News

A new vaccine to protect against a disease caused by the respiratory syncytial virus (RSV) has received a positive accelerated assessment from the European Medicines Agency. If approved, Abrysvo would be used for the passive immunisation of infants from birth through six months of age following administration to the mother during pregnancy. It would also be indicated for the active immunisation of adults 60 years and older. A formal decision is still to be issued by the European Commission.

A new special purpose biotech company, Mage Biologics Inc, has been launched in the US to advance development of a monoclonal antibody treatment for ulcerative colitis, a chronic, inflammatory bowel disease. The candidate product is being designed for oral administration, using sustained release technology designed by one of its founders.

Sandoz, the Swiss generics and biosimilar drug developer, is to invest $90 million at its site in Ljubljana, Slovenia to produce biosimilar medicines, which are off-patent drugs similar in mechanism of action to their reference biologic drugs. The new technical center is expected to drive biosimilar development, leading to the creation of about 200 new full-time jobs. The project is anticipated to complete by 2026.

argenx SE of the Netherlands has raised $1.27 billion from a global share offering after the exercise by underwriters of their options to buy more shares. This is an increase from the initial gross proceeds of $1.1 billion and will support development of the company’s pipeline of therapies for severe autoimmune diseases.

Novartis moved a step closer to becoming a dedicated proprietary drug developer with a decision by its board of directors to approve the spin-off of Sandoz, the company’s generics and biosimilar medicines business unit. The planned divestment will go to shareholders for a vote in September and, if approved, will take effect early in the fourth quarter. Following the spin-off, Sandoz will be listed on the SIX Swiss Exchange, with an American Depositary Receipt programme in the US.

Donanemab, a monoclonal antibody targeting beta-amyloid in Alzheimer’s disease, significantly slowed cognitive and functional decline in people with early symptomatic disease, the developer Eli Lilly and Co announced on 17 July. The results, from a Phase 3 trial, were disclosed at the 2023 Alzheimer’s Association International Conference and simultaneously published in the Journal of the American Medical Association.

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.