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On May 3, the U.S. Food and Drug Administration approved Vyndaqel (tafamidis meglumine) and Vyndamax (tafamidis) capsules for the treatment of the heart disease (cardiomyopathy) caused by transthyretin mediated amyloidosis (ATTR-CM) in adults. These are the first FDA-approved treatments for ATTR-CM. Unmet Medical Need (UMN) Parameters Current Unmet Medical Need in ATTR-CM Unmet Medical Need after Vyndaqel and Vyndamax Treatment Adequacy Current treatment provides symptomatic relief. New treatment affects disease progression Disease Severity Cardiac involvement
October 8, 2018 On September 14, 2018, the US Food and Drug Administration (FDA) has approved the humanized monoclonal antibody fremanezumab-vfrm (Ajovy, Teva Pharmaceuticals) for migraine prevention in adults. Migraine is a complex disorder characterized by recurrent episodes of headache, most often unilateral and in some cases associated with visual or sensory symptoms. Migraine is most common in women and has a strong genetic component. Migraine is a disabling neurological disease that affects more than
The U.S. Food and Drug Administration approved the first drug, Oxervate (cenegermin), for the treatment of neurotrophic keratitis on August 22, 2018. Oxervate received Orphan Drug Designation, Fast Track Status, and Breakthrough Therapy Designation, which led to Priority Review. Oxervate represents the first-ever topical biologic medication approved in ophthalmology, and is the first ever application of a human nerve growth factor as drug or treatment. Neurotrophic keratitis (NK) is a degenerative disease characterized by decreased
Scope of report The report provides a snapshot of the global therapeutic landscape of Spinal muscular atrophy. The report assesses Spinal muscular atrophy pipeline based on highest phase of development, type of sponsor, mechanism of action (MoA), route of administration (RoA), and molecule type. The report reviews Spinal muscular atrophy pipeline by companies and universities/research institutes based on information derived from company and industry-specific sources. The report covers pipeline products based on various stages of
Scope of report The report provides a snapshot of the global therapeutic landscape of Mucopolysaccharidosis III. The report assesses Mucopolysaccharidosis III pipeline based on highest phase of development, type of sponsor, mechanism of action (MoA), route of administration (RoA), and molecule type. The report reviews Mucopolysaccharidosis III pipeline by companies and universities/research institutes based on information derived from company and industry-specific sources. The report covers pipeline products based on various stages of development for Mucopolysaccharidosis
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