Company profile for GSK

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About

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, our partnerships, our work with communities and our efforts to prevent and treat disease around the world. We are a science-led global healthcare company with a mission: we want to help people to do more, feel better, live longer. The...
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, our partnerships, our work with communities and our efforts to prevent and treat disease around the world. We are a science-led global healthcare company with a mission: we want to help people to do more, feel better, live longer. The vaccines, medicines and consumer healthcare products that we research and develop can improve people’s health and well-being, ultimately helping them to live life to its fullest and contribute.

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CONTACT DETAILS

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Country
United Kingdom
Address
Address
980 Great West Road, Brentford, Middlesex TW8 9GS England
Telephone
Telephone
+44 (0)20 8047 5000
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INTERVIEW #SpeakPharma

[Sponsored by another company]
Alchem NicSelect™ grants customers royalty-free access to T-MAX™ tech for 3-in-1 vape satisfaction in flavour-restricted markets
With increasing flavour bans in key markets, vaping brands are facing significant challenges in providing satisfying alternatives to vapers and smokers looking to transition. Recognising this need, Alchem NicSelect™ is making a bold move by offering its key customers royalty-free and unrestricted geographical access to its revolutionary T-MAX™ technology.“At Alchem NicSelect™, we understand the urgency for vaping brands to adapt to new regulations without compromising on satisfaction. By offering royalty-free access to T-MAX™ technology, we empower our customers to provide the closest cigarette-like experience possible, even in markets with strict flavour restrictions,” said Riccardo Santambrogio, Europe Sales Manager.HIGHLIGHTS// offering royalty-free access to T-MAX™ technology/ unrestricted geographical access/ closest cigarette-like experience Addressing the biggest barrier: Nicotine satisfactionOne of the primary reasons many vapers are dissatisfied and smokers struggle to switch to vaping is that traditional nicotine solutions fail to replicate the rapid satisfaction provided by cigarettes. Nicotine replacement therapies (NRTs) and even conventional vaping products often lack the immediate nicotine hit, throat feel, and overall experience that smokers are accustomed to. T-MAX™ solves this problem by engineering a nicotine experience that closely mimics cigarette consumption without relying on flavours.T-MAX™ provides a unique 3-in-1 approach:1. The Speed of a Cigarette – Rapid nicotine delivery and rush within seconds for immediate satisfaction.2. The Power of Nicotine Salts – A stronger perceived nicotine effect without exceeding legal limits (20 mg/ml nicotine limit under the European Tobacco Products Directive). With T-MAX™, 8 mg/ml feels like 20 mg/ml, and 14 mg/ml feels like 40 mg/ml.3. The Throat Hit of Freebase Nicotine – Especially in a flavour-free formulation, the combined ingredients in T-MAX™ deliver an even more satisfying throat feel than expected from nicotine base, much closer to and more familiar with a cigarette throat feel that habitual smokers recognise.HIGHLIGHTS// unique 3-in-1 approach/ rush within seconds/ stronger perceived nicotine effect without exceeding legal limits/ more satisfying throat feel that habitual smokers recogniseNo flavour, but not less satisfyingWhile flavours have traditionally played a role in vaping adoption, market realities are shifting. With flavour bans spreading across regions, brands need solutions that deliver satisfaction without relying on taste. Consumer research has shown that T-MAX™ performs exceptionally well even without added flavours. Since most cigarette smokers do not smoke for the tobacco flavour but rather for the nicotine hit and habitual experience, T-MAX™ provides a viable alternative that aligns with new regulatory landscapes.HIGHLIGHTS// flavour bans spreading across regions/ T-MAX™ performs exceptionally well even without added flavoursEmpowering vape brands with free access to T-MAX™By granting customers royalty-free access to the T-MAX™ technology, Alchem NicSelect™ is removing barriers for vaping brands and original equipment manufacturers (OEMs) looking to adapt to regulatory changes. This open-access approach ensures that manufacturers can integrate T-MAX™ into their product lines without additional costs, allowing them to offer superior nicotine satisfaction in markets where flavours are no longer an option.HIGHLIGHTS// removing barriers for vaping brands and OEMs looking to adapt/ manufacturers can integrate T-MAX™ into product lines without additional costsThe future of vaping in restricted marketsWith T-MAX™, the vaping industry has a powerful tool to retain customers and convert smokers who have struggled with traditional vaping products. By delivering the key elements of cigarette satisfaction — without combustion or flavours — T-MAX™ is set to redefine what a satisfying vape experience means in a post-flavour-ban world.“Our commitment to innovation and accessibility means we are providing our customers with the solutions they need to navigate an evolving regulatory landscape. T-MAX™ allows brands to offer a highly satisfying experience that mimics smoking without relying on flavours. The message is clear: no flavour, but not less satisfying”, added Santambrogio.HIGHLIGHTS// powerful tool to retain customers and convert smokers/ delivering the key elements of cigarette satisfaction without combustion or flavours/ no flavour, but not less satisfying

