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    Granules India Limited has high volume world-class facilities for APIs, PFIs, & FDFs, serving customers in over 80 countries.

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    Egis is a Hungarian generic pharma company with 110 years history. Our activities incorporate all areas of the pharma value chain.

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    Biophore is a research-driven global pharmaceutical company focused on niche APIs for the generic industry.

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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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    INTERVIEW #SpeakPharma

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    “LGM Pharma has made significant strides in meeting the evolving needs of its clients”

    “LGM Pharma has made significant strides in meeting the evolving needs of its clients”

    This week, SpeakPharma interviews four senior executives of LGM Pharma — Shailesh Vengurlekar (Senior VP, Quality and Regulatory Affairs), Deepak Thassu (Senior VP, R&D and Regulatory Submission), Selwyn Lustman (Senior VP, Global Sourcing and Procurement), and Mike Stenberg (VP, Business Development). The four VPs talk about expansion in manufacturing capabilities of the Florida-based contract development and manufacturing organization (CDMO), expertise that makes LGM a strong partner and the criteria it adopts while selecting its suppliers.  HIGHLIGHTS// expansion in manufacturing capabilities/ expertise that makes LGM a strong partner/ criteria for selecting its suppliers LGM Pharma recently invested heavily in expanding its CDMO capabilities by 50 percent. Can you share why offering standalone analytical testing services is important to LGM Pharma’s growth strategy? How does it benefit your clients? Vengurlekar: This recent expansion in CDMO capabilities is part of LGM Pharma’s growth strategy that lays importance on diversification. One key area of this diversification is the offering of standalone Analytical Testing Services (ATS). This service plays a crucial role in supporting our clients by providing them with greater flexibility and reliability. LGM Pharma is already a well-established leader in the API supply chain. We have now identified a significant need in the market and are now serving compounding pharmacies, including 503A and 503B facilities. These pharmacies not only require high-quality, GMP-compliant APIs, but also need a trusted, compliant, and capable laboratory to analyze both their APIs and compounded products. Recognizing this opportunity to further support our clients, LGM Pharma has expanded into ATS. We have witnessed tremendous growth since we’ve launched these services. By offering ATS under a separate legal entity — LGM Pharma Solutions — we are able to provide an additional layer of flexibility to our clients. This structure eliminates any conflict of interest. While LGM Pharma LLC handles API supply, LGM Pharma Solutions focuses on delivering top-tier ATS, all under the same LGM Pharma umbrella. This setup enhances trust and allows our clients to work with us more seamlessly. HIGHLIGHTS// diversified into standalone ATS/ well-established leader in API supply chain/ serving compounding pharmacies/ offering APIs and ATS under different legal entities. While suppositories offer clear advantages for certain medications, can you describe how LGM Pharma plans to leverage its expertise in this area to address specific unmet needs in the growing women’s health market? Thassu: We’re taking a dual approach to enhance both our R&D and manufacturing capabilities. First, we’ve introduced a new semi-automatic machine that allows us to produce smaller batches more efficiently. This is particularly important for the suppository segment, where demand doesn’t require large-scale production. The new system enables quicker adjustments to the manufacturing process, providing us with greater flexibility of producing small batches. Second, many of the materials we handle in the women’s health sector are sensitive to heat, light, and oxygen. To address this, we’re upgrading our facility to accommodate these specialized requirements. This ensures we can develop and manufacture products while maintaining the integrity of heat-, light-, and oxygen-sensitive ingredients. Additionally, we’re working closely with clients to prepare for various technical challenges. Whether it’s processing homeopathic ingredients or handling delicate fermentation-based materials, which are highly sensitive to both light and heat, our team has upgraded its skills and equipment to manage these complexities. From technology advancements in manufacturing to specialized handling conditions and improved technical expertise, we’ve made significant strides to ensure we can meet the evolving needs of our clients and their products. HIGHLIGHTS// dual approach to enhance R&D and manufacturing capabilities/ upgrading facilities to accommodate specialized requirements/ working with clients to address challenges. The pandemic underscored supply chain problems. Can you detail the specific criteria LGM Pharma uses while selecting suppliers for its manufacturing processes? Lustman: LGM looks at many facets of a manufacturer before proceeding to approve them for a specific project. We start by checking their regulatory history with the US Food and Drug Administration (FDA) and other authorities. We try to find out if they have received any warning letters. What is their inspection history? Have they received NAIs (no action indicated) and VAIs (voluntary action indicated)? We further investigate the company’s overall business status — we need to know that they are a stable partner to work with in the long term. Manufacturers are then assessed for their overall technology and the number of employees working in various fields, such as R&D, quality control, quality assurance, regulatory affairs, manufacturing, and the educational levels of these employees. Once we have established that the manufacturer is a potential partner, we check their status for a particular project. We look at their advantages, and whether they have a non-infringing route of synthesis (ROS) that will allow early launch. Are they developing a second process that will be more competitive in pricing? And, does the manufacturer have the necessary capacity and/or spare capacity for the project that we are assessing? We need to know whether the drug master file (DMF) has been registered, the current batch size, and the potential for increase in batch size. Pricing is a key indicator — we need to know whether the pricing of the manufacturer is competitive or not, and if the manufacturer will be able to compete in the future as the project matures. LGM always assesses for quality, price, and delivery. Goods must be of the correct quality, at the right price, with delivery time as desired, in order to meet commercial needs. HIGHLIGHTS// investigate various facets of manufacturer before approving them for a project/ look at advantages, non-infringing ROS/ assess for quality, price, delivery Can you highlight specific capabilities and experiences LGM Pharma possesses that make it a strong partner for companies developing antibody-drug-conjugates (ADCs)? Stenberg: ADCs are often peptides linked with small molecules. However, they may also be peptides linked with oligonucleotides. Regardless, LGM can help manage the supply chain associated with the components that are used in the conjugation of the ADC. LGM has extensive experience, and an extensive network around sourcing and managing the supply chain associated with ADC components. LGM’s experience and capabilities extend to sourcing peptides, small molecules or oligonucleotides used in the conjugation process. Additionally, given our deep relationships in the supply chain aspect of this process, LGM may also be able to identify partners who can help with the conjugation process itself. HIGHLIGHTS// extensive experience, network around sourcing, managing supply chain associated with ADC components / identify partners that can help with conjugation process

