Janssen

Trophy
#AACR #Award #Events #Janssen #Oncology

Janssen’s Hait honoured for achievements in cancer research

The 2025 AACR-Margaret Foti Award for Leadership and Extraordinary Achievements in Cancer Research will be presented to William Hait, Fellow of the AACR Academy, during the AACR Annual Meeting 2025.  Hait served as the Global Head of Janssen Research and Development and was the executive vice president,… Read More

#Cancer Research #News

Therapeutic antibodies
#Alzheimer's #Antibodies #Cancer #Covid-19 #Engineered antibodies #Immunology #Janssen #Monoclonal antibodies #Rare disease #Therapeutic Antibodies

Podcast: Where is the innovation in the therapeutic antibody market?

This is the latest episode of the free DDW narrated podcast, titled “Where is the innovation in the therapeutic antibody market?”, which covers two articles written for DDW Volume 24 – Issue 3, Summer 2023. They are called: “Finding the North Star of therapeutic antibodies” and “Which diseases… Read More

#News

X-ray showing colon cancer
#Colorectal cancer #Janssen #Monoclonal antibodies #Oncology #Phase II trial

Metastatic colon cancer: 49% response for combination therapy

Janssen-Cilag has shared new data from the Phase Ib/II OrigAMI-1 study at the European Society of Medical Oncology (ESMO) 2024 Congress. The results show that amivantamab combined with chemotherapy demonstrated promising antitumour activity in patients with RAS/BRAF wild-type (WT) metastatic colorectal cancer (mCRC) who have not… Read More

#Cancer Research #News #Trending News

Monoclonal antibody
#Autoimmune disease #Janssen #Monoclonal antibodies #Neurology #Phase III trial

Janssen reports positive data for myasthenia gravis treatment

Janssen-Cilag has reported positive results from its Phase III Vivacity-MG3 study assessing its nipocalimab therapy for the treatment of patients with generalised myasthenia gravis (gMG). The Johnson & Johnson company showcased the data in a presentation at the European Academy of Neurology (EAN) 2024 Congress and… Read More

#News

Bladder
#Bladder cancer #CHMP #Genetics / genomics #Janssen #Oncology

CHMP okays first therapy targeting FGFR3 alterations in bladder cancer

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Janssen-Cilag’s Balversa (erdafitinib). It is recommended as a monotherapy to treat adult patients with unresectable or metastatic urothelial carcinoma, harbouring susceptible FGFR3 genetic alterations who… Read More

#News #Regulatory

CAR-T therapy
#CAR-T #European Commission #Janssen #Myeloma #Oncology #Phase III trial

EC expands use of BCMA-targeted CAR-T therapy

The European Commission (EC) has approved a Type II variation for Carvykti (ciltacabtagene autoleucel; cilta-cel) for the treatment of adult patients with relapsed and refractory multiple myeloma (RRMM). It is approved in patients who have received at least one prior therapy, including an immunomodulatory agent (IMiD)… Read More

#News #Regulatory

Therapeutic antibodies
#Antibodies #Engineered antibodies #Immunology #Janssen #Monoclonal antibodies

Finding the North Star of therapeutic antibodies

Listen to this article on the DDW Podcast: Katie Abouzahr is the Vice President, Autoantibody Portfolio and Maternal Fetal Disease Area Leader 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… Read More

#Exclusive Content

Myeloma cells
#Cancer research #Janns #Janssen #Myeloma #National Institute for Health and Care Excellence (NICE) #Oncology

UK regulator gives green light to combination for multiple myeloma

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… Read More

#News #Regulatory

Bladder cancer
#Bladder cancer #EMA #Janssen #Marketing approval authorisation #Regulatory #Urothelial carcinoma

Janssen submits EMA filing for bladder cancer treatment 

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)… Read More

#Cancer Research #News

Blood cells
#Artificial intelligence (AI) #Collaboration #Haematology #Intelligent OMICS #Janssen #Multi-omics #Oncology

Intelligent OMICS and Janssen enter AI research collaboration

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… Read More

#Business & Investment #News

European Commission
#Bispecific Antibodies #EU #European Commission #Janssen #Myeloma #Oncology

“Important new approach” to myeloma now available in the EU

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… Read More

#News #Regulatory

Prostate cancer cells
#FDA #Gene mutation #Janssen #Oncology #Phase III trial #Prostate cancer

FDA approves dual action tablet for BRCA-positive prostate cancer

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,… Read More

#News #Regulatory

FDA
#Bispecific Antibodies #FDA #Janssen #Myeloma #Oncology

Janssen myeloma drug approved in US via a restricted programme

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. Read More

#News #Regulatory

Multiple myeloma
#Bispecific Antibodies #Cancer research #CHMP #EMA #Janssen #Myeloma #Oncology

CHMP recommendation for bispecific antibody talquetamab

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… Read More

#News #Regulatory

Pregnant woman in hospital
#Janssen #Phase II trial #Pregnancy #Trial data

Janssen reveals positive trial data for nipocalimab

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… Read More

#News

Pills
#EMA #Europe #Hypertension #Janssen #Phase III trial

Janssen seeks EMA approval for hypertension combination therapy

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… Read More

#News #Regulatory