Applicable
iTeos Reports Positive Objective Response Rate in GALAXIES Lung-201 Study
Details : EOS-448 (belrestotug, TIGIT antibody) with dostarlimab is being investigated for previously untreated, unresectable, locally advanced or metastatic PD-L1 selected NSCLC.
Brand Name : EOS-448
Molecule Type : Large molecule
Upfront Cash : Not Applicable
September 14, 2024
Details:
Flu mRNA (GSK4382276A) is a intramuscularly administered mRNA-based multivalent seasonal influenza vaccine, which is being evaluated for the treatment of seasonal influenza.
Lead Product(s): GSK4382276A
Therapeutic Area: Infections and Infectious Diseases Brand Name: Flu mRNA
Study Phase: Phase IIProduct Type: Vaccine
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 13, 2024
Lead Product(s) : GSK4382276A
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
British Drugmaker GSK Moves mRNA Flu Vaccine to Late-Stage Trials
Details : Flu mRNA (GSK4382276A) is a intramuscularly administered mRNA-based multivalent seasonal influenza vaccine, which is being evaluated for the treatment of seasonal influenza.
Brand Name : Flu mRNA
Molecule Type : Vaccine
Upfront Cash : Not Applicable
September 13, 2024
Details:
Flu mRNA (GSK4382276) is an investigational mRNA-based multivalent vaccine, which is currently being evaluated for the treatment of seasonal influenza.
Lead Product(s): GSK4382276A
Therapeutic Area: Infections and Infectious Diseases Brand Name: Flu mRNA
Study Phase: Phase IIProduct Type: Vaccine
Sponsor: CureVac
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 12, 2024
Lead Product(s) : GSK4382276A
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : CureVac
Deal Size : Not Applicable
Deal Type : Not Applicable
CureVac Partner GSK Reports Positive Phase 2 Data from Seasonal Influenza mRNA Vaccine
Details : Flu mRNA (GSK4382276) is an investigational mRNA-based multivalent vaccine, which is currently being evaluated for the treatment of seasonal influenza.
Brand Name : Flu mRNA
Molecule Type : Vaccine
Upfront Cash : Not Applicable
September 12, 2024
Details:
GSK3943104, an HSV-targeted immunotherapy, is being investigated in early-stage therapeutic herpes simplex virus infection.
Lead Product(s): GSK3943104
Therapeutic Area: Infections and Infectious Diseases Brand Name: GSK3943104
Study Phase: Phase I/ Phase IIProduct Type: Vaccine
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 11, 2024
Lead Product(s) : GSK3943104
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase I/ Phase II
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
GSK's Experimental Herpes Vaccine Fails to Meet Main Goal in Trial
Details : GSK3943104, an HSV-targeted immunotherapy, is being investigated in early-stage therapeutic herpes simplex virus infection.
Brand Name : GSK3943104
Molecule Type : Vaccine
Upfront Cash : Not Applicable
September 11, 2024
Details:
GSK3511294 (depemokimab) is the first ultra-long-acting biologic with a binding affinity for IL-5. It is being evaluated for the treatment of severe asthma With an eosinophilic phenotype.
Lead Product(s): Depemokimab
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: GSK3511294
Study Phase: Phase IIIProduct Type: Large molecule
Sponsor: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable September 09, 2024
Lead Product(s) : Depemokimab
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
GSK to Approach FDA With Positive Phase III Data For Long-Acting Asthma Med
Details : GSK3511294 (depemokimab) is the first ultra-long-acting biologic with a binding affinity for IL-5. It is being evaluated for the treatment of severe asthma With an eosinophilic phenotype.
Brand Name : GSK3511294
Molecule Type : Large molecule
Upfront Cash : Not Applicable
September 09, 2024
Regulatory Info :
Registration Country : Switzerland
Dosage Form : Drinking Solution
Dosage Strength : 20mg/ml
Packaging :
Brand Name : Ziagen
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Dosage Form : Tabl
Dosage Strength : 300mg
Packaging :
Brand Name : Ziagen
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Italy
Dosage Form : Abacavir 20Mg/Ml 240Ml Oral Us...
Dosage Strength : os soluz bottle 240 ml 20 m...
Packaging :
Brand Name : Ziagen
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Italy
Dosage Form : Abacavir 300Mg 60 Units Oral U...
Dosage Strength : 60 cpr riv div 300 mg
Packaging :
Brand Name : Ziagen
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Norway
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 300 mg
Packaging : Blister
Brand Name : Ziagen
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Sweden
Dosage Form : ORAL SOLUTION
Dosage Strength : 20 MG / ML
Packaging :
Brand Name : Ziagen
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Sweden
Dosage Form : FILM COATED PILL
Dosage Strength : 300 MG
Packaging :
Brand Name : Ziagen
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Sweden
Regulatory Info :
Registration Country : Norway
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 300 mg/150 mg/300 mg
Packaging : Box
Brand Name : Trizivir
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Norway
Dosage Form : Antic-calc Tablet, Film Coated
Dosage Strength : 300 mg/150 mg/300 mg
Packaging : Blister
Brand Name : Trizivir
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Norway
Regulatory Info :
Registration Country : Italy
Dosage Form : Abacavir+Lamivudine 600+300Mg ...