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    09 Nov 2024
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    Medical Breakthroughs in 2024: Alzheimer’s, schizophrenia, COPD, MASH see pathbreaking treatments

    Medical Breakthroughs in 2024: Alzheimer’s, schizophrenia, COPD, MASH see pathbreaking treatments

    This year has seen pivotal advancements in medical innovation. The US Food and Drug Administration (FDA) has approved several groundbreaking therapies that promise to transform patient care across multiple therapeutic areas.Some of the therapies approved have revolutionary delivery mechanisms, while others are first-in-class treatments for previously unaddressed conditions. This week, PharmaCompass brings you a compilation of new pathbreaking approvals of 2024, including advancements in neurology, chronic conditions, mental health conditions, and innovative solutions for various other ailments.Lilly, Alpha Cognition, BMS transform neurological care with new Alzheimer’s, schizophrenia drugsThe neurological treatment landscape saw several major breakthroughs in 2024, particularly in the treatment of Alzheimer’s disease (AD). Eli Lilly’s Kisunla represents a significant advancement in treating early, symptomatic AD. Following decades of failed efforts, Kisunla’s approval, along with that of Eisai-Biogen’s Leqembi last year, marks a turning point in addressing AD.The drug works by targeting and clearing beta amyloid plaque from the brain, thereby attacking the disease’s underlying pathology, rather than just managing symptoms. Administered as an infusion every four weeks, Kisunla’s Medicare coverage makes it accessible to patients in the US who desperately need new treatment options. Alpha Cognition’s Zunveyl emerged as a promising new oral treatment for mild-to-moderate Alzheimer’s-related dementia. Only the second oral AD treatment approved by the FDA in over a decade, Zunveyl is a prodrug, or a biologically inactive compound that can be metabolized by the body to produce a drug. It remains inactive as it passes through the stomach and enhances cholinergic function in the brain.Perhaps one of the most exciting breakthroughs of 2024 was Bristol-Myers Squibb’s Cobenfy. This revolutionary antipsychotic medication for schizophrenia represents the first novel approach to treatment since the 1950s. Unlike traditional antipsychotics that target dopamine receptors, Cobenfy works through cholinergic receptors, offering new hope to patients who struggle with the side effects of conventional treatments.Traditional antipsychotics have been associated with several mild and serious side effects such as weight gain, feeling unmotivated and sluggish, high rates of cardiac disease, and even early death. Cobenfy’s innovative mechanism of action has generated excitement in the medical community. Experts project Cobenfy to bring in US$ 7.5 billion in peak annual sales, thereby validating BMS’ recent, US$ 14-billion acquisition of Karuna Therapeutics.Verona, Sanofi’s drugs revolutionize COPD care; Madrigal’s Rezdiffra offers hope to MASH patients The landscape of chronic obstructive pulmonary disease (COPD) treatment saw remarkable advances in 2024. Verona Pharma’s Ohtuvayre brings the first new mechanism of action in over two decades for COPD treatment. This dual-action, inhaled medication serves as both a bronchodilator and an anti-inflammatory agent, offering a comprehensive approach to symptom management.Adding to this progress, Sanofi and Regeneron’s Dupixent achieved a historic milestone by becoming the first biologic approved for treating COPD. Dupixent is Sanofi’s best-selling drug. It is poised to cross over € 21 billion (US$ 23.5 billion) in