Impressions: 1261

https://www.pharmacompass.com/speak-pharma/alchem-nicselect-grants-customers-royalty-free-access-to-t-max-tech-for-3-in-1-vape-satisfaction-in-flavour-restricted-markets

Radio Compass
06 May 2025

VLOG #PharmaReel

[Sponsored by another company]
This PharmaReel showcases Allsino Pharmaceutical, a company that provides GMP-certified RSMs and APIs to global pharma companies, specializing in peptides, oligonucleotides, and small molecule CDMO services. Allsino has a presence in the US, EU, China and Japan.

Impressions: 1512

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DATA COMPILATION #PharmaFlow

[Sponsored by another company]
J&J’s Intra‑Cellular buyout, BMS’ oncology gambit, Sanofi’s Blueprint acquisition drive mega deals in H1 2025
The pharmaceutical industry has witnessed a wave of mergers, acquisitions, and strategic partnerships so far in the first half (H1) of 2025, with deal values exceeding US$ 170 billion.PharmaCompass’ data shows oncology alone accounted for nearly US$ 47 billion in deal value, followed by US$ 18 billion each in immunology and psychiatry, US$ 17 billion in nutrition/weight loss and US$ 7 billion in neurology.Pharma majors such as Johnson & Johnson and Bristol Myers Squibb led with two deals worth over US$ 10 billion each. Sanofi executed a series of deals in the immunology and neuro-inflammation space. And Eli Lilly stood out for its aggressive dealmaking, which spanned oncology, pain, RNA therapies, and AI-driven oligonucleotides. In all, it signed seven deals worth over US$ 1 billion each. View Pharma & Biotech Acquisitions, Deals & Agreements in 2025 as of June 14 (Free Excel Available)H1 records several mega deals as J&J buys Intra-Cellular, BMS ties up with BioNTech, Sanofi acquires BlueprintJohnson & Johnson dominated headlines with its US$ 14.6 billion acquisition of Intra-Cellular Therapies in January 2025. This marks the largest biopharma deal since Novo Nordisk’s US$ 16.5 billion acquisition of Catalent in February 2024. This acquisition positions J&J as a formidable player in the neuroscience space. Bristol Myers Squibb entered into a US$ 11.1 billion partnership with BioNTech. The deal structure — US$ 3.5 billion in unconditional payments and up to US$ 7.6 billion in milestone payments — demonstrates BMS’ confidence in BNT327, a next-generation bispecific antibody in phase 3 trials for treating extensive stage small cell lung cancer and non-small cell lung cancer.Sanofi acquired Blueprint Medicines for US$ 9.5 billion in order to enhance its rare disease portfolio. The French drugmaker is also creating a comprehensive immunology portfolio. The company signed a US$ 1.9 billion deal for Dren Bio’s DR-0201 bispecific antibody for autoimmune diseases. Sanofi also acquired Vigil Neuroscience for US$ 470 million for its phase 2-ready Alzheimer’s disease candidate. Additionally, the drugmaker secured a US$ 1.84 billion global license agreement with Earendil Labs for two next-generation bispecific antibodies.Pfizer’s US$ 6.05 billion partnership with 3SBio provides it global licensing rights (excluding China) for SSGJ-707, a bispecific antibody currently undergoing multiple clinical trials in China for non-small cell lung cancer, metastatic colorectal cancer, and gynecological tumors. View Pharma & Biotech Acquisitions, Deals & Agreements in 2025 as of June 14 (Free Excel Available) Obesity gold rush sees Roche, AbbVie, Sciwind ink deals; Novo pledges over US$ 5 bn across three dealsThe obesity therapeutics market has triggered intense competition among pharmaceutical giants. Roche’s US$ 5.3 billion partnership with Zealand Pharma is focused on petrelintide, an amylin analog designed to preserve lean mass better than existing GLP-1-based treatments. The collaboration combines petrelintide with Roche’s dual GLP-1/GIP receptor agonist CT-388, creating a differentiated obesity treatment.Market leader Novo Nordisk has promised over US$ 5 billion across three major obesity deals in 2025. The US$ 2.2 billion Septerna collaboration targets oral small molecule medicines for obesity and cardiometabolic diseases.Novo signed a separate US$ 2 billion agreement with China’s United Biotechnology for UBT251, a triple agonist for GLP-1, GIP, and glucagon receptors in phase 2 clinical development for obesity, type 2 diabetes, and other diseases. The company’s third major deal, a US$ 1 billion partnership with Lexicon Pharmaceuticals, provides it access to LX9851, a molecule in