Cabozantinib- API Insight, 2018

Cabozantinib, sold under the brand name of Cabometyx and Cometriq, is used for the treatment of medullary thyroid cancer and a second line treatment for renal cell carcinoma. It is a small molecule inhibitor of the tyrosine kinases c-Met and VEGFR2, and also inhibits AXL and RET. Discovered and developed by Exelixis Inc., its side-effects include increased liver enzymes, diarrhea, low calcium, mouth sores, decreased appetite and nausea.

In advanced renal cell carcinoma, which is a form of kidney cancer, Cabozantinib is used in those patients who have been previously treated with a type of cancer medicine called ‘vascular endothelial growth factor (VEGF) inhibitor. It is also used in patients who have not undergone previous treatment and whose cancer is at moderate or high risk. In hepatocellular carcinoma, which is a form of liver cancer, it is used in patients who have already been treated with the cancer medicine such as Sorafenib. It is currently marketed in Europe and the U.S.

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This report provides details of the drug and the API manufacturers across the 7 major markets which includes U.S, EU5, and Japan. It includes the overview, mechanism, regulatory milestones, strategic developments, the historical and forecasted sales.

The pipeline analysis of the drug by phase which would include the product description and development activities including information about clinical results, designations, collaborations, licensing, grants, technology and others.

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Myelodysplastic Syndromes (MDS) – Epidemiology Insights (2016-2028)

Myelodysplastic syndromes (MDS) can be described as a group of hematologic malignancies, that occurr due to abnormality in blood-forming cells in the bone marrow. It is a rare blood cancer and can be mild, moderate or severe, in terms of severity.

This syndrome can be classified into three main types: MDS with single lineage dysplasia wherein a single type of blood cell appears abnormal; multilineage dysplasia causing two or more cell types to appear abnormal; and MDS with excess blasts, wherein the patients have a shortage of either red blood cells, white blood cells or platelets. Some prominent risk factors that increase the risk of myelodysplastic syndromes are aging, exposure to industrial chemicals, chemo- or radiation therapy, and smoking.

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MDS is an uncommon syndrome with an incidence of 4-5 patients per 100,000 populations. It increases with age and can reach up to 20-50 per 100,000 population, in patients aged over 60 years. According to a 2019 study, the annual incidence of pediatric MDS is approximately 1-4 cases/million, which accounts for less than 5% of childhood hematological malignancies.

The report covers historical and forecast epidemiology of the disease in the seven major markets including the U.S., EU5 (France, Germany, Italy, Spain, U.K.), and Japan. The report has been compiled by building an understanding of the disease, after reviewing numerous studies conducted by regulatory bodies in various countries.

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Uveal Melanoma Therapeutics - Pipeline Analysis 2018, Clinical Trials & Results, Patents, Designations

Uveal melanoma is the most common primary malignant tumour of intraocular malignancy, arises from melanocytes in the iris, and ciliary body. The most common symptoms of uveal carcinoma include blurred vision, photopsia, visual field loss, visible tumour, pain, and metamorphopsia.

The management of uveal melanoma can be divided into globe-preserving therapy or enucleation. Globe-preserving therapies can broadly classified into radiation, surgical, and laser therapy. The drug candidates of uveal melanoma disease pipeline include, but not limited to, nivolumab and IMCgp100. Some of the companies having drugs in the uveal melanoma therapeutics pipeline includes Harmonic Pharma, Immunocore Ltd. and Celldex Therapeutics, Inc.

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The report provides a comprehensive understanding of the pipeline activities covering all drug candidates under various stages of development, with the detailed analysis of pipeline and clinical trials.

Pipeline analysis of drugs by phases includes product description and development activities including information about clinical results, designations, collaborations, licensing, grants, technology, and others.

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Tuberous Sclerosis Therapeutics - Pipeline Analysis 2018, Clinical Trials & Results

Tuberous sclerosis, also known as tuberous sclerosis complex, is a genetic disorder characterized by the growth of numerous noncancerous (benign) tumors in many parts of the body. It can occur in the brain, skin, kidneys, and other organs, in some cases leading to significant health problems. The signs and symptoms of the disease vary from person to person.

Virtually all affected people have skin abnormalities, including patches of unusually light-coloured skin, areas of raised and thickened skin, and growths under the nails. It can also cause facial angiofibromas, tumors on the face beginning in childhood. Some affected children have the characteristic features of autism, a developmental disorder that affects communication and social interaction.

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The drug candidates of tuberous sclerosis disease pipeline include, but not limited to, cannabidiol, and TAK-935. Novartis AG, GW Pharmaceuticals plc and Takeda Pharmaceutical Company Limited are some of the major companies having drugs in the tuberous sclerosis therapeutics pipeline.

