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.
The Food and Drug Administration has approved a new device for closing small holes in the heart called patent foramen ovales (PFO), which in some patients can be a cause of recurrent strokes. The non-surgical device can be inserted through a catheter in a vein in the leg.
A new medicine that is expected to protect against a rare liver disease known as primary biliary cholangitis, has been recommended for approval in the European Union following a Phase 3 study in which the treatment showed a clear benefit over placebo.
The European Medicines Agency has appealed against a court order preventing it from releasing documents relating to two marketed medicines, arguing that the disclosures are consistent with its policy on transparency.
The Food and Drug Administration has approved a new device for people with Type 1 diabetes – the first to automatically monitor blood glucose levels and release insulin at the appropriate dose. The so-called ‘artificial pancreas’ is intended to adjust insulin levels in the blood with little or no input from the user.