The European Commission yesterday announced a new initiative with the European pharmaceutical industry for proposals under the Innovative Medicines Initiative to boost European research into Ebola. The Innovative Medicines Initiative aims to improve healthcare by quickening the development of, and patient access to, innovative medicines, principally in areas where there is an unmet need for
European regulators have given approval to Boehringer Ingelheim and Eli Lilly’s diabetes combo drug, Jentadueto. The pharmaceutical organisations announced earlier today that they received marketing authorisation from the European Commission (EC) for Jentadueto, which combines metformin with the dipeptidyl peptidase (DPP)-IV inhibitor Trajenta (linagliptin) in a single pill. The approval was expected after the European
Cell Therapeutics has obtained conditional approval in Europe for their lymphoma drug, Pixuvri. The European Commission has given the okay for Pixuvri (pixantrone) as monotherapy for the treatment of adults with multiply relapsed or refractory aggressive non-Hodgkin B-cell lymphomas (NHL), making it the first authorised treatment in this patient setting in the continent. The decision
Novartis announced earlier today that the European Commission has approved an update to their Glivec (imatinib) label to include 36 months of treatment after surgery, for adults with KIT (CD117)-positive gastrointestinal stromal tumours (GIST) who met the inclusion conditions of the pivotal study. The prolonged treatment has been demonstrated to increase recurrence-free survival and the
AstraZeneca announced earlier today that the European Commission has granted marketing authorisation for their thyroid cancer pill, Caprelsa (vandetanib). The approval was given for the treatment of aggressive and symptomatic medullary thyroid cancer (MTC) in patients with unresectable locally advanced or metastatic disease. The announcement comes three months after the European Medicines Agency’s Committee for
The European Commission has dropped the charges against Servier, a French independent pharmaceutical company, which accused the French company of providing “misleading and incorrect information” as part of a high-profile review of the pharmaceuticals sector and practices to postpone the market entry of generic drugs. In July 2010, the European Commission sent a ‘statement of
Astellas and partner Optimer Pharmaceuticals announced yesterday that regulators in Europe have given the green light to their antibiotic Dificlir. The European Commission has approved Dificlir (fidaxomicin) for the treatment of Clostridium Difficile infections (CDI) in adults, which can cause severe diarrhoea. The approval is based on two Phase III trials which compared Dificlir with
AstraZeneca and Bristol-Myers Squibb are celebrating after European regulators approved two of their diabetes drugs. AstraZeneca and Bristol-Myers Squibb Company announced today that the European Commission has granted marketing authorisation for Komboglyze, which combines the DPP-4 inhibitor Onglyza (saxagliptin) with metformin in a once-a-day tablet. The combination is to be used as an adjunct to
The European Commission (EC) has approved a new Pfizer drug for the treatment of transthyretin familial amyloid polyneuropathy (TTR-FAP), a rare and fatal neurodegenerative disease affecting around 8,000 people worldwide. Vyndaqel (tafamidis; formerly Fx-1006A) becomes the first treatment approved anywhere in the world to treat the disease. The condition is characterised by deposits of amyloid
Amgen is the most recent drug maker to present data for a cholesterol drug that blocks the PCSK9 pathway. Phase I data presented at the American Heart Association meeting in Orlando showed that a single dose of Amgen’s AMG145, a monoclonal antibody, reduced levels of low density lipoprotein or ‘bad’ cholesterol by up to 64%