sales by 2030, with COPD likely to contribute US$ 2.9 billion, predict analysts. Over 390 million people are living with COPD worldwide.In the field of liver disease, Madrigal Pharmaceuticals’ Rezdiffra became the first FDA-approved treatment for metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver scarring. This approval represents a breakthrough in a field that has been notorious for being a graveyard for failed programs. Rezdiffra offers hope to patients with this common liver condition, which primarily affects those with obesity or type 2 diabetes. The American Liver Foundation has termed this approval a “game-changing” moment in hepatology.For the rare disease community, Ipsen’s Iqirvo emerged as the first new medicine approved in nearly a decade for primary biliary cholangitis (PBC). This first-in-class peroxisome proliferator-activated receptor (PPAR) agonist offers new hope for the approximately 100,000 Americans affected by this condition, particularly women aged 30 to 60 years.A significant breakthrough for patients with hypoparathyroidism came with the approval of Ascendis’ Yorvipath, making it the only treatment for hypoparathyroidism in adults. By directly addressing the underlying hormone deficiency, Yorvipath helps stabilize calcium levels in the blood, reducing the treatment burden associated with managing symptoms through calcium and vitamin D supplements alone.In the realm of pulmonary medicine, Merck’s Winrevair emerged as the first new therapy for pulmonary arterial hypertension (PAH) in over a decade. As the first approved activin-signaling inhibitor therapy, Winrevair represents a novel approach to treating this rare but severe condition that doctors call a “ticking time bomb”. The drug is the first treatment that targets the underlying cause of the lung condition, which typically leads to death within a decade of diagnosis.ARS Pharma launches nasal spray alternative to EpiPen, Eicos introduces med for severe frostbiteLeading the charge in innovative drug delivery is ARS Pharma’s Neffy, the first-ever nasal spray alternative to the EpiPen for treating severe allergic reactions. This groundbreaking advancement represents the first major innovation in anaphylaxis treatment in over a decade. For children and individuals with needle phobia, this nasal spray format addresses one of the most significant barriers to timely treatment of allergic emergencies. Speaking of emergency medicine, Eicos Sciences’ Aurlumyn made history as the first FDA-approved treatment for severe frostbite. This approval fills a critical gap in emergency care, offering a medical intervention that could prevent the need for amputation in severe cases.The cardiovascular space saw its first oral anti-hypertensive therapy that works through a new therapeutic pathway in almost 40 years. Idorsia’s Tryvio is a treatment for hypertension that offers new hope to patients whose blood pressure remains inadequately controlled on existing medications. Idorsia expects millions of patients to benefit from it.Our view This year, the pharmaceutical industry has taken a remarkable leap forward by addressing some of healthcare’s most challenging conditions. Treatments like BMS’ Cobenfy for schizophrenia and Madrigal’s Rezdiffra for MASH demonstrate the industry’s growing ability to translate science into practical therapies. With the growing use of artificial intelligence in the drug industry, we hope that these approvals are just a precursor to a bevy of pathbreaking therapies in the years to come. 
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    GSK’s itch prospect hits mark in phase 3 liver disease trial
    GSK’s itch prospect hits mark in phase 3 liver disease trial

