Nathalie Moll, Director General of the European Federation of Pharmaceutical Industries and Associations (EFPIA) gives her take on the industry response to the pandemic; highlighting the benefits of focused effort and what can be achieved through unified collaboration.
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The European Medicines Agency (EMA)
The European Commission (EC) have approved UCB’s Bimzelx (bimekizumab) for the treatment of moderate to severe plaque psoriasis.
With new EU IDMP guidance now published, how can pharma firms reap the benefits of a digital product information management future? Here, Iperion’s Adnan Jamil explains.
Forxiga’s approval, based on unprecedented Phase III data, is the most significant advancement in chronic kidney disease (CKD) treatment in over 20 years.
The EMA's drug safety committee (PRAC) recommends updating risks of Janssen COVID-19 Vaccine, though the benefit-risk balance remains unchanged.
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.
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).
The FDA and other global regulators are co-operating to address inadequacies in clinical research that leave pregnant and breastfeeding women lacking data on which to base their medical decisions.
Based on new clinical results, the EMA is recommending Moderna’s Spikevax COVID-19 vaccine be approved for use in children aged 12 to 17 years.
The Pharmacovigilance Risk Assessment Committee (PRAC) provided safety warnings on COVID-19 vaccines, and found no evidence linking Zynteglo to blood cancer.
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.
Drugs recommended for approval by the European Medicines Agency’s human medicines committee included a gene therapy and two generics, among five others.
The new ATU programme may support more efficient use of healthcare spending but could it mean fewer patients receive early access to treatments? Here, experts from Charles River Associates discuss the new ATU programme reforms and how they could impact pharma.