A Phase 3 trial of Kymriah (tisagenlecleucel), the pioneering chimeric antigen receptor (CAR) T cell therapy, did not meet its primary endpoint of event-free survival in patients with aggressive B cell non-Hodgkin lymphoma, Novartis announced on 24 August.
Pfizer Inc is expanding its presence in oncology with the acquisition of Trillium Therapeutics Inc, a Canadian company with a pipeline of early-stage therapies for treating haematological malignancies and solid tumours. The company’s two lead products target CD47, a molecule that tumours use to evade the immune system.
Valneva SE has started submitting regulatory data in support of its Covid-19 vaccine candidate to the UK Medicines and Healthcare products Regulatory Agency (MHRA) with a view to receiving an initial approval before the end of the year. The vaccine, VLA2001, is currently being studied in separate Phase 3 trials in the UK and New Zealand. Top-line results from the UK study are expected early in the fourth quarter.
The European Commission has approved funding from the Danish government to Bavarian Nordic A/S to support the company’s development of a vaccine for Covid-19. The funding will take the form of a repayable advance. The candidate vaccine, ABNCoV2, was developed by AdaptVac, a joint venture spun out of the University of Copenhagen, and licensed to Bavarian Nordic in July 2020. It uses AdaptVac’s viral capsid-like virus particle technology.
Interim data from an open-label extension study of bimekizumab, a treatment for plaque psoriasis, showed that a majority of patients who responded to the therapy at Phase 3, continued to benefit from the drug after two years. Bimekizumab is currently under review by the US Food and Drug Administration for the treatment of moderate-to-severe plaque psoriasis, a chronic inflammatory skin disease for which there is no cure. In June, it was given a positive opinion by the European Medicines Agency.
AstraZeneca Plc is discontinuing a Phase 3 trial of Ultomiris (ravulizumab), a newly acquired antibody therapy being investigated in amyotrophic lateral sclerosis, due to lack of efficacy. The decision was taken following a recommendation of the trial’s independent data monitoring committee. The trial did not throw up any new safety findings, the company announced on 20 August.
The loss of patent protection for Northera, a core hypotension product, depressed sales at H. Lundbeck A/S in the first half year and also affected its revenue forecast for the year. Partially offsetting this were sales gains for four medicines targeting neurological disorders as healthcare activity gradually recovered from the worst of the pandemic.
A new version of a Covid-19 vaccine being developed by CureVac NV and GlaxoSmithKline Plc has shown an improved immune response and protection in a preclinical study, compared with an earlier version of the vaccine, the two companies announced on 16 August.
The US Food and Drug Administration has approved a new indication for Xywav for the treatment of idiopathic hypersomnia, a chronic sleep disorder. The disorder causes people to be excessively sleepy during the day, even after a sound sleep the night before.
Xywav is already approved for excessive daytime sleepiness in patients with narcolepsy. The active ingredient of the drug is oxybate which is a controlled substance. Given its potential risks, Xywav will be subject to strict safety controls, the FDA said in an announcement on 12 August.
The accelerated approval pathway, a regulatory procedure used by the Food and Drug Administration to speed drugs to market that promise to treat serious medical conditions, is to be reviewed by the Office of Inspector General (OIG), the largest oversight body in the US government. Announced in early August, the review was triggered by the FDA’s accelerated approval on 7 June of Aduhelm, a treatment for Alzheimer’s disease. This decision led to the resignation of three members of an FDA advisory committee who argued that data presented in the drug’s application was inadequate.