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Forxiga approved in EU for chronic kidney disease treatment
Forxiga’s approval, based on unprecedented Phase III data, is the most significant advancement in chronic kidney disease (CKD) treatment in over 20 years.
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Drug Safety
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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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Libtayo® with chemotherapy trial stopped early due to success
Phase III trial of Libtayo® (cemiplimab) combined with chemotherapy stops early due to significant improvement in overall survival in lung cancer patients.
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Remetinostat shows promise as a BCC treatment in Phase II study
Remetinostat, a first-in-class histone deacetylase inhibitor gel, displayed signs of clinical efficacy in patients with basal cell carcinoma.
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Ritlecitinib improves scalp hair regrowth in alopecia trial
Ritlecitinib was shown to reduce scalp hair loss to less than or equal to 20 percent after six months in Pfizer’s Phase IIb/III trial.
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Blood thinners reduce need for organ support in COVID-19 patients
Clinical trial shows that treating moderately ill COVID-19 patients with a full-dose blood thinner reduced their need for organ support.
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Biogen announces results from Phase IIIb NOVA study for MS
Results from the NOVA study show every six-week dosing with natalizumab is as effective as every four-week in relapsing-remitting MS.
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NaviFUS begins clinical trial for brain tumour treatment
NaviFUS® was approved by the Taiwan FDA for use in a new clinical trial for the treatment of terminal primary brain tumours.
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Baricitinib reduces mortality of hospitalised COVID patients by 46 percent
New data shows Lilly’s Olumiant (baricitinib) significantly reduces the risk of death in hospitalised COVID-19 patients receiving invasive mechanical ventilation or ECMO.
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Understanding limitations of microbial detection methods is key, says expert
Microbial detection methods are inherently flawed by three key factors, here we summarise Tim Sandle’s explanation of the concerns surrounding microbial methods and sampling.
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Saphnelo approved to treat systemic lupus erythematosus
AstraZeneca’s Saphnelo (anifrolumab-fnia) has been approved in the US for patients with moderate to severe systemic lupus erythematosus.
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NICE approves cost-comparison fast-track appraisal pilot
A new approach to the cost-comparison fast-track appraisal process is being piloted this summer for the review of low-risk appraisals.
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FDA approves emergency use of REGEN-COVTM for COVID-19 prevention
The FDA have authorised REGEN-COV monoclonal antibody therapy for emergency use as prevention for COVID-19 in certain patients.
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FDARA implementation guidance for paediatric studies of molecularly targeted oncology drugs
This article addresses early planning for paediatric evaluation of certain molecularly targeted oncology drugs, including biological products, for which original New Drug Application (NDAs) and Biological License Application (BLAs) are expected to be submitted to FDA, in accordance with The FDA Reauthorization Act (FDARA).
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LBPs may offer hope to IBS patients in the near future, says report
Live biotherapeutic products (LBPs) are expected to help patients with IBS who currently have no US- or EMA-approved treatments.