The report provides a comprehensive understanding of the pipeline activities covering all drug candidates under various stages of development, with the detailed analysis of pipeline and clinical trials.

Pipeline analysis of drugs by phases includes product description and development activities including information about clinical results, designations, collaborations, licensing, grants, technology, and others.

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Thymic Carcinoma Therapeutics - Pipeline Analysis 2018, Clinical Trials & Results, Patents, Designations

Thymic carcinoma, also known as thymomas, is a rare type of cancer that forms in the cells present in the outside surface of the thymus. Thymus is a small organ that lies in the upper chest under the breastbone.

It is a part of the lymph system and produces certain types of white blood cells that helps the body to fight against infections. The tumor cells in a thymoma look like the normal cells of the thymus which grow slowly and rarely spread beyond the thymus.

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The drug candidates of thymic carcinoma disease pipeline include, but not limited to, pembrolizumab, and milciclib maleate. Some of the companies having drugs in the thymic carcinoma disease pipeline includes Merck & Co. Inc., NMS Group SpA and Tiziana Life Sciences plc.

The report provides a comprehensive understanding of the pipeline activities covering all drug candidates under various stages of development, with the detailed analysis of pipeline and clinical trials.

Pipeline analysis of drugs by phases includes product description and development activities including information about clinical results, designations, collaborations, licensing, grants, technology, and others.

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Sezary Syndrome Therapeutics - Pipeline Analysis 2018, Clinical Trials & Results

Sézary syndrome, a type of cutaneous T-cell lymphoma, affects Sézary cells present in the skin, lymph nodes and blood. It accounts approximately 3 to 5 percent of cases of cutaneous T-cell lymphoma. Sézary syndrome is more prevalent in males compared to females.

It is characterized by red, severely itchy rash that covers large areas of the body. The common symptoms of Sézary syndrome includes alopecia, lymphadenopathy, palmoplantar keratoderma, ectropion and abnormalities of the fingernails and toenails.

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The standard treatments for Sézary syndrome are combination of phototherapy and chemotherapy, and medications including vorinostat and romidepsin. Takeda Pharmaceutical Company Limited is in the process of developing brentuximab vedotin for the treatment of Sézary syndrome.

The report provides a comprehensive understanding of the pipeline activities covering all drug candidates under various stages of development, with the detailed analysis of pipeline and clinical trials.

Pipeline analysis of drugs by phases includes product description and development activities including information about clinical results, designations, collaborations, licensing, grants, technology, and others.

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Pontine Glioma Therapeutics - Pipeline Analysis 2018, Clinical Trials & Results

Pontine glioma is a malignant tumour which develops from the brain stem cells. Based on the grade of growth, it is categorized into anaplastic astrocytomas and glioblastoma multiforme (GBM). Pontine glioma is more prevalent in children than adults.

The common signs and symptoms of pontine glioma are squints, swallowing problems, slurred speech, facial weakness, abnormal gait, difficulty in writing and changes in personality and behaviour. The only efficient treatment for pontine glioma is radiotherapy; as surgery is not possible due to the tumor’s position in the brain stem.

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Company like Y-mAbs Therapeutics Inc. is in the process of developing omburtamab for the treatment of pontine glioma.

The report provides a comprehensive understanding of the pipeline activities covering all drug candidates under various stages of development, with the detailed analysis of pipeline and clinical trials.

Pipeline analysis of drugs by phases includes product description and development activities including information about clinical results, designations, collaborations, licensing, grants, technology, and others.

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Juvenile Myelomonocytic Leukemia Therapeutics - Pipeline Analysis 2018, Clinical Trials & Results, Patents

Juvenile myelomonocytic leukemia is a rare disease that occurs mostly in the children who are under four years of age. The abnormal growth of the monocytes results in the accumulation of monocytes in the bone marrow. This leads to improper functioning of the bone marrow.

The actual cause of juvenile myelomonocytic leukemia is still unknown; however, mutation in the RAS gene is observed in patients with the disease. Fatigue, weakness, dry cough, pallor, and fever are major symptoms of the medical condition.

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The University of Minnesota is in the process of developing stem cell therapy for the treatment of juvenile myelomonocytic leukemia. Celgene Corporation is also developing azacytidine, a DNA methylation inhibitor, for the treatment of this medical condition.

The report provides a comprehensive understanding of the pipeline activities covering all drug candidates under various stages of development, with the detailed analysis of pipeline and clinical trials.

Pipeline analysis of drugs by phases includes product description and development activities including information about clinical results, designations, collaborations, licensing, grants, technology, and others.