    20 Nov 2024

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    GSK Drug Meets Main Goal in Late-Stage Study for Itch Treatment
    GSK Drug Meets Main Goal in Late-Stage Study for Itch Treatment

    19 Nov 2024

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    https://www.reuters.com/business/healthcare-pharmaceuticals/gsk-drug-meets-main-goal-late-stage-study-treat-relentless-itch-2024-11-19/

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    GSK's ADC Blenrep delivers survival win against J&J's Darzalex
    GSK's ADC Blenrep delivers survival win against J&J's Darzalex

    14 Nov 2024

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    GSK Signs Parkinson’s Deal with Flagship’s Vesalius for $570M
    GSK Signs Parkinson’s Deal with Flagship’s Vesalius for $570M

    12 Nov 2024

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    https://www.fiercebiotech.com/biotech/gsk-inks-parkinsons-pact-flagships-vesalius-570b-biobucks

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    GSK takes aim at challenges facing gynecological cancer patients
    GSK takes aim at challenges facing gynecological cancer patients

    12 Nov 2024

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    GSK breaks up with BIO for 2025
    GSK breaks up with BIO for 2025

    09 Nov 2024

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    09 Nov 2024
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    Drugs in Development

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    ViiV Healthcare Announces Dovato is Effective in Treatment-Naïve HIV

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    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

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    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

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    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

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    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.


    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

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    Lead Product(s) : CMG1A46

    Therapeutic Area : Immunology

    Highest Development Status : Preclinical

    Recipient : Chimagen Biosciences

    Deal Size : $850.0 million

    Deal Type : Acquisition

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    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

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    GSK Blockbuster Hope Depemokimab Shrinks Polyps in Ph. 3 Trials

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    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

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    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

    DEALS_DEV arrow-down

    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

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    Japan's MHLW Reviews GSK's Blenrep Combo NDA for Multiple Myeloma

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    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

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    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

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    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

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    GSK Announces Positive Topline Data on Co-Administration of AREXVY and SHINGRIX

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    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

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    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

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    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

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    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.


    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

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    Lead Product(s) : Belrestotug,Dostarlimab

    Therapeutic Area : Oncology

    Highest Development Status : Phase III

    Recipient : Iteos Therapeutics

    Deal Size : Not Applicable

    Deal Type : Not Applicable

    DEALS_DEV arrow-down

    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

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    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.


    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

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    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

    DEALS_DEV arrow-down

    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

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    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.


    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

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    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

    DEALS_DEV arrow-down

    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

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    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.


    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

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    GSK

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    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

    DEALS_DEV arrow-down

    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

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    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.


    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

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    GSK

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    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

    DEALS_DEV arrow-down

    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

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    FDA Orange Book

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    Europe

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    01

    Brand Name : Ziagen

    United Kingdom
    Fi Europe 2024
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    Brand Name : Ziagen

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    Regulatory Info :

    Registration Country : Switzerland

    Abaca virus

    ViiV Healthcare

    Dosage Form : Drinking Solution

    Dosage Strength : 20mg/ml

    Packaging :

    Brand Name : Ziagen

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    Brand Name : Ziagen

    United Kingdom
    Fi Europe 2024
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    Regulatory Info :

    Registration Country : Switzerland

    Abaca virus

    ViiV Healthcare

    Dosage Form : Tabl

    Dosage Strength : 300mg

    Packaging :

    Brand Name : Ziagen

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Switzerland

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    Brand Name : Ziagen

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    Regulatory Info :

