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FDA approves J&J’s nasal spray for treatment-resistant depression

March 6, 2019 By Sarah Faulkner

Johnson & Johnson

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 […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Neurological, Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: janssen, Johnson & Johnson

FDA committee backs J&J’s nasal spray for depression

February 13, 2019 By Sarah Faulkner

Updated Janssen logo

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 […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Neurological, Pharmaceuticals, Wall Street Beat Tagged With: janssen, Johnson & Johnson

Johnson & Johnson, Apple ink collab for AFib study

January 17, 2019 By Sarah Faulkner

Updated Janssen logo

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 […]

Filed Under: Cardiovascular, Drug-Device Combinations, Featured, mHealth (Mobile Health), Pharmaceuticals, Vascular, Wall Street Beat Tagged With: Apple, janssen, johnsonandjohnson

Janssen touts topline data for long-acting, injectable HIV therapy

November 2, 2018 By Sarah Faulkner

Janssen updated logo

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 […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Pharmaceuticals, Wall Street Beat Tagged With: GlaxoSmithKline plc, janssen, johnsonandjohnson

J&J’s Janssen wins FDA nod for first non-chemo treatment for rare blood cancer

August 27, 2018 By Fink Densford

Janssen

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 […]

Filed Under: Food & Drug Administration (FDA), Oncology, Regulatory/Compliance Tagged With: janssen, johnsonandjohnson

J&J’s Janssen touts Ph3 data for antidepressant nasal spray

May 7, 2018 By Sarah Faulkner

Janssen

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 […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Neurological, Pharmaceuticals, Wall Street Beat Tagged With: janssen, johnsonandjohnson

J&J’s Janssen acquires cancer-killing virus tech

May 2, 2018 By Sarah Faulkner

Janssen

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 […]

Filed Under: Featured, Immunotherapy, Mergers & Acquisitions, Oncology, Pharmaceuticals, Wall Street Beat Tagged With: janssen, johnsonandjohnson

FDA approves first two-drug HIV regimen in a single pill

November 22, 2017 By Sarah Faulkner

Juluca HIV drug

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 […]

Filed Under: Featured, Food & Drug Administration (FDA), Pharmaceuticals, Regulatory/Compliance, Wall Street Beat Tagged With: janssen, viivhealthcare

Janssen’s respiratory panel wins 510(k) clearance

September 5, 2017 By Sarah Faulkner

Janssen diagnostics

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 […]

Filed Under: Diagnostics, Featured, Food & Drug Administration (FDA), Respiratory, Wall Street Beat Tagged With: janssen, johnsonandjohnson

Xarelto, aspirin combo reduces risk of cardiovascular events in pivotal Ph3 trial

August 28, 2017 By Sarah Faulkner

Janssen

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 […]

Filed Under: Cardiovascular, Clinical Trials, Featured, Pharmaceuticals, Vascular, Wall Street Beat Tagged With: Bayer AG, janssen, johnsonandjohnson

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