A drug originally approved to treat diabetes has now received clearance to also be used for patients with heart failure. The drug, Farxiga (dapagliflozin), is a sodium-glucose co-transporter 2 (SGLT2) inhibitor which works by helping the kidneys lower blood glucose levels. On 6 May, the US Food and Drug Administration authorised Farxiga to treat adults with heart failure with reduced ejection fraction with and without Type 2 diabetes.
The cancer charity Cancer Research UK has chosen a bispecific protein therapeutic as a new development project, electing to take the molecule, CB213, into a Phase I clinical trial in patients with solid tumours. The therapeutic is being developed by Crescendo Biologics Ltd, which announced a partnership with the charity on 5 May. Crescendo has a preclinical portfolio of molecules targeting a range of cancers. The molecules are small, and based on the variable domain of the heavy chain of an antibody.
Norway-based BerGenBio ASA has raised NOK 500 million (€45.4 million) in an oversubscribed private share placement to support the development of its oncology portfolio which focuses on AXL inhibition. The lead candidate, bemcentinib, is in five Phase 2 studies as a single agent, or in combination, in acute myeloid leukaemia and non-small cell lung cancer.
A candidate vaccine against Lyme disease has been given a boost following a collaboration announced on 30 April between the vaccine’s developer Valneva SE and Pfizer Inc. The vaccine, VLA15, is currently in Phase 2 as a prophylactic treatment against Lyme disease. Under the agreement, Valneva will fund 30% of development costs up to regulatory submission. Pfizer will lead late-stage development and be responsible for commercialisation, paying Valneva tiered royalties on product sales starting at 19%.
Bavarian Nordic A/S has received a new order under a 2017 contract with the US government to supply its non-replicating smallpox vaccine to the US strategic national stockpile. The vaccine, Jynneos, is indicated for people who have been determined to be at high risk for infection from smallpox or monkeypox, which both belong to the Orthopoxvirus genus of viruses. It was approved by the Food and Drug Administration in September 2019. According to the Centers for Disease Control and Prevention, the last natural outbreak of smallpox in the US occurred in 1949.
A triple combination therapy for asthma Enerzair Breezhaler, which includes a digital sensor to help patients monitor their treatments, has received a positive opinion from the European Medicines Agency. Assuming formal approval by the European Commission, the drug will be available as a maintenance treatment for asthma in adult patients whose disease is not adequately controlled by a corticosteroid and a long-acting beta2 agonist.
Newron Pharmaceuticals SpA has stopped development of sarizotan, a small molecule drug for Rett syndrome, after the Phase 3 STARS trial failed to meet its primary and secondary endpoints. Rett syndrome is a severe neurodevelopmental disorder, mainly affecting females, for which there are no approved treatments.
Remdesivir has become the first antiviral drug to be approved to treat coronavirus disease 2019 (COVID-19) in the US after showing promising results in a randomised, controlled trial of 1,063 patients sponsored by the US National Institute of Allergy and Infectious Diseases (NIAID). On 1 May, two days after the trial results were announced, the Food and Drug Administration issued an emergency use authorisation for the drug enabling it to be used for adults and children hospitalised with severe disease.
Novartis produced double-digit sales increases for core products in the first quarter, consolidating gains after a period of restructuring and acquisitions in 2019. Net sales for the quarter were $12.3 billion, up by 11% from a year earlier at actual exchange rates, and by 13% at constant rates. Behind the gains was strong demand for Entresto, the company’s treatment for heart failure; Kisqali, a new breast cancer drug; and Cosentyx, a treatment for plaque psoriasis.
AstraZeneca Plc has partnered with the University of Oxford to develop, manufacture and distribute a candidate vaccine for COVID-19 that is based on technology originating from the university and its 2016 spin-out Vaccitech Ltd. The vaccine, ChAdOx1 nCoV-19, is in a Phase 1 clinical trial to test its safety and efficacy in healthy volunteers. Initial results from the study are expected to be reported in June.