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Merck’s Keytruda®: update on trials and outcomes
EPR’s Anna Begley summarises some of the key results from trials of Merck’s Keytruda® (pembrolizumab) cancer treatment.
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Drug Safety
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WHO recommends groundbreaking malaria vaccine for children
The World Health Organization (WHO) recommends GSK's RTS,S/AS01 (RTS,S) malaria vaccine for use in children in sub-Saharan Africa.
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EMA approve Comirnaty®and Spikevax booster doses
The EMA concludes that booster doses of the COVID-19 vaccines Comirnaty and Spikevax can be given to people with severely weakened immune systems.
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New FDA draft guidance on microbiological quality of NSDs
The draft guidance discusses product development considerations, risk assessments and cGMPs relevant to microbiological control in non-sterile drug (NSD) manufacturing.
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Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights, September 2021
The EMA’s drug safety committee (PRAC) assessed risks of thrombocytopenia and venous thromboembolism with the Janssen COVID-19 Vaccine.
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Amlitelimab shows 80 percent improvement in atopic dermatitis
Late-breaking data highlights the emerging clinical profile of amlitelimab in adults with inadequately controlled atopic dermatitis.
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Janssen’s RSV vaccine provides 80 percent protection in Phase II study
The investigational respiratory syncytial virus (RSV) vaccine candidate demonstrated 80 percent efficacy in adults aged 65 and older.
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Enhertu HER2-directed cancer treatment: key trials and results
EPR's Anna Begley reviews some of the latest results for AstraZeneca’s Enhertu (trastuzumab deruxtecan) HER2-directed cancer therapy.
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First patient dosed with BioNTech’s mRNA-based immunotherapy
BioNTech expands clinical oncology portfolio with first patient dosed in Phase II trial of mRNA-based vaccine for colorectal cancer.
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Ganaplacide/lumefantrine combination a potential new malaria treatment
In a study conducted in children under 12 years old, the ganaplacide/lumefantrine combination significantly reduced malaria infection.
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Ronapreve™ reduces COVID-19 viral load within seven days
Phase II/III trial shows Ronapreve significantly reduced viral load in seronegative patients hospitalised with COVID-19, complimenting previous findings.
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Bimekizumab achieves sustained levels of skin clearance over two years
Interim results from the BE BRIGHT study shows that bimekizumab is effective and safe for the treatment of moderate to severe psoriasis.
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Three-year Dovato study shows non-inferiority to TAF-based regimens
Dovato demonstrated non-inferior efficacy compared to TAF-based regimens in virologically suppressed adults with HIV-1 in Phase III study.
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Promising Phase II results for Lyme disease vaccine candidate
Valneva and Pfizer’s Lyme disease vaccine VLA15 displayed a seroconversion rate of 100 percent for all OspA serotypes in Phase II study.
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Sanofi’s first mRNA vaccine shows neutralising antibody seroconversion
Sanofi’s first mRNA COVID-19 vaccine displayed neutralising antibody seroconversion in 91 to 100 percent of participants in a Phase I/II study.
