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About the Company : At GSK we have a challenging mission: to improve the quality of human life by enabling people to do more, feel better, live longer. Find out how this shapes everything we do, including our R&D, ...
Details:
Trelegy Ellipta is an inhaled medication used to treat symptoms of COPD. It's a combination inhaler containing fluticasone furoate, umeclidinium, and vilanterol.
Lead Product(s): Fluticasone Furoate,Umeclidinium Bromide,Vilanterol Trifenatate
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Trelegy Ellipta
Study Phase: Approved FDFProduct Type: Steroid
Recipient: Theravance Biopharma
Deal Size: $225.0 million Upfront Cash: $225.0 million
Deal Type: Agreement June 02, 2025
Lead Product(s) : Fluticasone Furoate,Umeclidinium Bromide,Vilanterol Trifenatate
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved FDF
Recipient : Theravance Biopharma
Deal Size : $225.0 million
Deal Type : Agreement
Theravance Sells Remaining Trelegy Ellipta Royalties to GSK for $225 Million
Details : Trelegy Ellipta is an inhaled medication used to treat symptoms of COPD. It's a combination inhaler containing fluticasone furoate, umeclidinium, and vilanterol.
Product Name : Trelegy Ellipta
Product Type : Steroid
Upfront Cash : $225.0 million
June 02, 2025
Details:
Nucala (mepolizumab) is the first targeted anti-Interleukin-5 (IL-5) biologic. It is indicated for the treament of COPD with an eosinophilic phenotype.
Lead Product(s): Mepolizumab
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Nucala
Study Phase: Approved FDFProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 22, 2025
Lead Product(s) : Mepolizumab
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
FDA Approves Nucala (Mepolizumab) for Adults with COPD in The US
Details : Nucala (mepolizumab) is the first targeted anti-Interleukin-5 (IL-5) biologic. It is indicated for the treament of COPD with an eosinophilic phenotype.
Product Name : Nucala
Product Type : Antibody
Upfront Cash : Inapplicable
May 22, 2025
Details:
Through the acquisition, GSK will leverage Boston lead asset, BOS-580 (efimosfermin alfa). It is a phase III-ready, investigational specialty medicine to treat steatotic liver disease.
Lead Product(s): Efimosfermin Alpha
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Brand Name: BOS-580
Study Phase: Phase IIProduct Type: Protein
Recipient: Boston Pharmaceuticals
Deal Size: $2,000.0 million Upfront Cash: $1,200.0 million
Deal Type: Acquisition May 14, 2025
Lead Product(s) : Efimosfermin Alpha
Therapeutic Area : Hepatology (Liver, Pancreatic, Gall Bladder)
Highest Development Status : Phase II
Recipient : Boston Pharmaceuticals
Deal Size : $2,000.0 million
Deal Type : Acquisition
GSK to Buy Liver Disease Drug for up to $2 Billion
Details : Through the acquisition, GSK will leverage Boston lead asset, BOS-580 (efimosfermin alfa). It is a phase III-ready, investigational specialty medicine to treat steatotic liver disease.
Product Name : BOS-580
Product Type : Protein
Upfront Cash : $1,200.0 million
May 14, 2025
Details:
GSK4057190 (dostarlimab) in combination with GSK4428859A (belrestotug) is currently being evaluated for the treatment of advanced/metastatic non-small-cell lung cancer.
Lead Product(s): Belrestotug,Dostarlimab,Nelistotug
Therapeutic Area: Oncology Brand Name: GSK4428859A
Study Phase: Phase IIProduct Type: Antibody
Recipient: Iteos Therapeutics
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 13, 2025
Lead Product(s) : Belrestotug,Dostarlimab,Nelistotug
Therapeutic Area : Oncology
Highest Development Status : Phase II
Recipient : Iteos Therapeutics
Deal Size : Inapplicable
Deal Type : Inapplicable
iTeos Shares Interim Results of Belrestotug Combo in PD-L1+ NSCLC Patients
Details : GSK4057190 (dostarlimab) in combination with GSK4428859A (belrestotug) is currently being evaluated for the treatment of advanced/metastatic non-small-cell lung cancer.
