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The monoclonal antibody Actemra (tocilizumab) was approved for emergency use in hospitalised paediatric and adult COVID-19 patients based on results from four clinical trials.
In this article, Aman Khera, the Global Head of Regulatory Strategy for Worldwide Clinical Trials, makes a case for regulatory involvement in drug development from start to finish and explains how the role of the regulator is changing, as well as what this means for pharma.
In this virtual roundtable, Scott Bradley (Principal Research Scientist, Eli Lilly and Company), Joan Malmstrøm (Principal Scientist, Novo Nordisk) and Kelly Sackett (Principal Scientist, Pfizer) exemplified how high-resolution nuclear magnetic resonance (NMR) is a key technology that provides critical information about protein structure and dynamics. Here, the participants offer some…
In this article, EPR’s Hannah Balfour explores the current usage of monoclonal antibody therapies for COVID-19, with commentary from Professor Adrian Streinu-Cercel of the Carol Davila University of Medicine and Pharmacy.
Psychedelic drugs are gaining popularity in the pharmaceutical R&D sector because of their apparent benefits for people suffering with neuropsychiatric disorders - and those which are resistant to existing therapies in particular. In this article, Imperial College London’s Professor David Nutt discusses the evidence underlying the development of psychedelic therapies…
Pharmacovigilance obligations present significant challenges for biotechs. Small companies face the same rigor as large pharma - and it does not help that there is divergence between the requirements of the FDA, the EU and its member states. Here, seasoned pharmacovigilance experts and non-executive advisors to Arriello, Eric Caugant in…
EU recommends that batches of Janssen COVID-19 Vaccine not be released for use due to a cross contamination report, while the FDA authorises use of drug substance from the facility where the contamination occurred.
Monoclonal antibody therapies found to reduce progression to severe disease, risk of hospitalisation and death in transplant recipients with mild to moderate COVID-19.
Aduhelm™ (aducanumab-avwa) is the first new treatment approved for Alzheimer’s since 2003 and the first therapy to target the fundamental pathophysiology of the disease – amyloid plaques.
Here EPR summarises the latest news from Moderna on the licensure, supply and distribution of its mRNA COVID-19 vaccine.
Data from the Phase III JUNIPERA trial shows more patients with juvenile idiopathic arthritis achieved and maintained improvements in joint symptoms with Cosentyx® (secukinumab).
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.
In a Phase III trial sugemalimab meaningfully improved progression free survival in patients with stage III non-small cell lung cancer (NSCLC).
New Phase II/III study data shows Moderna’s COVID-19 vaccine is safe and immunogenic in patients aged 12 to less than 18 years old.
The European Commission has approved once daily oral Ponvory (ponesimod) for the treatment of relapsing multiple sclerosis in adult patients.
