Novel chemotherapeutic pro-drug approved for FIH trial in the UK
If the proof-of concept trial of AVA6000 Pro-doxorubicin is successful, it could lead to a pipeline of pro-drug chemotherapies with limited toxicity, say the drug's developers.
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Pfizer-BioNTech COVID-19 vaccinee sera less able to neutralise South African variant
While the sera were able to neutralise SARS-CoV-2 viruses expressing the B.1.351-spike mutations in vitro, the neutralisation was almost two thirds weaker than for an early strain.
First patient dosed with therapeutic prostate cancer vaccine
The trial will evaluate the safety, tolerability and immunogenicity of Ultimovacs’ prostate cancer-specific therapeutic TET-based vaccine.
EMA receives conditional marketing authorisation application for Janssen’s COVID-19 vaccine
The European Medicines Agency will now review additional data on the efficacy, safety and quality of the COVID-19 Vaccine Janssen, deciding whether to approve the vaccine for use in the EU.
Lynparza crosses superiority boundary for invasive disease-free survival at interim analysis
The OlympiA trial will conduct its primary analysis early, after the Independent Data Monitoring Committee found it met its primary endpoint in BRCA mutated early breast cancer patients.
AstraZeneca’s COVID-19 vaccines listed for emergency use by WHO
The Emergency Use Listing will allow doses of the COVID-19 vaccines to be distributed through COVAX, the WHO’s vaccine allocation facility.
250mn Europeans to be vaccinated with COMIRNATY® by the end of 2021
Pfizer and BioNTech have agreed to supply the European Union with 200 million additional doses of COMIRNATY in 2021, making the total 500 million doses.
Chemspec Europe 2021 postponed
The 35th International Exhibition for Fine and Speciality Chemicals will now take place as live and digital hybrid event from 29 to 30 September 2021.
UK conditionally approves new treatment for HER2 positive breast cancer
The UK has conditionally approved Enhertu® (trastuzumab deruxtecan) as a monotherapy for the treatment of unresectable or metastatic HER2 positive breast cancer based on Phase II trial results.
EMA initiates rolling review of CureVac’s CVnCoV COVID-19 vaccine
The rolling review will assess CVnCoV’s efficacy and immunogenicity data as it becomes available, speeding the decision process for an eventual marketing authorisation application.
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Fresenius Kabi Oncology Ltd to pay $50mn for destroying records ahead of an FDA Inspection
The Indian drug company pleaded guilty to concealing and destroying records containing evidence of its Kalyani plant manufacturing drugs in contravention to FDA requirements prior to a 2013 inspection.
EC approves first high concentration, low-volume adalimumab biosimilar
YuflymaTM (CT-P17) has been approved for the treatment of thirteen chronic inflammatory diseases, including rheumatoid arthritis, ulcerative colitis and psoriatic arthritis, in Europe.
Two new developments in kidney cancer treatments
Studies suggest there are better treatment options than sunitinib for kidney cancers; cabozantinib in metastatic papillary kidney cancer and lenvatinib/pembrolizumab for renal cell carcinoma.
February Pharmacovigilance Risk Assessment Committee (PRAC) meeting highlights
The EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) began two new reviews and wrote guidance for healthcare professionals on the potential side effects of Strimvelis, Venclyxto and Zolgensma.
Novel ionic liquid enables uniform chemotherapy delivery in solid tumours
Co-injecting doxorubicin with LATTE, a novel ionic liquid formulation, resulted in uniform chemotherapy delivery and successful ablation in solid tumours.
