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Tislelizumab reduces risk of death by 30 percent in oesophageal cancer trial
In a Phase III trial, Novartis’ investigational checkpoint inhibitor tislelizumab improved overall survival in patients with oesophageal squamous cell carcinoma.
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Drug Safety
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Lynparza® improves invasive disease-free survival in high-risk early breast cancer trial
In the Phase III OlympiA trial, Lynparza® (olaparib) reduced the risk of cancer recurrences or death by 42 percent in patients with BRCA-mutated high-risk early breast cancer.
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Putting safety at the heart of clinical research outsourcing strategy
Pharma companies outsourcing clinical research support without focusing on safety are paying the price. Here, Natalia Vlcek, Pharmacovigilance Manager and EU QPPV at Arriello Group, offers some practical tips for ensuring best practice when it comes to safety in clinical research outsourcing.
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US begins testing mixed COVID-19 vaccine regimens
A Phase I/II trial will enrol 150 individuals already vaccinated against COVID-19 with one vaccine and assess the safety and immunogenicity of a booster dose of a different COVID-19 vaccine.
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Risankizumab induces deep remissions in Crohn’s disease trial
Phase III trial data shows more than half of patients with moderate to severe Crohn's disease treated with risankizumab (Skyrizi®) 360mg achieved clinical remission in a year.
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Cosentyx® reduces risk of juvenile idiopathic arthritis flares by 72 percent
Data from the Phase III JUNIPERA trial shows more patients with juvenile idiopathic arthritis achieved and maintained improvements in joint symptoms with Cosentyx® (secukinumab).
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First-in-human universal flu vaccine trial begins
The US National Institutes of Health have begun a first-in-human trial to assess the safety and immunogenicity of a potential universal influenza vaccine candidate, FluMos-v1.
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Cilta-cel induces deep and durable responses in relapsed or refractory multiple myeloma trial
New trial data shows 98 percent of heavily pre-treated relapsed/refractory multiple myeloma patients responded to Janssen’s ciltacabtagene autoleucel (cilta-cel).
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WHO lists the Sinovac-CoronaVac COVID-19 vaccine emergency use
The WHO Emergency Use Listing means Sinovac’s COVID-19 vaccine is now eligible for distribution under COVAX.
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EMA recommends first COVID-19 vaccine for children aged 12 to 15
The EMA is recommending that the Comirnaty® COVID-19 vaccine’s indication be extended to include children aged 12 to 15 years.
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First patient treated with potentially curative HIV cell and gene therapy
The first-in-human study will evaluate the safety and efficacy AGT103-T, a cell and gene therapy product for HIV, in up to six participants.
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Vaccine slows loss of insulin production in type 1 diabetes genetic subgroup
In a Phase II trial, injecting GAD-alum into the lymph nodes of newly diagnosed type 1 diabetes patients with a genetic variant slowed insulin production degradation.
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FDA approves sotrovimab for emergency use in treating COVID-19
The FDA granted emergency use authorisation to the monoclonal antibody sotrovimab as a treatment for mild-to-moderate COVID-19 in certain adult and paediatric patients.
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Researchers may know the cause of COVID-19 vaccine related blood clots
Investigators at the Goethe University of Frankfurt believe that post-transcriptional modifications may be causing the clotting problems associated with recombinant vector COVID-19 vaccines.
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Could medicinal cannabis be the answer to the opioid crisis?
New data from the UK shows 86 percent of pain patients found medicinal cannabis more effective than any other medication, including opioids.