    Registration Country : Italy

    Abacavir

    ViiV Healthcare

    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

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    Brand Name : Ziagen

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    Regulatory Info :

    Registration Country : Italy

    Abacavir

    ViiV Healthcare

    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

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    Brand Name : Ziagen

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    Fi Europe 2024
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    Regulatory Info :

    Registration Country : Norway

    Abacavir

    ViiV Healthcare

    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

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    Brand Name : Ziagen

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    Regulatory Info :

    Registration Country : Sweden

    abacavir sulfate

    ViiV Healthcare

    Dosage Form : ORAL SOLUTION

    Dosage Strength : 20 MG / ML

    Packaging :

    Brand Name : Ziagen

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

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    Brand Name : Ziagen

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    Fi Europe 2024
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    Regulatory Info :

    Registration Country : Sweden

    abacavir sulfate

    ViiV Healthcare

    Dosage Form : FILM COATED PILL

    Dosage Strength : 300 MG

    Packaging :

    Brand Name : Ziagen

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Sweden

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    Brand Name : Trizivir

    United Kingdom
    Fi Europe 2024
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    Regulatory Info :

    Registration Country : Norway

    Abacavir Sulfate

    ViiV Healthcare

    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

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    United Kingdom
    Fi Europe 2024
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    Regulatory Info :

    Registration Country : Norway

    Abacavir Sulfate

    ViiV Healthcare

    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

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    Brand Name : Kivexa

    United Kingdom
    Fi Europe 2024
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    Regulatory Info :

    Registration Country : Italy

    Abacavir; Lamivudine

    ViiV Healthcare

    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

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    Australia

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    Brand Name : Ziagen

    United Kingdom
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    Regulatory Info :

    Registration Country : Australia

    abacavir

    ViiV Healthcare

    Dosage Form : tablet

    Dosage Strength : 300 mg

    Packaging : 60

    Brand Name : Ziagen

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    Regulatory Info :

    Registration Country : Australia

    abacavir

    ViiV Healthcare

    Dosage Form : oral

    Dosage Strength : 20 mg/mL

    Packaging : 1

    Brand Name : Ziagen

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    Brand Name : Kivexa

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    Regulatory Info :

    Registration Country : Australia

    abacavir + lamivudine

    ViiV Healthcare

    Dosage Form : Film-coated Tablet; Film-coate...

    Dosage Strength : 600MG; 300MG

    Packaging : 30

    Brand Name : Kivexa

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    Registration Country : Australia

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    Brand Name : Malarone

    United Kingdom
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    Regulatory Info :

    Registration Country : Australia

    atovaquone + proguanil

    GSK

    Dosage Form : Tablet; Tablet

    Dosage Strength : 250MG; 100MG

    Packaging : 12

    Brand Name : Malarone

    Approval Date :

    Application Number :

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    Registration Country : Australia

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    Brand Name : Vocabria

    United Kingdom
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    Regulatory Info :

    Registration Country : Australia

    cabotegravir

    ViiV Healthcare

    Dosage Form :

    Dosage Strength :

    Packaging : 30

    Brand Name : Vocabria

    Approval Date :

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    Registration Country : Australia

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    Brand Name : Cabenuva

    United Kingdom
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    Regulatory Info :

    Registration Country : Australia

    cabotegravir (&) rilpivirine

    ViiV Healthcare

    Dosage Form : Injection; Injection

    Dosage Strength : 200MG; 300MG

    Packaging : 1

    Brand Name : Cabenuva

    Approval Date :

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    Registration Country : Australia

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    Brand Name : Tivicay

    United Kingdom
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    Regulatory Info :

    Registration Country : Australia

    dolutegravir

    ViiV Healthcare

    Dosage Form : tablet

    Dosage Strength : 50 mg

    Packaging : 30

    Brand Name : Tivicay

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    Regulatory Info :

    Registration Country : Australia

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    Brand Name : Triumeq

    United Kingdom
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    Registration Country : Australia

    dolutegravir + abacavir + lamivudine

    ViiV Healthcare

    Dosage Form : Tablet; Tablet; Tablet

    Dosage Strength : 50MG; 600MG; 300MG

    Packaging : 30

    Brand Name : Triumeq

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    Registration Country : Australia