preclinical development for obesity and associated metabolic disorders.Sciwind Biosciences secured a US$ 2.5 billion global licensing and collaboration agreement with Verdiva Bio Limited for the global development and commercialization of a portfolio of metabolic diseases therapies. AbbVie entered the amylin arena through its US$ 2.2 billion Gubra partnership for GUB014295, a candidate in phase 1 trials for treating obesity. View Pharma & Biotech Acquisitions, Deals & Agreements in 2025 as of June 14 (Free Excel Available) Molecular glue degraders draw investments; Lilly signs seven deals over US$ 1 billion eachMolecular glue degraders have emerged as a transformative therapeutic modality, attracting significant investment across multiple partnerships. AbbVie’s US$ 1.64 billion collaboration with Neomorph leverages the biotech’s leading molecular glue discovery platform for oncology and immunology applications.Genentech’s potential US$ 2.1 billion partnership with Orionis Biosciences focuses on small-molecule monovalent glue medicines for novel and challenging oncology targets. This is the second partnership between the two companies, following their initial 2023 collaboration.Eli Lilly has collaborated with Magnet Biomedicine, utilizing Magnet’s TrueGlue discovery platform for oncology applications. The deal could be worth up to US$ 1.3 billion.Eli Lilly has emerged as one of 2025’s most active dealmakers, with approximately seven deals exceeding US$ 1 billion each. The company’s US$ 2.5 billion Scorpion Therapeutics acquisition provides access to STX-478, an experimental oral therapy in early-stage trials for breast cancer and advanced solid tumors, potentially addressing 30 to 40 percent of hormone-positive breast cancer patients.On June 17, Lilly announced the acquisition of gene-editing startup Verve Therapeutics for US$ 1.3 billion. Lilly’s US$ 1 billion SiteOne acquisition announced in May brings STC-004, a phase 2-ready non-opioid chronic pain treatment to its pipeline. Other partnerships announced by Lilly include a US$ 1.4 billion capsid licensing deal with Sangamo for central nervous system disease genomic medicines and a US$ 1.3 billion collaboration with South Korean company Rznomics for RNA-based hearing loss treatments. Lilly has also strengthened its oligonucleotide pipeline through a potential US$ 1 billion collaboration with Creyon Bio for AI-designed oligonucleotide therapies targeting RNA. View Pharma & Biotech Acquisitions, Deals & Agreements in 2025 as of June 14 (Free Excel Available) Merck KGaA acquires SpringWorks for US$ 3.9 bn; Novartis buys out Anthos for US$ 3.1 bnAstraZeneca signed a US$ 5.3 billion AI-led research agreement with China’s CSPC Pharmaceuticals Group to advance the discovery of novel oral candidates for immunological diseases. Merck KGaA acquired SpringWorks for US$ 3.9 billion in April, which gave it access to two FDA-approved therapies — Ogsiveo (nirogacestat), the first and only approved therapy for adult patients with progressing desmoid tumors requiring systemic treatment, and Gomekli (mirdametinib), the first and only FDA-approved therapy for adults and children with neurofibromatosis type 1-associated plexiform neurofibromas.Novartis’ US$ 3.1 billion Anthos Therapeutics acquisition centered around abelacimab, a potential first-in-class monoclonal antibody currently in three phase 3 studies for stroke and systemic embolism prevention in atrial fibrillation patients.GSK’s US$ 2 billion acquisition of Boston Pharmaceuticals’ efimosfermin targets steatotic liver disease (fatty liver disease). The medicine is also in clinical development for MASH treatment. GSK’s second major deal involved the US$ 1.15 billion acquisition of US biotech IDRx, strengthening its gastrointestinal cancer portfolio.The pharma industry also drew some private equity interest as Bain Capital acquired Japan’s Mitsubishi Tanabe Pharma from Mitsubishi Chemical Group for US$ 3.3 billion. View Pharma & Biotech Acquisitions, Deals & Agreements in 2025 as of June 14 (Free Excel Available) Our viewDespite an uncertain geopolitical environment, the year has seen a surge in M&As and dealmaking in the first half of 2025. However, a sizable chunk of the acquisitions were bolt-on transactions, indicating that companies are not ready to take on risks, and are buying out smaller players who strategically fit into their operations. Going forward, there are indications that M&A activity will stay strong throughout 2025. 

