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Drug Research & Development API


The FDA gave the green light in late May 2015 with their approval of a quarterly dosing schedule of Paliperidone Palmitate, also known as Invega Trinza. Marketed by Janssen Pharmaceuticals this novel dosing regimen is the first ever quarterly dosing therapy for patients with Schizophrenia. Paliperidone is dispensed to patients via an intramuscular injection every[…]

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Exciting news was presented at ENDO 2015 regarding the use of Denosumab for osteoporosis in post-menopausal women who are at high risk for bone fractures. Results from a comprehensive trial coined Freedom showed the use of Denosumab successfully increased bone mineral density (BMD) at cortical bone sites, particularly the 1/3 radius skeletal site which does[…]

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Patients with non-small cell lung cancer, also known as NSCLC, are anxiously awaiting a decision from the FDA’s Oncologic Drugs Advisory Committee regarding Eli Lilly’s introduction of Necitumumab to the already formidable Gemcitabine and Cisplatin combination. Both Gemcitabine and Cisplatin are currently the first line-treatment for patients diagnosed with NSCLC, and the addition of Necitumumab[…]

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On July 24, 2015 the FDA approved Sonidegib, marketed by Novartis AG as the once daily pill Odomzoa for the treatment of locally advanced basal cell carcinoma. Specifically for patients with locally advanced basal cell carcinoma that has recurred following surgery or radiation therapy, or who are not candidates for surgery or radiation therapy. Sonidegib,[…]

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While Brivaracetam is being evaluated as an adjunctive therapy in patients diagnosed with Epilepsy and partial onset seizures, animal models have piqued the curiosity of R&D experts as to Brivaracetam being a potential treatment for Alzheimer’s patients. As a unique product with a high-affinity synaptic vesicle protein 2A ligand, Brivaracetam is currently marketed by UCB,[…]

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Known as Restless Legs Syndrome, or RLS, this disruptive condition occurs in roughly 7% of the population worldwide. While patients older than age 65 are most commonly diagnosed, there are children who experience RLS as well. With approximately 10% of children experiencing a sleep disorder globally, the diagnosis of RLS in the adolescent population is[…]

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On July 2, 2015 the FDA announced its approval for the potent duo of Lumacaftor and Ivacaftor to treat patients suffering from Cystic Fibrosis (CF). Coined Orkambi, which is marketed by Vertex Pharmaceuticals, this effectual treatment is specifically approved for patients ages 12 and older who have the homozygous F508 mutation of the CF transmembrane[…]

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Known as the brand name Cystic Fibrosis drug Kalydeco, marketed by Vertex Pharmaceuticals, Ivacaftor recently received an MAA line extension. As of June 2015 children ages two through five who have specific mutations in the CFTR gene may be administered Ivacaftor as therapy. As a unique, tolerable and effectual treatment Ivacaftor acts as a novel[…]

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Entresto, the novel combination therapy which combines Sacubitril and Valsartan, was FDA approved on July 7, 2015. Previously known as the investigational compound LCZ696, Entresto received an FDA nod to reduce the risk of both hospitalization and cardiovascular mortality in patients with chronic heart failure, especially those with a reduced ejection fraction and an NYHA[…]

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