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    Brand Name : Dovato

    United Kingdom
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    Regulatory Info :

    Registration Country : Australia

    dolutegravir + lamivudine

    ViiV Healthcare

    Dosage Form : Tablet; Tablet

    Dosage Strength : 50MG; 300MG

    Packaging : 30

    Brand Name : Dovato

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    Brand Name : Juluca

    United Kingdom
    Pharmtech & Ingredients
    Not Confirmed
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    Brand Name : Juluca

    United Kingdom
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    • EDQM
    • WHO-GMP
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    Regulatory Info :

    Registration Country : Australia

    dolutegravir + rilpivirine

    ViiV Healthcare

    Dosage Form : Tablet; Tablet

    Dosage Strength : 50MG; 25MG

    Packaging : 30

    Brand Name : Juluca

    Approval Date :

    Application Number :

    Regulatory Info :

    Registration Country : Australia

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    Excipients

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    01

    EMPTY HARD GELATIN CAPSULES

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

    Fi Europe 2024
    Not Confirmed
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    EMPTY HARD GELATIN CAPSULES

    United Kingdom

    USDMF, CEP/COS, JDMF, EU-WC, NDC, KDMF, VMF, Others

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    Fi Europe 2024
    Not Confirmed
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    USDMF Inactive-api
    ✖

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 5770

    Submission : 1985-04-08

    Status : Inactive

    Type : IV

     CEP/COS JDMF EU-WC NDC KDMF VMF Others AUDIT
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    USDMF

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    01

    EMPTY HARD GELATIN CAPSULES

    Pharmtech & Ingredients
    Not Confirmed
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    EMPTY HARD GELATIN CAPSULES

    United Kingdom
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    Pharmtech & Ingredients
    Not Confirmed
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    GSK

    GDUFA

    DMF Review : N/A

    Rev. Date :

    Pay. Date :

    DMF Number : 5770

    Submission : 1985-04-08

    Status : Inactive

    Type : IV

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    Inspections and registrations

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    FDA

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    01

    FDA Audited

    USA
    BMWS24
    Not Confirmed
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    FDA Audited

    USA
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    BMWS24
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2008-11-07

    GSK

    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

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    FDA Audited

    USA
    BMWS24
    Not Confirmed
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    FDA Audited

    USA
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    BMWS24
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2009-06-11

    GSK

    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

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    03

    FDA Audited

    USA
    BMWS24
    Not Confirmed
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    FDA Audited

    USA
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    BMWS24
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2010-02-19

    GSK

    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

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    04

    FDA Audited

    USA
    BMWS24
    Not Confirmed
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    FDA Audited

    USA
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    BMWS24
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-04-19

    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 : 2010-04-19

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    05

    FDA Audited

    USA
    BMWS24
    Not Confirmed
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    FDA Audited

    USA
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    BMWS24
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2010-04-19

    GSK

    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

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    06

    FDA Audited

    USA
    BMWS24
    Not Confirmed
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    FDA Audited

    USA
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    BMWS24
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2010-07-27

    GSK

    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

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    07

    FDA Audited

    USA
    BMWS24
    Not Confirmed
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    FDA Audited

    USA
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    BMWS24
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2011-01-27

    GSK

    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

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    08

    FDA Audited

    USA
    BMWS24
    Not Confirmed
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    FDA Audited

    USA
    arrow
    BMWS24
    Not Confirmed

    District Decision : Voluntary Action Indicated

    Inspection End Date : 2012-01-27

    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 : 2012-01-27

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    FDA Audited

    USA
    BMWS24
    Not Confirmed
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    FDA Audited

    USA
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    BMWS24
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2012-01-27

    GSK

    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

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    10

    FDA Audited

    USA
    BMWS24
    Not Confirmed
    arrow

    FDA Audited

    USA
    arrow
    BMWS24
    Not Confirmed

    District Decision : No Action Indicated

    Inspection End Date : 2012-12-19

    GSK

    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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