The FDA has cleared Bayer and Johnson & Johnson’s anticoagulant Xarelto for use in hospitalised, acutely ill medical patients at risk of serious blood clots. The approval came as a result of data from the MAGELLAN and MARINER trials of Xarelto (rivaroxaban), which showed that the drug could be safely used to prevent venous thromboembolism
GlaxoSmithKline and collaborator, Johnson & Johnson, have filed for approval of RA drug sirukumab in the EU. If the drug gains approval it will compete with Roche’s Actemra, which is currently worth $1.5bn. GSK and J&J’s Janssen Biologics unit are seeking EMA approval for their drug in combination with methotrexate in patients who have failed
Samsung Bioepis’ biosimilar of J&J’s blockbuster anti-inflammatory, infliximab, has won regulatory approval in Europe, which could potentially expand access to anti-TNF therapies in the region. Like its reference product, Flixabi has been cleared by the EU Commission for the treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis. The decision
The European regulatory body has granted approval to Pharmacyclics’ / Johnson & Johnson’s Janssen unit’s Imbruvica for two types of blood cancer. The European Commission has specifically approved the drug for mantle cell lymphoma (MCL) or patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy, or first-line in those with
Johnson & Johnson have announced that they have received regulatory approvals on both sides of the Atlantic for two of their key drugs, Olysio and Invokana. On Friday the US regulatory body, the Food and Drug Administration (FDA), approved Olysio (simeprevir) to treat chronic hepatitis C virus infection. The drug was co-developed by Johnson and
GlaxoSmithKline and Johnson & Johnson (J&J) announced yesterday that they have started Phase III clinical trials of their investigational rheumatoid arthritis (RA) treatment, sirukumab. Johnson & Johnson’s Janssen Biologics unit in Ireland and GlaxoSmithKline have begun a Phase III development programme for sirukumab (otherwise known as CNTO 136), a human anti-interleukin (IL)-6 monoclonal antibody. The
Johnson & Johnson’s Janssen Research & Development unit yesterday announced that they have filed a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for bedaquiline, in the hope that it will be the first drug with a new mechanism of action for tuberculosis (TB) in over 40 years. Specifically, Janssen is
Janssen Research & Development announced earlier this week that they have submitted supplemental New Drug Applications (sNDAs) to the US FDA (Food and Drug Administration). Janssen are pursuing approval from the FDA for the use of XARELTO (rivaroxaban), an oral anticoagulant, to treat patients with deep vein thrombosis (DVT) or pulmonary embolism (PE) and prevention
It has been reported that Johnson & Johnson’s bid to resolve alleged claims of illegal marketing of the antipsychotic blockbuster, Risperdal, which could cost the organisation about $1 billion, has been scuppered by the US Department of Justice. A tentative deal between Johnson & Johnson and federal prosecutors in Philadelphia was reached a couple of
Sweden’s Orexo suffered a major setback yesterday after the announcement that Johnson & Johnson had decided to end the firms’ anti-inflammatory collaboration. The agreement with the healthcare company’s Janssen Pharmaceuticals unit aligned around two research projects in the arachidonic acid field. The OX-CLI and OX‑ESI programmes were concentrated on developing treatments for asthma, chronic obstructive
