News

Novartis has responded to a statement from the US Food and Drug Administration on 6 August in which the regulator raised the issue of manipulation of product testing data in the production process for Zolgensma, the recently approved gene therapy for spinal muscular atrophy.

Novo Nordisk A/S has raised its financial guidance for 2019 based on recent sales figures for its non-insulin diabetes products Victoza and Ozempic and the obesity product Saxenda. At the same time, it cautioned that competition has intensified for its insulin and haemophilia products.

Bayer AG is to take full ownership of BlueRock Therapeutics LP, a regenerative medicines company that is developing engineered cell therapies in the fields of neurology, cardiology and immunology. Bayer, together with Versant Ventures, launched BlueRock in 2016 at a time of heightened interest in cell based therapies.

GlaxoSmithKline Plc has shifted three candidate vaccines targeting filoviruses to the US non-profit organisation, the Sabin Vaccine Institute, as it restructurings its portfolio to put a bigger emphasis on oncology, HIV and respiratory diseases. The products are prophylactic vaccines to prevent infection from the Ebola Zaire, Ebola Sudan and Marburg viruses. They entered GSK’s portfolio when the UK company acquired Okairos AG in 2013.

MorphoSys AG is planning a regulatory filing in Europe for its first wholly-owned antibody therapeutic for cancer, tafasitamab, in addition to completing a rolling submission for the same drug with the US Food and Drug Admission. The plans for a marketing authorisation application to the European Medicines Agency were disclosed with the release of the company’s second quarter results and represent an acceleration of the commercialisation plans for tafasitamab, a treatment for refractory diffuse large B cell lymphoma.

A candidate antibiotic designed to treat patients with serious infections passed the first of two Phase 3 hurdles after patients with acute bacterial skin and skin structure infections responded to treatment. The drug, ceftobiprole medocaril, is being studied in patients with acute bacterial skin and skin structure infections as well as in Staphylococcus aureus bloodstream infections. It is being developed by Basilea Pharmaceutica Ltd of Switzerland.

Verona Pharma Plc has reported positive Phase 2 results for a dry powder inhaler formulation of ensifentrine, its candidate product for chronic obstructive pulmonary disease (COPD). Ensifentrine is a dual inhibitor of the intracellular enzymes phosphodiesterase 3 and 4 for moderate to severe COPD. It has been shown to act as both a bronchodilator and an anti-inflammatory agent.

Less than a month after entering a collaboration with Genentech, Sosei Heptares has concluded a new G protein-coupled receptor (GPCR)-directed partnership with Takeda Pharmaceutical Company Ltd. The companies said they will initially discover targets for new gastrointestinal medicines, but this could expand to other therapeutic areas in the future.

Takeda already has a discovery collaboration with Sosei Heptares in the gastrointestinal area.

Roche said that its checkpoint antibody Tecentriq (atezolizumab) plus chemotherapy has shown positive results in a Phase 3 study of patients with previously untreated metastatic urothelial carcinoma compared with chemotherapy alone. The study, IMvigor130, is said to be the first positive outcome of an immunotherapy combination in this patient population.

France-based Transgene SA and its South Korean partner SillaJen Inc have stopped a Phase 3 study of the candidate oncolytic virus therapy Pexa-Vec for liver cancer early because it was considered unlikely to meet its primary endpoint of overall survival. There were no reported safety concerns, the companies said.