Promising Phase II data mean it could be third time lucky for Roche in disease with no approved treatments.
The potential for Roche’s Gazyva (obinutuzumab) to become the first ever approved treatment for lupus nephritis has received a boost with a breakthrough therapy designation from the US Food and Drug Administration.
The company confirmed the designation on 18 September, indicating the FDA’s support based on compelling data from Roche’s Phase II NOBILITY trial, unveiled in June
Company surprises investors with Jørgensen's exit but insists its strategy will not change.
The US regulator’s decision has taken Biohaven and investors by surprise, with the reason for a ‘major amendment’ status not clear.
Recent moves in the industry include changes at the top at Akamis Bio, Innospera Pharma & Ispen, plus Astellas Korea appoints an ex-Novartis Korea executive.
