Gene and cell therapy executives, meeting in Stockholm in early April, spoke positively about the sector in the wake of the European Medicines Agency’s positive opinion for Strimvelis, a gene therapy for severe combined immunodeficiency due to adenosine deaminase deficiency (ADA-SCID), an ultra-rare disease.
MedDay SAS, a France-based biotech, has raised €34 million in a Series B financing round to conduct a confirmatory Phase 3 study in the US of its formulation of biotin in patients with progressive multiple sclerosis (MS).
UK-based Heptares Therapeutics has outlicensed a portfolio of early-stage neurology compounds to Allergan Plc in order to accelerate their development for the treatment of cognitive impairment and neurobehavioural symptoms in Alzheimer’s disease and other disorders.
Anergis SA of Switzerland has raised CHF 5 million (€4.6 million) from its existing investors to finance a further intermediate study of its lead vaccine against birch pollen allergy. The Phase 2b study is expected to start in the fall of 2016 and enroll 450 patients.
A ruling by the Obama administration to further tighten rules against tax inversions has led to the termination of a pending $160 billion merger between Pfizer Inc and Allergan Plc. Meanwhile Shire Plc has said that its merger with Baxalta will go ahead.
Daratumumab has received a positive opinion from the European Medicines Agency, paving the way towards marketing approval for a treatment that has been shown to work in patients with multiple myeloma, an incurable blood cancer.
A new gene therapy developed by the San Raffaele Telethon Institute for Gene Therapy together with GlaxoSmithKline Plc, has been given a positive review by the European Medicines Agency. If approved by the European Commission, it will only be the second gene-based product to reach the market in the west.
UK-based Scancell Holdings Plc has raised £6.1 million from a private share placement and an open offer to shareholders enabling it to make plans to start a combination study of its lead cancer vaccine called SCIB1 and a checkpoint inhibitor.
A Phase 3 development programme for the prospective osteoarthritis drug fulranumab has been stopped early by Janssen Research & Development because of a change in strategic priorities. The decision was not based on any safety issues, the company said.
In order to protect the safety of the US blood supply, the Food and Drug Administration has given clearance for the use of an experimental diagnostic developed by Roche to test blood donations for the Zika virus. While the test has not yet been formally approved, it is being allowed for use in screening.