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Following a negative Advisory Committee (AdCom) decision, the US Food and Drug Administration (FDA) has rejected Intercept’s Ocaliva (obeticholic acid) for the treatment of pre-cirrhotic fibrosis due to nonalcoholic steatohepatitis (NASH) in a complete response letter (CRL) to the company. 

In a 23 June conference call, the company announced that it would begin the process of shutting down the REGENERATE trial (NCT02548351), with an aim to complete this process by the end of 2023. 

Intercept will continue to collect study data until the trial is fully terminated. Furthermore, the biotech has already begun “winding down” its NASH-related investment into research and development, commercial, medical affairs and administrative function. 

The company will also cut down its workforce by a third to minimise operating expenses, beginning in the coming weeks with plans to complete this by the end of 2023. Intercept will pivot its focus to Ocaliva’s use for primary biliary cholangitis (PBC), preserving the workforce in this department.

Pfizer has terminated one of its glucagon-like peptide-1 receptor agonist (GLP-1-RA) candidates as the race heats up to market the first oral weight loss drug. 

The loss of lotiglipron means Pfizer will rest its hopes on its other candidate danuglipron to take on Novo Nordisk and Eli Lilly for the first marketed weight loss pill.  The market responded accordingly to Pfizer’s announcement about shelving the program, with shares in the company opening 3% lower on Monday morning compared to pre-announcement market close (23 June). 

The decision to scrap lotiglipron was due to elevated levels of transaminases seen in two Phase I studies and a currently ongoing Phase II study. Pfizer said no liver-related symptoms or side effects were observed and added that the increase in transaminase levels has not been seen in any of its danuglipron trials. Pfizer has already published results for danuglipron in the Journal of the American Medical Association Network Open.

Vertex Pharmaceuticals and Lonza have entered a strategic partnership to establish a facility at Portsmouth, New Hampshire, US, to manufacture Vertex’s cell therapies for type 1 diabetes (T1D). 

The companies will collaborate in the development and scale-up of the production of the cell therapy portfolio, and jointly fund the construction of the facility. The 130,000ft² site will be run by Lonza and will create 300 new jobs. Construction will commence later this year. 

The companies will produce the investigational stem cell-derived, fully differentiated insulin-producing islet cell therapy portfolio of Vertex for T1D patients. 

The key focus will be on Vertex’s VX-880 and VX-264 programmes, which are currently in the clinical trial stage. VX-880 has shown clinical proof-of-concept while VX-264 is being analysed in a Phase I/II trial.

Eli Lilly and Boehringer Ingelheim have received approval from the US Food and Drug Administration (FDA) for Jardiance (empagliflozin) 10mg and 25mg tablets to treat type 2 diabetes in children aged 10 years and above. 

The tablets are intended to reduce blood sugar, along with modification of diet and exercise in these patients. 

Jardiance is a prescription medicine that helps lower the risk of hospitalisation and cardiovascular death for adults with heart failure. 

It also helps decrease the risk of cardiovascular death in adults with type 2 diabetes. The US regulator has approved the therapy based on data from the DINAMO Phase III study, which showed that Jardiance significantly reduced haemoglobin A1c, a blood test determining average blood sugar levels over the previous three months, compared to placebo. 

The double-blind, parallel group, randomised and multicentre study recruited participants aged 10-17 years with type 2 diabetes previously treated with insulin or metformin.

Synthetic biology biopharma Biostar Pharma announced is ready to advance its utidelone injectable (UTD1) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC), following approval from the US Food and Drug Administration (FDA) for the study. 

UTD1 is a microtubule stabilising agent, acting as an anti-neoplastic drug. It is currently marketed for breast cancer treatment in China and trialled globally for treating pancreatic, gastric, bile duct, ovarian, prostate and breast cancers, as well as solid tumours. 

Designated as BG01-2202, this latest trial will be an open-label, randomised, controlled clinical study of UTD1 versus chemotherapy drug docetaxel. It will be conducted at 50 sites across ten countries in the US, Europe and Asia Pacific regions. A Phase III study to evaluate UTD1 versus docetaxel in patients that have failed chemotherapy with a platinum-containing regimen is also currently underway in China. This latest study approval follows a previous open-label, multi-centre Phase II trial conducted in China (NCT03693547).