Janssen Pharmaceutical has received approval from the FDA for the use of Canagliflozin to minimise the risk of major adverse cardiovascular (CV) events in adults. The indication covers CV events such as heart attack, stroke or death in patients with type 2 diabetes (T2D) and have a known CV condition. Canagliflozin is an oral, prescription
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
The UK’s National Institute for Health and Clinical Excellence (NICE) has issued final draft guidance recommending Janssen Cilag’s Incivo (telaprevir), in combination with Roche’s peginterferon alfa and ribavirin, as an option for the treatment of genotype 1 chronic hepatitis C in adults with compensated liver disease. The final draft guidance recommends the drug as an
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
