Do you have any advice for pharma companies to ensure they are prepared? “The pharmaceutical industry has primary responsibility for the continuity of supply of medicines and ensuring they are compliant with regulatory requirements. Thus, EMA and EU authorities have been reminding industry of the need to plan and take any necessary regulatory steps to
Although there have been various warnings about the supply train issues that will happen if a so-called “hard Brexit” occurs, the UK and EU have been unable to refine terms on how drugs will move amongst countries. As a result the NHS is also having to scramble to figure out how to mitigate possible drug
Yvette Cleland comments on the latest Clinical Professionals Industry Analytics report, “What do we expect the impact of the EMA leaving the UK to be?” “The Dutch government’s successful bid to host the European Medicines Agency (EMA) has already faced its first hurdle, the temporary offices in which it was proposed to house some staff
Kite Pharma has submitted the first CAR-T cell therapy in Europe, with the aim of gaining permission to market its axicabtagene ciloleucel to treat patients with three subtypes of aggressive non-Hodgkin lymphoma (NHL). CAR-T is a new treatment approach that it is specifically manufactured for each individual patient, allowing for a more personalised and effective
Johnson & Johnson (J&J) has announced that they have received regulatory approvals on both sides of the Atlantic for Olysio and Invokana. The US regulatory body, the Food and Drug Administration (FDA), approved Olysio (simeprevir) on Friday to treat chronic hepatitis C virus infection. The drug was co-developed with Sweden’s Medivir.
GlaxoSmithKline (GSK) and Theravance’s inhaled lung drug, Relvar, has been approved by Europe’s regulatory body to treat both asthma and chronic obstructive pulmonary disease (COPD). Relvar is a combination of the inhaled corticosteroid fluticasone furoate and the long-acting beta2 agonist (LABA) vilanterol, and is delivered through the Ellipta inhaler. The drug has already been approved
Advisors to the European Medicines Agency (EMA) have voted in support of approving GlaxoSmithKline/ Theravance’s Relvar Ellipta for both asthma and chronic obstructive pulmonary disease (COPD). The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has delivered a response recommending marketing authorisation for Relvar Ellipta, a combination of the inhaled corticosteroid fluticasone
The European Union’s medicines advisory body has issued a public health warning regarding codine. Parents have been advised not to give codeine to children under 12. European Medicine Agency’s (EMA) recommendation may stir up an EU-wide legal review to regulate the painkiller’s use. How the drug is used was looked into by EMA’s risk assessment committee.
The European Medicines Agency’s (EMA) Committee for Orphan Medicinal Products (COMP) have confirmed that they will incorporate the views of patients, increase international cooperation and collaborate with health technology assessment (HTA) bodies, with the aim of gaining a better understanding for orphan drug designation. The European Union (EU) orphan medicinal product regulation was started 12
The European Medicines Agency (EMA) has granted GlaxoSmithKline’s (GSK) melanoma drug an accelerated review. The melanoma drug, a MEK inhibitor named trametinib, is requesting a European licence as both a monotherapy and in combination with their investigational BRAF inhibitor dabrafenib, for the medication of patients with unresectable or metastatic melanoma with a BRAF V600 mutation.