News

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.

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.

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.

AstraZeneca Plc reported another quarter of growth in the three months to 31 March, continuing a trend that started more than a year ago with the launch of new medicines for cancer and diabetes. It now has nine products with annual sales of $1 billion or more. During the quarter, sales increased across every geographical region and therapy area, especially for oncology. Group revenue reached $6.4 billion for an increase of 16% at actual exchange rates, and 17% at constant rates.

A Phase 3 study of the antiviral remdesivir in patients with advanced COVID-19 has delivered positive results, the first indication that a treatment for the disease may be within reach. Preliminary data from the trial were disclosed on 29 April by the sponsor, the US National Institute of Allergy and Infectious Diseases.