The Belgian drug regulator has approved the start of a Phase 3 trial of an autologous cell therapy for patients with chronic heart failure – understood to be the first such trial ever. The therapy was developed by Cardio3 BioSciences SA and the US Mayo Clinic.
Medivir AB of Sweden expects to start a Phase 2 study early next year of a new combination treatment for hepatitis C, as part of its ongoing efforts to build a franchise around its protease inhibitor, simeprevir (TMC435).
Ablynx NV of Belgium and Algeta ASA of Norway have announced plans to investigate synergies between their technologies to find out whether there is scope to develop new therapies for cancer.
The US Food and Drug Administration has approved a new seasonal influenza vaccine from Novartis – the first vaccine of its kind to be produced using cultured animal cells instead of fertilized chicken eggs.
Oxford BioMedica Plc has given a clinical update on its gene therapy programmes for ocular diseases, highlighting the safety of its early-stage therapy for a subtype of the deaf-blindness disorder, Usher syndrome. Sanofi SA has in-licensed the programme.
At a time when Big Pharma is aggressively shedding research assets, venture capital firms with an appetite for risk are discovering new investment opportunities.
Dealmaking is at the heart of business development. But not all deals are the same. At a meeting of Bio-Europe in Hamburg, Germany on 13 November, business development executives from four companies talked about deals that have transformed their companies.
The first vaccine to treat Meningitis B infection has been recommended for approval by the European Medicines Agency. Developed by Novartis, the vaccine would help protect all age groups, including infants, against the disease.
Zealand Pharma A/S’s glucagon-like peptide-1 agonist, Lyxumia (lixisenatide), has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) as a treatment for Type 2 diabetes. The drug is partnered with Sanofi SA.
Bavarian Nordic A/S has secured two new contracts from the US government valued at up to $18.9 million for vaccines that are being developed for Marburg haemorrhagic fever and foot-and-mouth disease. Both are based on a recombinant viral vector technology.