Impressions: 6576

https://www.pharmacompass.com/radio-compass-blog/j-j-s-intra-cellular-buyout-bms-oncology-gambit-sanofi-s-blueprint-acquisition-drive-mega-deals-in-h1-2025

#PharmaFlow by PHARMACOMPASS
19 Jun 2025

NEWS #PharmaBuzz

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https://www.reuters.com/legal/litigation/us-senator-investigates-gsk-pulling-childrens-asthma-inhaler-2025-06-27/

REUTERS
28 Jun 2025

https://www.fiercepharma.com/pharma/gsk-bharat-biotech-slash-price-first-malaria-vaccine-less-5-2028

FIERCE PHARMA
26 Jun 2025

https://www.businesswire.com/news/home/20250623981547/en/FDA-approves-Benlysta-belimumab-Autoinjector-for-children-with-active-lupus-nephritis

BUSINESSWIRE
24 Jun 2025

https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761043

FDA
20 Jun 2025

https://www.gsk.com/en-gb/media/press-releases/gsk-licenses-shigella-vaccine-candidate-to-bharat-biotech-for-continued-development/

PRESS RELEASE
14 Jun 2025

https://www.pharmabiz.com/NewsDetails.aspx?aid=178452&sid=1

PHARMABIZ
13 Jun 2025

LISTED APIs

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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, our partnerships, our work with communities and our efforts to prevent and treat disease around the world. We are a science-led global healthcare company wi...
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, our partnerships, our work with communities and our efforts to prevent and treat disease around the world. We are a science-led global healthcare company with a mission: we want to help people to do more, feel better, live longer. The vaccines, medicines and consumer healthcare products that we research and develop can improve people’s health and well-being, ultimately helping them to live life to its fullest and contribute.
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GSK

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, our partnerships, our work with communities and our efforts to prevent and treat disease around the world. We are a science-led global healthcare company with a mission: we want to help people to do more, feel better, live longer. The vaccines, medicines and consumer healthcare products that we research and develop can improve people’s health and well-being, ultimately helping them to live life to its fullest and contribute.

