Janssen Research & Development LLC, of Raritan, N.J., a unit of Johnson & Johnson, said the FDA granted priority review to its new drug application for simeprevir (TMC435), an NS3/4A protease inhibitor for once-daily administration with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adults with compensated liver disease

Janssen Research & Development LLC, of Raritan, N.J., a unit of Johnson & Johnson, said the FDA granted a breakthrough therapy designation for daratumumab for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), or who are double refractory to a PI and IMiD

Janssen-Cilag International NV, of Beerse, Belgium, a unit of Johnson & Johnson, submitted a marketing authorization application to the European Medicines Agency for a fixed-dose combination of canglifozin and immediate-release metformin for Type II diabetes

Janssen Research & Development LLC, of Raritan, N.J., a unit of Johnson & Johnson, said the FDA issued a second complete response letter regarding a supplemental new drug application for Xarelto (rivaroxaban) for the reduction of the risk of cardiovascular events in patients with acute coronary syndrome

Janssen Research & Development LLC, of Titusville, N.J., a unit of Johnson & Johnson, said its San Diego-based Janssen Labs added a Concept Lab, a shared laboratory to offer entrepreneurs access to bench spaces for early stage research, and an Open Collaboration Space, an open-plan office setting designed to provide companies and individuals with desk space

Janssen-Cilag International NV, of Beerse, Belgium, a unit of Johnson & Johnson, said the European Commission approved an extension for once-daily Zytiga (abiraterone acetate), expanding the indication to include its use, in combination with prednisone or prednisolone, for the treatment of metastatic castration-resistant prostate cancer in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated

Janssen Research & Development LLC, of Raritan, N.J., a unit of Johnson & Johnson, submitted a new drug application (NDA) to the FDA for a fixed-dose therapy combining canagliflozin and immediate-release metformin in Type II diabetes

Janssen Pharmaceutical Cos., of Raritan, N.J., a unit of Johnson & Johnson, said it does not intend to enforce the patents it owns and controls on the antiretroviral drug darunavir, provided the darunavir product is medically acceptable and is used only in resource-limited settings

Janssen Research & Development LLC, of Raritan, N.J., a unit of Johnson & Johnson, said it established a global cross-pharmaceutical investigator databank designed to improve efficiencies of industry-sponsored clinical trials

Mylan Inc., of Pittsburgh, and Famy Care Ltd., of Mumbai, India, agreed to a settlement with Janssen Pharmaceuticals Inc., a unit of Johnson & Johnson, of New Brunswick, N.J., resolving patent litigation related to norgestimate/ethinyl estradiol tablets 0

Janssen Pharmaceuticals Inc. (unit of Johnson & Johnson, of New Brunswick, N.J.) said the FDA has approved Xarelto (rivaroxaban), an oral anticoagulant, for the treatment of deep vein thrombosis (DVT) and/or pulmonary embolism (PE), and to reduce the risk of recurrence of DVT and PE following initial treatment

Janssen-Cilag International, of Beerse, Belgium, a unit of Johnson & Johnson, said the European Commission approved a 100-mg/mg oral suspension of Prezista (darunavir) and the use of the drug co-administered with low-dose ritonavir for the treatment of HIV-1 infection in antiretroviral therapy-experienced pediatric patients, ages 3 and older, weighing at least 15 kg

Under the terms, Janssen, a unit of Johnson & Johnson, gains exclusive rights to ASP015K in exchange for an undisclosed up-front payment, future milestone payments and royalties

Janssen-Cilag International NV, of Beerse, Belgium, a unit of Johnson & Johnson, said the European Commission granted approval for the subcutaneous administration of Velcade (bortezomib) in multiple myeloma

Janssen Biotech Inc., of Horsham, Pa., a unit of Johnson & Johnson, said it submitted a biologics license application requesting approval of an intravenous formulation of anti-tumor necrosis factor-alpha drug Simponi (golimumab) for the treatment of adults with moderately to severely active rheumatoid arthritis

Janssen Research & Development LLC, of Raritan, N.J, a unit of Johnson & Johnson, said it submitted a complete response to the FDA for the use of anticoagulant Xarelto (rivaroxaban) to reduce the risk of secondary cardiovascular events in patients with acute coronary syndrome (ACS), and also resubmitted its supplemental new drug application for Xarelto to reduce the risk of stent thrombosis in patients with ACS

Janssen Research & Development LLC, of Raritan, a unit of Johnson & Johnson, said the FDA granted priority review to its new drug application for bedaquiline (TMC207) to treat pulmonary multidrug-resistant tuberculosis in adults as part of combination therapy

Janssen-Cilag International NV, of Beerse, Belgium, a unit of Johnson & Johnson, submitted a marketing authorization application to the European Medicines Agency seeking conditional approval for the use of TMC207 (bedaquiline) as part of combination therapy for pulmonary, multidrug-resistant tuberculosis (MDR-TB

Janssen Biotech Inc., of Horsham, Pa., a unit of Johnson & Johnson, said it submitted a supplemental biologics license application to the FDA and a Type II Variation to the European Medicines Agency requesting approval of Simponi (golimumab) in adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy