EMA reaches out to academia
The European Medicines Agency EMA) has formalised its ongoing relationship with universities in order to tap into research that could lead to new medicines and provide regulatory guidance to academic entrepreneurs.
The European Medicines Agency EMA) has formalised its ongoing relationship with universities in order to tap into research that could lead to new medicines and provide regulatory guidance to academic entrepreneurs.
The privately-owned Belgian drug developer Ogeda SA is to be acquired by Astellas Pharma Inc of Japan in a deal potentially valued at €800 million. Ogeda is developing products for women’s health that target G-protein coupled receptors (GPCRs).
A Phase 3 trial in which patients with active rheumatoid arthritis (RA) were treated with the monoclonal antibody sirukumab, or placebo, met its primary endpoint of relief from swelling even in those who had failed to respond to two or more biological drugs.
The opportunities for commercialising cell and gene therapies appeared relatively bright as the first quarter drew to a close, helped by new finance and the prospective approval of the first cancer products made from engineered T cells.
An early clinical trial of a candidate treatment for pancreatic cancer developed by Halozyme Therapeutics Inc has been suspended after the independent data monitoring committee determined that it was unlikely to improve the patients’ overall survival.
A Phase 2 study of the monoclonal antibody daratumumab in three types of non-Hodgkin’s lymphoma has been stopped early because it failed to reach predefined targets for overall response, Genmab A/S announced on 30 March.
Novartis has become the second developer to have a candidate chimeric antigen receptor T (CAR T) cell therapy for cancer accepted by the US Food and Drug Administration for review. If successful, the two applications will mark a new era in cancer therapy.
Could 2017 be a pivotal year for RNAi? According to Ali Mortazavi, the chief executive of Silence Therapeutics Plc, this is a strong possibility if upcoming data from the trial of a short interfering RNA (siRNA) molecule being developed by Alnylam Pharmaceuticals Inc are positive.
Mereo BioPharma Group Plc has announced a private share placement intended to raise £15 million to support development of a treatment for osteogenesis imperfecta, a genetic disorder characterised by bones that break easily.
The Norwegian oncology developer BerGenBio ASA is making an initial public offering of its shares on the Oslo Stock Exchange in order to support development of a Phase 2 compound targeting three cancer indications.