A proposed liberalisation of rules that govern financial transactions in the European Union is the subject of a public consultation that started on 20 January and will continue until 17 March. The consultation is being managed by the European Commission.
The Food and Drug Administration (FDA) has given its first approval to a drug for spinal muscular atrophy, a hereditary disease that causes weakness and muscle wasting. The drug, Spinraza (nusinersen), is an antisense oligonucleotide that binds to RNA in order to regulate gene expression.
A new JAK inhibitor for patients with rheumatoid arthritis (RA) has been recommended for approval by the European Medicines Agency. If authorised by the European Commission, it would be the first RA drug to be launched in Europe with this mechanism of action.
The UK is to allow a technique for preventing an inherited disorder known as mitochondrial disease in cases where other treatments are ineffective. The treatment, known as mitochondrial donation, was approved on 15 December.
The Food and Drug Administration (FDA) has approved Maci, an autologous tissue-engineered product for the repair of cartilage defects in the knee, the first product of its kind to be authorised for the US. Maci is manufactured by Vericel Corp, formerly Aastrom Biosciences Inc.
Five pharmaceutical companies have been cited by a unit of the ABPI, the UK pharmaceutical industry association, for violations of its code of practice. The companies are Grünenthal, Boehringer Ingelheim, Eli Lilly, AstraZeneca and Janssen.
Boehringer Ingelheim GmbH and Eli Lilly and Company have won a second indication for their jointly developed diabetes drug Jardiance (empagliflozin) which belongs to a new class of drugs known as sodium glucose transporter 2 (SGLT2) inhibitors.
Regulators in both the US and Europe are preparing for the first submissions of a new class of cancer drugs that have been shown to vanquish cancer in some patients b
Kite Pharma Inc plans to make a US regulatory submission for its lead chimeric antigen receptor (CAR) T cell therapy for patients with non-Hodgkin lymphoma starting at the end of December. Following talks with the Food and Drug Administration, the US company announced in early November that it will make a rolling regulatory submission.
France-based Nicox SA said it anticipates a regulatory review of its glaucoma drug latanoprostene bunod to take place soon, and if the result is positive, the treatment could be on the US market by mid-2017.