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EFPIA calls for harmonisation of GMO procedures in investigational drugs
The European Federation of Pharmaceutical Industries will implement a new regulation to co-ordinate genetically modified organism procedures.
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Therapeutics
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Lumakras™ displays positive results in Phase Ib cancer study
Lumakras™ (sotorasib) demonstrated effective response rates against non-small cell lung cancer and colorectal cancer in Phase Ib trial.
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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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Opaganib reduces COVID-19 mortality by 62 percent in Phase II/III study
Opaganib is the first oral pill-based therapy to significantly reduce mortality outcomes in hospitalised COVID-19 patients.
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New FDA draft guidance on microbiological quality of NSDs
The draft guidance discusses product development considerations, risk assessments and cGMPs relevant to microbiological control in non-sterile drug (NSD) manufacturing.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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NICE recommends first sickle cell disease treatment in 20 years
Crizanlizumab recommended as a treatment option for preventing recurrent sickle cell crises for people aged 16 and over in the UK.
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New EFPIA network created to combat cardiovascular diseases
The European Federation of Pharmaceutical Industries and Associations (EFPIA) has initiated the CVD Network to improve policies for patients.
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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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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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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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Radionuclide therapy a promising option to treat HER2 breast cancer
The radionuclide treatment combines radioactive iodine therapy with single-domain antibodies to target the HER2 antigen.
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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.
