argenx SE has reported that a subcutaneous formulation of its marketed drug Vyvgart achieved a 61% reduction in the risk of relapse in patients with the rare neurological disorder, chronic inflammatory demyelinating polyneuropathy (CIDP) compared with placebo. Data from the registrational ADHERE study were reported on 17 July.
The European Commission has imposed a €432 million fine on Illumina Inc – its largest fine ever –for proceeding with the acquisition of the diagnostic group GRAIL Inc before the deal had been approved by the EU regulator. The fine was announced on 12 July alongside a symbolic fine of €1,000 on GRAIL for enabling the transaction to complete.
Eli Lilly and Co is to acquire Versanis Bio Inc of the US in a transaction valued at up to $1.93 billion in order to expand its presence in cardiometabolic medicine development. The acquisition, in cash, will be the company’s third in less than a month, giving it a candidate product for obesity that is in a Phase 2b study. The acquisition was announced on 14 July. Lilly’s earlier announced deals included the takeover of DICE Therapeutics Inc, with a project in psoriasis, and Sigilon Therapeutics Inc, with a project for type 1 diabetes.
BioGeneration Ventures (BGV) of the Netherlands has raised €150 million for a fifth venture fund which will enable it continue creating new biotech companies and provide financial support to those already building portfolios. BGV Fund V was oversubscribed, generating funds from existing and new investors, of which 78% were of US origin. Existing investors also contributed, including Eli Lilly and Co, Novo Holdings, and Bristol Myers Squibb Co. The fund’s close was announced on 13 July.
NodThera Ltd of the UK, with offices in Boston and Seattle, US, has reported data from a small molecule drug being tested in volunteers which showed reductions in neuroinflammatory and inflammatory biomarkers – the first human data from a project intended to treat Parkinson’s disease. The results were reported on 11 July. The drug, NT-0796, was administered to elderly volunteers and within seven days, showed a decline in biomarkers including the cerebrospinal fluid (CSF) neurofilament light chain (NfL), a key indicator of neurodegeneration.
Twenty years after its launch as a nanomedicines company, Nanobiotix SA of France has secured a major licensing deal enabling it to complete development and commercialise a radioenhancer for use with radiotherapy to treat patients with multiple, difficult cancers. The agreement with Janssen Pharmaceutica NV, part of Johnson & Johnson Inc, was announced on 10 July. It carries potential payments of up to $1.8 billion in development, regulatory and sales milestones as well as royalties on net sales of the product NBTXR3.
The European Medicines Agency is reviewing the safety of three medicines used for the treatment of weight loss and type 2 diabetes in light of reports from the Icelandic Medicines Agency of suicidal thoughts and attempted self-injury amongst patients taking the drugs. The review will focus on the glucagon-like peptide 1 (GLP-1) receptor agonists liraglutide (Saxenda) and semaglutide (Ozempic and Wegovy), all three of which have been developed by Novo Nordisk A/S. The investigation will involve an analysis of 150 reports of possible self-harm and suicidal thoughts.
The first gene therapy to treat severe haemophilia A was approved by the US Food and Drug Administration on 30 June, adding a novel treatment to the existing group of drugs for the bleeding disorder. The therapy, Roctavian, is an adeno-associated virus (AAV) vector-based therapy intended to be used as a one-time treatment. It is administered as a single dose by intravenous infusion.
AstraZeneca Plc said that its antibody-drug conjugate (ADC) datopotamab deruxtecan generated positive data from patients in a Phase 3 lung cancer trial, but that some Grade 5 events were observed in the study. A spokesperson for AstraZeneca said on 11 July that some Grade 5 interstitial lung disease events were observed which are being investigated. Overall the safety profile of the drug was consistent with previous studies, she added.
The US Food and Drug Administration approved the first allogeneic cell therapy for type 1 diabetes on 28 June, making it possible for people with severe hypoglycaemia to receive an additional treatment for achieving targeted blood glucose levels. Lantidra is an allogeneic pancreatic islet cell therapy made from deceased donor pancreatic cells.