Janssen

Katie Abouzahr is the Vice President and leads the Autoantibody Portfolio Development Team at the Janssen Pharmaceutical Companies of Johnson & Johnson. She speaks with Megan Thomas about the future for Janssen’s investigational medicine nipocalimab and antibody therapeutics at large. A day in the life On a day-to-day basis, Katie Abouzahr is accountable for and […]

The National Institute for Health and Care Excellence (NICE) has recommended Darzalex (daratumumab) in combination with lenalidomide and dexamethasone (DLd) for untreated multiple myeloma (MM) for routine use on the NHS in England and Wales. The therapy is now recommended within an NHS setting for the treatment of adults with newly diagnosed MM where an […]

The Janssen Pharmaceutical Companies of Johnson & Johnson has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of erdafitinib for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible fibroblast growth factor receptor 3 (FGFR3) genetic alterations, with disease progression during or […]

AI drug discovery company Intelligent OMICS and Janssen Research & Development have agreed a target discovery collaboration to evaluate novel biological targets for the treatment of haematological cancers. The collaboration will combine Intelligent OMICS’ AI platform, which uses multi-omics data and deep learning algorithms to uncover therapeutic opportunities for treatment, with Janssen’s expertise in data […]

The European Commission (EC) has granted conditional marketing authorisation (CMA) for Janssen’s Talvey (talquetamab) as monotherapy for relapsed and refractory multiple myeloma (RRMM). It is approved in adult patients who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated disease progression on the […]

Janssen’s Akeega (niraparib and abiraterone acetate) is now available in the US for adult patients with deleterious or suspected deleterious BRCA-positive metastatic castration-resistant prostate cancer (mCRPC) following FDA approval. It is the first dual action tablet combining a PARP inhibitor with abiraterone acetate, given with prednisone, to be approved in this indication. “As a physician, […]

The FDA has granted accelerated approval to Janssen’s talquetamab-tgvs (Talvey) for adults with relapsed or refractory multiple myeloma. It has been approved in patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Talquetamab is a bispecific T cell engaging antibody that […]

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended conditional marketing authorisation for Janssen’s Talvey (talquetamab). The drug has received a positive opinion for use as a monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM) who have received at least three […]

Janssen has announced positive results from the proof-of-concept Phase II UNITY trial for the treatment of pregnant individuals at high risk of early-onset severe (EOS) haemolytic disease of the foetus and newborn (HDFN). A statistically significant (54%) proportion of participants who received nipocalimab achieved the primary endpoint of a live birth at or after gestational […]

Janssen has submitted a marketing authorisation application to the European Medicines Agency (EMA) seeking approval of single tablet combination therapy (STCT) of macitentan and tadalafil for pulmonary arterial hypertension (PAH). The single tablet combination therapy of macitentan 10mg and tadalafil 40mg (M/T STCT) is intended for the long-term treatment of pulmonary arterial hypertension (PAH, World […]

Janssen has presented new data from across its oncology pipeline at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago. Talquetamab Talquetamab is an investigational GPRC5D-directed bispecific antibody currently in clinical development. Updated results from the Phase II MonumenTAL-1 study show that with a median of 13-19 months of follow-up, talquetamab continues to […]

The Janssen Pharmaceutical Companies of Johnson & Johnson have submitted a Type II variation application to the European Medicines Agency (EMA) seeking approval of Carvykti (ciltacabtagene autoleucel; cilta-cel) for relapsed and lenalidomide-refractory multiple myeloma. The application is supported by data from the Phase III CARTITUDE-4 study, which evaluated the safety profile and efficacy of cilta-cel […]

The European Commission (EC) has granted marketing authorisation for Akeega (niraparib and abiraterone acetate [AA]) for adults with metastatic castration-resistant prostate cancer (mCRPC) and BRCA1/2 mutations (germline and/or somatic). The drug is given in the form of a dual action tablet (DAT), with prednisone or prednisolone, and is approved in patients for whom chemotherapy is […]

New data has revealed a long-term response in patients with advanced non-small cell lung cancer (NSCLC) taking Rybrevant (amivantamab). The CHRYSALIS study is evaluating amivantamab in patients with advanced non-small cell lung cancer (NSCLC) and epidermal growth factor receptor (EGFR) exon 20 insertion mutations whose disease progressed on prior platinum-based chemotherapy. Data from the study […]

Janssen has revealed updated results from the Phase III MAGNITUDE study, which show that a combination therapy including niraparib, a poly (ADP-ribose) polymerase (PARP) inhibitor, slowed prostate cancer progression.  The drug was investigated in combination with abiraterone acetate plus prednisone (AAP) in patients with metastatic castration-resistant prostate cancer (mCRPC) with or without specific homologous recombination […]

An investigational HIV vaccine regimen was safe but did not provide protection against HIV, an independent data and safety monitoring board (DSMB) has determined.  The regimen was tested among men who have sex with men (MSM) and transgender people. The HPX3002/HVTN 706, or ‘Mosaico’, Phase III clinical trial began in 2019 and involved 3,900 volunteers […]