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, ...

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Drugs in Development

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  • Deals

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

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GSK

United Kingdom
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GSK

United Kingdom
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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

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  • Development Update

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

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GSK

United Kingdom
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GSK

United Kingdom
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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

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  • Deals

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

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GSK

United Kingdom
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GSK

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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

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  • Development Update

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

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GSK

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GSK

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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

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  • Development Update

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

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GSK

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GSK

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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

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  • Deals

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

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GSK

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GSK

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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

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  • Development Update

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

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GSK

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GSK

United Kingdom
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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

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  • Development Update

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

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GSK

United Kingdom
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GSK

United Kingdom
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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

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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

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ViiV Healthcare

United Kingdom
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ViiV Healthcare

United Kingdom
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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

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  • Development Update

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

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GSK

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GSK

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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

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

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FDF Dossiers

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Brand Name : Fluarix Tetra

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Brand Name : Fluarix Tetra

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GSK

Dosage Form : INJ

Brand Name : Fluarix Tetra

Dosage Strength : 15ug

Packaging : 0.5X1ug

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Brand Name : Fluarix Tetra

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Brand Name : Fluarix Tetra

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GSK

Dosage Form : INJ

Brand Name : Fluarix Tetra

Dosage Strength : 15ug

Packaging : 0.5X1ug

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Brand Name : Ziagen

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Brand Name : Ziagen

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ViiV Healthcare

Dosage Form : Drinking Solution

Brand Name : Ziagen

Dosage Strength : 20mg/ml

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Brand Name : Ziagen

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Brand Name : Ziagen

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ViiV Healthcare

Dosage Form : Tabl

Brand Name : Ziagen

Dosage Strength : 300mg

Packaging :

Approval Date :

Application Number :

Regulatory Info :

Registration Country : Switzerland

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Brand Name : Trizivar

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Brand Name : Trizivar

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GSK

Dosage Form : TAB

Brand Name : Trizivar

Dosage Strength : 300mg

Packaging : 60X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Brand Name : Kivexa

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Brand Name : Kivexa

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GSK

Dosage Form : TAB

Brand Name : Kivexa

Dosage Strength : 600mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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Brand Name : Trelavue

Indo Livestock Expo
Not Confirmed
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Brand Name : Trelavue

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Indo Livestock Expo
Not Confirmed

GSK

Dosage Form : TAB

Brand Name : Trelavue

Dosage Strength : 600mg

Packaging : 30X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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08

Brand Name : Ziagen Tablets

Indo Livestock Expo
Not Confirmed
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Brand Name : Ziagen Tablets

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Indo Livestock Expo
Not Confirmed

GSK

Dosage Form : TAB

Brand Name : Ziagen Tablets

Dosage Strength : 300mg

Packaging : 60X1mg

Approval Date :

Application Number :

Regulatory Info : Originator

Registration Country : South Africa

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09

Brand Name : Ziagen Oral Solution

Indo Livestock Expo
Not Confirmed
arrow

Brand Name : Ziagen Oral Solution

arrow
Indo Livestock Expo
Not Confirmed

GSK

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

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10

Brand Name : Ziagen

Indo Livestock Expo
Not Confirmed
arrow

Brand Name : Ziagen

arrow
Indo Livestock Expo
Not Confirmed

ViiV Healthcare

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

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FDA Orange Book

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01

Brand Name : ZIAGEN

Indo Livestock Expo
Not Confirmed
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Brand Name : ZIAGEN

Indo Livestock Expo
Not Confirmed
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ViiV Healthcare

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 :

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02

Brand Name : ZIAGEN

Indo Livestock Expo
Not Confirmed
arrow

Brand Name : ZIAGEN

Indo Livestock Expo
Not Confirmed
arrow

ViiV Healthcare

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

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03

Brand Name : TRIUMEQ

Indo Livestock Expo
Not Confirmed
arrow

Brand Name : TRIUMEQ

Indo Livestock Expo
Not Confirmed
arrow

ViiV Healthcare

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 :

