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Nasal spray could help prevent depression relapse
SPRAVATO® nasal spray helped treatment-resistant depression patients remain remission and relapse free in a Phase III trial.
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Janssen
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Early efficacy of arthritis therapy predicts long-term benefits
Tremfya® trial analysis showing early skin and enthesitis response for active psoriatic arthritis could indicate long-term clinical response including disease remission.
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Full data set for new buffer stock blending system freely available
NIIMBL and BioPhorum reveal open-access design models for a new buffer stock blending system that could help reduce bottlenecks in biomanufacturing plants.
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New initiative will calculate carbon footprint of clinical trials
The new methodology will assess the carbon impact of clinical trials and recommend ways to reduce it.
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FDA approves Carvykti for patients with multiple myeloma
US FDA approval based on 98 percent response rate in multiple myeloma patients treated once with Carvykti (ciltacabtagene autoleucel, cilta-cel).
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Pistoia Alliance launches Women in STEM leadership pilot
A new collaborative initiative involving 15 large pharma companies will support diversity in executive roles and cross-company leadership skills development.
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Cilta-cel achieves progression-free survival in multiple myeloma patients
In the Phase Ib/II trial, cilta-cel achieved minimal residual disease negativity in 92 percent of patients and improved survival.
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Six COVID-19 boosters are safe and effective, shows Phase II study
Study finds six different COVID-19 vaccine boosters increase immunity and pose no safety concerns, although immune responses varied.
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Oral milvexian reduces risk of postoperative venous thromboembolism
Milvexian showed a 12 percent rate of postoperative venous thromboembolism compared to the benchmark rate of 30 percent in a Phase II study.
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NICE approves first long-acting injectable HIV-1 treatment
NICE has published draft guidance recommending cabotegravir, the first long-acting injectable treatment for HIV-1 infection in adults.
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Crohn’s patients achieve 65 percent clinical remission with Tremfya®
At week 48 of the Phase II trial, 65 percent of patients with Crohn's disease receiving Tremfya® achieved clinical remission.
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Developing drug pipelines
Kris Sterkens, Company Group Chairman of Janssen EMEA and Managing Director of Janssen Pharmaceutica considers how alterations made to COVID-19 vaccine development procedures could benefit future drug development pipelines.
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FDA joins Bespoke Gene Therapy Consortium (BGTC) for rare diseases
The consortium also consists of 10 pharmaceutical companies and five organisations to accelerate gene therapies to treat rare diseases.
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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, August 2021
The EMA's drug safety committee (PRAC) recommends updating risks of Janssen COVID-19 Vaccine, though the benefit-risk balance remains unchanged.
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Has the threat of waiving COVID-19 vaccine intellectual property rights had its desired effect?
In this final article on the TRIPS waiver for COVID-19 vaccines, medicines, diagnostics and technologies, EPR’s Hannah Balfour considers whether it is the correct strategy to overcome COVID-19 treatment inequalities and explores other options.
