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FDA Breakthrough Therapy Status


The end of June 2014 brought exciting news for Insmed’s liposomal Amikacin, known as the brand name Arikace, with a Breakthrough Status award from the FDA. Amikacin was specifically designated Breakthrough Status for treatment refractory nontuberculous mycobacterial lung disease in adult patients. As an inhaled antibiotic Amikacin is effectual for treating chronic nontuberculous mycobacterial lung[…]

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Daclatasvir has been in the pharmaceutical spotlight lately as part of a new hepatitis C cocktail. Bristol-Myers Squibb revealed their achievement of a breakthrough drug designation from the FDA for the Daclatasvir based combination hepatitis C treatment. The FDA’s decision to grant a breakthrough designation for this oral drug combination of Daclatasvir and Asunaprevir is[…]

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On February 3, 2014 the FDA announced their decision to grant breakthrough therapy status to the formidable anemia medication Eltrombopag. The Eltrombopag breakthrough therapy status is based on successful data from a Phase 2 study of Eltrombopag in patients with severe aplastic anemia. The aforementioned study participants were ideal for treatment with Eltrombopag as they[…]

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On January 14, 2014 the FDA declared a Breakthrough Therapy designation for Dabrafenib, also known as the brand name Tafinlar as a single agent to treat certain types of lung cancer, specifically for the treatment of metastatic BRAF V600E mutation-positive non-small cell lung cancer. The target patient population should have already previously received one line[…]

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Pfizer and GlaxoSmithKline Combat Melanoma An announcement was made by pharmaceutical giants Pfizer and GlaxoSmithKline at the end of November 2013 regarding their agreement to combine efforts in researching a novel melanoma treatment. The clinical study the two companies have commenced involves adult patients with unresectable, metastatic melanoma. This partnership will be a Phase I/II[…]

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The end of October 2013 saw a nod from the FDA given to Gilead’s New Drug Application for Sofosbuvir. As a greatly needed treatment for hepatitis C Sofosbuvir has proven to be effectual and tolerable in a number of studies. Sofosbuvir is marketed by Gilead Science, Inc. and is clearly set up for success in[…]

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Positive studies of the recombinant human relaxin-2, known as Serelaxin, have continued to emerge, offering excitement in the pharmaceutical arena. On October 25, 2013 study data published on Medscape via The Lancet revealed the most recent data from a randomized and placebo controlled trial. This trial, coined RELAX-AHF, aimed to test the hypothesis that patients[…]

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On September 17, 2013 the FDA announced that Breakthrough Status was awarded to Volasertib. Currently marketed by Boehringer Ingelheim, this Volasertib breakthrough designation by the FDA is encouraging for patients suffering from acute myeloid leukemia. Volasertib is unique as it is a selective and powerful polo-like kinase inhibitor. Although Volasertib is currently an unapproved and[…]

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Patients suffering from the rare neuromuscular disorder Lambert-Eaton myasthenic syndrome have recently received life changing news. On August 27, 2013 the FDA decided to grant Amifampridine Phosphate a Breakthrough Therapy Designation, also known as BTD.  Marketed by BioMarin as the brand name Firdapse, Amifampridine Phosphate offers a crucial new hope for patients enduring this fatal[…]

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The advent of the FDA Safety and Innovation Act of 2012 has led to an onslaught of new cancer treatments waiting to be approved. Now that the FDA can legally create a new status, known as a “breakthrough” designation, patients with life-threatening diseases such as cancer can obtain their medications faster and more efficiently. However,[…]

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