Dosage Strength : 30 cpr riv 600 mg + 300 mg
Packaging :
Brand Name : Kivexa
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
Regulatory Info :
Registration Country : Australia
Dosage Form : tablet
Dosage Strength : 300 mg
Packaging : 60
Brand Name : Ziagen
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Dosage Form : oral
Dosage Strength : 20 mg/mL
Packaging : 1
Brand Name : Ziagen
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Dosage Form : Film-coated Tablet; Film-coate...
Dosage Strength : 600MG; 300MG
Packaging : 30
Brand Name : Kivexa
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Dosage Form : Tablet; Tablet
Dosage Strength : 250MG; 100MG
Packaging : 12
Brand Name : Malarone
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Dosage Form :
Dosage Strength :
Packaging : 30
Brand Name : Vocabria
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Dosage Form : Injection; Injection
Dosage Strength : 200MG; 300MG
Packaging : 1
Brand Name : Cabenuva
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Dosage Form : tablet
Dosage Strength : 50 mg
Packaging : 30
Brand Name : Tivicay
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
dolutegravir + abacavir + lamivudine
Dosage Form : Tablet; Tablet; Tablet
Dosage Strength : 50MG; 600MG; 300MG
Packaging : 30
Brand Name : Triumeq
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Dosage Form : Tablet; Tablet
Dosage Strength : 50MG; 300MG
Packaging : 30
Brand Name : Dovato
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Regulatory Info :
Registration Country : Australia
Dosage Form : Tablet; Tablet
Dosage Strength : 50MG; 25MG
Packaging : 30
Brand Name : Juluca
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Australia
Excipients
USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5770
Submission : 1985-04-08
Status : Inactive
Type : IV
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 5770
Submission : 1985-04-08
Status : Inactive
Type : IV
Excipients Web Link
Inspections and registrations
District Decision : No Action Indicated
Inspection End Date : 2008-11-07
City : Aiken
State : SC
Country/Area : US
Zip : 29805-9384
District : ATL
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2008-11-07
District Decision : No Action Indicated
Inspection End Date : 2009-06-11
City : Durham
State : NC
Country/Area : US
Zip : 27709-0143
District : ATL
Center : CDER
Project Area : Bioresearch Monitoring
District Decision : No Action Indicated
Inspection End Date : 2009-06-11
District Decision : No Action Indicated
Inspection End Date : 2010-02-19
City : Durham
State : NC
Country/Area : US
Zip : 27709-0143
District : ATL
Center : CDER
Project Area : Postmarket Surv. and Epidemiolog...
District Decision : No Action Indicated
Inspection End Date : 2010-02-19
District Decision : Voluntary Action Indicated
Inspection End Date : 2010-04-19
City : Aiken
State : SC
Country/Area : US
Zip : 29805-9384
District : ATL
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2010-04-19
District Decision : Voluntary Action Indicated
Inspection End Date : 2010-04-19
City : Aiken
State : SC
Country/Area : US
Zip : 29805-9384
District : ATL
Center : CFSAN
Project Area : Food Composition, Standards, Lab...
District Decision : Voluntary Action Indicated
Inspection End Date : 2010-04-19
District Decision : No Action Indicated
Inspection End Date : 2010-07-27
City : Durham
State : NC
Country/Area : US
Zip : 27709-0143
District : ATL
Center : CDER
Project Area : Bioresearch Monitoring
District Decision : No Action Indicated
Inspection End Date : 2010-07-27
District Decision : No Action Indicated
Inspection End Date : 2011-01-27
City : Aiken
State : SC
Country/Area : US
Zip : 29805-9384
District : ATL
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2011-01-27
District Decision : Voluntary Action Indicated
Inspection End Date : 2012-01-27
City : Aiken
State : SC
Country/Area : US
Zip : 29805-9384
District : ATL
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2012-01-27
District Decision : No Action Indicated
Inspection End Date : 2012-01-27
City : Aiken
State : SC
Country/Area : US
Zip : 29805-9384
District : ATL
Center : CFSAN
Project Area : Food Composition, Standards, Lab...
District Decision : No Action Indicated
Inspection End Date : 2012-01-27
District Decision : No Action Indicated
Inspection End Date : 2012-12-19
City : Durham
State : NC
Country/Area : US
Zip : 27709-0143
District : ATL
Center : CDER
Project Area : Bioresearch Monitoring
District Decision : No Action Indicated
Inspection End Date : 2012-12-19
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GSK is a supplier offers 119 products (APIs, Excipients or Intermediates).
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