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.
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.
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.
A candidate treatment for patients with glaucoma, Vesneo, has reached its primary endpoint in a Phase 3 development programme, showing that it can effectively lower intraocular pressure, according to Nicox SA, the developer.
Shire Plc said that it has reached agreement with the US government to pay $56.5 million in fines to settle a civil investigation relating to its sales and marketing practices for three medicines for attention deficit hyperactivity disorder and two for ulcerative colitis.
Regeneron Pharmaceuticals Inc is to appeal against a decision of the European Patent Office (EPO) to revoke its patent for transgenic mouse technology, a patent that was successfully challenged by Kymab Ltd of the UK.