Regulation & Policy

Common rules for HTA

A decades’ long discussion in the EU about how to establish common rules for assessing the value of new medicines has come to a conclusion with a proposal from the European Commission on 31 January to regulate health technology assessment (HTA).

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Location

Belgium

Positive opinion for haemophilia drug

The European Medicines Agency is recommending approval of a new medicine for haemophilia A developed by Roche that is intended to prevent bleeding or reduce the frequency of bleeding episodes in patients who have developed resistance to existing medicines.

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Location

Switzerland

Lynparza approved for breast cancer

A cancer drug that was dropped from development in 2011 but put back into clinical testing two years later with a different group of patients, has received approval for a third indication from the US Food and Drug Administration. The newest approval is to treat patients with certain types of breast cancer whose tumours have a BRCA gene mutation.

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Location

United States

FDA approves new gene therapy

The first gene therapy for patients with an inherited retinal disease was authorised by the US Food and Drug Administration on 19 December, bringing the number of approved gene therapies in the US up to three. Luxturna (voretigene neparvovec-rzyl), was developed by Spark Therapeutics Inc.

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Location

United States

Positive opinion for stem cell therapy

The European Medicines Agency has issued a positive opinion for an allogeneic stem cell therapy to treat complex perianal fistulas in patients with Crohn’s disease. The product, Alofisel (darvadstrocel), was developed by TiGenix NV of Belgium.

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Location

Belgium

Reimbursement of €149,000 for Zalmoxis

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.

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Location

Italy

FDA approves first follow-on diabetes drug

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.

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Location

United States

Amsterdam to be new home for EMA

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.

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Location

Belgium

New FDA guidance for cells, tissues

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.

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Location

United States

New drug for CMV after transplants

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.

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Location

United Kingdom

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