Product Name : GSK4428859A
Product Type : Antibody
Upfront Cash : Inapplicable
May 13, 2025
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: Approved FDFProduct Type: Antibody-drug Conjugate
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable April 19, 2025
Lead Product(s) : Belantamab Mafodotin,Bortezomib,Dexamethasone
Therapeutic Area : Oncology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
GSK's Blenrep Combinations Approved by UK MHRA in Relapsed/refractory 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.
Product Name : Blenrep
Product Type : Antibody-drug Conjugate
Upfront Cash : Inapplicable
April 19, 2025
Details:
Under the licensing agreement, GSK will develop novel medicines for neurodegenerative diseases by utilizing ABL Bio's blood-brain barrier (BBB) shuttle platform, Grabody-B.
Lead Product(s): Undisclosed
Therapeutic Area: Neurology Brand Name: Undisclosed
Study Phase: UndisclosedProduct Type: Antibody
Recipient: ABL Bio
Deal Size: $2,725.3 million Upfront Cash: $49.6 million
Deal Type: Licensing Agreement April 06, 2025
Lead Product(s) : Undisclosed
Therapeutic Area : Neurology
Highest Development Status : Undisclosed
Recipient : ABL Bio
Deal Size : $2,725.3 million
Deal Type : Licensing Agreement
ABL Bio Licenses Brain Drug Platform to GSK for Neuro Diseases
Details : Under the licensing agreement, GSK will develop novel medicines for neurodegenerative diseases by utilizing ABL Bio's blood-brain barrier (BBB) shuttle platform, Grabody-B.
Product Name : Undisclosed
Product Type : Antibody
Upfront Cash : $49.6 million
April 06, 2025
Details:
Blujepa (gepotidacin) is the first in a new class of oral antibiotics which inhibits topoisomerase II/IV. It is approved for the treatment of uncomplicated urinary tract infections.
Lead Product(s): Gepotidacin
Therapeutic Area: Infections and Infectious Diseases Brand Name: Blujepa
Study Phase: Approved FDFProduct Type: Antibiotic
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 25, 2025
Lead Product(s) : Gepotidacin
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Blujepa (Gepotidacin) FDA-Approved for Uncomplicated Urinary Tract Infections
Details : Blujepa (gepotidacin) is the first in a new class of oral antibiotics which inhibits topoisomerase II/IV. It is approved for the treatment of uncomplicated urinary tract infections.
Product Name : Blujepa
Product Type : Antibiotic
Upfront Cash : Inapplicable
March 25, 2025
Details:
Nucala (mepolizumab) is the first targeted anti-Interleukin-5 (IL-5) biologic. It is being investigated for the treament of COPD with an eosinophilic phenotype.
Lead Product(s): Mepolizumab
Therapeutic Area: Pulmonary/Respiratory Diseases Brand Name: Nucala
Study Phase: Phase IIIProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 24, 2025
Lead Product(s) : Mepolizumab
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
EMA Reviews GSK’s Nucala Expansion for COPD Treatment
Details : Nucala (mepolizumab) is the first targeted anti-Interleukin-5 (IL-5) biologic. It is being investigated for the treament of COPD with an eosinophilic phenotype.
Product Name : Nucala
Product Type : Antibody
Upfront Cash : Inapplicable
March 24, 2025
Details:
VH109, a CD4-binding broadly neutralising antibody, in combination with monthly cabotegravir long-acting (CAB LA), successfully kept viral levels suppressed in adults living with HIV.
Lead Product(s): VH109,Cabotegravir
Therapeutic Area: Infections and Infectious Diseases Brand Name: VH3810109
Study Phase: Phase IIProduct Type: Antibody
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable March 12, 2025
Lead Product(s) : VH109,Cabotegravir
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
ViiV’s N6LS Antibody Maintains Long-Acting Viral Suppression in HIV Treatment
Details : VH109, a CD4-binding broadly neutralising antibody, in combination with monthly cabotegravir long-acting (CAB LA), successfully kept viral levels suppressed in adults living with HIV.
