The European Medicines Agency has recommended two new cancer drugs for approval in Europe, each with an entirely different mechanisms of action. The first is a PARP inhibitor for ovarian cancer and the second, a photodynamic therapy for prostate cancer.
The Italian gene therapy company, Genenta Science srl, has raised €7 million in a Series B financing round to support development of a second tumor indication for its technology platform in addition to multiple myeloma. The funding was announced on 13 September.
Novo Nordisk A/S has reached an agreement with the US government and several states to pay $58.65 million to settle claims of mis-communication over the risks of Victoza, its glucagon-like peptide-1 (GLP-1) drug for Type 2 diabetes. The settlement was announced on 5 September.
A Phase 3 trial of the Bavarian Nordic A/S candidate vaccine for prostate cancer, Prostvac, has been declared futile based on the results of a preplanned interim analysis. The trial’s independent data monitoring committee is recommending the study be discontinued.
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 & 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.
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.
Vasant Narasimhan, global head of drug development and chief medical officer of Novartis, is to become the company’s chief executive on 1 February 2018, succeeding Joseph Jimenez who has held the job since 2010.
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.
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.