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.
Merck have suffered a hindrance this week with the withdrawal of their Marketing Authorization Application for ridaforolimus in Europe. The European Medicines Agency (EMA) was evaluating ridaforolimus as a possible maintenance treatment for patients with soft tissue sarcoma or primary malignant bone tumour. Merck have licensed the drug, an M-TOR inhibitor from Ariad Pharmaceuticals.
Boehringer Ingelheim announced earlier today that they have submitted their first oncology compound, afatinib, to European regulators. The German firm filed a marketing authorisation application to the European Medicines Agency (EMA) for the approval of afatinib as a treatment for patients with EGFR (ErbB1) mutation positive non-small cell lung cancer (NSCLC). Boehringer confirmed that afatinib