The FDA has approved Johnson & Johnson‘s (NYSE:JNJ) esketamine nasal spray for people living with treatment-resistant depression. The company’s product, Spravato, is an intranasal formulation of ketamine – a horse tranquilizer that is also known as Special K. The drug won support for approval from an FDA advisory committee earlier this year. Spravato is the […]
FDA committee backs J&J’s nasal spray for depression
An FDA advisory committee has voted to support Johnson & Johnson‘s (NYSE:JNJ) Spravato esketamine nasal spray product as a therapy for adults living with treatment-resistant depression. J&J’s Janssen touted that if the U.S. regulatory agency decides to approve Spravato, it would be the first medicine in 30 years to sport a new mechanism of action […]
Johnson & Johnson, Apple ink collab for AFib study
Johnson & Johnson‘s (NYSE:JNJ) Janssen and Apple (NSDQ:AAPL) said today that the two companies inked a deal to study if an app from J&J in combination with the Apple Watch’s ECG app and irregular rhythm notifications can improve outcomes for people living with atrial fibrillation. The study is slated to measure the impact of the Apple Watch […]
Janssen touts topline data for long-acting, injectable HIV therapy
Johnson & Johnson‘s (NYSE:JNJ) Janssen touted topline results this week from a Phase III trial of its long-acting, injectable two-drug regimen for the treatment of HIV. The study found that long-acting, once-monthly rilpivirine and cabotegravir had comparable efficacy to GlaxoSmithKline‘s (NYSE:GSK) oral Triumeq product. Janssen and ViiV Healthcare also reported that virologic response and drug resistance […]
J&J’s Janssen wins FDA nod for first non-chemo treatment for rare blood cancer
Johnson & Johnson‘s (NYSE:JNJ) Janssen division said today that it won new FDA approval for its Imbruvica, clearing it for use in treating the rare blood cancer Waldenström’s macroglobulinemia in combination with ritumixab. The approval expands the label for Imbruvica to include combination use with ritumixab, and represents “the first approved non-chemotherapy combination option for the […]
J&J’s Janssen touts Ph3 data for antidepressant nasal spray
Johnson & Johnson‘s (NYSE:JNJ) Janssen revealed data today from two Phase III trials of its investigational esketamine nasal spray in patients with treatment-resistant depression. The Titusville, N.J.-based company said that if approved by the FDA, esketamine would represent one of the first new approaches designed to treat refractory major depressive disorder in the last 50 […]
J&J’s Janssen acquires cancer-killing virus tech
Johnson & Johnson‘s (NYSE:JNJ) Janssen Biotech said today that it agreed to acquire BeneVir Biopharm and its T-Stealth oncolytic virus platform. The privately-held biopharmaceutical company engineers cancer-killing viruses that are designed to infect and destroy cancer cells. Janssen plans to develop BeneVir’s preclinical candidates for the treatment of solid tumor cancers. According to the terms […]
FDA approves first two-drug HIV regimen in a single pill
The FDA yesterday approved the first two-drug regimen available in a single pill for the maintenance treatment of HIV. The drug, Juluca, combines ViiV Healthcare‘s integrase strand transfer inhibitor and Janssen Therapeutics‘ non-nucleoside reverse transcriptase inhibitor. The treatment is indicated for adults with HIV who are virologically suppressed on a stable anti-retroviral regimen for at […]
Janssen’s respiratory panel wins 510(k) clearance
Johnson & Johnson (NYSE:JNJ) subsidiary Janssen Diagnostics said today that it won 510(k) clearance from the FDA for its Idylla respiratory panel. The diagnostic test, developed in partnership with Biocartis Group, helps physicians identify viral respiratory infections, including infection from respiratory syncytial virus and influenza virus. The company’s assay uses nasopharyngeal swabs to collect samples and […]
Xarelto, aspirin combo reduces risk of cardiovascular events in pivotal Ph3 trial
Johnson & Johnson (NYSE:JNJ) subsidiary Janssen touted data today from a pivotal Phase III trial showing that Xarelto plus aspirin reduced the risk of major cardiovascular events in patients with stable coronary and peripheral artery disease compared to aspirin alone. Treatment with Xarelto twice per day and aspirin once-daily cut the risk of major cardiovascular events […]
