Drug Development Pharma - August 17, 2015
Orexo’s ZUBSOLV approved
Orexo has announced that the US Food and Drug Administration has approved ZUBSOLV (buprenorphine/naloxone CIII sublingual tablet) for induction of buprenorphine maintenance therapy in patients with opioid dependence. The approval expands on the current indication for ZUBSOLV, originally approved by the U.S. FDA on July 3, 2013, and is based on data from two Phase […]
Drug Development Pharma - August 13, 2015
New vaccine against Ebola virus
The Research Council of Norway’s Programme for Global Health and Vaccination Research (GLOBVAC) is co-funding testing of a new vaccine against Ebola. Preliminary results from the Norwegian-led trial underway in Guinea, published in the medical journal The Lancet, indicate that the vaccine may provide complete protection against Ebola virus disease. The vaccine study is a […]
Drug Development Pharma - July 18, 2015
Lung Cancer Drug Slows Disease
Astra Zeneca’s experimental lung cancer pill delayed the progression of the disease by more than a year, the company said at the European Lung Cancer Congress 2015 in Geneva, Switzerland, recently. The data came from the firm’s Phase II study on approximately 300 patients, which showed a 54 percent overall response rate, surpassing the 9.6-month […]
Drug Development Pharma - July 16, 2015
Priority Review for Janssen Drug
The US Food and Drug Administration (FDA) has approved under priority review Janssen Pharmaceuticals’ New Drug Application (NDA) for the three-month long-acting atypical antipsychotic Invega Trinza. Priority review is a designation for drugs that, if approved, would offer significant improvement in the treatment of serious conditions. In a long-term maintenance trial, 93 percent of patients […]
Drug Development Pharma - July 1, 2015
EC Approves Sobi Drug for HT-1
The European Commission has approved an oral suspension formulation of Swedish Orphan Biovitrum’s (Sobi) Orfadin (nitisinone). The orphan drug treats Hereditary Tyrosinaemia type-1 (HT-1), a rare genetic and potentially fatal condition that affects infants and children and can result in liver and kidney failure if untreated, according to PMLiVE. “The European Medicines Agency has called […]
Drug Development Pharma - June 9, 2015
Janssen Submits BLA to FDA
Genmab A/S’s licensing partner Janssen Biotech, Inc. has initiated a rolling submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for daratumumab for double refractory multiple myeloma. The submission is for using daratumumab to treat patients with multiple myeloma who have received at least three different lines of therapy […]
