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Artificial Intelligence (AI) and Intelligent Augmentation (IA) in pharmaceutical industry present with a real opportunity to do R&D differently. There needs to be a fundamental shift in drug discovery and AI and IA both holds the key to bringing revolution to the pharma industry into the 21st Century. The current drug discovery process needs to shift dramatically in order to meet the needs both of society and patients. AI and IA both can operate more

CAR T cell therapy has been a success in hematological malignancies. The FDA and EMA approved CART19 (Kymriah & Yescarta) to treat pediatric relapsed or refractory acute lymphoblastic leukemia (ALL) and for adult relapsed or refractory large B cell lymphoma in 2017 & 2018 respectively. For solid tumors, CAR T cell therapy has shown promising results in early phase of clinical trials. Results of most of the trials are awaited. Here is the glimpse for

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