July/August 2026 • PharmaTimes Magazine • 9
// CONDITIONS //
Agomab outlines design of phase 2b NOV ERA study in fibrostenosing Crohn’s disease
Agomab Therapeutics has announced the design of its phase 2b NOV ERA study of ontunisertib in fibrostenosing Crohn’s disease, following alignment with the US Food and Drug Administration on key elements of the trial. The company expects to begin dosing participants in the second half of 2026.
Agomab said the study will evaluate its oral, GI-restricted ALK5 inhibitor in a condition that affects around 46% of Crohn’s disease patients and for which no approved pharmacological therapies exist.
Fibrotic strictures in the intestinal tract can cause obstructive symptoms that lead to dietary change, malnutrition and surgery.
The company has agreed the study’s primary efficacy endpoint with the FDA, focusing on endoscopic passability at Week 24 as assessed by the SES-CD narrowing score. The protocol has been submitted to the FDA, cleared central IRB approval in the US and received approval from Health Canada. Clinical Trial Applications have also been filed in multiple territories, including the EU and Asia Pacific.
Philippe Wiesel, Chief Medical Officer of Agomab, said: “The NOV ERA study breaks new ground as the first phase 2b study in FSCD, an area of high unmet medical need, and will inform dose selection and pivotal endpoints.”
Pierre Fabre wins EC approval for Braftovi regimen for mCRC
Laboratoires Pierre Fabre has secured European Commission approval for Braftovi (encorafenib) in combination with cetuximab and FOLFOX for the first-line treatment of adults with BRAFV600E-mutant metastatic colorectal cancer (mCRC).
The decision is based on results from the phase 3 Breakwater trial, which compared the regimen with oxaliplatin-based chemotherapy with or without bevacizumab in previously untreated patients.
Eric Ducournau, Chief Executive Officer, Laboratoires Pierre Fabre said: “We are extremely pleased to be able to expand the availability of encorafenib in combination with cetuximab and FOLFOX for the first-line treatment of adult patients with BRAFV600E-mutant mCRC.
“Today’s EC decision for this regimen marks the approval of the only targeted therapy in the EU for this patient population in the first-line setting and an important milestone in that it helps to address a significant unmet need for patients and clinicians, for whom treatment options have been limited.”
Breakwater showed that the combination delivered a statistically significant and clinically meaningful improvement in progression-free survival, with median PFS of 12.8 months versus 7.1 months for chemotherapy.
The regimen also met the dual primary endpoint of objective response rate, achieving 60.9% in the primary analysis set compared with 40%.
NICE has issued final draft guidance recommending daratumumab with bortezomib, lenalidomide and dexamethasone (D-VRd) for adults with untreated multiple myeloma who are unsuitable for an autologous stem cell transplant.
The decision means eligible patients in England and Wales will gain access to the UK’s only licensed subcutaneous CD38-directed antibody quadruplet for first line usel survival through the NHS.
AbbVie’s Aquipta (atogepant) has been recommended by NICE as an option for the acute treatment of migraine with or without aura in adults, provided patients have previously tried at least two triptans that did not work well enough, or could not take them, and had insufficient response to NSAIDs and paracetamol.
The decision follows MHRA marketing authorisation granted in April 2026. Suitable patients in England and Wales are now expected to gain access to the oral treatment on the NHS.
Johnson & Johnson has welcomed the Scottish Medicines Consortium’s decision to accept Talvey (talquetamab) for use within NHS Scotland for adults with relapsed and refractory multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and have shown disease progression on their last treatment.
Lundbeck has presented new migraine data at the European Academy of Neurology Congress 2026, which took place between 27-30 June in Geneva.
Five presentations showcased its current and future approaches to migraine prevention, including new analyses for eptinezumab and primary phase 2b PROCEED data for the investigational treatment bocunebart.
A major independent review led by Donna Ockenden found that hundreds of mothers and babies died or were harmed due to deeply embedded systemic failures at Nottingham University Hospitals NHS Trust.
The report identified 444 women and 76 newborns who suffered potentially avoidable harm, including stillbirths, maternal deaths, brain injuries and severe complications. Failures included understaffing, bullying, racism, poor incident investigation and staff repeatedly ignoring women’s concerns.
Resident doctor leaders accused Northern Ireland’s health minister of ‘burying his head in the sand’ as they prepared to go out on strike owing to pay erosion.
It follows a 24-hour strike (in the form of Christmas Day cover) by consultants and specialist, associate specialist and specialty doctors in Northern Ireland on Thursday.
Stephen Montgomery, chair of the BMA Northern Ireland resident doctors committee, said they had been left with no choice but to call further strikes.