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04

Brand Name : TRIUMEQ PD

Indo Livestock Expo
Not Confirmed
arrow

Brand Name : TRIUMEQ PD

Indo Livestock Expo
Not Confirmed
arrow

ViiV Healthcare

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 :

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05

Brand Name : EPZICOM

Indo Livestock Expo
Not Confirmed
arrow

Brand Name : EPZICOM

Indo Livestock Expo
Not Confirmed
arrow

ViiV Healthcare

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 :

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06

Brand Name : TRIZIVIR

Indo Livestock Expo
Not Confirmed
arrow

Brand Name : TRIZIVIR

Indo Livestock Expo
Not Confirmed
arrow

ViiV Healthcare

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 :

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07

Brand Name : EXCEDRIN (MIGRAINE R...

Indo Livestock Expo
Not Confirmed
arrow

Brand Name : EXCEDRIN (MIGRAINE R...

Indo Livestock Expo
Not Confirmed
arrow

Haleon

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 :

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08

Brand Name : EMPRACET W/ CODEINE ...

Indo Livestock Expo
Not Confirmed
arrow

Brand Name : EMPRACET W/ CODEINE ...

Indo Livestock Expo
Not Confirmed
arrow

GSK

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 :

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09

Brand Name : EMPRACET W/ CODEINE ...

Indo Livestock Expo
Not Confirmed
arrow

Brand Name : EMPRACET W/ CODEINE ...

Indo Livestock Expo
Not Confirmed
arrow

GSK

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 :

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10

Brand Name : ADVIL DUAL ACTION WI...

Indo Livestock Expo
Not Confirmed
arrow

Brand Name : ADVIL DUAL ACTION WI...

Indo Livestock Expo
Not Confirmed
arrow

Haleon

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 :

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Excipients

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Inspections and registrations

Upload your audits for free, ask us

FDA

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01

FDA Audited

USA
Indo Livestock Expo
Not Confirmed
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FDA Audited

USA
arrow
Indo Livestock Expo
Not Confirmed

GSK

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

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02

FDA Audited

USA
Indo Livestock Expo
Not Confirmed
arrow

FDA Audited

USA
arrow
Indo Livestock Expo
Not Confirmed

GSK

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

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03

FDA Audited

USA
Indo Livestock Expo
Not Confirmed
arrow

FDA Audited

USA
arrow
Indo Livestock Expo
Not Confirmed

GSK

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

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04

FDA Audited

USA
Indo Livestock Expo
Not Confirmed
arrow

FDA Audited

USA
arrow
Indo Livestock Expo
Not Confirmed

GSK

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

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05

FDA Audited

USA
Indo Livestock Expo
Not Confirmed
arrow

FDA Audited

USA
arrow
Indo Livestock Expo
Not Confirmed

GSK

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

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06

FDA Audited

USA
Indo Livestock Expo
Not Confirmed
arrow

FDA Audited

USA
arrow
Indo Livestock Expo
Not Confirmed

GSK

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

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07

FDA Audited

USA
Indo Livestock Expo
Not Confirmed
arrow

FDA Audited

USA
arrow
Indo Livestock Expo
Not Confirmed

GSK

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

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08

FDA Audited

USA
Indo Livestock Expo
Not Confirmed
arrow

FDA Audited

USA
arrow
Indo Livestock Expo
Not Confirmed

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

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09

FDA Audited

USA
Indo Livestock Expo
Not Confirmed
arrow

FDA Audited

USA
arrow
Indo Livestock Expo
Not Confirmed

GSK

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

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10

FDA Audited

USA
Indo Livestock Expo
Not Confirmed
arrow

FDA Audited

USA
arrow
Indo Livestock Expo
Not Confirmed

GSK

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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