Product Name : VH3810109
Product Type : Antibody
Upfront Cash : Inapplicable
March 12, 2025
Details:
Penmenvy approved for use in individuals aged 10 to 25 years. The vaccine targets 5 major serogroups of Neisseria meningitidis (A, B, C, W, & Y) which commonly cause invasive meningococcal disease.
Lead Product(s): Meningococcal Groups A, B, C, W, and Y Vaccine
Therapeutic Area: Infections and Infectious Diseases Brand Name: Penmenvy
Study Phase: Approved FDFProduct Type: Vaccine
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable February 15, 2025
Lead Product(s) : Meningococcal Groups A, B, C, W, and Y Vaccine
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
US FDA Approves GSK's Combo Meningococcal Vaccine
Details : Penmenvy approved for use in individuals aged 10 to 25 years. The vaccine targets 5 major serogroups of Neisseria meningitidis (A, B, C, W, & Y) which commonly cause invasive meningococcal disease.
Product Name : Penmenvy
Product Type : Vaccine
Upfront Cash : Inapplicable
February 15, 2025
Regulatory Info : Originator
Registration Country : South Africa
Dosage Form : INJ
Brand Name : Fluarix Tetra
Dosage Strength : 15ug
Packaging : 0.5X1ug
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
A/michigan/45/2015 (h1n1) Pdm09
Dosage Form : INJ
Brand Name : Fluarix Tetra
Dosage Strength : 15ug
Packaging : 0.5X1ug
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info :
Registration Country : Switzerland
Dosage Form : Drinking Solution
Brand Name : Ziagen
Dosage Strength : 20mg/ml
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info :
Registration Country : Switzerland
Dosage Form : Tabl
Brand Name : Ziagen
Dosage Strength : 300mg
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Switzerland
Regulatory Info : Originator
Registration Country : South Africa
Dosage Form : TAB
Brand Name : Trizivar
Dosage Strength : 300mg
Packaging : 60X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Dosage Form : TAB
Brand Name : Kivexa
Dosage Strength : 600mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Dosage Form : TAB
Brand Name : Trelavue
Dosage Strength : 600mg
Packaging : 30X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Dosage Form : TAB
Brand Name : Ziagen Tablets
Dosage Strength : 300mg
Packaging : 60X1mg
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info : Originator
Registration Country : South Africa
Dosage Form : SYR
Brand Name : Ziagen Oral Solution
Dosage Strength : 20mg/ml
Packaging : 240X1mg/ml
Approval Date :
Application Number :
Regulatory Info : Originator
Registration Country : South Africa
Regulatory Info :
Registration Country : Italy
Dosage Form : Abacavir 20Mg/Ml 240Ml O...
Brand Name : Ziagen
Dosage Strength : os soluz bottle 240 ml...
Packaging :
Approval Date :
Application Number :
Regulatory Info :
Registration Country : Italy
RLD : Yes
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : ZIAGEN
Dosage Strength : EQ 300MG BASE **Federal ...
Approval Date : 1998-12-17
Application Number : 20977
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code : AA
Dosage Form : SOLUTION; ORAL
Proprietary Name : ZIAGEN
Dosage Strength : EQ 20MG BASE/ML
Approval Date : 1998-12-17
Application Number : 20978
RX/OTC/DISCN : RX
RLD : Yes
TE Code : AA
RLD : Yes
TE Code :
ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE
Dosage Form : TABLET; ORAL
Proprietary Name : TRIUMEQ
Dosage Strength : EQ 600MG BASE;EQ 50MG BA...
Approval Date : 2014-08-22
Application Number : 205551
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE
Dosage Form : TABLET, FOR SUSPENSION; ORAL
Proprietary Name : TRIUMEQ PD
Dosage Strength : EQ 60MG BASE;EQ 5MG BASE...
Approval Date : 2022-03-30
Application Number : 215413
RX/OTC/DISCN : RX
RLD : Yes
TE Code :
RLD : Yes
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : EPZICOM
Dosage Strength : EQ 600MG BASE;300MG **Fe...
Approval Date : 2004-08-02
Application Number : 21652
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE
Dosage Form : TABLET; ORAL
Proprietary Name : TRIZIVIR
Dosage Strength : EQ 300MG BASE;150MG;300M...
