The Italian reimbursement authority has reached an agreement with MolMed SpA under which it will reimburse the company’s cell therapy for patients who have received a stem cell transplant at €149,000 per infusion. Treatment can require up to four infusions.
The US Food and Drug Administration has approved a follow-on, or biosimilar, medicine for diabetes from Sanofi SA that is intended to improve the control of blood sugar in children and adults with both Type 1 and Type 2 forms of the disease.
Amsterdam is to be the new home for the European Medicines Agency following Britain’s decision to leave the European Union, and give up its right to host EU institutions at the end of March 2019. The decision was announced on 20 November by the EU General Affairs Council.
The US Food and Drug Administrations has issued four guidance documents explaining how it intends to regulate products derived from human cells and tissues. The guidance updates rules that first took effect in 2005 and includes new incentives for developers of potentially life-saving therapies.
The European Medicines Agency has recommended a new medicine that can prevent cytomegalovirus (CMV) reactivation and disease in patients who have received an allogeneic stem cell transplant. The medicine, Prevymis (letermovir), was developed by Merck & Co Inc.
A new monoclonal antibody treatment for multiple sclerosis (MS) has been recommended for approval by the European Medicines Agency following clinical studies that showed significant benefits for patients with both relapsing and primary progressive forms of the disease.
The US Food and Drug Administration has granted an accelerated approval to Calquence (acalabrutinib), a new kinase inhibitor for the treatment of adults with mantle cell lymphoma, a rare and fast-growing type of non-Hodgkin lymphoma.
An agreement on the full mutual recognition of pharmaceutical factory inspections was reached on 1 November when the US Food and Drug Administration and the European Commission confirmed that they can now accept one another’s standards.
The US Food and Drug Administration has approved a second gene therapy to treat cancer, giving a further boost to developers of the new technologies. The approval is for Yescarta (axicabtagene ciloleucel), a chimeric antigen receptor (CAR) T cell therapy to treat adults with certain types of large B-cell lymphoma.
Sales of antibiotic drugs for the treatment of animals has declined in Europe against a backdrop of appeals from public health authorities to curb their use in food-producing species. Overuse of these drugs is linked to a rise in bacterial resistance to existing medicines.