News

AstraZeneca Plc expects revenue for the year to increase by a high single-digit percentage following a first quarter in which the figure reached $13.588 billion. This represented an increase of 7% on a reported basis, and 10% at constant exchange rate from the previous year. Core earnings per share are expected to rise by a low double-digit percentage, after increasing by 21% in the first three months. The core measure excludes amortisation and impairment charges for intangible assets.

Blenrep (belantamab mafodotine), an antibody-drug conjugate given speedy approvals in both  the US and the EU in 2020, and later withdrawn for insufficient efficacy, has won approval for a new market entry in the UK on the basis of two combination studies. The drug was developed by GSK Plc to treat patients with relapsed or refractory multiple myeloma, the third most common blood cancer globally.

The Alzheimer’s disease drug, Leqembi (lecanemab), has been approved by the European Commission following extra reviews of the product’s safety. The decision was announced on 16 April by the product’s co-developer BioArctic AB which will make the drug available to adults with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer’s disease. The patient group is specifically identified as people who have only one, or no copy, of the ApoE4 gene, a risk factor for the disease. 

A vaccine designed to prevent disease caused by the chikungunya virus, a mosquito-borne virus, has been approved in Brazil, an endemic country. Developed by Valneva SE of France, the vaccine IXCHIQ, is intended for individuals 18 years and older. Chikungunya disease, which causes muscle pain and joint swelling, has occurred in Africa, Asia, the Americas, Europe and islands in the Indian and Pacific oceans. According to the US Centers for Disease Control and Prevention, there is a risk that the virus could spread to unaffected areas by travellers.

Five medicinal products, each with multiple indications, have been assessed by scientific experts who are supporting the African Medicines Agency, a prospective regulatory authority for countries in the African Union. The medicines are all vaccines, some of which are indicated for cancers, and others for infectious diseases. The products are generic versions of well-established drugs, including bavencio, gardasil and pembrolizumab, and protect against diseases ranging from diphtheria and tetanus to non-small cell lung and colorectal cancers. 

The European Commission has outlined a strategy for building capacity in artificial intelligence across the 27-nation union alongside the first grants to execute it. Announced on 9 April, the strategy envisions the construction of new AI data centres and laboratories, the use of new algorithms, and the recruitment of skilled labour. 

A digital twin lung simulation technology, Twinhale, has been used for the first time in idiopathic pulmonary fibrosis (IPF) in a groundbreaking new study. The study by Munich, Germany-based company Ebenbuild, supports the development of a novel inhaled anti-CCN2 (formerly called CTGF) biologic, PRS-220, developed by Pieris Pharmaceuticals - now Pavella Therapeutics Inc.

A new drug for haemophilia that targets antithrombin, a protein that inhibits blood clotting, has been approved by the US Food and Drug Administration. Discovered by Alnylam Pharmaceuticals Inc and licensed to Sanofi SA, Qfitlia (fitusiran) will be used to treat patients with both haemophilia A and haemophilia B with or without inhibitors. The standard treatment for patients with haemophilia are clotting factor replacement therapies where patients with haemophilia A receive replacement for factor VIII and those with haemophilia B, replacement for factor IX.

Effective 7 April, the US Food and Drug Administration had lost 28 senior leaders who left the agency voluntarily or were fired following the Trump Administration’ decision to reduce the workforce by 3,500 people. The figures, compiled by the STAT news agency, show that departures included deputy directors and commissioners across all departments from the centres for devices and radiological health, to the centres for small molecule and biologic evaluation, and for tobacco regulation.

The US Food and Drug Administration announced plans on 10 April to phase out animal testing for monoclonal antibodies and other drugs – a safety requirement for the development of human medicines that was first introduced in 1938. The reason is to adopt new methods for evaluating safety that could harness technologies such as artificial intelligence while reducing research and development costs.