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[…]
Amikacin Glean Breakthrough Therapy Status
Antibacterial, Antibiotic, Drug Research & Development API, FDA Breakthrough Therapy Status, OTC and Compounding Product Tags: cystic fibrosis Jul 23, 2014
Daclatasvir Awarded FDA Breakthrough Therapy Designation
Anti-Retroviral / Anti-HIV, Antiviral, FDA Breakthrough Therapy Status Mar 10, 2014
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[…]
Eltrombopag Breakthrough Therapy Status Gives Hope to SAA Patients
Drug Research & Development API, FDA Breakthrough Therapy Status Tags: anemia Feb 12, 2014
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[…]
Dabrafenib Named Breakthrough Therapy for Lung Cancer
Chemotherapeutic / Anti-Neoplastic, Drug Research & Development API, FDA Breakthrough Therapy Status Tags: 1195765-45-7Dabrafenib and TrametinibTafinlarunresectable melanoma Jan 16, 2014
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[…]
New Trametinib and Palbociclib Combo Drug for Melanoma Being Studied
Chemotherapeutic / Anti-Neoplastic, Drug Research & Development API, FDA Breakthrough Therapy Status Tags: GlaxoSmithKlineMekinistmelanomametastatic breast cancermetastatic melanomaPfizerTrametinib Dec 17, 2013
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[…]
FDA Grants Sofosbuvir Breakthrough Therapy Designation
Anti-Retroviral / Anti-HIV, Antiviral, FDA Breakthrough Therapy Status Tags: GileadHepatitis CribavirinSofosbuvir Nov 01, 2013
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[…]
Serelaxin Works for the Treatment of Acute Heart Failure
Cardiovascular Agent, FDA Breakthrough Therapy Status Tags: heart failure Oct 25, 2013
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[…]
FDA Awards Volasertib Breakthrough Therapy Status for Acute Myeloid Leukemia
Chemotherapeutic / Anti-Neoplastic, FDA Breakthrough Therapy Status Tags: acute myeloid leukemiakinase inhibitor Sep 25, 2013
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[…]
Rare Breakthrough Therapy Designation for Amifampridine Phosphate
Cardiovascular Agent, Drug Research & Development API, FDA Approved 2010, FDA Breakthrough Therapy Status Tags: acetylcholine Sep 09, 2013
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[…]
Cancer Drugs with Breakthrough Status – on a Fast Track, But is it Fast Enough?
Chemotherapeutic / Anti-Neoplastic, FDA Breakthrough Therapy Status Tags: chronic lymphocytic leukemiaIbrutinibmelanoma Jul 22, 2013
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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