Regulation & Policy

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

ODAC recommends CAR-T cell therapy

An advisory committee to the US Food and Drug Administration has unanimously recommended that the agency approve the first engineered T cell therapy for cancer CTL019. The vote is not binding on the FDA, but the agency usually follows the recommendations of its advisory committees.

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Location

United States

New treatment for sickle cell disease approved in US

The first new drug for sickle cell disease in nearly 20 years has been approved by the US Food and Drug Administration. The treatment, Endari (L-glutamine oral powder), lowers oxidant damage to red blood cells thereby reducing complications of the disease.

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Location

United States

FDA offers plan to raise generic competition

The US Food and Drug Administration has made its first move to bring drug prices down under the new leadership of Commissioner Scott Gottlieb.

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Location

United States

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