Regulation & Policy

EMA recommends two new cancer drugs

The European Medicines Agency has recommended two new cancer drugs for approval in Europe, each with an entirely different mechanisms of action. The first is a PARP inhibitor for ovarian cancer and the second, a photodynamic therapy for prostate cancer.

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Location

United Kingdom

Novo to pay $58.65 million to settle probe

Novo Nordisk A/S has reached an agreement with the US government and several states to pay $58.65 million to settle claims of mis-communication over the risks of Victoza, its glucagon-like peptide-1 (GLP-1) drug for Type 2 diabetes. The settlement was announced on 5 September.

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Location

Denmark

FDA approves Novartis CAR T therapy

The US Food and Drug Administration has given its approval to Novartis’ gene therapy for the treatment of paediatric and young adult acute lymphoblastic leukaemia (ALL), Kymriah (tisagenlecleucel). It is the first decision of its kind for a technology that has achieved remissions for a significant number of very ill patients.

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Location

United States

FDA’s Gottlieb announces policy on stem cells

The US Food and Drug Administration has taken steps to curb the activities of unlicensed stem cell clinics while preparing for the roll-out in the autumn of a new regulatory framework for developers of cell and tissue-engineered products.

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Location

United States

European Commission to probe Bayer-Monsanto merger

Bayer AG’s proposed $66 billion acquisition of Monsanto Co has hit a roadblock following a decision by the European Commission to investigate whether the new group could reduce competition for pesticides, seeds and genetically-engineered plant traits.

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Location

Belgium

FDA approves targeted drug for ALL

The US Food and Drug Administration has approved Besponsa (inotuzumab ozogamicin), an antibody-drug conjugate, to treat adults with relapsed or refractory B-cell precursor acute lymphoblastic leukaemia (ALL).

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Location

United States

Imbruvica receives new indication for cGVHD

Imbruvica (ibrutinib), a Bruton’s tyrosine kinase (BTK) inhibitor developed by Pharmacyclics LLC, has received a further approval in the US – this time to treat adult patients with chronic graft versus host disease (cGVHD).

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Location

United States

FDA approves new Celgene drug for AML

The US Food and Drug Administration has approved Idhifa (enasidenib), a new targeted therapy from Celgene Corp for treating patients with relapsed or refractory acute myeloid leukaemia (AML). Also approved is a diagnostic that can detect a specific genetic mutation.

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Location

United States

FDA designation for Spark

A gene therapy developed by Spark Therapeutics Inc for an inherited retinal disease has received a paediatric designation from the US Food and Drug Administration. The decision is the agency’s way of highlighting the treatment’s potential for children and young adults.

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Location

United States

FDA approves new adjuvant for breast cancer

The US Food and Drug Administration has approved Nerlynx (neratinib), a new drug for lowering the risk of recurrent breast cancer in patients who have been treated with a regimen that includes trastuzumab, the targeted therapy for HER2-positive breast cancer.

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Location

United States

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