News

A candidate vaccine to prevent infection from the chikungunya virus has been accepted into the European Medicines Agency’s PRIME scheme, a programme of regulatory support for developers of medicines that meet a major public health need.

The vaccine is a biologic developed by Themis Bioscience GmbH of Austria and is currently undergoing Phase 2 studies in 600 patients across the US, the EU and South and Central America. The company hopes to receive marketing approval within three years.

Valneva SE is poised to bring its prophylactic vaccine for Lyme disease into a Phase 2 clinical study by the end of 2018 following positive discussions with the US Food and Drug Administration, the company announced on 2 July. The agency has given the product ‘fast track’ status in light of its potential contribution to public health.

Roche has reported positive results for a Phase 3 trial of its checkpoint antibody Tecentriq (atezolizumab) in combination with chemotherapy for the treatment of patients with metastatic triple negative breast cancer. The trial showed a statistically significant improvement in progression-free survival.

The European Medicines Agency is recommending approval of caplacizumab, a new drug for treating the rare blood disorder, acquired thrombotic thrombocytopenic purpura (aTTP). The disorder leads to extensive micro-clot formation in the small blood vessels and potential damage to vital organs.

The European Medicines Agency has given positive opinions for two chimeric antigen receptor (CAR) T cell therapies to treat blood cancers – bringing these medicines closer to the market for patients in the EU.

Novartis is proposing to spin off its Alcon division into a separately listed eye care devices company leaving it to focus on pharmaceutical discovery and development. The transaction will be put to shareholders for a vote in February 2019 and if approved, would be completed by 30 June of that year.

A nanoparticle device designed to enhance the effect of radiation in the treatment of cancer has delivered positive Phase 2/3 results in patients with soft tissue sarcoma. The device, NBTXR3, has been developed by Nanobiotix SA of France.

UK-based NodThera Ltd has raised £28 million in Series A financing to develop small molecule drugs to treat diseases driven by chronic inflammation. The financing was co-led by Sofinnova Partners and 5AM Ventures with further participation by Epidarex Capital and F-Prime Capital Partners.

The US Food and Drug Administration has approved Epidiolex, a treatment for severe forms of epilepsy that is based on cannabidiol, a purified drug substance derived from marijuana. Epidiolex was developed by GW Pharmaceuticals Plc.

It has been approved to treat Lennox-Gastaut syndrome and Dravet syndrome in patients two years of age and older.

The drug is the first approved treatment containing cannabidiol, a chemical component of the Cannabis sativa plant. It is also the first drug approved for patients with Dravet syndrome.

Belgium-based iTeos Therapeutics SA has raised $75 million in an oversubscribed Series B financing round to advance two of its immunotherapy candidates into the clinic and open a new office in Cambridge, Massachusetts, US.

The funding was led by MPM Capital with participation from the additional new investors HBM Partners, 6 Dimensions Capital and  Curative Ventures. All of the company’s existing investors also participated in the round.