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Hormone Sensitive Breast Cancer Therapeutics - Pipeline Analysis 2018, Clinical Trials & Results, Patents, Designations

Breast cancer generally occurs when breast cells grow uncontrollably. Mostly, breast cancer development starts in the duct that carries milk to the nipples. Some breast cancer cells develop in milk producing glands. As per the National Institutes of Health (NIH), in the U.S., 14.6% of all new cancer cases diagnosed every year are of breast cancer.

Also, as per the American Cancer Society (ACS), 1 in every 5 woman has cancer cell in their breast tumour with several growth promoting protein receptors on their surface. HER2 (human epidermal growth factor receptor 2) gene plays significant role in the development of breast cancer in most of the cases. Alpelisib is one of the key pipeline drug candidates for hormone sensitive breast cancer pipeline. Pfizer Inc., and Novartis AG are major players involved in the development of drugs for hormone sensitive breast cancer.

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The report provides a comprehensive understanding of the pipeline activities covering all drug candidates under various stages of development, with the detailed analysis of pipeline and clinical trials.

Pipeline analysis of drugs by phases includes product description and development activities including information about clinical results, designations, collaborations, licensing, grants, technology, and others.

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Gorlin Syndrome Therapeutics - Pipeline Analysis 2018, Clinical Trials & Results

Gorlin syndrome, also known as basal cell nevus syndrome, is an inherited genetic disorder characterized by multiple basal cell skin cancer. The common symptoms observed during Gorlin syndrome are calcium deposition in brain, jaw cysts, skeletal changes and developmental disability. The person with Gorlin syndrome appears with a prominent forehead, widely spaced eyes, small skin bumps and skin cysts.

Gorlin syndrome is screened by neurological evaluation, dental X-Ray and measurement of head size. The main treatment for Gorlin syndrome includes imiquimod cream, chemotherapy, photodynamic therapy and retinoids. Ascend Biopharmaceuticals Ltd. is in the process of developing ASN-002, a chemoimmunotherapy, for the treatment of Gorlin syndrome. PellePharm Inc., and F. Hoffmann-La Roche Ltd. are some other key players having drugs for Gorlin syndrome in their pipeline.

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The report provides a comprehensive understanding of the pipeline activities covering all drug candidates under various stages of development, with the detailed analysis of pipeline and clinical trials.

Pipeline analysis of drugs by phases includes product description and development activities including information about clinical results, designations, collaborations, licensing, grants, technology, and others.

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Angiopoietin (ANG) Inhibitors Therapeutics - Pipeline Analysis 2019, Clinical Trials & Results, Patents, Designations

Angiopoietin (ANG) receptor plays a crucial role in regulation of vascular permeability and pathological vascular remodelling during tumour angiogenesis, metastasis and inflammation. Thus, it has emerged as a new clinical approach for the development of therapeutics which treat cancer and ophthalmological diseases.

The exclusive function of these receptors in vascular stabilization also makes it an attractive target in organ transplantation, sepsis, vascular complications of diabetes and atherosclerosis. There are various types of angiopoietins identified which includes ANG-1, ANG-2, ANG-3 and ANG-4. ANG-2 is the most commonly targeted receptor for the treatment of various diseases and demonstrated as potential therapeutics for anti-angiogenesis treatment for patients suffering from cancer.

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Company like Regeneron Pharmaceuticals Inc. is developing a combination of nesvacumab and aflibercept which acts as ANG-2 inhibitor and vascular endothelial growth factor A inhibitor, respectively for the treatment of retinal diseases (wet age-related macular degeneration and diabetic macular oedema). F. Hoffmann-La Roche Ltd., Eli Lilly and Company, and Boehringer Ingelheim International GmbH are some other key players having extensive pipeline of angiopoietin inhibitors.

The report provides a comprehensive understanding of the pipeline activities covering all drug candidates under various stages of development, with detailed analysis of pipeline and clinical trials. Pipeline analysis of drugs by phases includes product description and development activities including information about clinical results, designations, collaborations, licencing, grants, technology and others.

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Spleen Tyrosine Kinase (Syk) Inhibitor Therapeutics - Pipeline Analysis 2018, Clinical Trials & Results, Patents

Spleen tyrosine kinase (Syk) is a protein that belongs to the family of tyrosine kinases with an ability to initiate the inflammatory responses, by connecting immune cell receptors to intracellular signaling pathways. Therefore, Syk is an attractive target for improving the symptoms related to acute and chronic inflammation. 

In addition, the role of protein is recognized as a promoter in various types of cancers ranging from leukemia to retinoblastoma. Syk protein facilitates the phosphorylation of protein on tyrosines and also involves in the B cell antigen receptor (BCR) signalling pathways. There are several drugs that effectively inhibit the Syk kinase but the off-target effect is a limiting factor. Currently, there are various Syk inhibitors that prevent release of inflammatory cytokines in vitro and IgE-driven mast cell degranulation.

