The National Institute for Health and Care Excellence (NICE) has shared draft guidance recommending AbbVie’s Aquipta (atogepant) as an option for preventing chronic and episodic migraines in adults who typically have at least four migraine days per month and where three previous preventative options have failed.

Eko Health has announced that the FDA has approved its low ejection fraction (low ef) detection artificial intelligence (AI).

Medincell and AbbVie have announced that they have entered into a collaboration to co-develop and commercialise up to six next-generation long-acting injectables (LAI) across multiple therapeutic areas and indications.

AstraZeneca and Daiichi Sankyo have announced that their biologics license application (bla) for datopotamab deruxtecan (dato-dxd) has been accepted in the US for the treatment of adult patients with unresectable or metastatic hormone receptor (hr)-positive, her2-negative breast cancer who have had prior systemic therapy for unresectable or metastatic disease.

Candel Therapeutics has announced that the FDA has granted orphan drug designation (ODD) to can-2409, Candel’s immunotherapy candidate, for the treatment of pancreatic cancer.

Considering sustainability within the pharma industry

UCB has announced that the FDA has accepted for review its supplemental biologics license application (sbla) for bimzelx (bimekizumab-bkzx), for the treatment of adult patients with moderate-to-severe hidradenitis suppurativa (hs).

Sanofi has announced positive results from its phase 3 LUNA 3 study, which assessed Rilzabrutinib 400mg twice daily oral treatment in adult patients with persistent or chronic immune thrombocytopaenia (itp).

GSK has announced positive results from its phase 3 EAGLE-1 trial for Gepotidacin, a potential first-in-class oral antibiotic for the treatment of uncomplicated urogenital gonorrhoea (GC) in adolescent and adult patients.

Novartis has announced new results from a pre-specified interim analysis of its phase 3 APPLAUSE-igan trial of Fabhalta (iptacopan),an investigational factor b inhibitor of the alternative complement pathway, in patients with iga nephropathy (igan).

Eli Lilly has announced positive topline results from its SURMOUNT-osa phase 3 trials, which demonstrated that tirzepatide injection (10mg or 15mg) significantly reduced the apnoea-hypopnea index (ahi) compared to placebo, therefore meeting its primary endpoints.

GSK has announced that the FDA has accepted for review a biologics license application (BLA) for its 5-in-1 meningococcal abcwy (menabcwy) vaccine candidate.