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. This included product sales of $6.3 billion and collaboration revenue of $43 million.
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.
GlaxoSmithKline Plc stepped up its vaccine activities in the first quarter while simultaneously launching a two-year programme to prepare for its split into two companies. The previously-announced separation will create two new entities: a new GSK biopharma company and a consumer healthcare company.
A Phase 3 lung cancer trial of the checkpoint antibody Libtayo (cemiplimab) has been stopped early due to a significant improvement in overall survival, the developers Sanofi SA and Regeneron Pharmaceuticals Inc announced on 27 April. Libtayo is a programmed death receptor-1 (PD-1) blocking antibody that frees the immune system to fight cancer. The drug has already been approved in the US to treat advanced cutaneous squamous cell carcinoma.
Compass Pathways Ltd has raised $80 million in a Series B investment round to support its lead product for treatment-resistant depression – a psilocybin therapy that has received breakthrough therapy designation from the US Food and Drug Administration.
Sanofi SA posted strong gains in both sales and operating profit in the first quarter boosted by medicine stockpiling during the COVID-19 pandemic in Europe. The quarterly result also featured a more than doubling of sales for the immunology drug Dupixent, which was co-developed with Regeneron Pharmaceuticals Inc.