News

Kåre Schultz to take charge at Teva Pharmaceutical

Country
Denmark

Kåre Schultz is set to move to Israel to take the top job at Teva Pharmaceutical Industries Ltd at a time of strategic uncertainty for the generic pharmaceuticals producer. Mr Schultz will be leaving H. Lundbeck A/S in Denmark where he has been chief executive since 2015.

Merck to acquire Rigontec

Country
Germany

Merck & Co Inc is to acquire Rigontec GmbH of Germany in order to strengthen its portfolio of immuno-oncology compounds led by pembrolizumab. Rigontec has assets that target the retinoic acid-inducible gene I (RIG-I) pathway, part of the innate immune system.

Gene therapy trial featured

Country
United States

A Phase 3 trial of a candidate gene therapy for retinal disorder has been highlighted in The Lancet as a possible standard for future trials of genetic medicines. The trial was conducted by Spark Therapeutics Inc whose therapy, voretigene neparvovec, is under review at the US Food and Drug Administration.

Nightstar plans $86 million US offering

Country
United Kingdom

Nightstar Therapeutics Ltd plans to raise up to $86 million in an initial public offering (IPO) of its shares on Nasdaq to advance its portfolio of gene therapies to treat rare inherited retinal diseases. A registration document was filed with the US Securities and Exchange Commission on 31 August.

FDA approves Novartis CAR T therapy

Country
United States

The US Food and Drug Administration has given its approval to Novartis’ gene therapy for the treatment of paediatric and young adult acute lymphoblastic leukaemia (ALL), Kymriah (tisagenlecleucel). It is the first decision of its kind for a technology that has achieved remissions for a significant number of very ill patients.

FDA’s Gottlieb announces policy on stem cells

Country
United States

The US Food and Drug Administration has taken steps to curb the activities of unlicensed stem cell clinics while preparing for the roll-out in the autumn of a new regulatory framework for developers of cell and tissue-engineered products.

Gilead to acquire Kite for $11.9 billion

Country
United States

Gilead Sciences Inc has made a dramatic entry to the field of regenerative medicine with an agreed bid for Kite Pharma Inc which has a portfolio of engineered cell therapies, the most advanced of which is under review in both the US and the EU.

European Commission to probe Bayer-Monsanto merger

Country
Belgium

Bayer AG’s proposed $66 billion acquisition of Monsanto Co has hit a roadblock following a decision by the European Commission to investigate whether the new group could reduce competition for pesticides, seeds and genetically-engineered plant traits.

Canakinumab reduces cardiovascular risk - Novartis

Country
Switzerland

Phase 3 trial results of canakinumab (Ilaris), a monoclonal antibody that targets interleukin 1 beta (IL-1 beta), have shown a significant 15% reduction of major cardiovascular events in people with a prior heart attack and inflammatory atherosclerosis.