The European Medicines Agency’s Committee for Advanced Therapies (CAT) is recommending that the marketing authorisation for the cartilage implant Maci be suspended because the developer, Genzyme (Sanofi SA), has closed the product’s EU manufacturing site.
From 1 January 2015, the European Medicines Agency will begin to publish clinical data used by companies to support their applications to market new drugs in the EU – a policy that is expected to have wide-ranging implications for medicines research across Europe.
Forbion Capital Partners and Life Sciences Partners, both based in the Netherlands, have together raised €172 million from investors in order to support companies active in the life sciences. Both venture capital companies were supported by investors in Europe and the US.
Oxford BioTherapeutics Ltd has selected an antibody-drug conjugate for clinical development which targets a B-cell malignancy. The preclinical candidate will be investigated in non-Hodgkin’s B-cell lymphoma, in addition to solid tumours.
Salix Pharmaceuticals Inc and Italy’s Cosmo Pharmaceuticals SpA have ended their plans to merge citing a shift in the political environment toward transactions of the kind being proposed. As a result, Salix will make a $25 million termination payment to Cosmo.
Eli Lilly and Company said it is discontinuing development of tabalumab, an anti-B-cell activating factor monoclonal antibody that was being tested in systemic lupus erythematosus. This follows a finding of insufficient efficacy in two pivotal Phase 3 trials.
For the first time, two patients suffering from a rare genetic blood disorder, for which there is currently no approved medicine, participated in a discussion at the main scientific committee of the European Medicines Agency where a candidate medicine for their disease was being reviewed.
The European Medicines Agency has given positive opinions for 15 new medicines including treatments for hepatitis C infection, Cushing’s syndrome and for non-small cell lung and gastric cancers. The decisions were announced on 26 September.
Adaptimmune Ltd, which is developing a T cell therapies for cancer and infectious disease, has raised $104 million in a Series A financing round to support its ongoing work in multiple cancer indications. The oversubscribed round was led by New Enterprise Associates of the US.
Probiodrug AG, a German specialist in Alzheimer’s disease, is planning to make an initial public offering of its shares on the Amsterdam Euronext exchange to support development of a drug that targets small amyloid-beta aggregates.