FDA Issues Complete Response Letter to Indivior for Opioid Overdose Nasal Spray December 2, 2015 The agency says the early stage uptake of naloxone did not fully meet its threshold compared with the reference product. Read More
Aeterna Zentaris to Distribute Armune’s Apifiny Test in the U.S. December 1, 2015 Apifiny is a non-PSA blood test for the detection of prostate cancer. Read More
Cellceutix Awarded Orphan Drug Designation for Retinoblastoma Treatment December 1, 2015 The candidate is being studied to treat a cancer of the retina that typically affects children under the age of 3. Read More
Covalon Technologies Wins Clearance for Catheter November 30, 2015 The catheter is designed to allow clinicians to drain a patient's bladder. Read More
FDA Approves Takeda’s Ninlaro to Treat Multiple Myeloma November 30, 2015 The drug is approved in combination with Celgene’s Revlimid and corticosteroid dexamethasone. Read More
SkylineDx Awarded CE-IVD Registration for MMprofiler November 25, 2015 The test helps to more accurately measure the prognosis of multiple myeloma patients. Read More
Servier Acquires Worldwide Rights to CAR-T Immunotherapy From Cellectis November 25, 2015 UCART19 is a TALEN gene-edited allogeneic chimeric antigen receptor T-cell immunotherapy to treat chronic lymphocytic leukemia. Read More
BSN Medical Acquires Wright Therapy Products November 24, 2015 Wright Therapy Products’ portfolio is designed for the treatment of lymphedema and chronic venous insufficiency. Read More
Amgen, Roche Drugs Declined by NICE November 24, 2015 Amgen’s Repatha had no clinical trial data, and the price of Roche’s Kadcyla remains too high. Read More
SurModics Acquires Creagh Medical for $32M November 23, 2015 Creagh is a balloon catheters manufacturer. Read More
Roche’s Genentech Exercises Option for Ophthotech’s Muscular Degeneration Drug November 23, 2015 Genentech will commercialize Fovista outside the U.S. Read More
Biosense Webster Acquires Coherex Medical November 20, 2015 Coherex manufactures the WaveCrest device, designed to block the most common source of blood clots. Read More