Approval Date : 2000-11-14
Application Number : 21205
RX/OTC/DISCN : DISCN
RLD : Yes
TE Code :
RLD : Yes
TE Code :
ACETAMINOPHEN; ASPIRIN; CAFFEINE
Dosage Form : TABLET; ORAL
Proprietary Name : EXCEDRIN (MIGRAINE RELIE...
Dosage Strength : 250MG;250MG;65MG
Approval Date : 1998-01-14
Application Number : 20802
RX/OTC/DISCN : OTC
RLD : Yes
TE Code :
RLD : No
TE Code :
ACETAMINOPHEN; CODEINE PHOSPHATE
Dosage Form : TABLET; ORAL
Proprietary Name : EMPRACET W/ CODEINE PHOS...
Dosage Strength : 300MG;30MG
Approval Date : 1982-01-01
Application Number : 83951
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : No
TE Code :
ACETAMINOPHEN; CODEINE PHOSPHATE
Dosage Form : TABLET; ORAL
Proprietary Name : EMPRACET W/ CODEINE PHOS...
Dosage Strength : 300MG;60MG
Approval Date : 1982-01-01
Application Number : 83951
RX/OTC/DISCN : DISCN
RLD : No
TE Code :
RLD : Yes
TE Code :
Dosage Form : TABLET; ORAL
Proprietary Name : ADVIL DUAL ACTION WITH A...
Dosage Strength : 250MG;125MG
Approval Date : 2020-02-28
Application Number : 211733
RX/OTC/DISCN : OTC
RLD : Yes
TE Code :
Excipients
Inspections and registrations
District Decision : No Action Indicated
Inspection End Date : 2017-08-03
City : Saint Louis
State : MO
Country/Area : US
Zip : 63102-2800
District : KAN
Center : CFSAN
Project Area : Food Composition, Standards, Lab...
District Decision : No Action Indicated
Inspection End Date : 2017-08-03
District Decision : No Action Indicated
Inspection End Date : 2017-08-03
City : Saint Louis
State : MO
Country/Area : US
Zip : 63102-2800
District : KAN
Center : CFSAN
Project Area : Foodborne Biological Hazards
District Decision : No Action Indicated
Inspection End Date : 2017-08-03
District Decision : No Action Indicated
Inspection End Date : 2017-08-03
City : Saint Louis
State : MO
Country/Area : US
Zip : 63102-2800
District : KAN
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2017-08-03
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-01-26
City : Carrigaline
State :
Country/Area : IE
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2017-01-26
District Decision : Voluntary Action Indicated
Inspection End Date : 2015-07-10
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 : 2015-07-10
District Decision : Voluntary Action Indicated
Inspection End Date : 2015-05-01
City : Carrigaline
State :
Country/Area : IE
Zip :
District : ORA
Center : CDER
Project Area : Drug Quality Assurance
District Decision : Voluntary Action Indicated
Inspection End Date : 2015-05-01
District Decision : No Action Indicated
Inspection End Date : 2014-09-29
City : Durham
State : NC
Country/Area : US
Zip : 27709-0143
District : ATL
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2014-09-29
District Decision : Voluntary Action Indicated
Inspection End Date : 2014-06-30
Novartis Vaccines and Diagnostics, Inc.
City : Marburg
State :
Country/Area : DE
Zip :
District : ORA
Center : CBER
Project Area : Vaccines and Allergenic Products
District Decision : Voluntary Action Indicated
Inspection End Date : 2014-06-30
District Decision : Voluntary Action Indicated
Inspection End Date : 2014-06-03
City : Collegeville
State : PA
Country/Area : US
Zip : 19426-2990
District : PHI
Center : CDER
Project Area : Bioresearch Monitoring
District Decision : Voluntary Action Indicated
Inspection End Date : 2014-06-03
District Decision : No Action Indicated
Inspection End Date : 2014-02-12
City : East Durham
State : NY
Country/Area : US
Zip : 12423-1416
District : NYK
Center : CDER
Project Area : Drug Quality Assurance
District Decision : No Action Indicated
Inspection End Date : 2014-02-12
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