Johnson & Johnson has announced positive topline results from a Phase III study evaluating Caplyta (lumateperone) for the treatment of manic episodes with or without mixed features in adults with bipolar I disorder. The study met its primary endpoint, with Caplyta demonstrating a statistically significant and rapid… Read More
Johnson & Johnson has announced final overall survival (OS) results from the Phase III PAPILLON study of first-line intravenous (IV) Rybrevant (amivantamab). The fully-human EGFR-MET bispecific antibody was assessed with carboplatin-pemetrexed chemotherapy, versus chemotherapy alone, in patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth… Read More
The European Commission (EC) has approved Johnson & Johnson’s Tecvayli (teclistamab) plus daratumumab for relapsed/refractory multiple myeloma, offering a potential new standard of care. The indication extension in combination with daratumumab is approved for the treatment of adults with relapsed or refractory multiple myeloma (RRMM) who have… Read More
The Medicines and Healthcare products Regulatory Agency (MHRA) has granted marketing authorisation to a treatment for metastatic hormone-sensitive prostate cancer (mHSPC). Akeega (niraparib and abiraterone acetate), developed by Johnson & Johnson, has been granted the authorisation as part of a combination regimen with prednisone or prednisolone and andogren deprivation therapy (ADT). … Read More
A new treatment for systemic lupus erythematosus (SLE) could significantly reduce disease activity, results show. Johnson & Johnson, which developed nipocalimab, says it is the first neonatal Fc receptor (FcRn) blocker to be studied in systemic lupus erythematosus. The blocker is designed to target and reduce pathogenic immunoglobulin… Read More
The European Commission has approved an indication extension for Akeega (niraparib and abiraterone acetate dual action tablet) with prednisone or prednisolone (AAP) in combination with androgen deprivation therapy (ADT). The regimen is now also approved for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) and… Read More
Johnson & Johnson’s Akeega (niraparib and abiraterone acetate dual action tablet) could soon be available to EU patients with metastatic hormone-sensitive prostate cancer with BRCA1/2 mutations, following a positive opinion from the Committee for Medicinal Products for Human Use (CHMP). The recommendation is for niraparib and abiraterone… Read More
Johnson & Johnson will acquire Halda Therapeutics for $3.05 billion, payable in cash at closing, subject to customary adjustments. Halda’s portfolio includes HLD-0915, a first-in-class, oral Regulated Induced Proximity Targeting Chimeras (RIPTAC) therapeutic, in development for metastatic castration-resistant prostate cancer (mCRPC). HLD-0915 is an innovative… Read More
Johnson & Johnson has revealed plans to increase its presence in North Carolina with a dedicated manufacturing facility at FUJIFILM’s new biopharmaceutical manufacturing site in Holly Springs, North Carolina. The $2 billion commitment to FUJIFILM over the next 10 years will expand the company’s US manufacturing capacity… Read More
The European Commission (EC) has approved Tremfya (guselkumab), the first dual-acting IL-23 inhibitor offering both subcutaneous (SC) and intravenous (IV) induction options, for adult patients with moderately to severely active Crohn’s disease. The approval is based on data which showed that guselkumab induction therapy administered either intravenously… Read More
The European Commission (EC) has approved a marketing authorisation (MA) for Johnson & Johnson’s Tremfya (guselkumab) for the treatment of adult patients with moderately to severely active ulcerative colitis (UC). It is approved in patients who had an inadequate response, lost response, or were intolerant to either… Read More
The European Commission (EC) has approved an indication extension for two of Johnson & Johnson’s monoclonal antibody therapies in oncology. The approval of Darzalex (daratumumab) has been extended to include a subcutaneous (SC) formulation in the frontline setting in combination with bortezomib, lenalidomide, and dexamethasone (daratumumab-VRd) for… Read More
Results from its first-line MARIPOSA trial show that Rybrevant (amivantamab) plus Lazcluze (lazertinib) significantly extended overall survival (OS) versus osimertinib in the first-line treatment of patients with locally advanced or metastatic non-small cell lung cancer (NSCLC). The patients have NSCLC with epidermal growth factor receptor (EGFR)… Read More
The European Commission (EC) has approved a Marketing Authorisation (MA) for Lazcluze (lazertinib), in combination with Rybrevant (amivantamab). It is approved for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions (ex19del) or exon… Read More
The US Food and Drug Administration (FDA) has granted Fast Track designation to posdinemab, a phosphorylated tau-directed monoclonal antibody (mAb). The therapy from Johnson & Johnson is being investigated to treat patients with early Alzheimer’s disease (AD) in the Phase IIb AuTonomy study. It has… Read More
The European Commission (EC) has extended the approval for Rybrevant (amivantamab), in combination with Lazcluze (lazertinib), to the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC). It is specifically approved for use in patients with epidermal growth factor receptor (EGFR) exon 19 deletions… Read More
