An immuno-oncology combination that had initially produced an objective response in a Phase 1/2 trial of patients with head and neck cancer, failed to show benefit in an extended patient population, Innate Pharma SA announced on 22 November.
A new small molecule drug intended to treat cystic fibrosis patients with the F508del gene mutation has been well tolerated in patients in a Phase 2 study, paving the way for its use as part of a triple therapy, Galapagos NV announced on 19 November.
Amsterdam is to be the new home for the European Medicines Agency following Britain’s decision to leave the European Union, and give up its right to host EU institutions at the end of March 2019. The decision was announced on 20 November by the EU General Affairs Council.
Roche has reported positive Phase 3 results for two different antibody therapeutics putting it in a leadership position for treating both non-small cell lung cancer and haemophilia A. The cancer trial was significant because it showed the benefits of using a checkpoint inhibitor as part of a triple therapy.
The US Food and Drug Administrations has issued four guidance documents explaining how it intends to regulate products derived from human cells and tissues. The guidance updates rules that first took effect in 2005 and includes new incentives for developers of potentially life-saving therapies.
What will it take to build an integrated capital market in Europe? This question engaged executives at a BioEurope conference in Berlin on 6 to 8 November. The answer was both short and sweet, and long and complex.
Ablynx NV, the Belgian antibody specialist, has released financial results for the first nine months of 2017 which show an operating loss due to significant outlays for research and development, but a strong cash balance. This was later augmented by a successful IPO on US Nasdaq.
Crispr Therapeutics AG and its joint venture with Bayer AG called Casebia Therapeutics LLP have signed an exclusive collaboration agreement with CureVac AG to develop therapeutics that exploit both the new gene editing and messenger RNA (mRNA) technologies.
The European Medicines Agency has recommended a new medicine that can prevent cytomegalovirus (CMV) reactivation and disease in patients who have received an allogeneic stem cell transplant. The medicine, Prevymis (letermovir), was developed by Merck & Co Inc.
A new monoclonal antibody treatment for multiple sclerosis (MS) has been recommended for approval by the European Medicines Agency following clinical studies that showed significant benefits for patients with both relapsing and primary progressive forms of the disease.