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Levolta Pharmaceuticals Inc. is developing a drug candidate, that acts as Syk inhibitor for the treatment of immunological diseases. Rigel Pharmaceuticals Inc. is developing fostamatinib as a Syk inhibitor for the treatment of chronic immune thrombocytopenia and autoimmune hemolytic anemia. Hutchison China MediTech Limited is also developing HMPL-523 as a Syk inhibitor for the treatment of cancer indications. Some of the companies having pipeline of Syk inhibitor include Genosco Inc., Asana BioSciences LLC, and others.

The report provides a comprehensive understanding of the pipeline activities covering all drug candidates under various stages of development, with the detailed analysis of pipeline and clinical trials. Pipeline analysis of drugs by phases includes product description and development activities including information about clinical results, designations, collaborations, licensing, grants, technology, and others.

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Glycogen Synthase Kinase 3 Beta (GSK-3β) Inhibitors Therapeutics - Pipeline Analysis 2019, Clinical Trials & Results

Glycogen synthase kinase 3 beta (GSK-3β) is an attractive target for the treatment of psychiatric disorders and neurodegenerative diseases. Many GSK-3β inhibitors have been developed for the treatment of different central nervous system disorders. But, for an effective therapy, high IC50 values should be avoided and ATP-competition should be reduced during enzyme-compound binding. Studies suggested that ATP non-competitive GSK-3 inhibitors such covalent inhibitors and allosteric modulators are emerging as a promising approach with better efficacy and safety.

Despite of many GSK-3β inhibitors in clinical studies, many challenges still remains. In a clinical study, certain adverse events caused by off-target activity of GSK-3β inhibitors were determined after the screening of compounds that bind to the ATP-competitive binding site conserved across a broad range of kinases. Thus, there is an urgent need of development of GSK-3β inhibitors that can selectively target individual pathways and differentiate between the non-phosphorylated and phosphorylated GSK-3β.

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Company like AMO Pharma Ltd. is in the process of developing AMO-02 as a small molecule which acts as a GSK-3β inhibitor for the treatment of congenital myotonic dystrophy.

The report provides a comprehensive understanding of the pipeline activities covering all drug candidates under various stages of development, with detailed analysis of pipeline and clinical trials. Pipeline analysis of drugs by phases includes product description and development activities including information about clinical results, designations, collaborations, licencing, grants, technology and others.

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Bone Metastases Therapeutics - Pipeline Analysis 2018, Clinical Trials & Results, Patents

Bone metastases is a common form of cancer of the skeleton that inhabits in bone marrow and stimulates the local bone activity. In this condition, the normal bone homeostasis disrupts which leads to the development of the tumour. Some of the major symptoms observed in patients with bone metastases are bone pain, spinal cord compression, and high blood calcium levels.

Bone metastases can be diagnosed by various types of imaging tests such as X-Ray, bone scan, positron emission tomography (PET), magnetic resonance imaging (MRI), and computed tomography (CT) scan, blood tests, urine tests, and bone biopsy. ChemoCentryx, Inc. is in the process of developing CCX354 as a CCR1 receptor antagonist for the treatment of bone metastases. Moreover, Amgen Inc. is developing denosumab as a RANKL ligand inhibitor for the treatment of this medical condition. Pfizer Inc., and Eli Lilly and Company are also key players having drugs for bone metastases in their pipeline.

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The report provides a comprehensive understanding of the pipeline activities covering all drug candidates under various stages of development, with the detailed analysis of pipeline and clinical trials.

Pipeline analysis of drugs by phases includes product description and development activities including information about clinical results, designations, collaborations, licensing, grants, technology, and others.

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Acquired Immunodeficiency Syndrome (AIDS) Related Cancer Therapeutics - Pipeline Analysis 2018, Clinical Trials & Results

Acquired immunodeficiency syndrome (AIDS) related cancer include those types of cancer which occurs in patients suffering from AIDS. People with AIDS are reported to be highly suspected to the occurrence of lymphomas.

According to the American Society of Clinical Oncology, Kaposi sarcoma is very common in patients with AIDS; whereas non-Hodgkin’s lymphoma is second most common in patients with AIDS. Women with AIDS are at high risk for developing cervical intraepithelial neoplasia. The National Cancer Institute is in the process of developing chemotherapy and HAART; and EPOCH-rituximab, for the treatment of AIDS related lymphoma.

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The report provides a comprehensive understanding of the pipeline activities covering all drug candidates under various stages of development, with the detailed analysis of pipeline and clinical trials.

Pipeline analysis of drugs by phases includes product description and development activities including information about clinical results, designations, collaborations, licensing, grants, technology, and others.

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