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.
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).
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).
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.
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.
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.
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.
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.
The US Food and Drug Administration has made its first move to bring drug prices down under the new leadership of Commissioner Scott Gottlieb.
Following an accelerated assessment, the European Medicines Agency is recommending two new combination drugs to treat infections caused by the hepatitis C virus (HCV). Both therapies are direct-acting antivirals and effective against all genotypes of the virus.